Readout Calendar
When CNS pipeline trials report — anticipated topline data, regulatory milestones, and full results, each linked to its program and source. 93 upcoming · 135 reported.
Upcoming
- 2023-12-06Anticipated
- Mid-2024Delayed
CN-105forIntracerebral hemorrhageTopline data
CN-CATCH, the 240-patient Chinese dose-finding Phase 2, listed an estimated primary completion of May 2024 but has produced no results and its registry record has not been updated since February 2024.
- after primary completion (Nov 2024)Delayed
Psilocybin (COMP360)forAnorexia nervosaTopline data
Phase 2 anorexia nervosa proof-of-concept (NCT05481736) completed Nov 2024; topline EDE result not yet disclosed.
- 2025-03-03Anticipated
Opakalim (BHV-7000)forBipolar disorderTopline data
- 2025-06-10Anticipated
TS-161forTreatment-resistant depressionFull results
- 1H 2025Anticipated
- September 2025Anticipated
Psilocybin (COMP360)forMajor depressive disorderTopline data
Phase 2 COMP360 recurrent-MDD topline anticipated (estimated primary completion Sep 2025); no results reported yet.
- 2025Delayed
Lenrispodun (ITI-214)forParkinson's diseaseTopline data
Phase 2 ITI-214-202 topline in Parkinson's disease (lenrispodun 30 mg vs placebo, Hauser-diary primary at Day 29).
- January 2026Anticipated
AXS-12 (reboxetine)forNarcolepsyRegulatory
Axsome guided to completing an NDA submission to the FDA for AXS-12 for cataplexy in narcolepsy in January 2026, after the FDA confirmed via pre-NDA meeting minutes that the regulatory data package would be sufficient.
- 1H 2026Anticipated
Lumateperone (ITI-007)forBipolar disorderTopline data
Anticipated topline from Phase 3 Study 451 (NCT06462586) of lumateperone 42 mg in acute bipolar mania (YMRS at Week 3).
- 2026-04-01Anticipated
ALTO-101forSchizophreniaTopline data
- 2H 2026Anticipated
Lumateperone (ITI-007)forBipolar disorderTopline data
Anticipated topline from Phase 3 Study 452 (NCT06462612) of lumateperone 42 mg in acute bipolar mania (YMRS at Week 3).
- 2Q 2026Anticipated
Fasedienol (PH94B)forSocial anxiety disorderTopline data
PALISADE-4 topline anticipated 2Q 2026; randomized portion complete.
- 1H 2026Anticipated
Ammoxetine (S-071031B)forMajor depressive disorderTopline data
Sertraline-controlled Phase 3 MDD topline anticipated; primary-completion estimate 30 Jun 2026.
- 1H 2026 start (topline thereafter)Anticipated
Brilaroxazine (RP5063)forSchizophreniaTopline data
RECOVER-2 confirmatory Phase 3 planned to initiate in 1H 2026.
- FDA decision expected 1H 2026Anticipated
TavapadonforParkinson's diseaseRegulatory
FDA decision on the tavapadon NDA anticipated in the first half of 2026.
- Pivotal Phase 2/3 initiation Q2 2026Anticipated
AXS-05 (dextromethorphan-bupropion)forTobacco use disorderRegistry results
Axsome plans to initiate a pivotal Phase 2/3 trial of AXS-05 in smoking cessation in Q2 2026
- Q3 2026Anticipated
Azetukalner (XEN1101)forEpilepsyRegulatory
FDA NDA submission for azetukalner in focal onset seizures planned for Q3 2026.
- July 2026Anticipated
ForvisirvatforMajor depressive disorderRegistry results
ClinicalTrials.gov estimated primary completion (and estimated study completion) of the confirmatory Phase 2b/3 study NCT06254612: 15 July 2026.
- 2H 2026Anticipated
TAK-360forNarcolepsyTopline data
Phase 2 idiopathic hypersomnia dose-finding topline — estimated primary completion 16 Jul 2026
- July 24, 2026Anticipated
CentanafadineforAttention-deficit/hyperactivity disorderRegulatory
FDA PDUFA target action date for the centanafadine ADHD NDA (children, adolescents, and adults).
- by mid-August 2026Anticipated
ML-007C-MAforSchizophreniaTopline data
Topline results from the Phase 2 ZEPHYR trial of ML-007C-MA (210/3 mg BID and 330/6 mg QD) versus placebo in acute exacerbation of schizophrenia — primary endpoint change from baseline in PANSS total score at Week 5 — expected by mid-August 2026.
- 2H 2026Anticipated
TAK-360forNarcolepsyTopline data
Phase 2 NT2 dose-finding topline (TAK-360-2001) — estimated primary completion 20 Aug 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.
- third quarter 2026Anticipated
Psilocybin (COMP360)forPost-traumatic stress disorderRegulatory
Pivotal Phase 2b/3 PTSD trial (REDEFINE / NCT07570654) planned to start; FDA accepted the IND on 2026-01-07.
- Q3 2026Anticipated
Elunetirom (ABX-002)forMajor depressive disorderTopline data
AMPLIFY Phase 2 topline (adjunctive MDD): HAMD-17 change at Week 6 vs. placebo, expected Q3 2026.
- 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).
- 2H 2026Anticipated
Azetukalner (XEN1101)forEpilepsyTopline data
X-TOLE3 Phase 3 topline (second pivotal focal-onset-seizure trial) anticipated; primary completion ~Oct 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.
- October 2026Anticipated
KYN-5356forSchizophreniaRegistry results
ClinicalTrials.gov estimated primary completion of the Phase 2 CIAS study NCT07191483: October 2026 (estimated study completion December 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.
- 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.
- 2026Anticipated
Milsaperidone (VHX-896)forMajor depressive disorderTopline data
Topline data anticipated from the Phase 3 adjunctive MDD study of milsaperidone (Bysanti).
- 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.
- 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
Solriamfetol (Sunosi)forBinge eating disorderTopline data
ENGAGE Phase 3 (solriamfetol in binge eating disorder) topline results anticipated in the second half of 2026.
- Q4 2026Anticipated
CYB003 (deupsilocin)forMajor depressive disorderTopline data
Phase 3 APPROACH topline data expected in Q4 2026.
- 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
AlixorextonforNarcolepsyTopline data
Vibrance-3 Phase 2 topline results anticipated in idiopathic hypersomnia (primary endpoint ESS at Week 8).
- fourth quarter 2026Anticipated
Psilocybin (COMP360)forTreatment-resistant depressionRegulatory
Full NDA submission targeted (FDA rolling review underway).
- 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.
- 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.
- 2026Anticipated
DT402forAutism spectrum disorderTopline data
Initial Phase 2a data for DT402 in autism spectrum disorder anticipated in 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)
- End of 2026Anticipated
VQW-765forSocial anxiety disorderTopline data
Phase 3 VQW-765 social anxiety disorder topline results expected by end of 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.
- 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.
- 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.
- 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
- 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).
- 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 601, the first 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 602, the second pivotal Phase 3 of lumateperone for irritability associated with autism spectrum disorder (pediatric); primary endpoint ABC-Irritability at Week 6.
- May 2027Anticipated
AlixorextonforNarcolepsyTopline data
Phase 3 Brilliance NT1 (Study 302) topline anticipated, evaluating the primary MWT endpoint at Week 12 in narcolepsy type 1.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
Direclidine (NBI-1117568)forSchizophreniaTopline data
Anticipated topline from Phase 3 acute study SCZ3029 (PANSS at Week 6).
- 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 SCZ3030 (PANSS at Week 6).
- 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).
- 2H 2027Anticipated
LB-102 (N-methylamisulpride)forSchizophreniaTopline data
Pivotal Phase 3 NOVA-2 topline (PANSS total at Week 6) anticipated in 2H 2027.
- 2H 2027Anticipated
Roluperidone (MIN-101)forSchizophreniaTopline data
Confirmatory Phase 3 (MIN-101C19) 12-week topline (primary: Marder NSFS) expected 2H 2027.
- 2027Anticipated
Solriamfetol (Sunosi)forExcessive daytime sleepinessTopline data
SUSTAIN Phase 3 (solriamfetol for excessive sleepiness in shift work disorder) topline anticipated in 2027.
- 2027Anticipated
AEF0217forDown SyndromeTopline data
Phase 2b dose-finding trial of AEF0217 in Down syndrome (NCT07334912): preliminary results anticipated in 2027.
- 2H 2027Anticipated
ALTO-207forTreatment-resistant depressionTopline data
ALTO-207 Phase 2b TRD topline (MADRS)
- 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
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.
- 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).
- 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.
- 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.
- 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
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.
- 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.
- 2028Anticipated
Azetukalner (XEN1101)forBipolar depressionTopline data
X-CEED Phase 3 topline in bipolar I/II depression (MADRS at Week 6) anticipated
- 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).
- 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.
- 2029Anticipated
Solriamfetol (Sunosi)forMajor depressive disorderTopline data
CLARITY Phase 3 (MDD with EDS) topline anticipated after a ~December 2028 primary completion.
- 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.
- 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.
- 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.
- No guidance — study completed 26 Nov 2025, topline undisclosedAnticipated
ENX-104forMajor depressive disorderTopline data
Topline from the Phase 1 multiple-ascending-dose study of ENX-104 in 48 patients with major depressive disorder with anhedonia (NCT07253324) — safety, tolerability, PK and pharmacodynamics, the first data in the target population. Completed 26 November 2025; nothing disclosed.
- No guidance — study completed 2 Sep 2025, results undisclosedAnticipated
ENX-104forMajor depressive disorderFull results
D2/D3 receptor occupancy results from the Phase 1 PET study of single-dose ENX-104 in 10 healthy volunteers (NCT07253272) — the dose-to-occupancy relationship that would anchor Phase 2 dose selection against the intended 10-50% occupancy window. Completed 2 September 2025; nothing disclosed.
Recently reported
- 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).
- 2026-06-18
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.
- 2026-06-04met
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)
- 2026-05-26terminated
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
- 2026-05-26met
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.
- 2026-05-26missed
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.
- 2026-05-12met
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.
- 2026-05-01met
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
- 2026-04-27met
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).
- 2026-04-02missed
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.
- 2026-03-21missed
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.
- 2026-02-23missed
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
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).
- 2026-02-20met
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.
- 2026-02-17met
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.
- 2026-02-10
OveporextonforNarcolepsyRegulatory
FDA accepted the oveporexton NDA for narcolepsy type 1 and granted Priority Review, with a PDUFA target action date in Q3 2026.
- 2026-01-20met
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.
- 2025-12-23pending
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.
- 2025-12-01missed
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).
- 2025-12-01met
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.
- 2025-12-01
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)
- 2025-11-12met
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.
- 2025-10-20missed
BNC210 (soclenicant)forSocial anxiety disorderTopline data
Phase 3 AFFIRM-1 missed its primary SUDS endpoint in social anxiety disorder; Neuphoria discontinues the SAD program.
- 2025-09-26
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
- 2025-09-01met
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.
- 2025-08-05mixed
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.
- 2025-07-14met
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).
- 2025-06-23met
Psilocybin (COMP360)forTreatment-resistant depressionTopline data
COMP005 met its primary endpoint: -3.6 MADRS vs placebo at Week 6 (p<0.001).
- 2025-06-07mixed
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.
- 2025-06-02met
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.
- 2025-04-08met
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
- 2025-04-01missed
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)
- 2025-03-06missed
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.
- 2025-01-28met
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.
- 2024-12-17met
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
BNC210 (soclenicant)forPost-traumatic stress disorderFull results
ATTUNE full results published in NEJM Evidence; hepatic enzyme elevations flagged.
- 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).
- 2024-12-05terminated
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).
- 2024-11-19met
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.
- 2024-09-26met
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).
- 2024-09-19missed
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.
- 2024-08-28met
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).
- 2024-06-18met
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.
- 2024-05-29met
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.
- 2024-05-21missed
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)
- 2024-04-22met
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.
- 2024-03-25met
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.
- 2024-02-27missed
Roluperidone (MIN-101)forSchizophreniaRegulatory
FDA issued a Complete Response Letter for the roluperidone NDA; at least one additional positive adequate/well-controlled study required.
- 2024-01-10missed
BI 1358894forMajor depressive disorderFull results
BI 1358894 Phase 2 dose-ranging trial in MDD negative: no separation from placebo on MADRS at week 6
- 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
Pediatric Phase 3 trial (children 4-12) met ADHD-RS-5 primary endpoint at week 6; positive topline announced Oct 27, 2023.
- 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.
- 2023-10-18met
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).
- 2023-09-29met
BNC210 (soclenicant)forPost-traumatic stress disorderTopline data
Phase 2b ATTUNE met its primary CAPS-5 endpoint in PTSD (p=0.048).
- 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).
- 2023-04-01mixed
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.
- 2023-02-13met
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).
- 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
- 2022-10-17missed
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).
- 2022-07-27met
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.
- 2022-06-22missed
Fasedienol (PH94B)forSocial anxiety disorderTopline data
PALISADE-1 missed its primary SUDS endpoint; tolerability favorable.
- 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.
- 2022-04-19terminated
BI 1358894forMajor depressive disorderFull results
Decentralized BI 1358894 MDD trial terminated for deficient enrollment (45 of target randomized)
- 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).
- 2022-02-01met
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%.
- 2021-09-23met
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).
- 2021-03-02mixed
Luvadaxistat (TAK-831)forSchizophreniaTopline data
INTERACT missed its primary negative-symptom endpoint (PANSS NSFS) but hit cognitive secondaries (BACS, SCoRS) at 50 mg.
- 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.
- 2020-12-07met
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).
- 2020-06-24missed
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).
- 2020-05-29missed
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).
- 2020-02-19met
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
- 2019-12-20met
Lumateperone (ITI-007)forSchizophreniaRegulatory
FDA approved Caplyta (lumateperone) 42 mg once daily for the treatment of schizophrenia in adults.
- 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)
- 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.
- 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.
- 2015-02-01pending
Apimostinel (GATE-202)forMajor depressive disorderTopline data
Naurex Phase 2 (NCT02067793): single-dose IV apimostinel reported rapid 24-hour antidepressant effect
- 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.