Which bipolar disorder drugs are in Phase 3?

Phase 3 (or later) programs for bipolar disorder include Milsaperidone (VHX-896) and Lumateperone (ITI-007).

What are the next bipolar disorder trial readouts?

Upcoming catalysts include Lumateperone (ITI-007) (1H 2026), Lumateperone (ITI-007) (2H 2026), AL001 (lithium–salicylate–L-proline) (Q3 2026) and Brenipatide (Primary completion Nov 2027 (RENEW-Bipolar-1)).

How many clinical trials are recruiting for bipolar disorder?

58 drug-interventional bipolar disorder trials are currently recruiting participants, out of 778 registered interventional trials.

Mood Disorders

Bipolar disorder drug pipeline

MeSH D001714

Subtypes: Bipolar depression

7 compounds from 7 companies are in active clinical development for bipolar disorder, including 2 at Phase 3 or beyond.

7Compounds

7Companies

2Phase 3+

5Upcoming readouts

62Trials recruiting

Phase 1/21

AL001 (lithium–salicylate–L-proline)Alzamend Neuro, Inc.GSK-3β Inhibitor

Phase 23

Phase 31

Lumateperone (ITI-007)Johnson & Johnson5-HT2A Antagonist

Approved1

Milsaperidone (VHX-896)Vanda Pharmaceuticals Inc.5-HT2A Antagonist

Discontinued1

Opakalim (BHV-7000)Biohaven Ltd.Kv7.2 Activator

Mechanisms: Small molecule (6) · Peptide (1)

Pipeline data compiled October 2026 · every fact sourced.

Upcoming readouts & recent results

1H 2026AnticipatedLumateperone (ITI-007)Topline dataNCT06462586
Anticipated topline from Phase 3 Study 451 (NCT06462586) of lumateperone 42 mg in acute bipolar mania (YMRS at Week 3). ↗
2H 2026AnticipatedLumateperone (ITI-007)Topline dataNCT06462612
Anticipated topline from Phase 3 Study 452 (NCT06462612) of lumateperone 42 mg in acute bipolar mania (YMRS at Week 3). ↗
Q3 2026AnticipatedAL001 (lithium–salicylate–L-proline)Topline dataNCT07540338
Topline lithium blood/brain PK and MRS data from the bipolar I 'Lithium in Brain' crossover study (AL001 vs lithium carbonate) at MGH. ↗
Primary completion Nov 2027 (RENEW-Bipolar-1)AnticipatedBrenipatideTopline dataNCT07286175
1H 2028AnticipatedDireclidine (NBI-1117568)Topline dataNCT07288320
Anticipated topline from the Phase 2 bipolar I mania study (NBI-1117568-BPD2036): change from baseline in YMRS total score at Day 21. ↗
2026-10-20ReportedRAP-219Topline datametNCT07046494
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. ↗
2026-04-07ReportedAL001 (lithium–salicylate–L-proline)Topline datapendingNCT06921590
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. ↗
2026-02-20ReportedMilsaperidone (VHX-896)Regulatorymet
FDA approves Bysanti (milsaperidone) for the acute treatment of manic or mixed episodes associated with bipolar I disorder (co-approved with schizophrenia). ↗
2025-03-03ReportedOpakalim (BHV-7000)Topline datamissedNCT06419582
Phase 2/3 bipolar mania study of BHV-7000 misses YMRS primary endpoint ↗

See the full catalyst calendar →

Compounds in development (7)

Compound	Company	Phase	Status	Mechanism
Milsaperidone (VHX-896)	Vanda Pharmaceuticals Inc.	Approved	Approved	5-HT2A Antagonist
Lumateperone (ITI-007)	Johnson & Johnson	Phase 3	Recruiting	5-HT2A Antagonist
Brenipatide	Eli Lilly and Company	Phase 2	Active	Glucagon-like peptide 1 receptor Agonist
Direclidine (NBI-1117568)	Neurocrine Biosciences, Inc.	Phase 2	Recruiting	M4 Agonist
RAP-219	Rapport Therapeutics, Inc.	Phase 2	Active	TARPγ8 NAM
AL001 (lithium–salicylate–L-proline)	Alzamend Neuro, Inc.	Phase 1/2	Recruiting	GSK-3β Inhibitor
Opakalim (BHV-7000)	Biohaven Ltd.	Discontinued	Discontinued	Kv7.2 Activator

Also in development for subtypes of Bipolar disorder

Trials recruiting now (58)

58 drug-interventional bipolar disorder trials recruiting now, of 778 registered interventional trials. Browse all on ClinicalTrials.gov →

Phase 4Risperidone vs Cariprazine in Acute Mania
Risperidone, Cariprazine
Pakistan Institute of Medical Sciencesn=50Started Jun 2027NCT07665073
Phase 4RNA Editing as a Biomarker of Antidepressant Response in Unipolar and Bipolar Depression (EDIT-ANDRE)
Vortioxetine, Cariprazine (Augmentation Phase)
Mayo Clinicn=120United States · 1 siteStarted Feb 2026NCT07266545
Phase 4Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder
semaglutide, Phentermine-Topiramate, naltrexone and bupropion (combination)
Mayo Clinicn=100United States · 1 siteStarted Jan 2026NCT07213466
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 4Exercise and Olanzapine-samidorphan
Olanzapine-samidorphan + exercise
New York State Psychiatric Instituten=30United States · 1 siteStarted Jun 2025NCT06740890
Phase 4Lithium for Prevention of Cognitive Declining in Mood Illnesses
Trace lithium dose plus treatment as usual, Placebo pill plus treatment as usual
University of Chilen=250Chile · 2 sitesStarted Nov 2024NCT06662526
Phase 4Lithium Versus Lamotrigine in Bipolar Disorder, Type II
Lithium Carbonate, Lamotrigine
University Hospital Bispebjerg and Frederiksbergn=200Denmark · 1 siteStarted May 2024NCT06184581
Phase 4Non-invasive BCI and Application Verification for Depressed People
SSRI
Shanghai Mental Health Centern=400China · 1 siteStarted Jul 2023NCT06417437
Phase 4Safety and Tolerability of Open-Labeled Iloperidone in Adolescents
Iloperidone
Vanda Pharmaceuticals Inc.n=100United States · 9 sitesStarted May 2023NCT05648591
Phase 4Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression (DUAG9)
Lithium, Cariprazine
Aalborg University Hospitaln=122Denmark · 1 siteStarted Dec 2022NCT05913947
Phase 4CLOZAPINE Response in Biotype-1
clozapine, risperidone
University of Texas Southwestern Medical Centern=524United States · 5 sitesStarted Mar 2022NCT04580134
Phase 3Pramipexole vs Placebo Treatment in Bipolar Disorder With Anhedonic Depression
Pramipexole
Daniel Lindqvistn=126Sweden · 1 siteStarted Sep 2026NCT07664852

Showing the 12 most advanced of 58 recruiting drug trials · see all on ClinicalTrials.gov →

Frequently asked

How many drugs are in development for bipolar disorder?: 7 compounds from 7 companies are in active clinical development for bipolar disorder, including 2 at Phase 3 or beyond.
Which bipolar disorder drugs are in Phase 3?: Phase 3 (or later) programs for bipolar disorder include Milsaperidone (VHX-896) and Lumateperone (ITI-007).
What are the next bipolar disorder trial readouts?: Upcoming catalysts include Lumateperone (ITI-007) (1H 2026), Lumateperone (ITI-007) (2H 2026), AL001 (lithium–salicylate–L-proline) (Q3 2026) and Brenipatide (Primary completion Nov 2027 (RENEW-Bipolar-1)).
How many clinical trials are recruiting for bipolar disorder?: 58 drug-interventional bipolar disorder trials are currently recruiting participants, out of 778 registered interventional trials.