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Major Depressive Disorder

CNS 3 original drugs

Novel Drugs

Reformulations

Active Trials

Drug Targets

CNS indication. Major Depressive Disorder has 3 FDA-approved novel treatments, led by Johnson & Johnson across 23 drug targets. Explore market leaders, treatments by mechanism, the clinical pipeline, and drug targets below.

Major Depressive Disorder Market Leaders

Companies with the most FDA-approved novel Major Depressive Disorder drugs.

Phase 3 Readouts Pro

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

Full calendar →

Q3 2026

CYB003

Cybin IRL Limited

Estimated · fresh NCT06564818

Q3 2026

Azetukalner

Xenon Pharmaceuticals Inc.

Estimated · aging NCT06775379

Q3 2026

Lumateperone

Intra-Cellular Therapies, Inc.

Estimated · aging NCT05850689

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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.

Major Depressive Disorder Treatments by Mechanism

Top 10 mechanisms across 32 industry trials with a known mechanism of action.

See full pipeline →

Atypical Antipsychotic

17 trials 7 sponsors

DAT

4 trials 1 sponsor

Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator

3 trials 2 sponsors

Melatonin Receptor Agonist

2 trials 2 sponsors

Dopamine transporter/Norepinephrine transporter

1 trials 1 sponsor

NET/SERT

1 trials 1 sponsor

Progestin Antagonist

1 trials 1 sponsor

Benzodiazepine

1 trials 1 sponsor

Acetylcholine Release Inhibitor

1 trials 1 sponsor

SERT

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.

Major Depressive Disorder Clinical Pipeline by Phase

640 industry-sponsored trials across 170 sponsors

Showing 60 of 60 trials

Sponsor	Asset	MoA	Status	Primary Completion	NCT
Neurocrine Biosciences	Valbenazine	—	RECRUITING	2027-01	NCT07105111
Janssen Korea, Ltd., Korea	Esketamine 56 mg	—	RECRUITING	2027-06-25	NCT07053345
Axsome Therapeutics, Inc.	AXS-05	—	RECRUITING	2026-03	NCT06223880
Luye Pharma Group Ltd.	Toludesvenlafaxine Hydrochloride Sustained-release Tablets	—	NOT YET RECRUITING	2027-02-28	NCT06426485
Bausch Health Americas, Inc.	bupropion hydrobromide	Dopamine transporter/Norepinephrine transporter	NOT YET RECRUITING	2029-07	NCT02129751
Neurocrine Biosciences	Valbenazine	—	COMPLETED	2024-12-27	NCT05859698
Johnson & Johnson	Esketamine	—	COMPLETED	2024-07-22	NCT04829318
Johnson & Johnson	Esketamine 56 mg	—	COMPLETED	2024-01-31	NCT04599855
AbbVie	—	—	COMPLETED	2022-12-06	NCT04390581
Teva Branded Pharmaceutical Products R&D, Inc.	Fremanezumab	—	COMPLETED	2022-08-31	NCT04041284
Supernus Pharmaceuticals, Inc.	ZULRESSO®	—	COMPLETED	2022-07-14	NCT05059600
H. Lundbeck A/S	Vortioxetine	—	COMPLETED	2022-07-06	NCT04294654
Field Trip Health	—	—	COMPLETED	2022-06-16	NCT05604794
Otsuka Pharmaceutical Development & Commercialization, Inc.	Brexpiprazole	Atypical Antipsychotic [EPC]	COMPLETED	2022-05-27	NCT04830215
H. Lundbeck A/S	Vortioxetine	—	COMPLETED	2022-02-11	NCT04288895
H. Lundbeck A/S	Vortioxetine	—	COMPLETED	2022-01-06	NCT04448431
Brainsway	—	—	COMPLETED	2020-07-01	NCT04679753
H. Lundbeck A/S	Vortioxetine	—	COMPLETED	2020-02-21	NCT03835715
Takeda	Vortioxetine	—	COMPLETED	2019-03-01	NCT02371980
The Taub Group	Scopolamine and naltrexone	—	COMPLETED	2018-11-20	NCT03386448
Assurex Health Inc.	—	—	COMPLETED	2018-11	NCT02466477
Takeda	Vortioxetine	—	COMPLETED	2018-02-06	NCT02972632
Takeda	Ramelteon	Melatonin Receptor Agonist [EPC]	COMPLETED	2018-01-31	NCT02669082
Lundbeck Canada Inc.	vortioxetine	—	COMPLETED	2017-07-06	NCT02332954
AbbVie	—	—	COMPLETED	2016-12-14	NCT02980783
Forest Laboratories	Levomilnacipran ER	—	COMPLETED	2016-09-16	NCT02288325
Xian-Janssen Pharmaceutical Ltd.	Escitalopram	—	COMPLETED	2015-05	NCT01870843
Forest Laboratories	Vilazodone	—	COMPLETED	2014-10	NCT01573598
Forest Laboratories	Vilazodone	—	COMPLETED	2013-06	NCT01473381
Taiwan Otsuka Pharm. Co., Ltd	Aripiprazole	Atypical Antipsychotic [EPC]	COMPLETED	2013-05	NCT01429831
Eli Lilly	Duloxetine	—	COMPLETED	2013-03	NCT01051466
Forest Laboratories	Vilazodone	—	COMPLETED	2013-02	NCT01473394
Forest Laboratories	Escitalopram	—	COMPLETED	2013-01	NCT01198795
Pfizer	desvenlafaxine succinate sustained-release 50 mg/day	—	COMPLETED	2012-07	NCT01432457
Pfizer	varenicline	—	COMPLETED	2012-06	NCT01078298
Xian-Janssen Pharmaceutical Ltd.	Escitalopram	—	COMPLETED	2012-02	NCT01814085
Pfizer	desvenlafaxine succinate sustained-release	—	COMPLETED	2011-06	NCT01121484
Xian-Janssen Pharmaceutical Ltd.	Escitalopram	—	COMPLETED	2011-05-31	NCT01814098
Eli Lilly	Duloxetine	—	COMPLETED	2011-03	NCT01070329
Eli Lilly	Duloxetine hydrochloride	—	COMPLETED	2011-02	NCT00960986
Pfizer	Desvenlafaxine Succinate Sustained-Release Formulation 50 mg	—	COMPLETED	2011-02	NCT01056289
Eli Lilly	Duloxetine	—	COMPLETED	2010-12	NCT00985504
Eli Lilly	Duloxetine	—	COMPLETED	2010-10	NCT01000805
Pfizer	Desvenlafaxine Succinate Sustained Release	—	COMPLETED	2010-08	NCT00952653
Nang Kuang Pharmaceutical Co., Ltd.	Smilon®	—	COMPLETED	2010-08	NCT01119924
Boehringer Ingelheim	Duloxetine 60 mg QD	—	COMPLETED	2010-06	NCT00844194
Eli Lilly	Duloxetine Hydrochloride	—	COMPLETED	2010-02	NCT00810069
Wyeth is now a wholly owned subsidiary of Pfizer	—	—	COMPLETED	2009-07	NCT00788944
Eli Lilly	Duloxetine	—	COMPLETED	2009-07	NCT00696774
Eli Lilly	duloxetine	—	COMPLETED	2009-02	NCT00666757
Otsuka Pharmaceutical Development & Commercialization, Inc.	Aripiprazole or other oral antipsychotics	—	TERMINATED	2018-10-17	NCT03643159
Novartis	Venlafaxine	—	TERMINATED	2013-09	NCT01436643
GSK	paroxetine 10mg tablet	—	TERMINATED	2011-02	NCT00812812
Rafa Laboratories	hypericum	—	TERMINATED	2010-11	NCT00557427
Alto Neuroscience	Sertraline	—	WITHDRAWN	2023-05-30	NCT04388202
Alto Neuroscience	Duloxetine	—	WITHDRAWN	2023-05-30	NCT04388189
Otsuka Pharmaceutical Development & Commercialization, Inc.	Brexpiprazole	Atypical Antipsychotic [EPC]	WITHDRAWN	2023-03-22	NCT05504486
Sage Therapeutics	Brexanolone	—	WITHDRAWN	2021-08	NCT04273191
GSK	Paroxetine CR	—	WITHDRAWN	2014-09	NCT01916200
Wyeth is now a wholly owned subsidiary of Pfizer	Effexor XR	NET/SERT	WITHDRAWN	2011-10	NCT00878748

Showing 100 of 248 trials (top 100 by completion date — export for full list)

Sponsor	Asset	MoA	Status	Primary Completion	NCT
Cybin IRL Limited	CYB003	—	RECRUITING	2026-08	NCT06564818
Xenon Pharmaceuticals Inc.	Azetukalner	—	RECRUITING	2026-08	NCT06775379
Intra-Cellular Therapies, Inc.	Lumateperone	—	RECRUITING	2026-09	NCT05850689
CSPC Ouyi Pharmaceutical Co., Ltd.	Dextromethorphan and Bupropion Sustained-Release Tablets	—	RECRUITING	2026-09-30	NCT06958692
Johnson & Johnson	Seltorexant	—	RECRUITING	2026-12-30	NCT06559306
AbbVie	Cariprazine	—	RECRUITING	2027-03	NCT04777357
Cybin IRL Limited	CYB003	—	RECRUITING	2027-03-18	NCT06793397
Xenon Pharmaceuticals Inc.	Azetukalner	—	RECRUITING	2027-05	NCT07076407
Sunshine Lake Pharma Co., Ltd.	Mitizodone Phosphate tablets	—	RECRUITING	2027-07	NCT04984512
Neurocrine Biosciences	NBI-1065845	—	RECRUITING	2027-07	NCT06963021
Neurocrine Biosciences	NBI-1065845	—	RECRUITING	2027-07	NCT06911112
Neurocrine Biosciences	NBI-1065845	—	RECRUITING	2027-07	NCT06786624
Definium Therapeutics US, Inc.	DT120	—	RECRUITING	2027-09	NCT07592689
Eli Lilly	Brenipatide	—	RECRUITING	2028-02	NCT07412756
Vanda Pharmaceuticals	Milsaperidone	—	RECRUITING	2028-03	NCT06830044
Neurocrine Biosciences	NBI-1065845	—	RECRUITING	2028-07	NCT07196501
Johnson & Johnson	Seltorexant	—	RECRUITING	2028-08-24	NCT07573176
Axsome Therapeutics, Inc.	Solriamfetol 150 MG	—	RECRUITING	2028-12	NCT07484217
Neurocrine Biosciences	NBI-1065845	—	RECRUITING	2029-05	NCT06966401
Takeda	Vortioxetine tablets	—	RECRUITING	2029-09-30	NCT07204314
Johnson & Johnson	Esketamine	—	RECRUITING	2031-04-09	NCT07227454
Korea Otsuka Pharmaceutical Co., Ltd.	Abilify 2, 5, 10, 15mg (Tablet)	—	RECRUITING	2025-11	NCT03423680
Neumora Therapeutics, Inc.	NMRA-335140	—	ACTIVE NOT RECRUITING	2027-06	NCT06029439
Definium Therapeutics US, Inc.	DT120	—	ACTIVE NOT RECRUITING	2026-05-20	NCT06941844
Neumora Therapeutics, Inc.	NMRA-335140	—	ACTIVE NOT RECRUITING	2026-05	NCT06058039
Neumora Therapeutics, Inc.	NMRA-335140	—	ACTIVE NOT RECRUITING	2026-05	NCT06058013
COMPASS Pathways	Psilocybin	—	ACTIVE NOT RECRUITING	2026-02	NCT05711940
COMPASS Pathways	Psilocybin	—	ACTIVE NOT RECRUITING	2025-05-28	NCT05624268
Tasly Pharmaceutical Group Co., Ltd	JS1-1-01 low-dose group	—	NOT YET RECRUITING	2026-12-31	NCT07485595
NeuroRx, Inc.	NRX-101	—	NOT YET RECRUITING	2027-12-31	NCT07227103
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.	Ammoxetine	—	NOT YET RECRUITING	2026-06-30	NCT06827431
Lipocine Inc.	LPCN 1154A	—	COMPLETED	2026-01-16	NCT06979544
Zhejiang Huahai Pharmaceutical Co., Ltd.	Levomilnacipran Hydrochloride Extended-Release Capsules	—	COMPLETED	2025-06-13	NCT07253207
Axsome Therapeutics, Inc.	Solriamfetol 300 mg	—	COMPLETED	2024-12-31	NCT06360419
Neumora Therapeutics, Inc.	NMRA-335140	—	COMPLETED	2024-12-03	NCT06029426
Johnson & Johnson	Aticaprant	—	COMPLETED	2024-11-08	NCT05550532
Intra-Cellular Therapies, Inc.	Lumateperone	—	COMPLETED	2024-10-14	NCT05061719
Johnson & Johnson	Aticaprant	—	COMPLETED	2024-09-18	NCT05455684
Intra-Cellular Therapies, Inc.	Lumateperone	—	COMPLETED	2024-04-12	NCT05061706
Intra-Cellular Therapies, Inc.	Lumateperone	—	COMPLETED	2024-02-22	NCT04985942
Johnson & Johnson	Seltorexant	—	COMPLETED	2023-10-03	NCT04513912
Relmada Therapeutics, Inc.	REL-1017	—	COMPLETED	2023-07-27	NCT04855760
Biogen	SAGE-217	—	COMPLETED	2023-06-22	NCT03864614
Janssen-Cilag, S.A.	Esketamine	—	COMPLETED	2023-06-16	NCT04476446
Johnson & Johnson	Seltorexant	—	COMPLETED	2023-04-25	NCT04533529
Johnson & Johnson	Esketamine Nasal Spray	—	COMPLETED	2022-12-30	NCT02782104
Intra-Cellular Therapies, Inc.	Lumateperone	—	COMPLETED	2022-11-30	NCT04285515
Relmada Therapeutics, Inc.	REL-1017	—	COMPLETED	2022-11-01	NCT04688164
Relmada Therapeutics, Inc.	REL-1017	—	COMPLETED	2022-09-13	NCT05081167
AbbVie	Cariprazine	—	COMPLETED	2022-09-05	NCT03573297
Mochida Pharmaceutical Company, Ltd.	Desvenlafaxine 100 mg	—	COMPLETED	2022-07-21	NCT04345471
Otsuka Pharmaceutical Development & Commercialization, Inc.	Brexpiprazole	Atypical Antipsychotic [EPC]	COMPLETED	2022-07-08	NCT03538691
Otsuka Pharmaceutical Co., Ltd.	Brexpiprazole	Atypical Antipsychotic [EPC]	COMPLETED	2022-06-06	NCT03697603
Praxis Precision Medicines	PRAX-114	—	COMPLETED	2022-05-05	NCT04832425
Biogen	SAGE-217	—	COMPLETED	2022-03-15	NCT04442503
H. Lundbeck A/S	Vortioxetine 10 mg/day	—	COMPLETED	2022-01-21	NCT02709655
Janssen-Cilag International NV	Esketamine 28 mg	—	COMPLETED	2022-01-20	NCT04338321
Biogen	SAGE-217	—	COMPLETED	2021-10-25	NCT04476030
AbbVie	Cariprazine	—	COMPLETED	2021-09-30	NCT03738215
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.	Duloxetine Hydrochloride Enteric-coated Capsule	—	COMPLETED	2021-09-22	NCT04364997
AbbVie	Cariprazine	—	COMPLETED	2021-09-06	NCT03739203
Johnson & Johnson	Esketamine 56 mg	—	COMPLETED	2021-04-13	NCT03434041
Biogen	SAGE-217	—	COMPLETED	2021-03-26	NCT04442490
Otsuka Pharmaceutical Co., Ltd.	Brexpiprazole	Atypical Antipsychotic [EPC]	COMPLETED	2021-03-17	NCT03737474
AbbVie	Levomilnacipran ER	—	COMPLETED	2021-03-01	NCT03569475
Supernus Pharmaceuticals, Inc.	Brexanolone	—	COMPLETED	2021-01-08	NCT03665038
Luye Pharma Group Ltd.	LY03005 extended-release tablet	—	COMPLETED	2020-12-24	NCT04853407
Axsome Therapeutics, Inc.	AXS-05 (dextromethorphan and bupropion) oral tablets	—	COMPLETED	2020-10-23	NCT04039022
ACADIA Pharmaceuticals Inc.	Pimavanserin	—	COMPLETED	2020-04-30	NCT03968159
H. Lundbeck A/S	Vortioxetine	—	COMPLETED	2020-04-16	NCT03108625
Axsome Therapeutics, Inc.	AXS-05	—	COMPLETED	2020-03-20	NCT02741791
Alkermes, Inc.	ALKS 5461	—	COMPLETED	2020-02-26	NCT03188185
Axsome Therapeutics, Inc.	AXS-05	—	COMPLETED	2019-11-26	NCT04019704
Shionogi	Duloxetine Hydrochloride	—	COMPLETED	2019-11-08	NCT03315793
Biogen	SAGE-217	—	COMPLETED	2019-09-24	NCT03672175
Forest Laboratories	Levomilnacipran	—	COMPLETED	2019-08-19	NCT02431806
H. Lundbeck A/S	Vortioxetine 10 mg/day	—	COMPLETED	2019-07-02	NCT02709746
Johnson & Johnson	Esketamine	—	COMPLETED	2019-04-11	NCT03097133
Naurex, Inc, an affiliate of Allergan plc	Rapastinel	—	COMPLETED	2019-02-22	NCT02951988
Johnson & Johnson	Esketamine	—	COMPLETED	2018-12-18	NCT03039192
Naurex, Inc, an affiliate of Allergan plc	Rapastinel	—	COMPLETED	2018-12-12	NCT02943564
Naurex, Inc, an affiliate of Allergan plc	Rapastinel	—	COMPLETED	2018-12-06	NCT03002077
Biogen	SAGE-217 15/20 mg Oral Solution	—	COMPLETED	2018-11-15	NCT02978326
Naurex, Inc, an affiliate of Allergan plc	Rapastinel	—	COMPLETED	2018-10-26	NCT02943577
Naurex, Inc, an affiliate of Allergan plc	Rapastinel	—	COMPLETED	2018-09-21	NCT02932943
Forest Laboratories	Vilazodone	—	COMPLETED	2018-09-11	NCT02372799
Forest Laboratories	Vilazodone	—	COMPLETED	2018-07-23	NCT02436239
Takeda	Vortioxetine	—	COMPLETED	2018-03-16	NCT02389816
Johnson & Johnson	Esketamine	—	COMPLETED	2018-02-20	NCT02417064
Johnson & Johnson	Esketamine	—	COMPLETED	2018-02-15	NCT02493868
Forest Laboratories	Cariprazine	—	COMPLETED	2018-01-18	NCT02670538
Alkermes, Inc.	ALKS 5461	—	COMPLETED	2017-11-20	NCT02141399
Johnson & Johnson	Esketamine (Intranasal Spray)	—	COMPLETED	2017-10-28	NCT02497287
Supernus Pharmaceuticals, Inc.	SAGE-547 60 μg/kg/h	—	COMPLETED	2017-09-24	NCT02942004
Supernus Pharmaceuticals, Inc.	SAGE-547 90 μg/kg/h	—	COMPLETED	2017-09-17	NCT02942017
Johnson & Johnson	Esketamine	—	COMPLETED	2017-08-10	NCT02422186
Forest Laboratories	Cariprazine	—	COMPLETED	2017-07-19	NCT02670551
Johnson & Johnson	Esketamine	—	COMPLETED	2017-06-01	NCT02418585
Otsuka Pharmaceutical Development & Commercialization, Inc.	OPC-34712	—	COMPLETED	2017-04-18	NCT01360866
Ybrain Inc.	—	—	COMPLETED	2016-12	NCT02657980

Showing 100 of 207 trials (top 100 by completion date — export for full list)

Sponsor	Asset	MoA	Status	Primary Completion	NCT
atai Therapeutics, Inc.	VLS-01-203 BU	—	RECRUITING	2026-08-01	NCT06524830
Gilgamesh Pharmaceuticals	GM-2505	—	RECRUITING	2026-10	NCT06236880
Beckley Psytech Limited	BPL-003	—	RECRUITING	2026-11	NCT05660642
Alto Neuroscience	ALTO-300	—	RECRUITING	2026-12	NCT05922878
Mapi Pharma Ltd.	Cariprazine Depot	—	RECRUITING	2026-12-31	NCT07185815
Supernus Pharmaceuticals, Inc.	SPN-821 2400 mg	—	RECRUITING	2026-12-31	NCT07226661
Seaport Therapeutics	SPT-300	—	RECRUITING	2027-03	NCT07065240
Draig Therapeutics Ltd	DT-101	—	RECRUITING	2027-05	NCT07610473
ACADIA Pharmaceuticals Inc.	ACP-211	—	RECRUITING	2027-08	NCT07284667
Draig Therapeutics Ltd	DT-101	—	RECRUITING	2027-08	NCT07300969
AbbVie	Icalcaprant	—	RECRUITING	2027-09	NCT07276997
Syndeio Biosciences, Inc	Zelquistinel	—	RECRUITING	2027-09	NCT06547489
Alto Neuroscience	ALTO-207	—	RECRUITING	2027-11	NCT07553637
Tonix Pharmaceuticals, Inc.	TNX-102 SL	—	RECRUITING	2028-02	NCT07621237
Syndeio Biosciences, Inc	Zelquistinel	—	RECRUITING	2028-03-30	NCT07115329
Sichuan Purity Pharmaceutical Technology Co., Ltd.	Low Dose PRT042 nasal spray	—	RECRUITING	2026-06	NCT07193901
Autobahn Therapeutics, Inc.	ABX-002	—	RECRUITING	2026-06	NCT06633016
Hangzhou PhecdaMed Co., Ltd.	TJ0113	—	RECRUITING	2026-05-25	NCT07018245
Sirtsei Pharmaceuticals, Inc.	SP-624	—	ACTIVE NOT RECRUITING	2026-07-15	NCT06254612
Ono Pharmaceutical Co., Ltd.	ONO-1110	—	ACTIVE NOT RECRUITING	2026-08-31	NCT06792136
Johnson & Johnson	JNJ-89495120	—	ACTIVE NOT RECRUITING	2026-06-26	NCT06785012
Autobahn Therapeutics, Inc.	ABX-002	—	ACTIVE NOT RECRUITING	2026-04-22	NCT06869187
Chase Therapeutics Corporation	CTC-501	—	ACTIVE NOT RECRUITING	2025-12-30	NCT03642964
Eleusis Therapeutics	ELE-101	—	ACTIVE NOT RECRUITING	2025-12	NCT05434156
COMPASS Pathways	Psilocybin	—	ACTIVE NOT RECRUITING	2025-09	NCT05733546
Chengdu Kanghong Pharmaceutical Group Co., Ltd.	KH607 tablet	—	NOT YET RECRUITING	2027-01	NCT07096791
Afasci Inc	AFA-281	—	NOT YET RECRUITING	2027-06-01	NCT06710431
Enalare Therapeutics Inc.	ENA-001	—	NOT YET RECRUITING	2027-06-15	NCT06137638
Neurocentrx Pharma Pty Ltd	KET-AD	—	NOT YET RECRUITING	2028-01-30	NCT07644767
BioLite, Inc.	PDC-1421 Capsule	—	NOT YET RECRUITING	2028-02-28	NCT03833206
Soterix Medical	—	—	NOT YET RECRUITING	2028-06-01	NCT07287839
Chengdu Kanghong Pharmaceutical Group Co., Ltd.	KH607 tablets	—	NOT YET RECRUITING	2025-12	NCT07101120
Biohaven Therapeutics Ltd.	BHV-7000	—	COMPLETED	2026-03-18	NCT06423781
Suven Life Sciences Limited	Ropanicant	—	COMPLETED	2026-02-23	NCT06836063
Biohaven Therapeutics Ltd.	BHV-7000	—	COMPLETED	2025-11-07	NCT06419608
Otsuka Pharmaceutical Development & Commercialization, Inc.	SEP-363856	—	COMPLETED	2025-11-06	NCT05593029
DuKang Pharmaceuticals, Inc.	NORA520 Dose 1	—	COMPLETED	2025-09-11	NCT06285916
Nanjing Minova Pharmaceutical Co., Ltd.	MI078 capsule dose 1	—	COMPLETED	2025-08-07	NCT06963580
Jiangsu Nhwa Pharmaceutical Co., Ltd.	NH102	—	COMPLETED	2025-07-30	NCT06842992
Neurocrine Biosciences	NBI-1070770	—	COMPLETED	2025-07-25	NCT06267846
Clexio Biosciences Ltd.	CLE-100	—	COMPLETED	2025-06-06	NCT06340958
Reunion Neuroscience Inc	RE104 for Injection	—	COMPLETED	2025-05-22	NCT06342310
Otsuka Pharmaceutical Development & Commercialization, Inc.	Centanafadine	—	COMPLETED	2025-05-16	NCT05536414
Boehringer Ingelheim	5 mg BI 1569912	—	COMPLETED	2025-05-02	NCT06558344
Alto Neuroscience	ALTO-203 25 μg	—	COMPLETED	2025-04-14	NCT06391593
Beckley Psytech Limited	BPL-003	—	COMPLETED	2025-03-28	NCT05870540
Gilgamesh Pharmaceuticals	GM-1020	—	COMPLETED	2025-03-04	NCT06309277
Boehringer Ingelheim	BI 1569912	—	COMPLETED	2025-02-26	NCT06280235
Biomind Labs Inc.	Sublingual administration	—	COMPLETED	2025-02-15	NCT06812221
Navitor Pharmaceuticals, Inc.	NV-5138	—	COMPLETED	2025-01-21	NCT05066672
Mapreg	MAP4343	—	COMPLETED	2024-11-07	NCT03870776
Tasly Pharmaceutical Group Co., Ltd	JS1-1-01 low-dose group	—	COMPLETED	2024-10-23	NCT06259526
GH Research Ireland Limited	GH001	—	COMPLETED	2024-10-04	NCT05800860
Alto Neuroscience	ALTO-100	—	COMPLETED	2024-09-05	NCT05712187
Navitor Pharmaceuticals, Inc.	NV-5138	—	COMPLETED	2024-08-18	NCT06235905
Suven Life Sciences Limited	Ropanicant	—	COMPLETED	2024-07-19	NCT06126497
Actinogen Medical	Xanamem™	—	COMPLETED	2024-07-01	NCT05657691
Brii Biosciences Limited	BRII-296	—	COMPLETED	2024-03-13	NCT06057012
Denovo Biopharma LLC	Liafensine	—	COMPLETED	2024-02-06	NCT05113771
Boehringer Ingelheim	BI 1358894	—	COMPLETED	2024-01-10	NCT04521478
Neurocrine Biosciences	NBI-1065845	—	COMPLETED	2024-01-10	NCT05203341
Novartis	MIJ821 Subcutaneous Injection 1 mg	—	COMPLETED	2023-11-28	NCT05454410
Cybin IRL Limited	CYB003	—	COMPLETED	2023-10-16	NCT05385783
Tonix Pharmaceuticals, Inc.	TNX-601 ER	—	COMPLETED	2023-09-29	NCT05686408
Beijing Greatway Pharmaceutical Technology Co.,Ltd.	GW117 Tablets	—	COMPLETED	2023-09-28	NCT06796868
Xenon Pharmaceuticals Inc.	XEN1101 10 mg	—	COMPLETED	2023-09-18	NCT05376150
Ancora Bio, Inc. d/b/a EmbarkNeuro, Inc.	ANC-501	—	COMPLETED	2023-08-14	NCT05439603
Neurocrine Biosciences	NBI-1065846	—	COMPLETED	2023-07-07	NCT05165394
Seelos Therapeutics, Inc.	SLS-002	—	COMPLETED	2023-06-17	NCT04669665
Alto Neuroscience	ALTO-300 oral (PO) tablet	—	COMPLETED	2023-05-05	NCT05118750
Alto Neuroscience	ALTO-300 PO Tablet	—	COMPLETED	2023-04-26	NCT05157945
Johnson & Johnson	Midazolam	Benzodiazepine [EPC]	COMPLETED	2023-03-31	NCT03185819
Alto Neuroscience	ALTO-100 PO Tablet	—	COMPLETED	2023-01-13	NCT05419869
Alto Neuroscience	ALTO-100 PO tablet	—	COMPLETED	2022-12-01	NCT05117632
Perception Neuroscience	PCN-101	—	COMPLETED	2022-11-10	NCT05414422
Small Pharma Ltd	SPL026	—	COMPLETED	2022-10-01	NCT04673383
Clexio Biosciences Ltd.	CLE-100	—	COMPLETED	2022-09-21	NCT04103892
Praxis Precision Medicines	10 mg PRAX-114	—	COMPLETED	2022-07-15	NCT04969510
Sirtsei Pharmaceuticals, Inc.	SP-624	—	COMPLETED	2022-06-27	NCT04479852
Neumora Therapeutics, Inc.	NMRA-335140	—	COMPLETED	2022-04-08	NCT04221230
Otsuka Pharmaceutical Co., Ltd.	OPC-64005 20 mg , Once-daily	—	COMPLETED	2022-02-08	NCT04244253
GH Research Ireland Limited	5 Methoxy N,N Dimethyltryptamine	—	COMPLETED	2021-11-06	NCT04698603
COMPASS Pathways	Psilocybin	—	COMPLETED	2021-10-14	NCT04739865
Johnson & Johnson	JNJ-61393215	—	COMPLETED	2021-09-02	NCT04080752
COMPASS Pathways	Psilocybin	—	COMPLETED	2021-07-30	NCT03775200
Axsome Therapeutics, Inc.	AXS-05	—	COMPLETED	2021-07-30	NCT04608396
Johnson & Johnson	JNJ-67953964	—	COMPLETED	2020-05-06	NCT03559192
Sumitomo Pharma America, Inc.	SEP-4199 200 mg	—	COMPLETED	2020-04-23	NCT03543410
Novartis	MIJ821	—	COMPLETED	2020-03-23	NCT03756129
Celon Pharma SA	Esketamine DPI - low dose	—	COMPLETED	2020-03-15	NCT03965858
Zhejiang Huahai Pharmaceutical Co., Ltd.	Hypidone Hydrochloride tablets	—	COMPLETED	2019-12-18	NCT03739632
Minerva Neurosciences	MIN-117 5.0 mg	—	COMPLETED	2019-11-21	NCT03446846
Syndeio Biosciences, Inc	AGN-241751	—	COMPLETED	2019-10-23	NCT03726658
VistaGen Therapeutics, Inc.	AV-101	—	COMPLETED	2019-10-01	NCT03078322
Janssen Pharmaceutical K.K.	Intranasal esketamine (28 mg)	—	COMPLETED	2019-08-19	NCT02918318
H. Lundbeck A/S	Vortioxetine infusion 25 mg	—	COMPLETED	2019-07-31	NCT03766867
Relmada Therapeutics, Inc.	REL-1017	—	COMPLETED	2019-07-30	NCT03051256
Syndeio Biosciences, Inc	AGN-241751	—	COMPLETED	2019-07-22	NCT03586427
Marinus Pharmaceuticals	Ganaxolone	Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]	COMPLETED	2019-07-05	NCT03460756
Avid Radiopharmaceuticals	Flortaucipir F18	—	COMPLETED	2019-06-26	NCT02278367

Showing 100 of 125 trials (top 100 by completion date — export for full list)

Sponsor	Asset	MoA	Status	Primary Completion	NCT
Enalare Therapeutics Inc.	ENA-001	—	RECRUITING	2026-07-30	NCT06967259
Corium Innovations, Inc.	Selegiline Transdermal Delivery System	—	NOT YET RECRUITING	2026-10-07	NCT07452692
Soterix Medical	Ketamine (0.25 mg/kg)	—	NOT YET RECRUITING	2027-12-01	NCT07307768
Synphatec (Shanghai) Biopharmaceutical Technology Co., Ltd.	SP-101 injection	—	NOT YET RECRUITING	2026-06-30	NCT07334249
Nyree Penn	Diprivan (propofol), Astra-Zeneca	—	NOT YET RECRUITING	2026-05-01	NCT06644573
Sirtsei Pharmaceuticals, Inc.	SP-624	—	COMPLETED	2026-05-11	NCT06570369
Alar Pharmaceuticals Inc.	ALA-3000	—	COMPLETED	2025-12-30	NCT06965569
Engrail Therapeutics INC	ENX-104	—	COMPLETED	2025-11-26	NCT07253324
Otsuka Pharmaceutical Development & Commercialization, Inc.	SEP-380135	—	COMPLETED	2025-09-12	NCT07549581
Vigonvita Life Sciences	LV232 40mg	—	COMPLETED	2025-01-19	NCT06476509
Biogen	Zuranolone	Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC]	COMPLETED	2024-10-18	NCT05655507
Nanjing Minova Pharmaceutical Co., Ltd.	MI078	—	COMPLETED	2024-03-18	NCT06982651
Brii Biosciences Limited	BRII-297	—	COMPLETED	2023-11-21	NCT05845840
Boehringer Ingelheim	BI 1569912	—	COMPLETED	2023-11-16	NCT04937829
Novartis	MIJ821	—	COMPLETED	2023-11-07	NCT05666687
Small Pharma Ltd	SPL026	—	COMPLETED	2023-08-03	NCT05553691
Jiangsu Nhwa Pharmaceutical Co., Ltd.	NH102	—	COMPLETED	2023-04-10	NCT07324408
Small Pharma Ltd	SPL026 IV	—	COMPLETED	2023-04-05	NCT05644093
Syndeio Biosciences, Inc	apimostinel	—	COMPLETED	2023-04-04	NCT05597241
Beijing Greatway Pharmaceutical Technology Co.,Ltd.	GW117 ODT	—	COMPLETED	2023-03-24	NCT06964711
Johnson & Johnson	Seltorexant Dose 1	—	COMPLETED	2023-03-16	NCT04451187
Jiangsu Hansoh Pharmaceutical Co., Ltd.	HS-10353	—	COMPLETED	2023-03-11	NCT05195203
Seasons Biotechnology (Taizhou) Co., Ltd.	Vortioxetine Hemihydrobromide Orally Disintegrating Tablets 5mg	—	COMPLETED	2022-11-25	NCT05416762
Digestome Therapeutics	DGX-001Dose 1	—	COMPLETED	2022-11-06	NCT05121831
Seasons Biotechnology (Taizhou) Co., Ltd.	Vortioxetine Hemihydrobromide Orally Disintegrating Tablets	—	COMPLETED	2022-10-27	NCT05416957
Luye Pharma Group Ltd.	LY03010 156 mg treatment group, deltoid	—	COMPLETED	2022-09-23	NCT05321602
Seasons Biotechnology (Taizhou) Co., Ltd.	Vortioxetine Hemihydrobromide Orally Disintegrating Tablets	—	COMPLETED	2022-09-02	NCT05417087
Soterix Medical	—	—	COMPLETED	2022-08-10	NCT04781127
Jiangsu Hansoh Pharmaceutical Co., Ltd.	HS-10345 84mg	—	COMPLETED	2022-04-30	NCT05196971
Jiangsu Nhwa Pharmaceutical Co., Ltd.	NH102	—	COMPLETED	2022-01-11	NCT05015192
Jiangsu HengRui Medicine Co., Ltd.	HR071603	—	COMPLETED	2021-06-01	NCT04108234
Zhejiang Huahai Pharmaceutical Co., Ltd.	Hypidone Hydrochloride tablets	—	COMPLETED	2021-01-11	NCT04598607
Sunshine Lake Pharma Co., Ltd.	HEC113995	—	COMPLETED	2020-08-12	NCT04623814
Sunshine Lake Pharma Co., Ltd.	HEC113995 PA•H2O tablets	—	COMPLETED	2019-12-06	NCT04591301
BioDelivery Sciences International	Belbuca 300 µg	—	COMPLETED	2019-10-27	NCT03996694
Boehringer Ingelheim	BI 1358894	—	COMPLETED	2019-08-27	NCT03854578
Navitor Pharmaceuticals, Inc.	NV-5138	—	COMPLETED	2019-06-09	NCT03606395
Johnson & Johnson	JNJ-42847922 20mg	—	COMPLETED	2019-04-29	NCT03374475
Luye Pharma Group Ltd.	LY03005	—	COMPLETED	2019-02-16	NCT03822065
Luye Pharma Group Ltd.	LY03005	—	COMPLETED	2018-07-17	NCT03733574
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.	Ammoxetine Hydrochloride Enteric-coated Tablets	—	COMPLETED	2018-07-11	NCT03456388
Suven Life Sciences Limited	SUVN-911	—	COMPLETED	2018-07-10	NCT03551288
Johnson & Johnson	Esketamine	—	COMPLETED	2018-06-29	NCT02919579
Suven Life Sciences Limited	SUVN-911	—	COMPLETED	2018-03-07	NCT03155503
Luye Pharma Group Ltd.	LY03005	—	COMPLETED	2017-12-22	NCT03357796
Syndeio Biosciences, Inc	zelquistinel	—	COMPLETED	2017-12-21	NCT04981561
Lee's Pharmaceutical Limited	Trazodone Hydrochloride prolonged-release tablets	—	COMPLETED	2017-11-30	NCT02785601
Lee's Pharmaceutical Limited	trazodone hydrochloride prolonged-release tablet	—	COMPLETED	2017-11-30	NCT02785614
Neurocrine Biosciences	TAK-653	—	COMPLETED	2017-09-11	NCT02561156
Johnson & Johnson	JNJ-54175446, 600 mg	—	COMPLETED	2017-06-02	NCT02902601
Luye Pharma Group Ltd.	LY03005	—	COMPLETED	2016-12-28	NCT02988024
GSK	Bupropion HCl XL tablet 150mg	—	COMPLETED	2016-06-29	NCT02698553
Janssen-Cilag International NV	JNJ-42847922	—	COMPLETED	2016-01-04	NCT02476058
Luye Pharma Group Ltd.	LY03005 extended-release tablets 40 mg	—	COMPLETED	2015-10-31	NCT03785652
Roche	Basimglurant	—	COMPLETED	2015-09	NCT02433093
Naurex, Inc, an affiliate of Allergan plc	NRX-1074 375 mg	—	COMPLETED	2015-04	NCT02366364
Luye Pharma Group Ltd.	LY03005	—	COMPLETED	2015-03	NCT02271412
P1vital Products Limited	—	—	COMPLETED	2015-01	NCT02800577
Johnson & Johnson	JNJ-42847922	—	COMPLETED	2014-12	NCT02067299
Johnson & Johnson	Aripiprazole, oral formulation	—	COMPLETED	2014-10	NCT02087579
Luye Pharma Group Ltd.	LY03005	—	COMPLETED	2014-08	NCT02055300
Neuralstem Inc.	NSI-189 Phosphate	—	COMPLETED	2014-02	NCT01520649
H. Lundbeck A/S	Vortioxetine (Lu AA21004)	—	COMPLETED	2013-09	NCT01607125
BioLite, Inc.	PDC-1421	—	COMPLETED	2013-07	NCT01774045
MSI Methylation Sciences, Inc.	Ademetionine	—	COMPLETED	2013-06-08	NCT04623034
Otsuka Pharmaceutical Development & Commercialization, Inc.	Brexpiprazole	Atypical Antipsychotic [EPC]	COMPLETED	2013-05	NCT01670279
Eli Lilly	LY2216684	—	COMPLETED	2012-08	NCT01460381
Astellas	FK949E	—	COMPLETED	2012-06-22	NCT01919008
Bristol-Myers Squibb	BMS-820836	—	COMPLETED	2012-05	NCT01396252
Eli Lilly	LY2216684	—	COMPLETED	2011-12	NCT01373931
Eli Lilly	LY2216684	—	COMPLETED	2011-12	NCT01460407
Pfizer	desvenlafaxine	—	COMPLETED	2011-12	NCT01443208
BlackThorn Therapeutics, Inc.	LY2940094	—	COMPLETED	2011-11	NCT01404091
Neuralstem Inc.	NSI-189 Phosphate	—	COMPLETED	2011-11	NCT01310881
Eli Lilly	LY2216684	—	COMPLETED	2011-09	NCT01380691
Eli Lilly	LY2216684	—	COMPLETED	2011-09	NCT01389752
AbbVie	ABT-436	—	COMPLETED	2011-09	NCT01380704
Astellas	FK949E	—	COMPLETED	2011-09	NCT01903200
BlackThorn Therapeutics, Inc.	LY2940094	—	COMPLETED	2011-09	NCT01263236
Eli Lilly	LY2216684	—	COMPLETED	2011-08	NCT01389765
Dong Wha Pharmaceutical Co. Ltd.	DWETR10	—	COMPLETED	2011-08	NCT01367080
Astellas	FK949E	—	COMPLETED	2011-05	NCT01924520
Eli Lilly	LY2216684	—	COMPLETED	2011-04	NCT01241435
Eli Lilly	LY2216684	—	COMPLETED	2011-03	NCT01263197
Eli Lilly	LY2216684	—	COMPLETED	2011-03	NCT01263223
Eli Lilly	Clopidogrel	—	COMPLETED	2011-03	NCT01263093
AstraZeneca	AZD6765	—	COMPLETED	2011-03	NCT01046630
Eli Lilly	LY2216684	—	COMPLETED	2011-02	NCT01275144
Eli Lilly	Warfarin	—	COMPLETED	2011-02	NCT01263119
Eli Lilly	LY2216684	—	COMPLETED	2011-02	NCT01266590
Eli Lilly	LY2216684	—	COMPLETED	2011-01	NCT01263106
Eli Lilly	LY2216684	—	COMPLETED	2011-01	NCT01243957
Eli Lilly	LY2216684	—	COMPLETED	2011-01	NCT01250873
Pfizer	desvenlafaxine succinate sustained release	—	COMPLETED	2010-11	NCT01190514
Bristol-Myers Squibb	BMS-820836	—	COMPLETED	2010-11	NCT00892840
AstraZeneca	—	—	COMPLETED	2010-10	NCT01217645
CeNeRx BioPharma Inc.	CX157	—	COMPLETED	2010-10	NCT01633437
GSK	Aripiprazole	Atypical Antipsychotic [EPC]	COMPLETED	2010-07	NCT01424449
Novartis	ABP688	—	COMPLETED	2010-05	NCT01528241
GSK	GSK356278	—	COMPLETED	2010-04-07	NCT01031186

Novel Major Depressive Disorder Drugs by Company (New molecular entities)

3 companies have an FDA-approved novel drug for Major Depressive Disorder.

Johnson & Johnson 1 drug

SPRAVATO

ESKETAMINE HYDROCHLORIDE

SOMERSET 1 drug

FABRE KRAMER 1 drug

GEPIRONE HYDROCHLORIDE

NDA 2023

Reformulations (24 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.