Readout Calendar
When CNS pipeline trials report — anticipated topline data, regulatory milestones, and full results, each linked to its program and source. 100 upcoming · 259 reported.
Upcoming 100
- 2H 2026Anticipated
TAK-360forNarcolepsyTopline data
Phase 2 idiopathic hypersomnia dose-finding topline — estimated primary completion 16 Jul 2026
- 2H 2026Anticipated
Dexmedetomidine sublingual film (BXCL501)forAcute Stress DisorderTopline data
Phase 2a RISE study of sublingual dexmedetomidine (BXCL501) in acute stress reactions after motor vehicle collision: topline expected after the estimated Sep 2026 primary completion.
- 2H 2026Anticipated
LYBALVI (olanzapine/samidorphan)forSchizophreniaTopline data
ENLIGHTEN-Youth pediatric Phase 3 (OLZ/SAM vs olanzapine; primary endpoint change in BMI Z-score) — topline anticipated around primary completion (est. Sep 2026).
- Q4 2026Anticipated
CYB003 (deupsilocin)forMajor depressive disorderTopline data
Phase 3 APPROACH (NCT06564818) topline data on track for Q4 2026
- 2H 2026Anticipated
Azetukalner (XEN1101)forEpilepsyTopline data
X-TOLE3 Phase 3 topline (second pivotal focal-onset-seizure trial) anticipated; primary completion ~Oct 2026.
- October 2026Anticipated
KYN-5356forSchizophreniaRegistry results
ClinicalTrials.gov estimated primary completion of the Phase 2 CIAS study NCT07191483: October 2026 (estimated study completion December 2026).
- September to October 2026Anticipated
RemlifanserinforAlzheimer's disease psychosisTopline data
Topline results from the Phase 2 RADIANT substudy of remlifanserin (ACP-204) 30 mg and 60 mg vs placebo in Alzheimer's disease psychosis (primary endpoint: change from baseline in SAPS-H+D at Week 6), expected September–October 2026.
- PDUFA 14 Nov 2026Anticipated
Dexmedetomidine sublingual film (BXCL501)forSchizophreniaRegulatory
FDA decision (PDUFA) on the sNDA to expand IGALMI (BXCL501) to at-home use for acute agitation in bipolar disorders or schizophrenia expected 14 Nov 2026.
- November 2026Anticipated
ABBV-932forGeneralized anxiety disorderRegistry results
ClinicalTrials.gov estimated primary completion of the Phase 2 adjunctive GAD study of ABBV-932 (NCT06846320): November 2026.
- November 2026Anticipated
NS-136forSchizophreniaRegistry results
ClinicalTrials.gov estimated primary completion of the Phase 2 study of NS-136 (80 mg and 120 mg QD vs placebo) in acute schizophrenia (primary endpoint: PANSS total score at week 5): November 2026 (estimated study completion December 2026).
- FY2026 (by Mar 2027)Delayed
TAK-360forNarcolepsyTopline data
Phase 2b NT2 dose-finding topline (TAK-360-2001, NCT06952699) — Takeda guides FY2026; CT.gov primary completion moved to 30 Nov 2026
- By end-2026Anticipated
JNJ-2056 (ACI-35.030)forAlzheimer's diseaseTopline data
Phase 2b ReTain (NCT06544616): primary completion estimated 22 Dec 2026 (ClinicalTrials.gov); timing may shift given the Feb-2026 recruitment pause.
- 2H 2026 / 2027Anticipated
Seltorexant (JNJ-42847922)forMajor depressive disorderTopline data
Confirmatory Phase 3 MDD3003 anticipated; primary completion estimated end of 2026.
- 2026 (per principal investigator)Anticipated
TazbentetolforSchizophreniaFull results
Full-cohort results (32 participants) from the Phase 2 study of tazbentetol in schizophrenia, expected in 2026.
- Q4 2026Anticipated
- 2H 2026Anticipated
ZatolmilastforFragile X syndromeFull results
Program-decision update on zatolmilast in fragile X syndrome: Shionogi plans to analyze the EXPERIENCE-302 open-label extension alongside exploratory analyses of EXPERIENCE-301/-204, engage the FDA, and update the FXS community in the second half of 2026 — effectively the program's go/no-go catalyst.
- fourth quarter 2026Anticipated
PT00114forGeneralized anxiety disorderRegulatory
US IND submission for PT00114 in generalized anxiety disorder targeted before end of 2026, following FDA Type B pre-IND written responses that identified no clinical-hold issues; first patient dosing targeted 1H 2027.
- Q4 2026Anticipated
EvenamideforSchizophreniaTopline data
ENIGMA-TRS 2 topline (evenamide 15 mg bid vs placebo, 12 weeks, >=400 documented-TRS patients; NCT07184619), guided for Q4 2026 — timing at risk from the US enrollment hold in effect since April 2026.
- Q4 2026Anticipated
EvenamideforSchizophreniaTopline data
ENIGMA-TRS 1 12-week primary efficacy results (evenamide 15/30 mg bid vs placebo, >=600 TRRIP-criteria TRS patients on SGAs including clozapine), expected Q4 2026.
- Later in 2026 (2H 2026)Anticipated
ForvisirvatforMajor depressive disorderTopline data
Topline results from the confirmatory Phase 2b/3 study SP-624-202 of forvisirvat 20 mg once daily vs placebo over 4 weeks in MDD (456 randomised; primary efficacy endpoint pre-specified in females), anticipated later in 2026.
- Q4 2026Anticipated
KYN-5356forSchizophreniaTopline data
Topline results from the Phase 2 proof-of-concept study of adjunctive KYN-5356 (three blinded dose levels vs placebo, 28 days) in cognitive impairment associated with schizophrenia — primary endpoint change from baseline at Day 28 in the digital BACS (BAC App) composite T-score — guided to Q4 2026.
- End of 2026Anticipated
VQW-765forSocial anxiety disorderTopline data
Phase 3 VQW-765 social anxiety disorder topline results expected by end of 2026
- 2H 2026Anticipated
MK-1167forAlzheimer's diseaseTopline data
Phase 2 topline efficacy/safety of MK-1167 (vs placebo) on cognition in mild-to-moderate Alzheimer's disease dementia (MK-1167-008)
- 2026Anticipated
DT402forAutism spectrum disorderTopline data
Initial Phase 2a data for DT402 in autism spectrum disorder anticipated in 2026
- 2H 2026Anticipated
TNX-102 SL (cyclobenzaprine HCl sublingual)forAcute Stress DisorderTopline data
Phase 2 OASIS topline (TNX-102 SL for acute stress reaction/disorder in ED trauma survivors) anticipated in 2H 2026.
- second half 2026Anticipated
Ulefnersen (ION363)forAmyotrophic lateral sclerosisTopline data
FUSION Phase 3 (ulefnersen vs placebo in FUS-ALS) — estimated primary completion in 2H 2026; would be the first controlled readout for a FUS-ALS therapy.
- fourth quarter 2026Anticipated
Psilocybin (COMP360)forTreatment-resistant depressionRegulatory
Full NDA submission targeted (FDA rolling review underway).
- 2H 2026Anticipated
AlixorextonforNarcolepsyTopline data
Vibrance-3 Phase 2 topline results anticipated in idiopathic hypersomnia (primary endpoint ESS at Week 8).
- 2H 2026Anticipated
AlixorextonforIdiopathic HypersomniaTopline data
Vibrance-3 Phase 2 topline results anticipated in idiopathic hypersomnia (primary endpoint: change in Epworth Sleepiness Scale at Week 8).
- 2H 2026Anticipated
Solriamfetol (Sunosi)forBinge eating disorderTopline data
ENGAGE Phase 3 (solriamfetol in binge eating disorder) topline results anticipated in the second half of 2026.
- 2H 2026Anticipated
Opakalim (BHV-7000)forEpilepsyTopline data
Top-line results expected from the first of two pivotal Phase 2/3 focal-epilepsy studies to support registration
- 2H 2026Anticipated
NMRA-511forAgitation in Alzheimer's diseaseInterim analysis
Anticipated readout from a multiple ascending dose (MAD) expansion cohort evaluating higher doses of NMRA-511, expected in 2H 2026.
- 2026Anticipated
Milsaperidone (VHX-896)forMajor depressive disorderTopline data
Topline data anticipated from the Phase 3 adjunctive MDD study of milsaperidone (Bysanti).
- H1 2027Anticipated
Azetukalner (XEN1101)forMajor depressive disorderTopline data
Phase 3 X-NOVA2 topline in major depressive disorder expected H1 2027.
- 1H 2027 enrollment start (topline thereafter)Delayed
Brilaroxazine (RP5063)forSchizophreniaTopline data
RECOVER-2 confirmatory Phase 3 has not started: enrollment guidance moved mid-2026 -> Q3 2026 -> 1H 2027, subject to additional financing; topline thereafter
- Late Q1 2027Anticipated
EcopipamforTourette syndromeRegulatory
FDA PDUFA action on ecopipam NDA targeted late Q1 2027 (Priority Review)
- 2027Anticipated
Lysergide D-tartrate (MM120 / LSD)forPost-traumatic stress disorderRegistry results
Phase 3 Haven study of DT120 ODT in PTSD expected to initiate in 2027
- Q1 2027Anticipated
NMRA-511forAgitation in Alzheimer's diseaseRegistry results
Anticipated initiation of a Phase 2 study of NMRA-511 in Alzheimer's disease agitation, planned for Q1 2027.
- January 2027Anticipated
NTX-1472forSocial anxiety disorderRegistry results
ClinicalTrials.gov estimated primary completion of the SOAR Phase 2 study (NCT07323784): January 2027 (estimated study completion also January 2027).
- Primary completion Feb 2027 (RENEW-Smk-1)Anticipated
BrenipatideforTobacco use disorderTopline data
- 1H 2027Anticipated
NBI-1065890forTardive DyskinesiaTopline data
Phase 2 NBI-1065890 vs placebo topline in tardive dyskinesia (primary endpoint: change from baseline in AIMS dyskinesia total score at Week 8)
- February 2027Anticipated
Luvesilocin (RE104)forGeneralized anxiety disorderRegistry results
ClinicalTrials.gov estimated primary completion of RECLAIM (NCT07489651): February 2027, with estimated study completion April 2027.
- 1H 2027Anticipated
Lumateperone (ITI-007)forAutism spectrum disorderTopline data
Anticipated topline of Study 602, the second pivotal Phase 3 of lumateperone for irritability associated with autism spectrum disorder (pediatric); primary endpoint ABC-Irritability at Week 6.
- 1H 2027Anticipated
Lumateperone (ITI-007)forAutism spectrum disorderTopline data
Anticipated topline of Study 601, the first pivotal Phase 3 of lumateperone for irritability associated with autism spectrum disorder (pediatric); primary endpoint ABC-Irritability at Week 6.
- early 2027Delayed
Xanomeline/trospium chloride (Cobenfy)forAlzheimer's disease psychosisTopline data
Topline results from ADEPT-2, the first acute-efficacy Phase 3 of Cobenfy in Alzheimer's disease psychosis (primary endpoint: change in NPI-C Hallucinations and Delusions score), now expected among readouts beginning early 2027.
- PDUFA May 1, 2027Anticipated
AXS-12 (reboxetine)forNarcolepsyRegulatory
FDA PDUFA target action date for the AXS-12 NDA in cataplexy in narcolepsy
- Mid-2027 (registry estimate May 2027)Anticipated
ZervimesineforAlzheimer's diseaseTopline data
Topline results from the ~540-patient Phase 2 START study of zervimesine in MCI/early Alzheimer's disease (18-month treatment; CDR-SB and ADAS-Cog endpoints), expected after all participants complete 18 months of treatment — around mid-2027 per the ClinicalTrials.gov estimated primary completion of May 2027.
- May 2027Anticipated
DT-101forMajor depressive disorderRegistry results
ClinicalTrials.gov estimated primary completion of AERON-1, the US Phase 2 adjunctive study of DT-101 in MDD (primary endpoint: change from baseline in MADRS total score at Day 56): May 2027.
- May 2027Anticipated
AlixorextonforNarcolepsyTopline data
Phase 3 Brilliance NT1 (Study 302) topline anticipated, evaluating the primary MWT endpoint at Week 12 in narcolepsy type 1.
- 2027Delayed
Xanomeline/trospium chloride (Cobenfy)forAlzheimer's disease psychosisTopline data
Topline from ADEPT-4, the second acute-efficacy Phase 3 of Cobenfy in Alzheimer's disease psychosis (NPI-C H+D primary endpoint): among readouts beginning early 2027 and spread across the year.
- 2027 (potential interim analysis late 2026)Delayed
Xanomeline/trospium chloride (Cobenfy)forAlzheimer's disease psychosisTopline data
Topline from ADEPT-1, the Phase 3 relapse-prevention (randomized-withdrawal) study of Cobenfy in Alzheimer's disease psychosis: among readouts beginning early 2027 and spread across the year, with a potential interim analysis later in 2026.
- 1H 2027Anticipated
NTX-1472forSocial anxiety disorderTopline data
Topline data from the Phase 2 SOAR proof-of-concept study of NTX-1472 210 mg once daily versus placebo in generalized social anxiety disorder — safety/tolerability primary, LSAS the key efficacy secondary — expected 1H 2027.
- 2Q 2027Anticipated
Luvesilocin (RE104)forGeneralized anxiety disorderTopline data
Topline results from the RECLAIM Phase 2 trial of a single 30 mg subcutaneous dose of RE104 versus placebo in generalized anxiety disorder (primary endpoint: change from baseline in HAM-A total score at Week 4), expected 2Q 2027.
- Mid-2027Anticipated
ITI-1284 (deulumateperone)forGeneralized anxiety disorderTopline data
Anticipated Phase 2 topline for monotherapy ITI-1284 in GAD (NCT06701903); primary completion targeted June 2027.
- Mid-2027Anticipated
ITI-1284 (deulumateperone)forGeneralized anxiety disorderTopline data
Anticipated Phase 2 topline for adjunctive ITI-1284 in GAD (NCT06480383); primary completion targeted June 2027.
- 2H 2027Anticipated
BHV-8000forParkinson's diseaseTopline data
Anticipated Phase 2/3 topline in early Parkinson's disease (primary endpoint: time to first qualifying worsening on MDS-UPDRS Part II)
- 2H 2027Anticipated
NBI-1117570forSchizophreniaTopline data
Anticipated topline from the Phase 2a inpatient schizophrenia study (PANSS total change at Day 35).
- 2H 2027Anticipated
IcalcaprantforMajor depressive disorderTopline data
Anticipated Phase 2 topline (MADRS change from baseline at week 6) for icalcaprant in major depressive disorder
- 2H 2027Anticipated
EmrusolminforMultiple System AtrophyTopline data
Anticipated Phase 2 (TOPAS-MSA) topline in multiple system atrophy (primary endpoint: change from baseline in UMSARS at week 48)
- 2H 2027Anticipated
ITI-1284 (deulumateperone)forAlzheimer's diseaseTopline data
Anticipated Phase 2 topline for ITI-1284 in psychosis associated with Alzheimer's disease (NCT06540833); primary completion targeted September 2027.
- Q4 2027Anticipated
ITI-1284 (deulumateperone)forAgitation in Alzheimer's diseaseTopline data
Anticipated Phase 2 topline for ITI-1284 in agitation associated with Alzheimer's dementia (NCT06651567); primary completion targeted October 2027.
- Q4 2027Anticipated
Direclidine (NBI-1117568)forSchizophreniaTopline data
Anticipated topline from Phase 3 acute study SCZ3029 (PANSS at Week 6).
- Primary completion Nov 2027 (RENEW-Scz-1)Anticipated
BrenipatideforSchizophreniaTopline data
- Primary completion Nov 2027 (RENEW-Bipolar-1)Anticipated
BrenipatideforBipolar disorderTopline data
- Q4 2027Anticipated
Iloperidone LAIforSchizophreniaTopline data
Anticipated topline from the Phase 3 randomized-withdrawal relapse-prevention study of iloperidone LAI vs placebo in schizophrenia (primary endpoint: time to symptom exacerbation/relapse).
- Q4 2027Anticipated
Direclidine (NBI-1117568)forSchizophreniaTopline data
Anticipated topline from Phase 3 acute study SCZ3030 (PANSS at Week 6).
- December 2027Anticipated
NRX-101 (D-cycloserine/lurasidone)forTreatment-resistant depressionRegistry results
ClinicalTrials.gov estimated primary completion of the Phase 2/3 SPARC-TMS trial of NRX-101 plus robotic TMS in treatment-resistant depression: December 2027 (study completion estimated June 2028).
- December 2027Anticipated
MasitinibforAmyotrophic lateral sclerosisRegistry results
ClinicalTrials.gov estimated primary completion of confirmatory Phase 3 AB19001 (NCT03127267): December 2027 (registry estimate, not company guidance).
- 2H 2027Anticipated
ML-007C-MAforAlzheimer's disease psychosisTopline data
Topline results from the Phase 2 VISTA trial of ML-007C-MA 210/3 mg BID versus placebo in hallucinations and delusions associated with Alzheimer's disease psychosis — primary endpoint change from baseline in NPI-C H+D score at Week 7 — expected in the second half of 2027.
- 2H 2027Anticipated
DT-101forMajor depressive disorderTopline data
Topline results from Tarian-1, the global Phase 2 monotherapy study of DT-101 in major depressive disorder (primary endpoint: change from baseline in MADRS total score at Day 42), anticipated in the second half of 2027.
- 2H 2027Anticipated
ALTO-207forTreatment-resistant depressionTopline data
ALTO-207 Phase 2b TRD topline (MADRS)
- 2027Anticipated
AEF0217forDown SyndromeTopline data
Phase 2b dose-finding trial of AEF0217 in Down syndrome (NCT07334912): preliminary results anticipated in 2027.
- 2027Anticipated
Solriamfetol (Sunosi)forExcessive daytime sleepinessTopline data
SUSTAIN Phase 3 (solriamfetol for excessive sleepiness in shift work disorder) topline anticipated in 2027.
- 2H 2027Anticipated
Roluperidone (MIN-101)forSchizophreniaTopline data
Confirmatory Phase 3 (MIN-101C19) 12-week topline (primary: Marder NSFS) expected 2H 2027.
- 2H 2027Anticipated
LB-102 (N-methylamisulpride)forSchizophreniaTopline data
Pivotal Phase 3 NOVA-2 topline (PANSS total at Week 6) anticipated in 2H 2027.
- 2028Anticipated
ML-007C-MAforSchizophreniaTopline data
Phase 3 ZEPHYR-2 registrational trial topline expected in 2028
- January 2028Anticipated
RemlifanserinforAlzheimer's disease psychosisRegistry results
ClinicalTrials.gov estimated primary completion of the full RADIANT master protocol (NCT06159673), which covers both Phase 3 confirmatory substudies: January 2028 (estimated study completion February 2028).
- Primary completion Feb 2028 (RENEW-MDD-1)Anticipated
BrenipatideforMajor depressive disorderTopline data
- 2028Anticipated
TNX-102 SL (cyclobenzaprine HCl sublingual)forMajor depressive disorderTopline data
Phase 2 HORIZON topline (MADRS change at Week 6) in MDD anticipated following an estimated February 2028 primary completion.
- February 2028Anticipated
PDC-1421forMajor depressive disorderRegistry results
ClinicalTrials.gov estimated primary completion of the Phase I/II PDC-1421 (ABV-1601) study in depression in cancer patients: February 2028
- February 2028Anticipated
RemlifanserinforLewy body dementia psychosisRegistry results
ClinicalTrials.gov estimated primary completion of the Phase 2 Lewy body dementia psychosis efficacy study (NCT07029581, ACP-204-012): February 2028 (estimated study completion March 2028).
- 1H 2028Anticipated
Direclidine (NBI-1117568)forBipolar disorderTopline data
Anticipated topline from the Phase 2 bipolar I mania study (NBI-1117568-BPD2036): change from baseline in YMRS total score at Day 21.
- Primary completion Mar 2028 (RENEW-Op-1)Anticipated
BrenipatideforOpioid use disorderTopline data
- 1Q 2028Anticipated
LB-102 (N-methylamisulpride)forBipolar depressionTopline data
Phase 2 ILLUMINATE-1 topline (MADRS-10 change at Week 6) in bipolar I depression anticipated in 1Q 2028.
- 1H 2028Anticipated
AXS-14 (esreboxetine)forFibromyalgiaTopline data
Topline results anticipated from the pivotal Phase 3 FORWARD trial (NCT07398417) of AXS-14 (esreboxetine) in fibromyalgia; randomized-withdrawal primary endpoint is time to loss of therapeutic response.
- Primary completion Apr 2028 (RENEW-ALC-2)Anticipated
BrenipatideforAlcohol use disorderTopline data
- Primary completion Apr 2028 (RENEW-ALC-1)Anticipated
BrenipatideforAlcohol use disorderTopline data
- 2028Anticipated
Azetukalner (XEN1101)forBipolar depressionTopline data
X-CEED Phase 3 topline in bipolar I/II depression (MADRS at Week 6) anticipated
- July 2028Anticipated
PT150 (Org 34517)forAlcohol use disorderRegistry results
ClinicalTrials.gov estimated primary completion of the PT150 human laboratory study in alcohol use disorder (NCT06712602): July 2028.
- October 2028Anticipated
NTI164forRett syndromeRegistry results
ClinicalTrials.gov estimated primary completion of the Phase II/III placebo-controlled crossover study of NTI164 in Rett syndrome: October 2028 (not yet recruiting; estimated start July 2027).
- January 2029Anticipated
LHP588forAlzheimer's diseaseRegistry results
ClinicalTrials.gov estimated primary completion of the Phase 2 SPRING trial (NCT06847321) of LHP588 25 mg and 50 mg vs placebo in P. gingivalis-positive mild-to-moderate Alzheimer's disease: January 2029 (estimated study completion 2029-03-15).
- March 2029Anticipated
PT150 (Org 34517)forPost-traumatic stress disorderRegistry results
ClinicalTrials.gov estimated primary completion of the Phase 2 PT150 PTSD trial in veterans (NCT07187011): March 2029.
- 2029Anticipated
Apimostinel (GATE-202)forMajor depressive disorderTopline data
Phase 2 apimostinel +/- ASAT in MDD: primary completion anticipated 2029
- 2029Anticipated
MK-2214forAlzheimer's diseaseTopline data
Anticipated Phase 2 readout in early Alzheimer's disease: change in tau PET SUVr (primary), per estimated primary completion April 2029.
- 1H 2029Anticipated
LB-102 (N-methylamisulpride)forMajor depressive disorderTopline data
LB Pharmaceuticals plans to initiate a Phase 2 adjunctive-MDD trial of LB-102 in early 2027, with topline data expected in 1H 2029.
- 2029Anticipated
Solriamfetol (Sunosi)forMajor depressive disorderTopline data
CLARITY Phase 3 (MDD with EDS) topline anticipated after a ~December 2028 primary completion.
- July 2029Anticipated
NTI164forAutism spectrum disorderRegistry results
ClinicalTrials.gov estimated primary completion of the Phase 3 Beyond Harmony study of NTI164 in autism spectrum disorder: July 2029.
- July 2029Anticipated
- Date TBDAnticipated
Dexmedetomidine sublingual film (BXCL501)forOpioid use disorderTopline data
Larger confirmatory trial of BXCL501 in opioid withdrawal anticipated but not designed/scheduled as of Mar 2026.
- Date TBDAnticipated
Dexmedetomidine sublingual film (BXCL501)forAgitation in Alzheimer's diseaseTopline data
Confirmatory TRANQUILITY In-Care Phase 3 (~150 patients, 60 mcg PRN, care setting) planned but not yet started as of Q1 2026.
No upcoming readouts match these filters.
Recently reported 259
- 2026-10-20met
RAP-219forBipolar disorderTopline data
Positive Phase 2 topline for RAP-219 in acute bipolar mania: 3.1-point placebo-adjusted YMRS improvement at Week 3 (p=0.045); CGI-BP mania severity also significant (p=0.024); well tolerated.
- 2026-09-21missed
EMB-001 (metyrapone/oxazepam)forCocaine use disorderRegistry results
Phase 2 EMB-001 in cocaine use disorder misses primary endpoint: continuous abstinence weeks 11-13 in 2/41 (EMB-001) vs 0/41 (placebo), p=0.092.
- 2026-08-14met
AXS-05 (dextromethorphan-bupropion)forTobacco use disorderRegistry results
Pivotal Phase 3 smoking-cessation trial of AXS-05 (NCT07766655) registered and recruiting
- 2026-08-12met
Lysergide D-tartrate (MM120 / LSD)forGeneralized anxiety disorderTopline data
Phase 3 Voyage topline: single-dose DT120 ODT meets primary in GAD (HAM-A −5.4 pts vs placebo at Week 12, p<0.0001)
- 2026-08-06mixed
Fasedienol (PH94B)forSocial anxiety disorderTopline data
Phase 2 repeat-dose study topline: safety objective met for two-dose regimen; efficacy numerically separated from placebo but not statistically significant (exploratory)
- 2026-08-06met
NTI164forAutism spectrum disorderFull results
HARMONY Phase II/III (54 children with Level II/III ASD, NTI164 up to 20 mg/kg/day vs placebo for 8 weeks) published: statistically significant improvements over placebo in overall clinical severity, adaptive functioning, social responsiveness and affective symptoms, with a favourable safety profile.
- 2026-07-27met
Ammoxetine (S-071031B)forMajor depressive disorderTopline data
Chinese Phase 3 (HA1406-007) topline: primary met in depression — MADRS change at Week 8 significantly superior to placebo (p<0.0001), numerically superior to active control
- 2026-07-27mixed
ML-007C-MAforSchizophreniaTopline data
Phase 2 ZEPHYR topline: primary met at 210/3 mg BID (PANSS -4.5 vs placebo, ES 0.37, p=0.015); 330/6 mg QD dose missed the primary
- 2026-07-24met
CentanafadineforAttention-deficit/hyperactivity disorderRegulatory
FDA approved SIMTRIYO (centanafadine) on the 2026-07-24 PDUFA date for ADHD in adults and pediatric patients aged 6+
- 2026-07-07met
Psilocybin (COMP360)forTreatment-resistant depressionFull results
COMP006 Phase 3 Part B: 26-week durability and safety data in TRD
- 2026-06-30missed
Fasedienol (PH94B)forSocial anxiety disorderTopline data
PALISADE-4 Phase 3 topline: fasedienol missed primary and secondary endpoints in social anxiety disorder public speaking challenge
- 2026-06-25met
CentanafadineforAttention-deficit/hyperactivity disorderTopline data
Phase 3b topline: centanafadine XR 280 mg met primary endpoint in adults with ADHD and comorbid anxiety (AISRS LS mean change -18.5 vs -12.6 placebo at week 8)
- 2026-06-23missed
CN-105forIntracerebral hemorrhageFull results
S-CATCH: the randomized Phase 2b in 60 Singaporean ICH patients confirmed safety but missed on 90-day functional outcome (mRS <=3 77.8% vs 66.7%, p=0.35).
- 2026-06-23mixed
CN-105forIntracerebral hemorrhageTopline data
S-CATCH Phase 2b published: CN-105 safe and well tolerated in acute ICH, but no statistically significant improvement in 90-day mRS
- 2026-06-22met
Lysergide D-tartrate (MM120 / LSD)forMajor depressive disorderTopline data
Phase 3 Emerge topline: single-dose DT120 ODT meets primary in MDD (MADRS −8.1 pts vs placebo at Week 6, p<0.0001)
- 2026-06-18
EcopipamforTourette syndromeRegulatory
Teva submitted the U.S. NDA for ecopipam in pediatric Tourette syndrome (guided for 2H 2026; submitted 2026-06-18).
- 2026-06-17met
RopanicantforMajor depressive disorderTopline data
Phase 2b (NCT06836063) topline in major depressive disorder: ropanicant 45 mg twice daily met the primary endpoint, change from baseline in MADRS total score at Week 6, with an ML-estimated mean difference versus placebo of -3.572 in the Full Analysis Set (p = 0.038); no result was disclosed for the 30 mg twice-daily arm.
- 2026-06-15missed
Navacaprant (NMRA-140)forMajor depressive disorderTopline data
KOASTAL-2 and KOASTAL-3 both missed; Neumora discontinued navacaprant for MDD.
- 2026-06-15met
OveporextonforNarcolepsyFull results
SLEEP 2026: FirstLight/RadiantLight secondary and exploratory endpoints (function via FINI, cognition, nighttime sleep/REM)
- 2026-06-04met
Elunetirom (ABX-002)forBipolar depressionTopline data
AMPLIFY-BD met its primary endpoint: HAMD-17 -16.8 at Week 6 (p<0.001), 75% response, 50% remission in adjunctive bipolar depression.
- 2026-06-03met
Mebufotenin (inhaled 5-MeO-DMT, GH001)forPostpartum depressionFull results
Phase 2a postpartum depression results published in Journal of Clinical Psychiatry (DOI 10.4088/JCP.25m16284)
- 2026-05-27met
Opakalim (BHV-7000)forEpilepsyTopline data
Opakalim IGE proof-of-concept topline: median time to 2nd generalized tonic-clonic seizure 141 vs 47 days (placebo)
- 2026-05-27met
Opakalim (BHV-7000)forEpilepsyInterim analysis
Opakalim focal-epilepsy open-label extension: ≥50% seizure reduction in 54% of six-month completers (75 mg QD)
- 2026-05-26met
EcopipamforTourette syndromeTopline data
D1AMOND Phase 3 met primary and secondary endpoints: ecopipam delayed time to relapse vs placebo in pediatric (HR=0.5, p=0.0084) and combined (HR=0.5, p=0.0050) Tourette populations; published in JAMA Neurology.
- 2026-05-26terminated
Opakalim (BHV-7000)forEpilepsyInterim analysis
IGE proof-of-concept (SHINE) terminated early; ~3-fold prolongation in median time to second GTC seizure (141 vs 47 days), no formal statistics
- 2026-05-26missed
LPCN 1154 (oral brexanolone)forPostpartum depressionFull results
Full Phase 3 results presented as an oral presentation (Pharmaceutical Pipeline session) and a poster at the 2026 ASCP Annual Meeting, Miami, 26-29 May 2026 — the detailed efficacy, onset, durability-to-day-30 and safety dataset behind the April topline miss.
- 2026-05-26met
EcopipamforTourette syndromeFull results
Phase 3 randomized-withdrawal full results published in JAMA Neurology: ecopipam halved relapse risk (pediatric HR 0.47, p=.008)
- 2026-05-21met
Fazamorexant (YZJ-1139)forInsomniaRegulatory
NMPA approved fazamorexant tablets (孟平 / Mengping) for adult insomnia — the first domestically developed Chinese DORA.
- 2026-05-13missed
ZatolmilastforFragile X syndromeTopline data
EXPERIENCE-204 (adolescent) missed its primary endpoints (FXS-NRS language/communication and daily function) and its key secondary (CGI-I of Language) in male adolescents with fragile X syndrome; generally well tolerated, no new safety concerns.
- 2026-05-13missed
ZatolmilastforFragile X syndromeTopline data
EXPERIENCE-301 (adult) missed its primary endpoint: zatolmilast did not improve the NIH Toolbox Crystallized Cognition Composite vs placebo at Week 13 in adult males with fragile X syndrome, though significant caregiver-rated FXS-NRS language/communication and daily-function differences were observed ('suggestive of an efficacy signal', not conclusive).
- 2026-05-12met
LUMRYZ (sodium oxybate extended-release)forIdiopathic HypersomniaTopline data
REVITALYZ Phase 3 positive topline: LUMRYZ met the primary ESS endpoint and all key secondary endpoints (PGI-C, IHSS, ESS worsening on placebo), each p<0.0001, in adults with idiopathic hypersomnia; sNDA planned by end of 2026.
- 2026-05-12met
Fasedienol (PH94B)forSocial anxiety disorderInterim analysis
PALISADE-3 open-label extension preliminary data: fasedienol well-tolerated over up to 12 months of as-needed use; clinically relevant improvement on LSAS and SPIN over four months
- 2026-05-06missed
PDC-1421forAttention-deficit/hyperactivity disorderRegistry results
Phase 2 Part II of PDC-1421 (ABV-1505) in adult ADHD: posted results show no responder advantage over placebo (placebo 50%, low dose 39%, high dose 42%)
- 2026-05-04met
AXS-12 (reboxetine)forNarcolepsyRegulatory
AXS-12 NDA for cataplexy in narcolepsy submitted to the FDA (announced May 4, 2026)
- 2026-05-01met
ENX-104forMajor depressive disorderFull results
First-in-human single-ascending-dose results for ENX-104 presented at ASCP 2026: safe and well tolerated at all 5 dose levels with no serious or severe adverse events, dose-proportional plasma exposure, sustained central target engagement (dose-related decreases in adaptive tracking lasting >=48 h) and prolactin-confirmed peripheral D2/D3 antagonism.
- 2026-04-30met
AXS-05 (dextromethorphan-bupropion)forAgitation in Alzheimer's diseaseRegulatory
FDA approves AUVELITY (AXS-05) for agitation associated with dementia due to Alzheimer's disease — first non-antipsychotic approved
- 2026-04-29missed
ABBV-932forBipolar depressionTopline data
Phase 2 ABBV-932 bipolar depression study misses its primary MADRS endpoint overall, with an efficacy signal in the prespecified bipolar I subgroup and a placebo-like safety profile.
- 2026-04-27met
Lumateperone (ITI-007)forSchizophreniaRegulatory
FDA approved Caplyta (lumateperone) sNDA adding relapse-prevention data in schizophrenia (Study 304: HR 0.37, 63% lower relapse risk, p=0.0002).
- 2026-04-07pending
AL001 (lithium–salicylate–L-proline)forBipolar disorderTopline data
Healthy-subjects 'Lithium in Brain' study: qualitative MRS pharmacodynamics show AL001 reduced myo-inositol in 17 of 18 brain regions (vs 8 of 18 for lithium carbonate) with minimal glutamate effects, where lithium carbonate reduced glutamate across all 18 regions.
- 2026-04-02missed
LPCN 1154 (oral brexanolone)forPostpartum depressionTopline data
Phase 3 topline in postpartum depression: LPCN 1154 MISSED its primary endpoint — no statistically significant reduction in HAM-D17 total score versus placebo at hour 60 (placebo-adjusted -1.3, N=90) — while showing early separation at hour 12 (-3.9, p<0.01) and a differentiated tolerability profile with no excessive sedation, no loss of consciousness and no treatment-related SAEs.
- 2026-04-01missed
CN-105forPostoperative deliriumFull results
MARBLE: CN-105 was safe and feasible but did not significantly reduce postoperative delirium (19.3% vs 26.5%, OR 0.66, p=0.29) or CSF cytokines in 186 randomized older surgical patients.
- 2026-04-01missed
ALTO-101forSchizophreniaTopline data
Phase 2 POC topline in CIAS: primary EEG endpoint not met (theta-ITC n=83, d=0.34, p=0.052); Alto will not independently advance ALTO-101 in CIAS
- 2026-03-26pending
TazbentetolforSchizophreniaInterim analysis
Interim Phase 2 data (16 of 32 participants) for tazbentetol 300 mg vs placebo in schizophrenia: PANSS total -11.9 vs -5.6; PANSS positive -3.3 vs -0.1 (p=0.01); PANSS negative -1.8 vs -1.0; EEG gamma/alpha band-power changes; no severe adverse events.
- 2026-03-21missed
PosdinemabforAlzheimer's diseaseFull results
AuTonomy Phase 2b full results (AD/PD 2026): posdinemab missed the primary iADRS endpoint - no significant difference for either dose vs placebo at week 104; key secondaries also negative; tau-PET suggested slowed neurofibrillary-tangle accumulation. Program discontinued.
- 2026-03-09met
Azetukalner (XEN1101)forEpilepsyTopline data
X-TOLE2 Phase 3 POSITIVE: azetukalner cut monthly focal-onset seizure frequency -53.2% at 25 mg (placebo-adjusted -42.7%, p=6e-12) vs -10.4% placebo; supports Q3 2026 NDA.
- 2026-03-05met
Dexmedetomidine sublingual film (BXCL501)forOpioid use disorderTopline data
Investigator-sponsored Phase 1/2 (NCT05712707) topline: BXCL501 240 ug BID reduced opioid-withdrawal symptoms vs placebo (>30% SOWS-Gossop reduction) and numerically beat lofexidine with fewer adverse events.
- 2026-03-03missed
AmpreloxetineforMultiple System AtrophyTopline data
Phase 3 CYPRESS did not meet its primary endpoint (change in OHSA composite score at Week 8 of the double-blind randomized-withdrawal period); secondary endpoints showed similar trends; consistent pressor effect, generally well tolerated, no supine-hypertension signal.
- 2026-02-23missed
Elpipodect (MK-8189)forSchizophreniaFull results
Phase 2b (NCT04624243) missed: neither MK-8189 16 mg nor 24 mg separated from placebo on PANSS total at Week 6.
- 2026-02-20met
Olanzapine extended-release injectable suspension (TEV-'749)forSchizophreniaRegulatory
FDA accepted Teva's NDA for olanzapine extended-release injectable suspension (TEV-'749) for once-monthly treatment of schizophrenia in adults.
- 2026-02-20met
Milsaperidone (VHX-896)forBipolar disorderRegulatory
FDA approves Bysanti (milsaperidone) for the acute treatment of manic or mixed episodes associated with bipolar I disorder (co-approved with schizophrenia).
- 2026-02-18met
Methylone (TSND-201)forPost-traumatic stress disorderFull results
IMPACT-1 Phase 2 results published in JAMA Psychiatry: TSND-201 efficacious in PTSD
- 2026-02-17met
Psilocybin (COMP360)forTreatment-resistant depressionTopline data
COMP006 met its primary endpoint: -3.8 MADRS (two 25mg doses vs 1mg) at Week 6 (p<0.001).
- 2026-02-17pending
JNJ-2056 (ACI-35.030)forAlzheimer's diseaseInterim analysis
Phase 2b ReTain (NCT06544616): Janssen temporarily paused recruitment (17 Feb 2026); voluntary, not safety-related, pre-specified interim immunogenicity threshold met; dosing/follow-up of enrolled participants continues.
- 2026-02-17met
Psilocybin (COMP360)forTreatment-resistant depressionTopline data
COMP006 Phase 3 Part A topline: primary endpoint met in TRD (p<0.001)
- 2026-02-10
OveporextonforNarcolepsyRegulatory
FDA accepted the oveporexton NDA for narcolepsy type 1 and granted Priority Review, with a PDUFA target action date in Q3 2026.
- 2026-02-01missed
CrenezumabforAlzheimer's diseaseFull results
API ADAD Colombia full results published in The Lancet Neurology: no significant slowing of cognitive decline in PSEN1 E280A carriers treated 5-8 years; crenezumab retained a benign ARIA profile consistent with its IgG4 design.
- 2026-01-20met
Luvesilocin (RE104)forPostpartum depressionFull results
Full RECONNECT Phase 2 dataset presented at the ACNP Annual Meeting: MADRS separation from Day 1 sustained through Day 28, plus response, remission, HAM-A, CGI-I and Barkin Index of Maternal Function improvements, from a baseline MADRS of 33.4.
- 2026-01-05met
NMRA-511forAgitation in Alzheimer's diseaseTopline data
NMRA-511 Phase 1b signal-seeking study in Alzheimer's disease agitation met its goal: clinically meaningful placebo-adjusted CMAI reductions (notably 7.6/5.6 points at weeks 6/8 in the elevated-anxiety subgroup), favorable safety, no somnolence/sedation.
- 2025-12-24missed
Opakalim (BHV-7000)forMajor depressive disorderTopline data
Phase 2 proof-of-concept MDD study of BHV-7000 misses MADRS primary endpoint; Biohaven exits psychiatric development
- 2025-12-23pending
Brilaroxazine (RP5063)forSchizophreniaRegulatory
FDA recommends a confirmatory second Phase 3 (RECOVER-2) before a brilaroxazine schizophrenia NDA.
- 2025-12-17missed
Fasedienol (PH94B)forSocial anxiety disorderTopline data
PALISADE-3 missed its primary SUDS endpoint (large placebo response); no secondary difference.
- 2025-12-15missed
TolebrutinibforMultiple sclerosisTopline data
PERSEUS Phase 3 missed its primary endpoint in primary progressive MS: tolebrutinib did not delay time to 6-month composite confirmed disability progression vs placebo (n=767, 2:1); Sanofi will not pursue regulatory registration in PPMS.
- 2025-12-09met
PT00114forGeneralized anxiety disorderTopline data
Phase 1 multiple-dose topline: PT00114 well tolerated across all dose ranges; no serious adverse events; all participants completed dosing; adverse events consistent with an injectable peptide (injection-site reactions).
- 2025-12-01missed
Iclepertin (BI 425809)forSchizophreniaFull results
Pooled CONNEX Phase 3 results published in The Lancet Psychiatry: iclepertin no better than placebo on MCCB (p=0.63).
- 2025-12-01
MK-1167forAlzheimer's diseaseInterim analysis
Phase 1 healthy-volunteer biomarker data: single doses of MK-1167 modulate prefrontal-cortex glutamate metabolism measured by 13C-magnetic resonance spectroscopy (presented at CTAD 2025)
- 2025-12-01met
MK-2214forAlzheimer's diseaseFull results
Phase 1 first-in-human MK-2214 data at CTAD 2025: favorable safety/PK and CSF pS413 tau reductions consistent with near-saturating target engagement; FDA Fast Track granted.
- 2025-11-12met
AlixorextonforNarcolepsyTopline data
Vibrance-2 Phase 2 study in narcolepsy type 2 met the primary MWT endpoint at 14 mg and 18 mg, with ESS significant at 18 mg (p<0.05 adjusted).
- 2025-11-06met
Lumateperone (ITI-007)forMajor depressive disorderRegulatory
FDA approved Caplyta (lumateperone) as adjunctive therapy with antidepressants for MDD in adults.
- 2025-10-28met
Zalsupindole (DLX-001)forMajor depressive disorderTopline data
Phase 1b topline in 18 adults with recurrent MDD: well tolerated with no serious adverse events, no psychotomimetic, hallucinatory or dissociative effects and no acute or persistent cognitive impairment; increased absolute slow-wave delta and theta qEEG power in both cohorts; and approximately 50% MADRS reduction by Day 8 sustained through Day 36 in BOTH the once-daily (7-day) and the intermittent (Days 1 and 4) cohort. Announced together with FDA clearance of the Phase 2 IND including at-home self-administration.
- 2025-10-21missed
LatozinemabforFrontotemporal dementiaTopline data
Phase 3 INFRONT-3 failed: latozinemab significantly raised plasma progranulin (biomarker co-primary met) but did not slow FTD-GRN clinical progression on CDR plus NACC FTLD-SB (clinical co-primary missed); open-label extension and continuation study discontinued.
- 2025-10-20missed
BNC210 (soclenicant)forSocial anxiety disorderTopline data
Phase 3 AFFIRM-1 missed its primary SUDS endpoint in social anxiety disorder; Neuphoria discontinues the SAD program.
- 2025-10-15
PF-06412562 (CVL-562)forSchizophreniaRegistry results
Results of the Yale-led TRANSCENDS Phase 2 target-engagement study of CVL-562 in early-course schizophrenia posted to ClinicalTrials.gov.
- 2025-09-26
TavapadonforParkinson's diseaseRegulatory
AbbVie submitted the tavapadon NDA to the U.S. FDA for early and advanced Parkinson's disease.
- 2025-09-25met
JNJ-2056 (ACI-35.030)forAlzheimer's diseaseFull results
Phase 1b/2a (NCT04445831) full results published in eBioMedicine: ACI-35.030 induced anti-pTau IgG in 100% of early-AD participants, no safety concerns; ACI-35.030 selected to advance.
- 2025-09-20missed
BrexpiprazoleforPost-traumatic stress disorderRegulatory
FDA issues Complete Response Letter for brexpiprazole + sertraline sNDA in PTSD
- 2025-09-10met
Fazamorexant (YZJ-1139)forInsomniaFull results
Pivotal Phase 3 (YZJ-1139-3-01, 1,034 randomized) results premiered at World Sleep 2025: significant improvement in objective and subjective sleep parameters within 14 days, sustained over 6 months; 0.6% AE discontinuation, no rebound insomnia or withdrawal.
- 2025-09-08met
- 2025-09-01met
Ammoxetine (S-071031B)forMajor depressive disorderFull results
Phase 2 MDD trial positive: ammoxetine 40 and 60 mg/day beat placebo on MADRS at Week 8.
- 2025-08-27met
Dexmedetomidine sublingual film (BXCL501)forSchizophreniaTopline data
SERENITY At-Home (NCT05658510 Part 2) Phase 3 safety trial MET its primary endpoint: at-home 120 mcg sublingual dexmedetomidine well tolerated across 2,437 agitation episodes, supporting the sNDA.
- 2025-08-25met
Vornorexant (TS-142)forInsomniaRegulatory
Japan MHLW approved Vorzzz (vornorexant hydrate) 2.5/5/10 mg for insomnia.
- 2025-08-18met
Luvesilocin (RE104)forPostpartum depressionTopline data
RECONNECT Phase 2 topline in postpartum depression: a single 30 mg subcutaneous dose of RE104 met the primary endpoint with a 23.0-point MADRS reduction at Day 7 vs 17.2 points on 1.5 mg active control (difference 5.80; one-sided p=0.0094), with 77.1% response and 71.4% remission at Day 7 and no serious adverse events.
- 2025-08-15met
TNX-102 SL (cyclobenzaprine HCl sublingual)forFibromyalgiaRegulatory
FDA approved Tonmya (TNX-102 SL) for fibromyalgia in adults — first new fibromyalgia drug in over 15 years.
- 2025-08-11missed
Troriluzole (BHV-4157)forObsessive-compulsive disorderTopline data
Phase 3 OCD trial completed with no efficacy signal; Biohaven discontinues troriluzole in OCD.
- 2025-08-11met
PT150 (Org 34517)forAlcohol use disorderFull results
Phase 1 ethanol-interaction study of PT150: no significant pharmacokinetic interaction with alcohol and no serious adverse events (J Addict Med, 2025).
- 2025-08-05mixed
Nelivaptan (BH-200)forMajor depressive disorderTopline data
OLIVE (BH-200-03) Phase 2b topline in MDD: the prespecified primary endpoint — HAM-D17 change to Week 8 in genetic Subgroup C — was MISSED (-1.94, p=0.153), while the full mITT population (N=331) separated (-2.98, p=0.0003) and the best-performing genetic subgroup A (n=89) reached -4.47 (p=0.005) with separation from Week 1.
- 2025-08-01mixed
Psilocybin (COMP360)forAnorexia nervosaTopline data
Phase 2 anorexia PoC (NCT05481736, n=32): encouraging improvement in eating-disorder symptoms sustained through 12 weeks on 25mg, but underpowered with heavy control-arm dropout
- 2025-07-29met
ZervimesineforLewy body dementiaFull results
Full SHIMMER results presented in an AAIC 2025 podium presentation (with additional analyses spanning DLB and AD) and published in Alzheimer's & Dementia (Galvin et al. 2025): consistent benefit of zervimesine over placebo across neuropsychiatric, cognitive, motor and functional domains in mild-to-moderate DLB.
- 2025-07-14met
OveporextonforNarcolepsyTopline data
Phase 3 FirstLight and RadiantLight pivotal studies met all primary and key secondary endpoints (p<0.001) at week 12.
- 2025-07-09met
AlixorextonforNarcolepsyTopline data
Vibrance-1 Phase 2 study in narcolepsy type 1 met the primary MWT endpoint across all doses (4, 6, 8 mg) with statistically significant, dose-dependent improvements in wakefulness vs placebo.
- 2025-06-28met
Vornorexant (TS-142)forInsomniaFull results
Pivotal Phase 3 TS142-301 met primary (sSL) and key secondary (sSE) endpoints at both 5 mg and 10 mg (p<0.001).
- 2025-06-26met
NTI164forRett syndromeFull results
Open-label Phase I/II study of NTI164 in 11 girls with Rett syndrome published: improvement on CGI-I (p=0.028), CGI-S, RSBQ total score and caregiver burden after 12 weeks; well tolerated.
- 2025-06-23met
Psilocybin (COMP360)forTreatment-resistant depressionTopline data
COMP005 met its primary endpoint: -3.6 MADRS vs placebo at Week 6 (p<0.001).
- 2025-06-10terminated
TS-161forTreatment-resistant depressionFull results
NIMH Phase 2 crossover of TS-161 in TRD terminated for low recruitment; posted results show no drug-placebo difference (MADRS p=0.91)
- 2025-06-07mixed
Ulefnersen (ION363)forAmyotrophic lateral sclerosisFull results
Lancet case series (n=12, investigator-initiated): jacifusen reduced CSF neurofilament light chain by up to 82.8% at 6 months; one participant showed objective functional recovery, another remained asymptomatic — but two deaths (deemed unrelated) and uncontrolled design temper interpretation.
- 2025-06-04missed
- 2025-06-02met
Brilaroxazine (RP5063)forSchizophreniaFull results
Full 1-year RECOVER open-label extension positive: durable, dose-related efficacy with favorable long-term safety.
- 2025-05-19met
Olanzapine extended-release injectable suspension (TEV-'749)forSchizophreniaFull results
Completed Phase 3 SOLARIS long-term safety data: no PDSS observed through Week 56, supporting TEV-'749 as the first long-acting olanzapine without a post-injection monitoring requirement.
- 2025-05-14met
OveporextonforNarcolepsyFull results
Phase 2b (TAK-861-2001) met primary MWT endpoint and key secondary endpoints (ESS, weekly cataplexy rate); results published in the New England Journal of Medicine.
- 2025-04-22missed
Xanomeline/trospium chloride (Cobenfy)forSchizophreniaTopline data
ARISE (Phase 3, adjunctive to atypical antipsychotics) MISSED its primary endpoint: Cobenfy added to an atypical antipsychotic reduced PANSS total score by 2.0 points vs placebo+antipsychotic at week 6, not statistically significant (p=0.11).
- 2025-04-08met
AXS-05 (dextromethorphan-bupropion)forAgitation in Alzheimer's diseaseTopline data
Phase 3 AXS-05 AD-agitation program complete: ACCORD-2 relapse-prevention positive (HR 0.276, P=.001); ADVANCE-2 supportive but missed primary endpoint
- 2025-04-02met
MavoglurantforCocaine use disorderFull results
Phase 2 full results published in Science Translational Medicine: mavoglurant reduced cocaine use versus placebo in 68 adults with cocaine use disorder (NCT03242928), the evidence base for Stalicla's planned Phase 3.
- 2025-04-01missed
Solriamfetol (Sunosi)forMajor depressive disorderTopline data
PARADIGM Phase 3 missed its primary MADRS endpoint in the overall MDD population; signal seen in the severe-EDS subgroup.
- 2025-03-26missed
AEF0117 (lixosicone)forCannabis use disorderFull results
Final SICA2 analysis: primary endpoint confirmed not met; 1 mg reduced days of cannabis use (-16% vs placebo, P=0.077) with a positive high-motivation subgroup (P=0.038).
- 2025-03-25met
Solriamfetol (Sunosi)forAttention-deficit/hyperactivity disorderTopline data
FOCUS Phase 3 of solriamfetol in adult ADHD met its primary AISRS endpoint and key secondary endpoints (150 mg).
- 2025-03-19missed
Lysergide D-tartrate (MM120 / LSD)forAttention-deficit/hyperactivity disorderFull results
Phase 2a microdosing trial fails: repeated low-dose MM120 (LSD) no better than placebo for adult ADHD (AISRS p=0.7145)
- 2025-03-19mixed
GantenerumabforAlzheimer's diseaseFull results
DIAN-TU gantenerumab open-label extension (Lancet Neurology): amyloid PET fell profoundly (PiB-PET SUVR -0.71, p<0.0001); symptom-onset/progression risk halved in the longest-treated asymptomatic carriers (HR 0.53, 95% CI 0.27-1.03) but not overall (HR 0.79, 0.47-1.32); combined ARIA 53%, symptomatic ARIA-E 6%, no deaths.
- 2025-03-06missed
AticaprantforMajor depressive disorderTopline data
Phase 3 VENTURA program failed: J&J discontinued aticaprant for MDD on 2025-03-06 for insufficient efficacy; drug remained safe and well tolerated.
- 2025-03-03missed
Opakalim (BHV-7000)forBipolar disorderTopline data
Phase 2/3 bipolar mania study of BHV-7000 misses YMRS primary endpoint
- 2025-02-25missed
- 2025-01-28met
BPL-003 (intranasal 5-MeO-DMT benzoate)forAlcohol use disorderTopline data
BPL-003 Phase 2a open-label AUD study positive topline: single 10 mg dose + psychological support cut heavy drinking days (56%->13%) and raised abstinent days (33%->81%) at Week 12, with 50% maintaining complete abstinence over 3 months; well tolerated, no serious/severe AEs.
- 2025-01-16missed
Iclepertin (BI 425809)forSchizophreniaTopline data
Phase 3 CONNEX (CONNEX-1/-2/-3) missed primary (MCCB) and key secondary endpoints; iclepertin development in schizophrenia discontinued.
- 2025-01-10met
Mebufotenin (inhaled 5-MeO-DMT, GH001)forBipolar depressionTopline data
GH001 met primary endpoint in Phase 2a bipolar II depression POC: -16.8-point (51.9%) MADRS reduction at Day 8 (p=0.0099), 33% Day-8 remission (n=6)
- 2025-01-10met
Mebufotenin (inhaled 5-MeO-DMT, GH001)forPostpartum depressionTopline data
GH001 Phase 2a POC in postpartum depression met primary endpoint: -35.4-point MADRS reduction at Day 8 (p<0.0001), 100% remission
- 2025-01-10met
ForvisirvatforMajor depressive disorderInterim analysis
First cohort of the Phase 1 qEEG/Brain Network Analytics study SP-624-103 showed forvisirvat 20 mg once daily is centrally active in healthy adults: increased frontal-central beta power and decreased delta power versus placebo after single and 2-week dosing.
- 2025-01-08met
LB-102 (N-methylamisulpride)forSchizophreniaTopline data
Phase 2 NOVA-1 met its primary endpoint: significant PANSS total reduction at Week 4 at all LB-102 doses vs placebo, with favorable short-term safety.
- 2025-01-02missed
Navacaprant (NMRA-140)forMajor depressive disorderTopline data
KOASTAL-1 missed primary (MADRS) and key secondary (SHAPS) endpoints at Week 6.
- 2024-12-18met
ZervimesineforLewy body dementiaTopline data
Phase 2 SHIMMER topline (130 mild-to-moderate DLB patients, zervimesine 100/300 mg vs placebo, 6 months): primary safety/tolerability endpoint met, with exploratory efficacy signals across behavioral (NPI-12 -82% vs placebo decline), cognitive-fluctuation (CAF -91%), motor (UPDRS-III -62%) and functional (ADCS-ADL -52%) measures.
- 2024-12-17met
KYN-5356forSchizophreniaTopline data
Positive Phase 1 topline for KYN-5356: safe and well tolerated in 72 healthy volunteers, adequate plasma and CSF exposure, dose-dependent reduction of CSF kynurenic acid, statistically significant effects on cognition-linked EEG activity, and suggestive evidence of cognitive improvement — the first clinical evaluation of a selective KAT-II inhibitor in humans.
- 2024-12-16met
ELE-101 (intravenous psilocin benzoate)forMajor depressive disorderTopline data
Positive Phase 2a topline: single IV dose of ELE-101 produced mean >20-point MADRS reduction sustained to 3 months in MDD (n=6); 4/4 evaluable subjects in remission at Day 90
- 2024-12-12met
Zalsupindole (DLX-001)forMajor depressive disorderFull results
Full Phase 1 results for DLX-001 in 106 healthy volunteers, presented at the 2024 ACNP Annual Meeting: no serious adverse events, no psychotomimetic, hallucinatory or dissociative effects at any dose across 2-360 mg oral, dose- and time-dependent resting-state qEEG changes consistent with synaptic strengthening, and measurable cerebrospinal-fluid concentrations confirming CNS penetration at expected therapeutic doses.
- 2024-12-09met
TavapadonforParkinson's diseaseTopline data
TEMPO-2 (flexible-dose monotherapy, early PD) met primary endpoint: -9.1 point treatment difference on MDS-UPDRS II+III (p<0.0001).
- 2024-12-09met
BNC210 (soclenicant)forPost-traumatic stress disorderFull results
ATTUNE full results published in NEJM Evidence; hepatic enzyme elevations flagged.
- 2024-12-05terminated
Darigabat (CVL-865)forEpilepsyRegistry results
Open-label extension (NCT04686786) terminated early after REALIZE missed its primary objective
- 2024-11-26met
AXS-12 (reboxetine)forNarcolepsyTopline data
Long-term Phase 3 ENCORE trial met its randomized-withdrawal primary endpoint: patients switched to placebo had significantly greater worsening of cataplexy than those continuing AXS-12 (p=0.017), with significant worsening of cognition (p=0.011) and overall narcolepsy (p=0.024).
- 2024-11-20missed
DalzanemdorforHuntington's diseaseTopline data
Phase 2 DIMENSION topline: dalzanemdor missed the primary endpoint (change from baseline in SDMT at Day 84 vs placebo; n=189) with no statistically significant or clinically meaningful secondary-endpoint differences; Sage ends all development of dalzanemdor and closes the Phase 3 open-label PURVIEW study.
- 2024-11-19met
Psilocybin (COMP360)forPost-traumatic stress disorderTopline data
Open-label Phase 2 PTSD study showed durable CAPS-5 improvement through 12 weeks (-29.5 points from a 47.5 baseline) after a single 25mg dose; no serious adverse events.
- 2024-11-18met
CYB003 (deupsilocin)forMajor depressive disorderFull results
Phase 2 12-month durability: 100% response, 71% remission, ~23-pt MADRS reduction after two 16 mg doses.
- 2024-11-18met
AEF0217forDown SyndromeTopline data
Positive Phase 1/2 in young adults with Down syndrome: safety primary met; AEF0217 0.2 mg improved several VABS adaptive-behavior domains and modified a CB1-dependent EEG target-engagement marker vs placebo.
- 2024-11-11missed
Emraclidine (CVL-231)forSchizophreniaTopline data
EMPOWER-1 and EMPOWER-2 both missed the primary PANSS endpoint at Week 6; emraclidine schizophrenia monotherapy fails Phase 2.
- 2024-11-11missed
BalovaptanforPost-traumatic stress disorderFull results
EXUVIA Phase 2 in adult PTSD: balovaptan 10 mg did not separate from placebo on CAPS-5 total severity at week 12 (-17.2 vs -15.6) or on any secondary endpoint.
- 2024-10-31met
ZervimesineforAlzheimer's diseaseFull results
Pre-specified analysis of SHINE presented at CTAD (October 2024): mild-to-moderate AD participants with baseline plasma p-tau217 below the 1.0 pg/mL median treated with zervimesine (pooled 100/300 mg) showed a 95% reduction of cognitive decline at week 26 on ADAS-Cog 11 vs placebo, regardless of MMSE stratum — the analysis that defined the p-tau217 enrichment strategy FDA later endorsed for Phase 3.
- 2024-10-08missed
DalzanemdorforAlzheimer's diseaseTopline data
Phase 2 LIGHTWAVE topline: dalzanemdor missed the primary endpoint (WAIS-IV Coding Test score vs placebo at Day 84; n=174) in mild cognitive impairment and mild dementia due to Alzheimer's disease; Sage ends dalzanemdor development in AD.
- 2024-09-26met
TavapadonforParkinson's diseaseTopline data
TEMPO-1 (fixed-dose monotherapy, early PD) met primary endpoint at both 5 mg and 15 mg (p<0.0001 vs placebo).
- 2024-09-20met
TolebrutinibforMultiple sclerosisFull results
HERCULES full results at ECTRIMS 2024: 31% delay in time to onset of 6-month confirmed disability progression vs placebo (HR 0.69; 95% CI 0.55-0.88; p=0.0026); confirmed disability improvement nearly doubled (10% vs 5%; HR 1.88; nominal p=0.021).
- 2024-09-19missed
OPC-64005forMajor depressive disorderFull results
OPC-64005 Phase 2 MDD trial (NCT04244253, Japan, n=273) missed its primary MADRS endpoint at Week 6 (20 mg vs placebo p=0.288).
- 2024-09-18met
RopanicantforMajor depressive disorderTopline data
Phase 2a open-label proof-of-concept signal-detection study (NCT06126497) topline: ropanicant was generally well tolerated with no study-drug-related serious adverse events, and MADRS change from baseline at Week 2 was highly statistically significant (p < 0.0001) across all three dose arms, with 10.4 to 12.7 points of improvement at Day 14.
- 2024-09-12missed
Luvadaxistat (TAK-831)forSchizophreniaTopline data
ERUDITE Phase 2 missed its primary BACS cognition endpoint; Neurocrine discontinued luvadaxistat.
- 2024-09-04met
CN-105forPostoperative deliriumRegistry results
MARBLE tabular results posted to ClinicalTrials.gov: median Grade II+ adverse events per patient 1 (CN-105, n=137) versus 2 (placebo, n=49), p=0.025.
- 2024-09-03missed
AEF0117 (lixosicone)forCannabis use disorderTopline data
Phase 2b SICA2 missed its primary responder endpoint (cannabis use <=1 day/week) and key secondary abstinence endpoints.
- 2024-09-02mixed
TolebrutinibforMultiple sclerosisTopline data
GEMINI 2 Phase 3 missed its primary endpoint: tolebrutinib did not reduce annualized relapse rate vs teriflunomide in relapsing MS; disability benefit appeared only in the pooled GEMINI 1+2 key secondary (29% delay in 6-month CDW, nominal p=0.023).
- 2024-09-02mixed
TolebrutinibforMultiple sclerosisTopline data
GEMINI 1 Phase 3 missed its primary endpoint: tolebrutinib did not reduce annualized relapse rate vs teriflunomide in relapsing MS; pooled GEMINI 1+2 key secondary showed a 29% delay in 6-month confirmed disability worsening (HR 0.71; 95% CI 0.53-0.95; nominal p=0.023).
- 2024-09-02met
TolebrutinibforMultiple sclerosisTopline data
HERCULES Phase 3 met its primary endpoint: tolebrutinib delayed time to onset of 6-month confirmed disability progression vs placebo in non-relapsing secondary progressive MS - the first Phase 3 win in this population.
- 2024-08-28met
Direclidine (NBI-1117568)forSchizophreniaTopline data
Phase 2 met its primary endpoint: 20 mg QD gave placebo-adjusted PANSS -7.5 at Week 6 (p=0.011, ES 0.61).
- 2024-08-01missed
Elpipodect (MK-8189)forSchizophreniaFull results
Phase 2a (NCT03055338) missed primary PANSS total endpoint at Week 4 (trend only, p=0.074).
- 2024-07-29mixed
ZervimesineforAlzheimer's diseaseTopline data
Phase 2 SHINE topline (153 mild-to-moderate AD patients, zervimesine 100/300 mg vs placebo, 6 months): primary safety/tolerability endpoints met; cognitive signal favoring zervimesine, with the strongest effect emerging in patients with lower baseline plasma p-tau217.
- 2024-06-18met
Lumateperone (ITI-007)forMajor depressive disorderTopline data
Study 502 positive: lumateperone + antidepressant met MADRS primary (-4.5 vs placebo, p<0.0001) and CGI-S key secondary at Week 6.
- 2024-06-11mixed
DalzanemdorforHuntington's diseaseTopline data
Phase 2 SURVEYOR topline: primary endpoint met — a statistically significant baseline difference on the HD-CAB composite between HD participants and healthy volunteers — but only a small numerical dalzanemdor-placebo difference; well tolerated, no new safety signals.
- 2024-05-29met
Seltorexant (JNJ-42847922)forMajor depressive disorderTopline data
Pivotal Phase 3 MDD3001 met all primary and secondary endpoints — significant, clinically meaningful improvement in MADRS and sleep outcomes (ASCP 2024).
- 2024-05-29met
Olanzapine extended-release injectable suspension (TEV-'749)forSchizophreniaTopline data
Phase 3 SOLARIS trial: TEV-'749 met primary PANSS endpoint across all three dose groups at Week 8 (all P<0.0001), with key secondary endpoints (CGI-S, PSP) also met.
- 2024-05-22met
PT00114forGeneralized anxiety disorderTopline data
Phase 1 single-ascending-dose complete results: zero clinically-relevant adverse events in 30 subjects across five cohorts at subcutaneous doses up to 1,000 micrograms.
- 2024-05-21missed
Darigabat (CVL-865)forEpilepsyFull results
REALIZE Phase 2 in drug-resistant focal onset seizures FAILED — darigabat did not separate from placebo on the primary Response Ratio (p=0.823 at 7.5 mg BID; p=0.986 at 25 mg BID)
- 2024-04-30met
EvenamideforSchizophreniaTopline data
Study 008A topline (N=291): evenamide 30 mg bid add-on met the PANSS primary endpoint in chronic schizophrenia inadequately responding to a second-generation antipsychotic (PANSS -10.2 vs -7.6 on placebo at day 29, p<0.05, Cohen's d 0.33), with the key secondary CGI-S also positive and good tolerability.
- 2024-04-30mixed
NRX-101 (D-cycloserine/lurasidone)forBipolar depressionTopline data
Phase 2b/3 NRX-101 vs lurasidone in bipolar depression with subacute suicidal ideation (no ketamine lead-in): similar antidepressant effect (each about 50% MADRS reduction), a 33% advantage in sustained remission from suicidality that was not statistically significant, and about 70-75% less akathisia (P=0.076).
- 2024-04-22met
AticaprantforMajor depressive disorderFull results
Phase 2a (NCT03559192) positive: adjunctive aticaprant 10 mg reduced MADRS vs placebo at Week 6 (LSMD -2.1; p=0.044, 1-sided); well tolerated.
- 2024-04-18met
TavapadonforParkinson's diseaseTopline data
TEMPO-3 (adjunctive to levodopa, advanced PD) met primary endpoint: +1.1 h additional ON time without troublesome dyskinesia vs placebo (p<0.0001).
- 2024-04-16met
Lumateperone (ITI-007)forMajor depressive disorderTopline data
Study 501 positive: lumateperone + antidepressant met MADRS primary (-4.9 vs placebo, p<0.0001) and CGI-S key secondary at Week 6.
- 2024-04-16missed
DalzanemdorforParkinson's diseaseTopline data
Phase 2 PRECEDENT topline: dalzanemdor missed the primary endpoint (WAIS-IV Coding Test score vs placebo at Day 42; n=86) in mild cognitive impairment in Parkinson's disease; Sage stops dalzanemdor development in Parkinson's.
- 2024-03-25met
AXS-12 (reboxetine)forNarcolepsyTopline data
Phase 3 SYMPHONY trial met its primary endpoint: AXS-12 significantly reduced weekly cataplexy attacks vs placebo at Week 5 (rate ratio 0.49, p=0.018), with cataplexy remission in 33% vs 9.5% and improved EDS severity.
- 2024-03-15met
ND0612 (levodopa/carbidopa continuous subcutaneous infusion)forParkinson's diseaseFull results
BouNDless full results published in Lancet Neurology (Espay et al. 2024;23(5):465-476): +1.72 h/day ON time without troublesome dyskinesia (95% CI 1.08-2.36, p<0.0001), OFF time -1.40 h/day; first four hierarchical secondary endpoints met; infusion-site reactions the most common adverse event.
- 2024-02-27missed
Roluperidone (MIN-101)forSchizophreniaRegulatory
FDA issued a Complete Response Letter for the roluperidone NDA; at least one additional positive adequate/well-controlled study required.
- 2024-02-13missed
AVP-786 (deudextromethorphan-quinidine)forAgitation in Alzheimer's diseaseTopline data
Study 305 topline (2024-02-13): no statistically significant difference vs placebo on the CMAI primary; falls 8.6%/9.1% on AVP-786 vs 2.8% on placebo. The result that triggered termination of the AVP-786 program on 2024-05-22.
- 2024-01-10missed
BI 1358894forMajor depressive disorderFull results
BI 1358894 Phase 2 dose-ranging trial in MDD negative: no separation from placebo on MADRS at week 6
- 2024-01-04met
EvenamideforSchizophreniaFull results
Study 014/015 final 1-year results in TRS: PANSS improvement increased over time (-9.4 at 6 weeks, -12.7 at 6 months, -14.7 at 1 year; p<0.001), responder rate rose to 47.4% at 1 year, 75% completed 1 year of treatment, no psychotic relapses on treatment.
- 2023-12-20met
TNX-102 SL (cyclobenzaprine HCl sublingual)forFibromyalgiaTopline data
Second Phase 3 RESILIENT met its primary endpoint with high significance (p=0.00005); all six key secondaries positive.
- 2023-11-30met
CYB003 (deupsilocin)forMajor depressive disorderTopline data
Phase 2 met primary: -14 MADRS vs placebo at 3 wk (single 12 mg dose; p<0.0005); 79% remission at 6 wk after two 12 mg doses.
- 2023-10-30met
Brilaroxazine (RP5063)forSchizophreniaTopline data
Phase 3 RECOVER met its primary endpoint: brilaroxazine 50 mg cut PANSS total by 10.1 points vs placebo at Week 4 (p<0.001).
- 2023-10-27met
CentanafadineforAttention-deficit/hyperactivity disorderTopline data
Adolescent Phase 3 trial (13-17) met ADHD-RS-5 primary endpoint at week 6 (high dose); positive topline announced Oct 27, 2023.
- 2023-10-27met
CentanafadineforAttention-deficit/hyperactivity disorderTopline data
Pediatric Phase 3 trial (children 4-12) met ADHD-RS-5 primary endpoint at week 6; positive topline announced Oct 27, 2023.
- 2023-10-18met
Brezivaptan (TS-121 / ANC-501)forMajor depressive disorderTopline data
EmbarkNeuro open-label Phase 2 (NCT05439603, n=15) completed: mean MADRS reduction ~17.5 pts at 8 wk (single-arm, no placebo).
- 2023-10-10missed
RalmitarontforSchizophreniaFull results
Acute-exacerbation Phase 2 failed: neither ralmitaront 45 mg (+0.60 vs placebo, p=0.849) nor 150 mg (-2.83, p=0.362) separated on Week-4 PANSS total, while the risperidone 4 mg active control did (-10.45, p=0.001).
- 2023-09-29met
BNC210 (soclenicant)forPost-traumatic stress disorderTopline data
Phase 2b ATTUNE met its primary CAPS-5 endpoint in PTSD (p=0.048).
- 2023-09-21missed
SolanezumabforAlzheimer's diseaseFull results
Full A4 results published: no effect of solanezumab on cognitive decline or amyloid accumulation in preclinical Alzheimer's disease (Sperling et al., NEJM 2023).
- 2023-08-13met
NRX-101 (D-cycloserine/lurasidone)forBipolar depressionFull results
STABIL-B (Phase 2) published: after ketamine stabilization, NRX-101 beat lurasidone alone at maintaining improvement in depression (MADRS difference -7.7, p=0.03) and at reducing suicidal ideation (C-SSRS difference -1.5, p=0.02; CGI-SS p=0.03) in 22 patients with severe bipolar depression and acute suicidality.
- 2023-08-07met
Fasedienol (PH94B)forSocial anxiety disorderTopline data
PALISADE-2 met primary SUDS (p=0.015) and key secondary CGI-I (p=0.033) endpoints.
- 2023-06-29met
Dexmedetomidine sublingual film (BXCL501)forAgitation in Alzheimer's diseaseTopline data
TRANQUILITY II Phase 3 met its primary endpoint: 60 mcg sublingual dexmedetomidine cut PEC by 7.5 points at 2h vs 5.4 placebo (p=0.0112).
- 2023-05-23missed
RalmitarontforSchizophreniaInterim analysis
Negative-symptoms Phase 2 terminated after an interim analysis indicated ralmitaront was unlikely to meet its BNSS primary endpoint at Week 12.
- 2023-04-01mixed
SepranoloneforTourette syndromeTopline data
Sepranolone Phase 2a in Tourette syndrome: 28% YGTSS tic reduction vs 12.6% control (p=0.051); all secondary endpoints (PUTS, GTS-QOL, impairment) favored sepranolone; favorable safety.
- 2023-03-20met
Xanomeline/trospium chloride (Cobenfy)forSchizophreniaTopline data
EMERGENT-3 (Phase 3) topline positive: KarXT met the primary endpoint with an 8.4-point reduction in PANSS total score vs placebo at week 5, the third consecutive positive registrational trial.
- 2023-03-20met
EvenamideforSchizophreniaTopline data
Study 014 topline (all 161 TRS patients): evenamide add-on to antipsychotics well tolerated with clinically important benefit at 6 weeks; 95% completed the 6-week phase and 89% continued into the 46-week extension.
- 2023-03-08missed
SolanezumabforAlzheimer's diseaseTopline data
A4 study: solanezumab does not slow cognitive decline in preclinical (asymptomatic, amyloid-positive) Alzheimer's disease and does not clear brain amyloid plaque; Lilly ends solanezumab development for AD.
- 2023-02-13met
Lumateperone (ITI-007)forBipolar depressionFull results
Study 402 positive (42 mg): lumateperone adjunctive to lithium/valproate met the MADRS Week-6 primary in bipolar depression (LSMD -2.4, p=0.02).
- 2023-01-09met
ND0612 (levodopa/carbidopa continuous subcutaneous infusion)forParkinson's diseaseTopline data
BouNDless Phase 3 topline: ND0612 met the primary endpoint, delivering a clinically meaningful and statistically significant increase in ON time without troublesome dyskinesia vs optimized oral IR-LD/CD, and met the first secondary endpoints in the hierarchy.
- 2022-12-07missed
Esmethadone (REL-1017)forMajor depressive disorderTopline data
RELIANCE-I adjunctive missed its primary MADRS Day 28 endpoint (REL-1017 -15.1 vs placebo -12.9, not significant).
- 2022-12-02missed
VQW-765forSocial anxiety disorderTopline data
Phase 2 VQW-765 performance-anxiety study missed primary endpoint overall; significant in females
- 2022-11-14missed
GantenerumabforAlzheimer's diseaseTopline data
GRADUATE II failed: CDR-SB difference -0.19 vs placebo at week 116 (6% relative slowing, p=0.2998).
- 2022-11-14missed
GantenerumabforAlzheimer's diseaseTopline data
GRADUATE I failed: CDR-SB difference -0.31 vs placebo at week 116 (8% relative slowing, p=0.0954); amyloid removal lower than expected; ARIA-E 25%.
- 2022-10-17missed
ForvisirvatforMajor depressive disorderTopline data
Phase 2 SP-624-201 in MDD missed its all-comers primary endpoint (MADRS change from baseline at Week 4: LS mean difference -1.8, p=0.133), but a post-hoc analysis of the 205 female participants showed a 3.9-point greater MADRS reduction than placebo at Week 4 (p=0.008), with no effect in males.
- 2022-10-13missed
Esmethadone (REL-1017)forMajor depressive disorderTopline data
RELIANCE-III monotherapy missed its primary MADRS Day 28 endpoint (REL-1017 -14.8 vs placebo -13.9).
- 2022-08-08met
Xanomeline/trospium chloride (Cobenfy)forSchizophreniaTopline data
EMERGENT-2 (Phase 3) topline positive: KarXT met the primary endpoint with a statistically significant 9.6-point reduction in PANSS total score vs placebo at week 5 (p<0.0001), and met key secondary endpoints on PANSS positive, negative and Marder negative-factor subscales.
- 2022-08-01missed
BalovaptanforAutism spectrum disorderFull results
aV1ation Phase 2 (339 children and adolescents 5-17 with ASD, 24 weeks): no difference vs placebo on Vineland-II 2DC (LS-mean difference -0.16; 90% CI -2.56 to 2.23; P=.91) or any secondary endpoint.
- 2022-07-27met
LHP588forAlzheimer's diseaseTopline data
Cortexyme reported successful completion of the Phase 1 single- and multiple-ascending-dose study of COR588 (now LHP588): well tolerated from 25 mg to 200 mg with no serious adverse events, an 11-to-12-hour half-life supporting once-daily dosing, dose-proportional PK exceeding the exposure targeted for efficacy, and high CNS penetration confirmed after 10 days of dosing.
- 2022-07-19met
Rotigotine extended-release microspheres (LY03003)forParkinson's diseaseTopline data
Chinese pivotal Phase 3 of weekly LY03003 in early-stage Parkinson's disease (n=294) met its primary endpoint: statistically significant improvement in UPDRS Part II+III vs placebo (p<0.001), significant secondary endpoints, no IMP-related SAEs.
- 2022-06-22missed
Fasedienol (PH94B)forSocial anxiety disorderTopline data
PALISADE-1 missed its primary SUDS endpoint; tolerability favorable.
- 2022-06-16missed
CrenezumabforAlzheimer's diseaseTopline data
API ADAD Colombia prevention trial missed both co-primary endpoints in cognitively unimpaired PSEN1 E280A carriers; small numerical differences favored crenezumab but did not approach significance.
- 2022-05-01met
CentanafadineforAttention-deficit/hyperactivity disorderFull results
Adult Phase 3 trial (NCT03605680) met AISRS primary endpoint at both doses; published Adler et al. 2022, J Clin Psychopharmacol.
- 2022-05-01met
CentanafadineforAttention-deficit/hyperactivity disorderFull results
Adult Phase 3 trial (NCT03605836) met AISRS primary endpoint at both doses; published Adler et al. 2022, J Clin Psychopharmacol.
- 2022-04-30missed
AmpreloxetineforMultiple System AtrophyTopline data
REDWOOD Phase 3 did not meet its primary endpoint in the overall nOH population (PD, PAF, MSA); prespecified subgroup analysis suggested benefit driven by MSA patients.
- 2022-04-19terminated
BI 1358894forMajor depressive disorderFull results
Decentralized BI 1358894 MDD trial terminated for deficient enrollment (45 of target randomized)
- 2022-04-04missed
OsoresnontrineforSchizophreniaFull results
Phase 2 relapse-prevention trial negative: incidence of first relapse over 28 weeks 48.2% on pooled BI 409306 vs 49.6% on placebo (pooled HR 0.910, 95% CI 0.468-1.770, p=0.78; 25 mg HR 1.097, 50 mg HR 0.910); no PANSS-positive or CGI-S benefit. Trial terminated early (n=264) citing COVID-19 disruption.
- 2022-02-22missed
Enerisant (TS-091)forNarcolepsyFull results
Both Phase 2 fixed-dose trials of enerisant (TS-091) in narcolepsy missed the primary MWT endpoint; the optimal dose could not be determined (efficacy on ESS only at poorly tolerated 25-50 mg doses, while well-tolerated 5-10 mg doses lacked efficacy).
- 2022-02-10missed
BalovaptanforAutism spectrum disorderFull results
V1aduct Phase 3 (322 autistic adults, balovaptan 10 mg vs placebo, 24 weeks): terminated for futility; no improvement on Vineland-II 2DC (interim LS-mean change 2.91 vs 4.75 placebo; difference -1.84, 95% CI -5.15 to 1.48).
- 2022-02-01met
CN-105forIntracerebral hemorrhageFull results
CATCH: the open-label Phase 2a in 38 ICH patients met its safety primary with no excess hematoma expansion, and showed a 30-day mRS odds ratio of 2.69 (1.31-5.51) against matched historical controls.
- 2021-12-20met
Lumateperone (ITI-007)forBipolar depressionRegulatory
FDA approved Caplyta (lumateperone) for bipolar I and II depression in adults, as monotherapy and as adjunctive therapy with lithium or valproate.
- 2021-11-11mixed
Atuzaginstat (COR388)forAlzheimer's diseaseFull results
Additional GAIN top-line results presented at CTAD 2021 (Boston, 9-12 November 2021): expanded P. gingivalis-infection subgroup analyses reinforcing the ~50% slowing of cognitive decline in infected participants across multiple pre-specified infection-related subgroups and analysis methods, plus periodontal sub-study and safety detail.
- 2021-10-29met
OPC-64005forMajor depressive disorderFull results
OPC-64005 Phase 2 adult ADHD trial (NCT03324581, n=239) met its primary CAARS-O:SV endpoint vs placebo (p=0.0101); ADHD development later discontinued.
- 2021-10-26missed
Atuzaginstat (COR388)forAlzheimer's diseaseTopline data
GAIN Phase 2/3 topline MISSED both co-primary endpoints: atuzaginstat 40 mg and 80 mg BID showed no significant benefit on ADAS-Cog11 or ADCS-ADL at Week 48 in the overall 643-patient mild-to-moderate Alzheimer's cohort. A pre-specified P. gingivalis-saliva-positive subgroup (n=242) showed 57% slowing of cognitive decline at 80 mg BID (p=0.02), with no ADCS-ADL benefit and dose-related liver enzyme elevations up to 15%.
- 2021-09-30missed
AmpreloxetineforMultiple System AtrophyTopline data
SEQUOIA 4-week Phase 3 RCT in symptomatic nOH did not meet its primary endpoint; no supine-hypertension signal.
- 2021-09-23met
Lumateperone (ITI-007)forBipolar depressionFull results
Study 404 positive: lumateperone 42 mg monotherapy met the MADRS Week-6 primary in bipolar I/II depression (LSMD -4.6, ES -0.56, p<0.0001).
- 2021-09-16mixed
VixotrigineforNeuropathic painTopline data
Phase 2 CONVEY topline in painful small fiber neuropathy: vixotrigine 200 mg BID met the primary endpoint (change from baseline in average daily pain at Week 12 of the double-blind period, p=0.050 vs placebo); 350 mg BID did not (p=0.70).
- 2021-03-02mixed
Luvadaxistat (TAK-831)forSchizophreniaTopline data
INTERACT missed its primary negative-symptom endpoint (PANSS NSFS) but hit cognitive secondaries (BACS, SCoRS) at 50 mg.
- 2021-02-25met
Xanomeline/trospium chloride (Cobenfy)forSchizophreniaFull results
EMERGENT-1 (Phase 2) published in NEJM: xanomeline-trospium reduced PANSS total score by 11.6 points more than placebo at week 5 (p<0.001) in 182 hospitalized adults with acute schizophrenia, without D2-antagonist-typical adverse events.
- 2020-12-21missed
TNX-102 SL (cyclobenzaprine HCl sublingual)forPost-traumatic stress disorderTopline data
Phase 3 RECOVERY missed its primary CAPS-5 endpoint (p=0.343); PTSD program later deprioritized.
- 2020-12-16met
MasitinibforAlzheimer's diseaseTopline data
AB09004 topline (2020-12-16): masitinib 4.5 mg/kg/day met the ADAS-cog primary endpoint in mild-to-moderate Alzheimer's disease as add-on to standard of care (published values: between-group difference -2.15, 97.5% CI -3.48 to -0.81, p<0.001; ADCS-ADL co-primary difference +1.82, p=0.038); the independent titrated 6.0 mg/kg/day group was inconclusive.
- 2020-12-07met
TNX-102 SL (cyclobenzaprine HCl sublingual)forFibromyalgiaTopline data
Phase 3 RELIEF met its primary endpoint: TNX-102 SL 5.6 mg significantly reduced fibromyalgia pain at Week 14 (p=0.010).
- 2020-10-21met
SipagladenantforParkinson's diseaseTopline data
Positive Phase 2b topline: KW-6356 adjunct to levodopa met the primary endpoint in 502 Parkinson's disease patients — MDS-UPDRS Part III significantly improved (p=0.006 at 3 mg, p=0.049 at 6 mg QD) and daily OFF time decreased, with no major safety issues.
- 2020-09-16missed
AVP-786 (deudextromethorphan-quinidine)forSchizophreniaFull results
Phase 2 study 202 results posted to ClinicalTrials.gov: adjunctive AVP-786 missed the NSA-16 primary in residual schizophrenia (SPCD weighted z -1.79, p=0.073) - a trend, never announced by the company.
- 2020-06-24missed
Troriluzole (BHV-4157)forObsessive-compulsive disorderTopline data
Phase 2/3 OCD proof-of-concept missed its Week-12 Y-BOCS primary endpoint (p=0.22).
- 2020-06-01missed
Brezivaptan (TS-121 / ANC-501)forMajor depressive disorderFull results
Taisho Phase 2 (NCT03093025) missed primary: MADRS 10mg/50mg -9.0 vs placebo -6.4, no significant separation; trial terminated (sponsor decision).
- 2020-05-31missed
ZatolmilastforAlzheimer's diseaseTopline data
PICASSO AD Phase 2 missed its primary endpoint: BPN14770 did not separate from placebo on the RBANS Delayed Memory Index at Week 13 in 255 patients with early Alzheimer's disease (~+10 points in all arms); disclosed alongside Shionogi's acquisition of Tetra in May 2020.
- 2020-05-29missed
Roluperidone (MIN-101)forSchizophreniaTopline data
Phase 3 (MIN-101C07) narrowly missed primary PANSS Marder NSFS endpoint in ITT (p<=0.064); nominally significant in mITT (p<=0.044).
- 2020-03-31missed
AV-101 (L-4-chlorokynurenine)forMajor depressive disorderFull results
NIMH crossover trial in treatment-resistant depression (n=19): 4-Cl-KYN 1080-1440 mg/day for 14 days had no antidepressant effect on HAM-D versus placebo (treatment-by-time P=.16); CSF 7-Cl-KYNA mostly below detection.
- 2020-02-25missed
SPN-810 (molindone ER)forAttention-deficit/hyperactivity disorderTopline data
Phase 3 P302 (CHIME 2) of SPN-810 36 mg in impulsive aggression in children 6-11 with ADHD missed its primary endpoint (median 51.3% reduction in weekly IA episode frequency, p=0.961 vs placebo); Supernus halted all SPN-810 development in impulsive aggression.
- 2020-02-20met
MasitinibforMultiple sclerosisTopline data
AB07002 Phase 2b/3 topline (2020-02-20): masitinib 4.5 mg/kg/day met the primary endpoint in progressive MS, significantly reducing overall EDSS deterioration vs placebo (published value: between-group difference -0.097, 97% CI -0.192 to -0.002, p=0.0256); the independent uptitrated 6.0 mg/kg/day group was inconclusive.
- 2020-02-19met
ItruvoneforMajor depressive disorderFull results
Positive Phase 2A study of PH10 (itruvone) in MDD: statistically significant rapid-onset antidepressant effect on HAM-D-17 vs placebo
- 2020-02-10missed
GantenerumabforAlzheimer's diseaseTopline data
DIAN-TU-001 gantenerumab arm missed its cognitive primary endpoint in dominantly inherited Alzheimer's disease; amyloid, tau and neurofilament biomarkers moved in the desired direction.
- 2020-02-10missed
SolanezumabforAlzheimer's diseaseTopline data
Solanezumab arm of the DIAN-TU platform trial misses its cognitive primary endpoint in dominantly inherited Alzheimer's disease; Lilly will not pursue a submission in this population.
- 2019-12-20met
Lumateperone (ITI-007)forSchizophreniaRegulatory
FDA approved Caplyta (lumateperone) 42 mg once daily for the treatment of schizophrenia in adults.
- 2019-11-14missed
AV-101 (L-4-chlorokynurenine)forMajor depressive disorderTopline data
ELEVATE Phase 2 (adjunctive AV-101 1440 mg/day in MDD, n=199): AV-101 did not differentiate from placebo on change from baseline in MADRS-10; well tolerated, no psychotomimetic effects or SAEs.
- 2019-11-05missed
SPN-810 (molindone ER)forAttention-deficit/hyperactivity disorderTopline data
Phase 3 P301 (CHIME 1) of SPN-810 36 mg in impulsive aggression in children 6-11 with ADHD missed its primary endpoint: median 58.6% reduction in weekly IA episode frequency, p=0.092 vs placebo on the combined stage 1+2 analysis.
- 2019-09-27missed
AVP-786 (deudextromethorphan-quinidine)forAgitation in Alzheimer's diseaseTopline data
TRIAD-2 topline (2019-09-27): primary and key secondary endpoints not met - neither AVP-786 dose separated from placebo on CMAI change to week 12 (posted results p=0.789 and p=0.200).
- 2019-07-07met
MasitinibforAmyotrophic lateral sclerosisFull results
AB10015 Phase 2/3 published (Mora et al., ALS-FTD 2020, epub 2019-07-07): in the prespecified primary population (normal progressors, ALSFRS-R decline <1.1 pts/month), masitinib 4.5 mg/kg/day + riluzole slowed 48-week ALSFRS-R decline by 3.4 points vs placebo (95% CI 0.65-6.13, p=0.016; 27% slowing), with significant ALSAQ-40, FVC and time-to-event secondaries; no effect in the broader population or 3.0 mg/kg/day cohorts.
- 2019-07-02missed
PF-06412562 (CVL-562)forSchizophreniaFull results
Phase 1b of PF-06412562 in stable schizophrenia: safe and well tolerated, but no benefit over placebo on working memory, reward processing or 2-back accuracy over 15 days.
- 2019-05-23mixed
PDC-1421forMajor depressive disorderFull results
Phase 2 PDC-1421 (ABV-1504) in MDD: sponsor reports the high dose met its primary endpoint (MADRS -13.2 vs -9.2 placebo, ITT); the registry-posted Week-6 primary analysis is p=0.393
- 2019-05-08missed
BalovaptanforAutism spectrum disorderFull results
VANILLA Phase 2 (223 adult men with ASD, 12 weeks): no separation from placebo on the primary endpoint (SRS-2); dose-dependent improvements on the secondary Vineland-II composite at 4 mg and 10 mg.
- 2019-04-15met
AXS-05 (dextromethorphan-bupropion)forTobacco use disorderTopline data
AXS-05 meets primary endpoint in Phase 2 smoking-cessation trial: 25% greater reduction in cigarettes/day vs bupropion (P=.0016)
- 2019-03-25mixed
AVP-786 (deudextromethorphan-quinidine)forAgitation in Alzheimer's diseaseTopline data
TRIAD-1 topline (2019-03-25): mixed - the SPCD-combined CMAI primary was met on the higher AVP-786 dose (42.63 mg d6-DM/4.9 mg Q; posted-results p=0.008) but not the lower 28 mg dose (p=0.208).
- 2019-03-06missed
RapastinelforMajor depressive disorderInterim analysis
RAP-MD-04 adjunctive relapse-prevention Phase 3: interim analysis indicated primary and key secondary endpoints would not be met
- 2019-03-06missed
RapastinelforMajor depressive disorderTopline data
RAP-MD-03 pivotal adjunctive Phase 3: rapastinel did not differentiate from placebo on primary or key secondary endpoints
- 2019-03-06missed
RapastinelforMajor depressive disorderTopline data
RAP-MD-02 pivotal adjunctive Phase 3: rapastinel did not differentiate from placebo on primary or key secondary endpoints
- 2019-03-06missed
RapastinelforMajor depressive disorderTopline data
RAP-MD-01 pivotal adjunctive Phase 3: rapastinel did not differentiate from placebo on the primary endpoint (MADRS change at Week 3) or key secondary endpoints
- 2019-01-30missed
CrenezumabforAlzheimer's diseaseInterim analysis
CREAD 1/2 discontinued: the IDMC's preplanned interim analysis showed crenezumab 60 mg/kg IV q4w was unlikely to meet the CDR-SB primary endpoint in prodromal-to-mild Alzheimer's disease; no safety signal.
- 2018-08-20met
SipagladenantforParkinson's diseaseFull results
KW-6356 monotherapy improved motor symptoms vs placebo in early untreated Parkinson's disease (Phase 2, n=175): results presented at IAPRD 2018 and later published in Parkinsonism & Related Disorders (2024).
- 2018-07-27missed
TNX-102 SL (cyclobenzaprine HCl sublingual)forPost-traumatic stress disorderTopline data
Phase 3 HONOR stopped at interim for inadequate separation on the primary CAPS-5 endpoint in military-related PTSD.
- 2018-05-02missed
OsoresnontrineforSchizophreniaFull results
Phase 2 CIAS trial negative: no significant difference between BI 409306 (any of four doses, 10-100 mg once daily) and placebo on MCCB composite score change at 12 weeks (1.2-2.8 vs 2.5), and no SCoRS benefit, in 518 randomized patients with schizophrenia.
- 2018-02-01missed
OsoresnontrineforAlzheimer's diseaseTopline data
Both Phase 2 Alzheimer's trials of BI 409306 missed their efficacy endpoints; Boehringer Ingelheim announced further AD development would not be pursued (pooled prespecified primary analysis, n=457: no significant change vs placebo in NTB total z-score at week 12, and no secondary-endpoint signal).
- 2018-01-25missed
SolanezumabforAlzheimer's diseaseFull results
Full EXPEDITION3 results published: solanezumab 400 mg q4w did not significantly affect cognitive decline in mild Alzheimer's dementia (Honig et al., NEJM 2018;378:321-330).
- 2017-06-01met
CN-105forIntracerebral hemorrhageFull results
Phase 1 in 48 healthy adults: no significant safety issues on single or repeated IV dosing, linear PK with ~3.6 h half-life and no accumulation.
- 2016-11-23missed
SolanezumabforAlzheimer's diseaseTopline data
EXPEDITION3 misses its primary endpoint in mild Alzheimer's dementia (ADAS-Cog14, p=0.095); Lilly will not pursue regulatory submission for solanezumab in mild AD dementia.
- 2015-02-01pending
Apimostinel (GATE-202)forMajor depressive disorderTopline data
Naurex Phase 2 (NCT02067793): single-dose IV apimostinel reported rapid 24-hour antidepressant effect
- 2014-12-19missed
GantenerumabforAlzheimer's diseaseInterim analysis
SCarlet RoAD dosing halted for futility: gantenerumab 105/225 mg q4w was unlikely to meet its CDR-SB primary endpoint in prodromal Alzheimer's disease.
- 2014-07-16missed
CrenezumabforAlzheimer's diseaseTopline data
ABBY and BLAZE Phase 2 trials missed their primary endpoints in mild-to-moderate Alzheimer's disease; an exploratory trend in milder patients at 15 mg/kg IV motivated the CREAD dose escalation.
- 2014-04-30met
AmpreloxetineforFibromyalgiaTopline data
TD-9855 20 mg met the primary endpoint (change in average daily pain score) and FIQ/PGIC secondaries vs placebo in fibromyalgia; 5 mg missed the primary.
- 2014-01-23missed
SolanezumabforAlzheimer's diseaseFull results
Full EXPEDITION/EXPEDITION2 Phase 3 results published: solanezumab failed to improve cognition or functional ability in mild-to-moderate Alzheimer's disease (Doody et al., NEJM 2014;370:311-321).
- 2013-11-13missed
AmpreloxetineforAttention-deficit/hyperactivity disorderTopline data
TD-9855 did not meet the primary endpoint (AISRS total score vs placebo) at 5 mg or 20 mg in adult ADHD; ADHD program not continued.
- 2012-08-29missed
Pomaglumetad methionilforSchizophreniaInterim analysis
Independent futility analysis of HBBN concluded the second pivotal study was unlikely to succeed; Lilly stopped all Phase 3 development of pomaglumetad methionil the same day.
- 2012-08-24missed
SolanezumabforAlzheimer's diseaseTopline data
EXPEDITION and EXPEDITION2 both miss their co-primary cognitive and functional endpoints in mild-to-moderate Alzheimer's disease; pre-specified pooled secondary analyses suggest slowing of cognitive decline in mild AD only.
- 2012-07-11missed
Pomaglumetad methionilforSchizophreniaTopline data
HBBM, the first pivotal study, missed its primary PANSS endpoint in both the overall population and the prospectively defined HTR2A genetic subpopulation; risperidone separated in both.
- 2008-01-24missed
PT150 (Org 34517)forMajor depressive disorderFull results
Organon Phase 2 trial of Org 34517 (PT150) as adjunctive therapy in psychotic major depression missed its primary endpoint (900 mg vs placebo, PANSS positive sustained response, p=0.14).
- Date TBD
Seltorexant (JNJ-42847922)forMajor depressive disorderFull results
Phase 3 data comparing seltorexant to quetiapine XR as adjunctive therapy in MDD with insomnia symptoms presented at the 2025 Psych Congress.
No reported readouts match these filters.
Guidance date passed, result not yet confirmed 14
The company's guided window closed without a result we've verified against a source. Each is being re-checked; they are excluded from the upcoming calendar.
- Q3 2026Unconfirmed
AL001 (lithium–salicylate–L-proline)forBipolar disorderTopline data
- Q3 2026Unconfirmed
Elunetirom (ABX-002)forMajor depressive disorderTopline data
- third quarter 2026Unconfirmed
Psilocybin (COMP360)forPost-traumatic stress disorderRegulatory
- Sep 2026Unconfirmed
- Sep 2026 (third-party estimate)Unconfirmed
TavapadonforParkinson's diseaseRegulatory
- July 2026Unconfirmed
ForvisirvatforMajor depressive disorderRegistry results
- Q3 2026Unconfirmed
Fasedienol (PH94B)forSocial anxiety disorderRegulatory
- Q3 2026Unconfirmed
Azetukalner (XEN1101)forEpilepsyRegulatory
- 2H 2026Unconfirmed
Lumateperone (ITI-007)forBipolar disorderTopline data
- 1H 2026Unconfirmed
Lumateperone (ITI-007)forBipolar disorderTopline data
- 2025Unconfirmed
Lenrispodun (ITI-214)forParkinson's diseaseTopline data
- No guidance — study completed 26 Nov 2025, topline undisclosedUnconfirmed
ENX-104forMajor depressive disorderTopline data
- September 2025Unconfirmed
Psilocybin (COMP360)forMajor depressive disorderTopline data
- No guidance — study completed 2 Sep 2025, results undisclosedUnconfirmed
ENX-104forMajor depressive disorderFull results