Bipolar disorder drug pipeline
- MeSH D001714
Subtypes: Bipolar depression
5 compounds from 5 companies are in active clinical development for bipolar disorder, including 2 at Phase 3 or beyond.
Mechanisms: Small molecule (5)
Pipeline data compiled September 2026 · every fact sourced.
Upcoming readouts & recent results
Anticipated topline from Phase 3 Study 451 (NCT06462586) of lumateperone 42 mg in acute bipolar mania (YMRS at Week 3). ↗
Anticipated topline from Phase 3 Study 452 (NCT06462612) of lumateperone 42 mg in acute bipolar mania (YMRS at Week 3). ↗
Topline lithium blood/brain PK and MRS data from the bipolar I 'Lithium in Brain' crossover study (AL001 vs lithium carbonate) at MGH. ↗
Anticipated topline from the Phase 2 bipolar I mania study (NBI-1117568-BPD2036): change from baseline in YMRS total score at Day 21. ↗
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. ↗
FDA approves Bysanti (milsaperidone) for the acute treatment of manic or mixed episodes associated with bipolar I disorder (co-approved with schizophrenia). ↗
Phase 2/3 bipolar mania study of BHV-7000 misses YMRS primary endpoint ↗
Compounds in development (5)
| 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 |
| Direclidine (NBI-1117568) | Neurocrine Biosciences, Inc. | Phase 2 | Recruiting | M4 Agonist |
| 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
- Lumateperone (ITI-007)ApprovedJohnson & Johnsonfor Bipolar depression
- Azetukalner (XEN1101)Phase 3Xenon Pharmaceuticals Inc.for Bipolar depression
- ALTO-100 (amdiglurax)Phase 2Alto Neuroscience, Inc.for Bipolar depression
- Elunetirom (ABX-002)Phase 2Autobahn Therapeutics, Inc.for Bipolar depression
- LB-102 (N-methylamisulpride)Phase 2LB Pharmaceuticals Inc.for Bipolar depression
- Mebufotenin (inhaled 5-MeO-DMT, GH001)DiscontinuedGH Research PLCfor Bipolar depression
Trials recruiting now (61)
61 drug-interventional bipolar disorder trials recruiting now, of 778 registered interventional trials. Browse all on ClinicalTrials.gov →
Risperidone, Cariprazine
Vortioxetine, Cariprazine (Augmentation Phase)
semaglutide, Phentermine-Topiramate, naltrexone and bupropion (combination)
Valbenazine
Olanzapine-samidorphan + exercise
Trace lithium dose plus treatment as usual, Placebo pill plus treatment as usual
Lithium Carbonate, Lamotrigine
SSRI
Iloperidone
Lithium, Cariprazine
clozapine, risperidone
Pramipexole
Showing the 12 most advanced of 61 recruiting drug trials · see all on ClinicalTrials.gov →
Frequently asked
- How many drugs are in development for bipolar disorder?
- 5 compounds from 5 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 Direclidine (NBI-1117568) (1H 2028).
- How many clinical trials are recruiting for bipolar disorder?
- 61 drug-interventional bipolar disorder trials are currently recruiting participants, out of 778 registered interventional trials.