Schizophrenia drug pipeline

Upcoming readouts & recent results

• 2H 2026AnticipatedLYBALVI (olanzapine/samidorphan)Topline dataNCT05303064

  ENLIGHTEN-Youth pediatric Phase 3 (OLZ/SAM vs olanzapine; primary endpoint change in BMI Z-score) — topline anticipated around primary completion (est. Sep 2026). ↗

• October 2026AnticipatedKYN-5356Registry resultsNCT07191483

  ClinicalTrials.gov estimated primary completion of the Phase 2 CIAS study NCT07191483: October 2026 (estimated study completion December 2026). ↗

• PDUFA 14 Nov 2026AnticipatedDexmedetomidine sublingual film (BXCL501)Regulatory

  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 2026AnticipatedNS-136Registry resultsNCT07521683

  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). ↗

• Q4 2026AnticipatedKYN-5356Topline dataNCT07191483

  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. ↗

• Q4 2026AnticipatedEvenamideTopline 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. ↗

• Q4 2026AnticipatedEvenamideTopline dataNCT07184619

  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. ↗

• 1H 2027 enrollment start (topline thereafter)DelayedBrilaroxazine (RP5063)Topline datapending

  RECOVER-2 confirmatory Phase 3 has not started: enrollment guidance moved mid-2026 -> Q3 2026 -> 1H 2027, subject to additional financing; topline thereafter ↗

• 2H 2027AnticipatedNBI-1117570Topline dataNCT07288333

  Anticipated topline from the Phase 2a inpatient schizophrenia study (PANSS total change at Day 35). ↗

• Q4 2027AnticipatedDireclidine (NBI-1117568)Topline dataNCT06963034

  Anticipated topline from Phase 3 acute study SCZ3029 (PANSS at Week 6). ↗

• Q4 2027AnticipatedDireclidine (NBI-1117568)Topline dataNCT07105098

  Anticipated topline from Phase 3 acute study SCZ3030 (PANSS at Week 6). ↗

• Q4 2027AnticipatedIloperidone LAITopline dataNCT06961968

  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 2027AnticipatedLB-102 (N-methylamisulpride)Topline dataNCT07363577

  Pivotal Phase 3 NOVA-2 topline (PANSS total at Week 6) anticipated in 2H 2027. ↗

• 2H 2027AnticipatedRoluperidone (MIN-101)Topline dataNCT07565428

  Confirmatory Phase 3 (MIN-101C19) 12-week topline (primary: Marder NSFS) expected 2H 2027. ↗

• 2028AnticipatedML-007C-MATopline data

  Phase 3 ZEPHYR-2 registrational trial topline expected in 2028 ↗

• 2026-07-27ReportedML-007C-MATopline datamixedNCT07038876

  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 ↗

• 2026-04-27ReportedLumateperone (ITI-007)RegulatorymetNCT04959032

  FDA approved Caplyta (lumateperone) sNDA adding relapse-prevention data in schizophrenia (Study 304: HR 0.37, 63% lower relapse risk, p=0.0002). ↗

• 2026-04-01ReportedALTO-101Topline datamissedNCT06502964

  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 ↗

• 2026-02-23ReportedElpipodect (MK-8189)Full resultsmissedNCT04624243

  Phase 2b (NCT04624243) missed: neither MK-8189 16 mg nor 24 mg separated from placebo on PANSS total at Week 6. ↗

See the full catalyst calendar →

Compounds in development (24)

Trials recruiting now (106)

106 drug-interventional schizophrenia trials recruiting now, of 1,711 registered interventional trials. Browse all on ClinicalTrials.gov →

• Phase 4Clinical Trial of an IL-23 Inhibitor for Immune Activation in Clinical Trial of an IL-23 Inhibitor for Immune Activation in People With Schizophrenia

  Placebo, IL-23

  University of Maryland, Baltimoren=40United States · 1 siteStarted Sep 2026NCT07615075
• Phase 4A Study to Evaluate the Effect of KarXT on Urological Safety

  Xanomeline/trospium chloride

  Bristol-Myers Squibb Companyn=60United States · 13 sitesStarted Jan 2026NCT07221877
• Phase 4Bromocriptine for Patients With Schizophrenia and Prediabetes

  Bromocriptine

  VA Pittsburgh Healthcare Systemn=15United States · 1 siteStarted Jan 2026NCT03575000
• Phase 4Efficacy and Functional Recovery After Switching From Paliperidone Palmitate Injection to Oral Antipsychotics in Schizophrenia

  Paliperidone Palmitate Injection (PP1M)

  Jiangsu Province Nanjing Brain Hospitaln=120China · 1 siteStarted Oct 2025NCT07075237
• Phase 4Efficacy and Safety of Paliperidone in Schizophrenia - Bangladesh Study

  Paliperidone extended-release (ER)

  Sher-E-Bangla Medical Collegen=505Bangladesh · 1 siteStarted Sep 2025NCT07153835
• Phase 4A Study to Evaluate the Effectiveness of Valbenazine in Adult Participants With Tardive Dyskinesia (TD) Who Remain Symptomatic While Receiving or After Stopping a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor

  Valbenazine

  Neurocrine Biosciences, Inc.n=50United States · 22 sitesStarted Aug 2025NCT07105111
• Phase 4An Open-Label Study to Evaluate the Efficacy and Tolerability of Xanomeline/Trospium In First Episode/Early Phase Schizophrenia Patients

  Xanomeline/Trospium

  Vanguard Research Groupn=172United States · 1 siteStarted Apr 2025NCT06923891
• Phase 4An 8-week Open-label Study of an Accelerated and Slower Switching to Xanomeline/Trospium Following Atypical Antipsychotic Treatment in Participants With Schizophrenia

  Xanomeline and Trospium Chloride

  Collaborative Neuroscience Research, LLCn=100United States · 7 sitesStarted Apr 2025NCT06924255
• Phase 4Anticholinergic Deprescription in Schizophrenia

  Anticholinergic Deprescription, No Anticholinergic Deprescription

  Deepak K. Sarpal, M.D.n=105United States · 1 siteStarted Feb 2025NCT06562608
• Phase 4Maintenance Electroconvulsive Therapy (ECT) Versus Aripiprazole in Clozapine-resistant Schizophrenia

  Aripiprazole tablet

  All India Institute of Medical Sciences, Bhubaneswarn=40Started Aug 2024NCT06501339
• Phase 4The Effect of a Six Week Intensified Pharmacological Treatment for Schizophrenia Compared to Treatment as Usual in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.

  Clozapine, Second-line Antipsychotics (treatment as usual)

  Dr. Inge Wintern=418Austria, Germany +3 · 13 sitesStarted Aug 2024NCT05958875
• Phase 4Anti-Inflammatory Challenge in Schizophrenia

  Infliximab, Placebo

  Emory Universityn=60United States · 2 sitesStarted Apr 2024NCT05823532

Showing the 12 most advanced of 106 recruiting drug trials · see all on ClinicalTrials.gov →