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Bipolar Disorder

CNS 0 original drugs

Novel Drugs

Reformulations

Active Trials

Drug Targets

Phase 3 Readouts Pro

8 active Phase 3 trials with confidence-graded completion dates.

Full calendar →

Q2 2026

Lumateperone

Intra-Cellular Therapies, Inc.

Estimated · aging NCT06462612

Q4 2026

KarXT

Bristol-Myers Squibb

Estimated · fresh NCT06951711

Q2 2027

Lumateperone

Intra-Cellular Therapies, Inc.

Estimated · aging NCT06372964

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Anchored on CT.gov primary completion date. Topline announcements typically precede this by 3–9 months. Confidence labels combine date type (ACTUAL/ESTIMATED) with last-update freshness.

Treatments by Mechanism

Top 6 mechanisms across 11 industry trials with a known mechanism of action.

See full pipeline →

Atypical Antipsychotic

4 trials 3 sponsors

Anti-epileptic Agent

3 trials 1 sponsor

5HT2/5HT2A/D2

1 trials 1 sponsor

Mood Stabilizer

1 trials 1 sponsor

Melatonin Receptor Agonist

1 trials 1 sponsor

5-HT2A receptor/D2 receptor

1 trials 1 sponsor

MoA derived from FDA pharmClassEpc when intervention matches an approved drug. Codenamed clinical-stage assets without an approved counterpart show "—" and aren't grouped here — they're still in the phase tables below.

Clinical Pipeline by Phase

82 industry-sponsored trials across 30 sponsors

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Showing 10 of 10 trials

Sponsor	Asset	MoA	Status	Primary Completion	NCT
Neurocrine Biosciences	Valbenazine	—	RECRUITING	2027-01	NCT07105111
Neurocrine Biosciences	Valbenazine	—	COMPLETED	2024-12-27	NCT05859698
BioXcel Therapeutics Inc	Sublingual film containing Igalmi	—	COMPLETED	2024-04-29	NCT06041646
Eli Lilly	Olanzapine Fluoxetine Combination (OFC)	—	COMPLETED	2012-02	NCT00844857
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Risperidone	Atypical Antipsychotic [EPC]	COMPLETED	2011-07	NCT01050582
AstraZeneca	Quetiapine 600mg	—	COMPLETED	2009-08	NCT00521365
AstraZeneca	Quetiapine Immediate Release	—	COMPLETED	2009-08	NCT00926393
AstraZeneca	Quetiapine Fumarate	5HT2/5HT2A/D2	COMPLETED	2009-07	NCT00672490
Aziende Chimiche Riunite Angelini Francesco S.p.A	Lithium sulphate prolonged-release 660 mg	—	TERMINATED	2019-09-20	NCT03210480
Validus Pharmaceuticals	Carbamazepine	Mood Stabilizer [EPC]	TERMINATED	2018-11-01	NCT02623504

Showing 47 of 47 trials

Sponsor	Asset	MoA	Status	Primary Completion	NCT
Bristol-Myers Squibb	KarXT	—	RECRUITING	2026-11-02	NCT06951711
Intra-Cellular Therapies, Inc.	Lumateperone	—	RECRUITING	2027-04	NCT06372964
Bristol-Myers Squibb	Xanomeline/Trospium Chloride	—	RECRUITING	2027-06-28	NCT07140913
Intra-Cellular Therapies, Inc.	Lumateperone	—	RECRUITING	2027-12	NCT06229210
Xenon Pharmaceuticals Inc.	Azetukalner	—	RECRUITING	2028-06	NCT07172516
Bristol-Myers Squibb	KarXT	—	RECRUITING	2028-06-13	NCT06929273
Intra-Cellular Therapies, Inc.	Lumateperone	—	RECRUITING	2026-05	NCT06462612
Intra-Cellular Therapies, Inc.	Lumateperone	—	RECRUITING	2026-03	NCT06462586
Biohaven Therapeutics Ltd.	BHV-7000	—	COMPLETED	2025-01-15	NCT06419582
NeuroRx, Inc.	NRX-101	—	COMPLETED	2024-02-28	NCT03395392
Intra-Cellular Therapies, Inc.	Lumateperone	—	COMPLETED	2022-11-30	NCT04285515
NeuroRx, Inc.	NRX-101	—	COMPLETED	2021-01-01	NCT03402152
Intra-Cellular Therapies, Inc.	Lumateperone (ITI-007)	—	COMPLETED	2020-07-02	NCT02600507
BioXcel Therapeutics Inc	Sublingual film containing Dexmedetomidine (BXCL501)	—	COMPLETED	2020-05-21	NCT04276883
Intra-Cellular Therapies, Inc.	Lumateperone	—	COMPLETED	2019-03-01	NCT03249376
Intra-Cellular Therapies, Inc.	ITI-007 (Lumateperone)	—	COMPLETED	2019-01-28	NCT02600494
Sumitomo Pharma America, Inc.	Lurasidone 20, 40, 60, 80 mg, flexibly dosed	—	COMPLETED	2018-10-17	NCT01914393
Forest Laboratories	Cariprazine	—	COMPLETED	2018-01-18	NCT02670538
Forest Laboratories	Cariprazine	—	COMPLETED	2017-07-19	NCT02670551
Sumitomo Pharma Co., Ltd.	SM-13496	—	COMPLETED	2017-02-01	NCT01986101
Astellas Pharma Inc	FK949E	—	COMPLETED	2016-06-29	NCT01737268
Astellas Pharma Inc	FK949E	—	COMPLETED	2016-02-06	NCT02362412
GSK	Lamotrigine	Anti-epileptic Agent [EPC]	COMPLETED	2015-12	NCT01602510
Astellas Pharma Inc	FK949E	—	COMPLETED	2015-08-01	NCT01725308
Organon and Co	Asenapine	Atypical Antipsychotic [EPC]	COMPLETED	2014-09-05	NCT01349907
Sumitomo Pharma America, Inc.	Lurasidone	—	COMPLETED	2014-02	NCT01485640
Organon and Co	asenapine	Atypical Antipsychotic [EPC]	COMPLETED	2013-08-28	NCT01244815
GSK	lamictal	Anti-epileptic Agent [EPC]	COMPLETED	2013-08	NCT00723450
Sumitomo Pharma America, Inc.	lurasidone	—	COMPLETED	2013-02	NCT00868959
AstraZeneca	Quetiapine Fumarate (SEROQUEL) Extended Release	—	COMPLETED	2012-11	NCT01256177
Sumitomo Pharma America, Inc.	Lurasidone	—	COMPLETED	2012-08	NCT01284517
Sumitomo Pharma America, Inc.	lurasidone	—	COMPLETED	2012-02	NCT00868699
Sumitomo Pharma America, Inc.	lurasidone + (lithium or divalproex)	—	COMPLETED	2011-12	NCT00868452
Otsuka Pharmaceutical Development & Commercialization, Inc.	Aripiprazole	Atypical Antipsychotic [EPC]	COMPLETED	2011-10	NCT00665366
Forest Laboratories	Cariprazine	—	COMPLETED	2011-07	NCT01058096
AstraZeneca	Extended release quetiapine (quetiapine XR)	—	COMPLETED	2011-02	NCT00857584
AstraZeneca	Quetiapine XR	—	COMPLETED	2010-11	NCT00811473
GSK	BW430C (lamotrigine)	—	COMPLETED	2010-10	NCT00566020
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	Ziprasidone	—	TERMINATED	2020-07-31	NCT03768726
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	ziprasidone oral capsules	—	TERMINATED	2020-04-11	NCT02075047
Takeda	Ramelteon SL	—	TERMINATED	2015-03	NCT01467713
Takeda	Ramelteon	Melatonin Receptor Agonist [EPC]	TERMINATED	2014-08	NCT01677182
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	Ziprasidone HCL (oral)	—	TERMINATED	2011-02	NCT01113541
Xenon Pharmaceuticals Inc.	Azetukalner	—	ENROLLING BY INVITATION	2029-06	NCT07217860
Takeda	Ramelteon SL (Dose 1)	—	WITHDRAWN	2015-11	NCT01685151
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	ziprasidone oral capsules	—	WITHDRAWN	2011-10	NCT01124877
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	Ziprasidone Oral Capsules	—	WITHDRAWN	2011-04	NCT01117220

Showing 9 of 9 trials

Sponsor	Asset	MoA	Status	Primary Completion	NCT
Alto Neuroscience	ALTO-100	—	RECRUITING	2026-08	NCT06656416
Eli Lilly	Brenipatide	—	RECRUITING	2027-11	NCT07286175
Janssen Pharmaceutica N.V., Belgium	JNJ-55308942	—	COMPLETED	2024-05-17	NCT05328297
Celon Pharma SA	Esketamine DPI - low dose	—	COMPLETED	2021-01-03	NCT03965871
Biogen	SAGE-217	—	COMPLETED	2019-05-21	NCT03692910
NeuroRx, Inc.	NRX-101 Oral Capsule	—	COMPLETED	2018-08-31	NCT02974010
Forest Laboratories	cariprazine	—	COMPLETED	2010-06-15	NCT00852202
Biohaven Therapeutics Ltd.	BHV-7000	—	TERMINATED	2025-04-25	NCT06423794
H. Lundbeck A/S	Lu AA39959	—	TERMINATED	2009-06	NCT00771134

Showing 16 of 16 trials

Sponsor	Asset	MoA	Status	Primary Completion	NCT
BioXcel Therapeutics Inc	BXCL501 80 Micrograms	—	RECRUITING	2027-07-31	NCT05025605
Otsuka Pharmaceutical Development & Commercialization, Inc.	SEP-380135	—	COMPLETED	2025-09-12	NCT07549581
AbbVie	ABBV-932	—	COMPLETED	2025-03-04	NCT06024239
Otsuka Pharmaceutical Development & Commercialization, Inc.	Seroquel IR 300mg	—	COMPLETED	2019-10-30	NCT03872596
GSK	Lamotrigine	Anti-epileptic Agent [EPC]	COMPLETED	2015-11-11	NCT02513654
Johnson & Johnson	Aripiprazole, oral formulation	—	COMPLETED	2014-10	NCT02087579
Sun Pharmaceutical Industries Limited	SAPHRIS	5-HT2A receptor/D2 receptor	COMPLETED	2013-08	NCT01948024
Eli Lilly	LY2979165	—	COMPLETED	2012-06	NCT01383967
Eli Lilly	LY2979165	—	COMPLETED	2011-05	NCT01248052
AstraZeneca	AZD4451	—	COMPLETED	2011-04	NCT01196676
Pfizer	PF-04455242	—	COMPLETED	2009-12	NCT00988949
Pfizer	PF-04455242	—	COMPLETED	2009-07	NCT00938301
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	divalproex sodium ER/paliperidone ER	—	COMPLETED	2009-04	NCT01094249
Biogen	GSK1014802	—	COMPLETED	2008-12-31	NCT00908154
GSK	Vofopitant	—	TERMINATED	2010-06-10	NCT00907985
Pfizer	PF-04455242	—	TERMINATED	2009-12	NCT00939887

Novel Drugs by Company (New molecular entities)

No novel drugs found for this indication.

Reformulations (16 drugs) Click to expand

Reformulations are FDA-approved versions of existing molecules in new dosage forms (e.g., oral solution vs tablet, extended-release vs immediate-release). They require a new NDA but use an already-proven active ingredient.