Which schizophrenia drugs are in Phase 3?

Phase 3 (or later) programs for schizophrenia include Lumateperone (ITI-007), Dexmedetomidine sublingual film (BXCL501), Olanzapine extended-release injectable suspension (TEV-'749), Brilaroxazine (RP5063), Direclidine (NBI-1117568), Iloperidone LAI, LB-102 (N-methylamisulpride), LYBALVI (olanzapine/samidorphan) and Roluperidone (MIN-101).

What are the next schizophrenia trial readouts?

Upcoming catalysts include ALTO-101 (2026-04-01), Brilaroxazine (RP5063) (1H 2026 start (topline thereafter)), ML-007C-MA (by mid-August 2026) and LYBALVI (olanzapine/samidorphan) (2H 2026).

How many clinical trials are recruiting for schizophrenia?

107 drug-interventional schizophrenia trials are currently recruiting participants, out of 1,706 registered interventional trials.

Psychotic Disorders

Schizophrenia drug pipeline

ICD-11 6A20
MeSH D012559

17 compounds from 15 companies are in active clinical development for schizophrenia, including 9 at Phase 3 or beyond.

17Compounds

15Companies

9Phase 3+

13Upcoming readouts

115Trials recruiting

Approved 1
Filed (NDA) 2
Phase 3 6
Phase 2 4
Discontinued 4

Mechanisms: Small molecule (17)

Pipeline data compiled July 2026 · every fact sourced.

Upcoming readouts & recent results

2026-04-01AnticipatedALTO-101Topline dataNCT06502964
1H 2026 start (topline thereafter)AnticipatedBrilaroxazine (RP5063)Topline datapending
RECOVER-2 confirmatory Phase 3 planned to initiate in 1H 2026. ↗
by mid-August 2026AnticipatedML-007C-MATopline dataNCT07038876
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 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. ↗
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. ↗
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. ↗
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). ↗
2026-02-23ReportedElpipodect (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. ↗
2026-02-20ReportedOlanzapine extended-release injectable suspension (TEV-'749)Regulatorymet
FDA accepted Teva's NDA for olanzapine extended-release injectable suspension (TEV-'749) for once-monthly treatment of schizophrenia in adults. ↗
2025-12-23ReportedBrilaroxazine (RP5063)Regulatorypending
FDA recommends a confirmatory second Phase 3 (RECOVER-2) before a brilaroxazine schizophrenia NDA. ↗

See the full catalyst calendar →

Compounds in development (17)

Compound	Company	Phase	Status	Mechanism
Lumateperone (ITI-007)	Johnson & Johnson	Approved	Approved	5-HT2A Antagonist
Dexmedetomidine sublingual film (BXCL501)Fast Track	BioXcel Therapeutics, Inc.	Filed (NDA)	Active	alpha-2A adrenoceptor Agonist
Olanzapine extended-release injectable suspension (TEV-'749)	Teva Pharmaceutical Industries Ltd.	Filed (NDA)	Active	D2 Antagonist
Brilaroxazine (RP5063)	Reviva Pharmaceuticals Holdings, Inc.	Phase 3	Active	D2 Partial agonist
Direclidine (NBI-1117568)	Neurocrine Biosciences, Inc.	Phase 3	Active	M4 Agonist
Iloperidone LAI	Vanda Pharmaceuticals Inc.	Phase 3	Recruiting	5-HT2A Antagonist
LB-102 (N-methylamisulpride)	LB Pharmaceuticals Inc.	Phase 3	Active	D2 Antagonist
LYBALVI (olanzapine/samidorphan)	Alkermes plc	Phase 3	Recruiting	D2 Antagonist
Roluperidone (MIN-101)	Minerva Neurosciences, Inc.	Phase 3	Active	5-HT2A Antagonist
Emraclidine (CVL-231)	AbbVie Inc.	Phase 2	Active	M4 PAM
KYN-5356	Kynexis B.V.	Phase 2	Recruiting	KAT-II Inhibitor
ML-007C-MA	MapLight Therapeutics, Inc.	Phase 2	Active	M1 Agonist
NBI-1117570	Neurocrine Biosciences, Inc.	Phase 2	Recruiting	M4 Agonist
ALTO-101Fda Fast Track	Alto Neuroscience, Inc.	Discontinued	Discontinued	Phosphodiesterase 4 Inhibitor
Elpipodect (MK-8189)	Merck & Co., Inc.	Discontinued	Discontinued	PDE10A Inhibitor
Iclepertin (BI 425809)	Boehringer Ingelheim International GmbH	Discontinued	Discontinued	GlyT1 Inhibitor
Luvadaxistat (TAK-831)	Neurocrine Biosciences, Inc.	Discontinued	Discontinued	DAAO Inhibitor

Trials recruiting now (107)

107 drug-interventional schizophrenia trials recruiting now, of 1,706 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 107 recruiting drug trials · see all on ClinicalTrials.gov →

Frequently asked

How many drugs are in development for schizophrenia?: 17 compounds from 15 companies are in active clinical development for schizophrenia, including 9 at Phase 3 or beyond.
Which schizophrenia drugs are in Phase 3?: Phase 3 (or later) programs for schizophrenia include Lumateperone (ITI-007), Dexmedetomidine sublingual film (BXCL501), Olanzapine extended-release injectable suspension (TEV-'749), Brilaroxazine (RP5063), Direclidine (NBI-1117568), Iloperidone LAI, LB-102 (N-methylamisulpride), LYBALVI (olanzapine/samidorphan) and Roluperidone (MIN-101).
What are the next schizophrenia trial readouts?: Upcoming catalysts include ALTO-101 (2026-04-01), Brilaroxazine (RP5063) (1H 2026 start (topline thereafter)), ML-007C-MA (by mid-August 2026) and LYBALVI (olanzapine/samidorphan) (2H 2026).
How many clinical trials are recruiting for schizophrenia?: 107 drug-interventional schizophrenia trials are currently recruiting participants, out of 1,706 registered interventional trials.