Schizophrenia
CNS 1 original drugsMarket Leaders
Phase 3 Readouts Pro
12 active Phase 3 trials with confidence-graded completion dates.
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 7 mechanisms across 67 industry trials with a known mechanism of action.
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
566 industry-sponsored trials across 128 sponsors
| Sponsor | Asset | MoA | Status | Primary Completion | NCT |
|---|---|---|---|---|---|
| Neurocrine Biosciences | Valbenazine | — | RECRUITING | 2027-01 | NCT07105111 |
| Bristol-Myers Squibb | Xanomeline/trospium chloride | — | RECRUITING | 2027-12-30 | NCT07221877 |
| Vanda Pharmaceuticals | Iloperidone | Atypical Antipsychotic [EPC] | RECRUITING | 2026-03-31 | NCT05648591 |
| Neurocrine Biosciences | Valbenazine | — | COMPLETED | 2024-12-27 | NCT05859698 |
| BioXcel Therapeutics Inc | Sublingual film containing Igalmi | — | COMPLETED | 2024-04-29 | NCT06041646 |
| Janssen-Cilag International NV | Risperidone 3 mg | — | COMPLETED | 2024-04-16 | NCT04940039 |
| Sumitomo Pharma (Suzhou) Co., Ltd. | Lurasidone | — | COMPLETED | 2023-04-16 | NCT05011669 |
| Korea Otsuka Pharmaceutical Co., Ltd. | Abilify maintena | — | COMPLETED | 2021-11-19 | NCT03376763 |
| Indivior Inc. | PERSERIS | — | COMPLETED | 2020-05-12 | NCT03978832 |
| Johnson & Johnson | Risperidone 3 mg | — | COMPLETED | 2019-12-02 | NCT03713658 |
| Standard Chem. & Pharm. Co., Ltd. | Lurasidone | — | COMPLETED | 2019-09-17 | NCT03393026 |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | Aripiprazole | Atypical Antipsychotic [EPC] | COMPLETED | 2019-05-21 | NCT03568500 |
| Abdi İbrahim Otsuka | Aripiprazole 400mg LAI | — | COMPLETED | 2018-03-31 | NCT02697045 |
| Alkermes, Inc. | Aripiprazole Lauroxil | 5-HT1A receptor/5-HT2A receptor/D2 receptor | COMPLETED | 2017-07-11 | NCT02634320 |
| Xian-Janssen Pharmaceutical Ltd. | Paliperidone Palmitate | 5HT2A/D2 | COMPLETED | 2015-03 | NCT01947803 |
| Xian-Janssen Pharmaceutical Ltd. | Paliperidone Palmitate | 5HT2A/D2 | COMPLETED | 2014-12 | NCT01685931 |
| Johnson & Johnson | Paliperidone palmitate | 5HT2A/D2 | COMPLETED | 2013-12-31 | NCT01527305 |
| Janssen Scientific Affairs, LLC | paliperidone | Atypical Antipsychotic [EPC] | COMPLETED | 2013-12 | NCT01157351 |
| Sanofi | AMISULPRIDE | Dopamine-2 Receptor Antagonist [EPC] | COMPLETED | 2013-12 | NCT01795183 |
| Janssen Korea, Ltd., Korea | Paliperidone palmitate | 5HT2A/D2 | COMPLETED | 2013-09 | NCT01682161 |
| Eli Lilly | Olanzapine | Atypical Antipsychotic [EPC] | COMPLETED | 2013-05 | NCT00982020 |
| HK inno.N Corporation | A-prexa | — | COMPLETED | 2013-05 | NCT02137993 |
| Novartis | iloperidone | Atypical Antipsychotic [EPC] | COMPLETED | 2012-01 | NCT01207414 |
| Janssen-Cilag Turkey | Paliperidone extended-release (ER) | — | COMPLETED | 2011-10 | NCT00915512 |
| AstraZeneca | Seroquel XR- quetiapine fumarate extended release | — | COMPLETED | 2011-08 | NCT01213836 |
| Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Risperidone | Atypical Antipsychotic [EPC] | COMPLETED | 2011-07 | NCT01050582 |
| Janssen Korea, Ltd., Korea | Paliperidone | Atypical Antipsychotic [EPC] | COMPLETED | 2010-12 | NCT00784238 |
| Janssen Korea, Ltd., Korea | Paliperidone | Atypical Antipsychotic [EPC] | COMPLETED | 2010-10 | NCT00761579 |
| Janssen Korea, Ltd., Korea | Paliperidone | Atypical Antipsychotic [EPC] | COMPLETED | 2010-09 | NCT00761605 |
| Janssen-Cilag Ltd.,Thailand | Paliperidone extended release (ER) | — | COMPLETED | 2010-09 | NCT01387542 |
| Janssen Korea, Ltd., Korea | Paliperidone | Atypical Antipsychotic [EPC] | COMPLETED | 2010-07 | NCT00761189 |
| Janssen-Cilag S.p.A. | Paliperidone ER | — | COMPLETED | 2010-03 | NCT01362439 |
| AstraZeneca | Quetiapine XR (Seroquel XR) | — | COMPLETED | 2010-03 | NCT00954122 |
| Sanofi | amisulpride and risperidone | — | COMPLETED | 2010-01 | NCT00761670 |
| Janssen-Cilag Farmaceutica Ltda. | Paliperidone Extended Release (ER) | — | COMPLETED | 2009-12 | NCT01010776 |
| Janssen-Cilag, S.A. | Paliperidone ER | — | COMPLETED | 2009-11 | NCT01724359 |
| AstraZeneca | Quetiapine Fumarate XR | — | COMPLETED | 2009-07 | NCT00779506 |
| Johnson & Johnson Taiwan Ltd | Paliperidone ER | — | COMPLETED | 2009-06 | NCT01577186 |
| Johnson & Johnson Taiwan Ltd | Paliperidone ER | — | COMPLETED | 2009-05 | NCT00757705 |
| Johnson & Johnson Taiwan Ltd | Paliperidone ER | — | COMPLETED | 2009-04 | NCT01577160 |
| Sumitomo Pharma (Suzhou) Co., Ltd. | Blonanserin | — | TERMINATED | 2022-11-22 | NCT03784222 |
| Sumitomo Pharma (Suzhou) Co., Ltd. | Lurasidone | — | TERMINATED | 2022-11-18 | NCT05213143 |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | Aripiprazole or other oral antipsychotics | — | TERMINATED | 2018-10-17 | NCT03643159 |
| Johnson & Johnson Taiwan Ltd | Paliperidone extended-release | — | TERMINATED | 2015-06 | NCT01670071 |
| Janssen Korea, Ltd., Korea | Paliperdidone ER | — | TERMINATED | 2013-06 | NCT01592201 |
| Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | Ziprasidone HCL (oral) | — | TERMINATED | 2012-05 | NCT00748566 |
| Ortho-McNeil Janssen Scientific Affairs, LLC | paliperidone palmitate | 5HT2A/D2 | TERMINATED | 2010-03 | NCT00946985 |
| Janssen-Cilag G.m.b.H | Paliperidone ER | — | TERMINATED | 2009-12 | NCT00934635 |
| AstraZeneca | Quetiapine XR | — | TERMINATED | 2008-11 | NCT00681629 |
| Ortho-McNeil Janssen Scientific Affairs, LLC | paliperidone palmitate | 5HT2A/D2 | WITHDRAWN | 2012-09 | NCT01193166 |
| Sponsor | Asset | MoA | Status | Primary Completion | NCT |
|---|---|---|---|---|---|
| Alkermes, Inc. | OLZ/SAM | — | RECRUITING | 2026-09 | NCT05303064 |
| Newron Pharmaceuticals SPA | Evenamide 15 mg bid | — | RECRUITING | 2026-09-01 | NCT07184619 |
| SyneuRx International (Taiwan) Corp | NaBen® | — | RECRUITING | 2026-09-30 | NCT03094429 |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | SEP-363856 | — | RECRUITING | 2026-10-20 | NCT06894212 |
| Gedeon Richter Plc. | Cariprazine | — | RECRUITING | 2026-12-15 | NCT03817502 |
| LB Pharmaceuticals Inc. | LB-102 (50 mg tablet) | — | RECRUITING | 2027-06 | NCT07363577 |
| Neurocrine Biosciences | NBI-1117568 | — | RECRUITING | 2027-10 | NCT06963034 |
| Neurocrine Biosciences | NBI-1117568 | — | RECRUITING | 2027-11 | NCT07105098 |
| Vanda Pharmaceuticals | iloperidone | Atypical Antipsychotic [EPC] | RECRUITING | 2027-11 | NCT06961968 |
| Minerva Neurosciences | Roluperidone | — | RECRUITING | 2027-12 | NCT07565428 |
| Intra-Cellular Therapies, Inc. | Lumateperone | — | RECRUITING | 2027-12 | NCT06229210 |
| Otsuka Pharmaceutical Co., Ltd. | SEP-363856 | — | RECRUITING | 2028-03 | NCT07225712 |
| Bristol-Myers Squibb | KarXT | — | RECRUITING | 2028-09-23 | NCT06882785 |
| Neurocrine Biosciences | NBI-1117568 | — | RECRUITING | 2029-07 | NCT07227818 |
| Bristol-Myers Squibb | KarXT | — | RECRUITING | 2029-12-18 | NCT07288567 |
| Karuna Therapeutics, Inc., a Bristol Myers Squibb company | KarXT | — | RECRUITING | 2030-03-08 | NCT07424404 |
| Neurocrine Biosciences | NBI-1117568 | — | RECRUITING | 2031-12 | NCT07114874 |
| Karuna Therapeutics, Inc., a Bristol Myers Squibb company | Xanomeline and Trospium Chloride Capsules | — | RECRUITING | 2026-03-19 | NCT05304767 |
| Otsuka Pharmaceutical Co., Ltd. | OPC-34712FUM/ Brexpiprazole fumarate | — | RECRUITING | 2026-02 | NCT05325645 |
| Reviva Pharmaceuticals | Brilaroxazine | — | RECRUITING | 2025-02 | NCT05184335 |
| Otsuka Pharmaceutical Co., Ltd. | OPC-34712FUM/ Brexpiprazole fumarate | — | ACTIVE NOT RECRUITING | 2025-08 | NCT05326347 |
| Chengdu Kanghong Pharmaceutical Group Co., Ltd. | Hydrochloride Carliprazine capsules | — | NOT YET RECRUITING | 2026-06 | NCT06589817 |
| Qilu Pharmaceutical Co., Ltd. | 3-6mg QLM1016 | — | NOT YET RECRUITING | 2026-07 | NCT06799559 |
| LB Pharmaceuticals Inc. | LB-102 | — | NOT YET RECRUITING | 2028-12 | NCT07369154 |
| Qilu Pharmaceutical Co., Ltd. | Olanzapine-samidorphan; | — | NOT YET RECRUITING | 2026-04 | NCT06649214 |
| AbbVie | Cariprazine Flexible Dose | — | COMPLETED | 2025-10-06 | NCT04578756 |
| BioXcel Therapeutics Inc | BXCL501 | — | COMPLETED | 2025-08-15 | NCT05658510 |
| Click Therapeutics, Inc. | — | — | COMPLETED | 2025-06-20 | NCT05838625 |
| Click Therapeutics, Inc. | — | — | COMPLETED | 2025-06-13 | NCT06067984 |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | Brexpiprazole | Atypical Antipsychotic [EPC] | COMPLETED | 2025-04-22 | NCT03238326 |
| Karuna Therapeutics, Inc., a Bristol Myers Squibb company | Xanomeline and Trospium Chloride Capsules | — | COMPLETED | 2025-03-19 | NCT05145413 |
| Karuna Therapeutics, Inc., a Bristol Myers Squibb company | KarXT | — | COMPLETED | 2025-03-13 | NCT06572449 |
| Neurocrine Biosciences | Valbenazine | — | COMPLETED | 2025-02-04 | NCT05110157 |
| Boehringer Ingelheim | Iclepertin | — | COMPLETED | 2024-10-28 | NCT04860830 |
| Boehringer Ingelheim | Iclepertin | — | COMPLETED | 2024-10-18 | NCT04846881 |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | SEP-363856 | — | COMPLETED | 2024-09-23 | NCT05741528 |
| Boehringer Ingelheim | Iclepertin | — | COMPLETED | 2024-09-17 | NCT04846868 |
| Karuna Therapeutics, Inc., a Bristol Myers Squibb company | Xanomeline and Trospium Chloride Capsules | — | COMPLETED | 2024-09-16 | NCT05919823 |
| Intra-Cellular Therapies, Inc. | Lumateperone 42 mg | — | COMPLETED | 2024-07-25 | NCT04959032 |
| Karuna Therapeutics, Inc., a Bristol Myers Squibb company | Xanomeline and Trospium Chloride Capsules | — | COMPLETED | 2024-05-24 | NCT04820309 |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | SEP-363856 | — | COMPLETED | 2024-04-01 | NCT05628103 |
| Teva Branded Pharmaceutical Products R&D LLC | TV-44749 | — | COMPLETED | 2024-03-19 | NCT05693935 |
| ACADIA Pharmaceuticals Inc. | Pimavanserin | — | COMPLETED | 2024-01-25 | NCT04531982 |
| Lyndra Inc. | LYN-005 | — | COMPLETED | 2023-11-03 | NCT05779241 |
| Karuna Therapeutics, Inc., a Bristol Myers Squibb company | Xanomeline and Trospium Chloride Capsules | — | COMPLETED | 2023-10-03 | NCT04659174 |
| Alkermes, Inc. | ALKS 3831 | — | COMPLETED | 2023-09-06 | NCT03201757 |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | SEP-363856 75mg | — | COMPLETED | 2023-06-14 | NCT04092686 |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | SEP-363856 50mg | — | COMPLETED | 2023-05-12 | NCT04072354 |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | Brexpiprazole (OPC-34712) | — | COMPLETED | 2023-04-03 | NCT03198078 |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | SEP363856 | — | COMPLETED | 2022-12-30 | NCT04115319 |
| Karuna Therapeutics, Inc., a Bristol Myers Squibb company | Xanomeline and Trospium Chloride Capsules | — | COMPLETED | 2022-11-29 | NCT04738123 |
| Bukwang Pharmaceutical | Lurasidone HCL 160 mg | — | COMPLETED | 2022-10-26 | NCT03465787 |
| Karuna Therapeutics, Inc., a Bristol Myers Squibb company | Xanomeline and Trospium Chloride Capsules | — | COMPLETED | 2022-05-24 | NCT04659161 |
| Johnson & Johnson | PP6M injection Dose 1 | — | COMPLETED | 2022-05-03 | NCT04072575 |
| Teva Branded Pharmaceutical Products R&D, Inc. | TV-46000 | — | COMPLETED | 2021-12-02 | NCT03893825 |
| Alkermes, Inc. | ALKS 3831 | — | COMPLETED | 2021-12-01 | NCT03187769 |
| Otsuka Beijing Research Institute | Brexpiprazole | Atypical Antipsychotic [EPC] | COMPLETED | 2021-08-06 | NCT03874494 |
| Teva Branded Pharmaceutical Products R&D, Inc. | TV-46000 | — | COMPLETED | 2020-09-30 | NCT03503318 |
| Minerva Neurosciences | Roluperidone 32 mg | — | COMPLETED | 2020-05-26 | NCT03397134 |
| Johnson & Johnson | PP6M | — | COMPLETED | 2020-05-08 | NCT03345342 |
| BioXcel Therapeutics Inc | Sublingual film containing dexmedetomidine (BXCL501) | — | COMPLETED | 2020-05-06 | NCT04268303 |
| Rovi Pharmaceuticals Laboratories | Risperidone ISM 75 mg | — | COMPLETED | 2020-01-08 | NCT03870880 |
| Janssen Scientific Affairs, LLC | Aripiprazole | Atypical Antipsychotic [EPC] | COMPLETED | 2019-11-12 | NCT02431702 |
| Alkermes, Inc. | ALKS 3831 | — | COMPLETED | 2019-10-17 | NCT02873208 |
| H. Lundbeck A/S | Lu AF35700 | — | COMPLETED | 2019-10-10 | NCT02892422 |
| Otsuka Beijing Research Institute | Aripiprazole IM Depot | — | COMPLETED | 2019-07-22 | NCT03172871 |
| ACADIA Pharmaceuticals Inc. | Pimavanserin | — | COMPLETED | 2019-05-28 | NCT02970292 |
| Alkermes, Inc. | Paliperidone Palmitate | 5HT2A/D2 | COMPLETED | 2019-03-12 | NCT03345979 |
| Rovi Pharmaceuticals Laboratories | Risperidone ISM 75 mg | — | COMPLETED | 2018-12-17 | NCT03160521 |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | Aripiprazole | Atypical Antipsychotic [EPC] | COMPLETED | 2018-12-06 | NCT01129882 |
| Sumitomo Pharma Co., Ltd. | DSP-5423P 40mg | — | COMPLETED | 2018-12 | NCT02287584 |
| Alkermes, Inc. | ALKS 3831 | — | COMPLETED | 2018-11-07 | NCT02694328 |
| Sumitomo Pharma America, Inc. | Lurasidone 20, 40, 60, 80 mg, flexibly dosed | — | COMPLETED | 2018-10-17 | NCT01914393 |
| H. Lundbeck A/S | Risperidone | Atypical Antipsychotic [EPC] | COMPLETED | 2018-08-30 | NCT02717195 |
| Alkermes, Inc. | ALKS 3831 | — | COMPLETED | 2018-06-29 | NCT02669758 |
| Noven Pharmaceuticals, Inc. | Low Dose Asenapine maleate transdermal patch | — | COMPLETED | 2018-06 | NCT02876900 |
| Johnson & Johnson | Paliperidone palmitate 3 month formulation (PP3M) | — | COMPLETED | 2018-03-26 | NCT02713282 |
| Braeburn Pharmaceuticals | Risperidone implant | — | COMPLETED | 2017-09 | NCT02773576 |
| Alkermes, Inc. | ALK3831 | — | COMPLETED | 2017-05-25 | NCT02634346 |
| Sumitomo Pharma Co., Ltd. | DSP-5423P | — | COMPLETED | 2017-05 | NCT02335658 |
| Tanabe Pharma Corporation | MP-214 3mg | — | COMPLETED | 2016-10 | NCT01626872 |
| Indivior Inc. | RBP-7000 | — | COMPLETED | 2016-09 | NCT02203838 |
| Intra-Cellular Therapies, Inc. | ITI-007 | — | COMPLETED | 2016-08 | NCT02469155 |
| Alkermes, Inc. | ALKS 9072, Low Dose | — | COMPLETED | 2016-06 | NCT01895452 |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | Brexpiprazole | Atypical Antipsychotic [EPC] | COMPLETED | 2016-04 | NCT02194933 |
| FORUM Pharmaceuticals Inc | EVP-6124 | — | COMPLETED | 2016-02 | NCT01716975 |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | OPC-34712 | — | COMPLETED | 2016-01 | NCT01397786 |
| Sumitomo Pharma America, Inc. | Lurasidone 40 mg | — | COMPLETED | 2015-12 | NCT01911429 |
| H. Lundbeck A/S | Brexpiprazole | Atypical Antipsychotic [EPC] | COMPLETED | 2015-12 | NCT01810783 |
| FORUM Pharmaceuticals Inc | EVP-6124 | — | COMPLETED | 2015-12 | NCT01714661 |
| Otsuka Pharmaceutical Co., Ltd. | Aripiprazole | Atypical Antipsychotic [EPC] | COMPLETED | 2015-11 | NCT01942148 |
| FORUM Pharmaceuticals Inc | EVP-6124 | — | COMPLETED | 2015-10 | NCT01714713 |
| Tanabe Pharma Corporation | MP-214 3mg | — | COMPLETED | 2015-08 | NCT01625000 |
| Intra-Cellular Therapies, Inc. | ITI-007 | — | COMPLETED | 2015-07 | NCT02282761 |
| Otsuka Pharmaceutical Co., Ltd. | OPC-34712 | — | COMPLETED | 2015-06 | NCT01451164 |
| Sumitomo Pharma Co., Ltd. | SM-13496 | — | COMPLETED | 2015-05 | NCT01614912 |
| Otsuka Pharmaceutical Co., Ltd. | OPC-34712 | — | COMPLETED | 2015-05 | NCT01456897 |
| Organon and Co | Asenapine | Atypical Antipsychotic [EPC] | COMPLETED | 2015-04-22 | NCT01142596 |
| Sumitomo Pharma (Suzhou) Co., Ltd. | Lurasidone tablets | — | COMPLETED | 2015-04 | NCT02002832 |
| Alkermes, Inc. | ALKS 9072, Low | — | COMPLETED | 2015-04 | NCT01626456 |
| Sponsor | Asset | MoA | Status | Primary Completion | NCT |
|---|---|---|---|---|---|
| Mapi Pharma Ltd. | Cariprazine Depot | — | RECRUITING | 2026-12-31 | NCT07185815 |
| Novartis | GXV813 | — | RECRUITING | 2027-04-22 | NCT07467993 |
| Boryung Pharmaceutical Co., Ltd | BR5402A | — | RECRUITING | 2027-05 | NCT06821945 |
| Neurocrine Biosciences | NBI-1117570 | — | RECRUITING | 2027-08 | NCT07288333 |
| Eli Lilly | Brenipatide | — | RECRUITING | 2027-11 | NCT07410507 |
| AbbVie | Emraclidine | — | RECRUITING | 2028-02 | NCT07145918 |
| MapLight Therapeutics | ML-007C-MA | — | RECRUITING | 2030-02 | NCT07459647 |
| Alto Neuroscience | ALTO-101 | — | RECRUITING | 2026-02 | NCT06502964 |
| Kynexis B.V. | KYN-5356 low dose | — | RECRUITING | 2025-10 | NCT07191483 |
| MapLight Therapeutics | ML-007C-MA BID | — | ACTIVE NOT RECRUITING | 2026-08 | NCT07038876 |
| Spinogenix | SPG302 | — | ACTIVE NOT RECRUITING | 2026-03 | NCT06442462 |
| Anavex Life Sciences Corp. | ANAVEX3-71 oral capsules | — | ACTIVE NOT RECRUITING | 2025-06-30 | NCT06245213 |
| Luye Pharma Group Ltd. | LY03020 | — | NOT YET RECRUITING | 2027-12-31 | NCT07396870 |
| Jiangsu Hansoh Pharmaceutical Co., Ltd. | HS-10380 Low Dose | — | COMPLETED | 2026-01-02 | NCT07550387 |
| BioXcel Therapeutics Inc | BXCL501 Sublingual Film | — | COMPLETED | 2025-10-07 | NCT07116694 |
| AbbVie | CVL-231 30 mg | — | COMPLETED | 2025-06-25 | NCT05443724 |
| Recognify Life Sciences | RL-007 (Inidascamine) | — | COMPLETED | 2025-04-09 | NCT05686239 |
| LB Pharmaceuticals Inc. | LB-102 | — | COMPLETED | 2024-12-04 | NCT06179108 |
| AbbVie | Emraclidine 10 mg | — | COMPLETED | 2024-08-23 | NCT05227690 |
| AbbVie | Emraclidine 15 mg | — | COMPLETED | 2024-08-15 | NCT05227703 |
| Neurocrine Biosciences | NBI-1117568 | — | COMPLETED | 2024-07-10 | NCT05545111 |
| Merck | Elpipodect | — | COMPLETED | 2024-06-21 | NCT04624243 |
| Celon Pharma SA | CPL500036 - low dose | — | COMPLETED | 2024-06-05 | NCT05278156 |
| Delpor, Inc. | — | — | COMPLETED | 2023-02-10 | NCT04418466 |
| Zhejiang Jingxin Pharmaceutical Co., Ltd. | JX11502MA | — | COMPLETED | 2022-12-27 | NCT06356389 |
| Boehringer Ingelheim | BI 425809 | — | COMPLETED | 2022-09-30 | NCT03859973 |
| Roche | RO6889450 | — | COMPLETED | 2022-06-21 | NCT04512066 |
| Biogen | BIIB104 | — | COMPLETED | 2022-03-23 | NCT03745820 |
| Recognify Life Sciences | RL-007 | — | COMPLETED | 2021-10-28 | NCT04822883 |
| Newron Pharmaceuticals SPA | Evenamide | — | COMPLETED | 2021-02-20 | NCT04461119 |
| Neurocrine Biosciences | Luvadaxistat | — | COMPLETED | 2020-12-29 | NCT03382639 |
| Concert Pharmaceuticals | CTP-692 | — | COMPLETED | 2020-12-22 | NCT04158687 |
| Lyndra Inc. | LYN-005 | — | COMPLETED | 2020-12-22 | NCT04567524 |
| Neurocrine Biosciences | Luvadaxistat | — | COMPLETED | 2020-12-21 | NCT03359785 |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | Aripiprazole | Atypical Antipsychotic [EPC] | COMPLETED | 2020-07-08 | NCT04030143 |
| Boehringer Ingelheim | BI 425809 dose 1 | — | COMPLETED | 2019-12-27 | NCT02832037 |
| Roche | Basmisanil | — | COMPLETED | 2019-12-12 | NCT02953639 |
| Astellas Pharma Global Development, Inc. | ASP4345 | — | COMPLETED | 2019-10-21 | NCT03557931 |
| ACADIA Pharmaceuticals Inc. | Pimavanserin | — | COMPLETED | 2019-10-16 | NCT02970305 |
| Novartis | — | — | COMPLETED | 2019-09-26 | NCT03751280 |
| Neurocrine Biosciences | TAK-041 | — | COMPLETED | 2019-09-11 | NCT03319953 |
| Karuna Therapeutics, Inc., a Bristol Myers Squibb company | Xanomeline and Trospium Chloride Capsules | — | COMPLETED | 2019-09-04 | NCT03697252 |
| Pharmathen S.A. | Paliperidone | Atypical Antipsychotic [EPC] | COMPLETED | 2019-05-02 | NCT03425552 |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | SEP-363856 | — | COMPLETED | 2019-01-29 | NCT02970929 |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | SEP-363856 | — | COMPLETED | 2018-07-31 | NCT02969382 |
| Merck | Elpipodect | — | COMPLETED | 2018-01-09 | NCT03055338 |
| Braeburn Pharmaceuticals | Risperidone Implant | — | COMPLETED | 2017-08 | NCT02658357 |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | AVP-786 | — | COMPLETED | 2017-07-21 | NCT02477670 |
| Alkermes, Inc. | Samidorphan + olanzapine (ALKS 3831) | — | COMPLETED | 2017-01-11 | NCT02161718 |
| Newron Pharmaceuticals SPA | NW-3509A | — | COMPLETED | 2016-12 | NCT02624167 |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | Aripiprazole + IEM (Ingestible Event Marker) | — | COMPLETED | 2016-09 | NCT02722967 |
| Takeda | TAK-063 20 mg | — | COMPLETED | 2016-07-13 | NCT02477020 |
| Boehringer Ingelheim | BI 409306 100 mg QD | — | COMPLETED | 2016-05-26 | NCT02281773 |
| Pierre Fabre Medicament | F17464 | — | COMPLETED | 2015-12 | NCT02151656 |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | — | — | COMPLETED | 2015-07 | NCT02219009 |
| Intra-Cellular Therapies, Inc. | ITI-007 | — | COMPLETED | 2015-07 | NCT02288845 |
| SK Life Science, Inc. | SKL15508 | — | COMPLETED | 2015-06 | NCT02205099 |
| Rovi Pharmaceuticals Laboratories | Risperidone ISM | — | COMPLETED | 2015-03 | NCT02086786 |
| Posit Science Corporation | — | — | COMPLETED | 2015-03 | NCT01422902 |
| Jazz Pharmaceuticals | GWP42003 | — | COMPLETED | 2015-01-08 | NCT02006628 |
| Alkermes, Inc. | Samidorphan (Low Dose) | — | COMPLETED | 2014-12 | NCT01903837 |
| AbbVie (prior sponsor, Abbott) | ABT-126 | — | COMPLETED | 2014-04 | NCT01655680 |
| Omeros Corporation | OMS643762 | — | COMPLETED | 2014-04 | NCT01952132 |
| AbbVie (prior sponsor, Abbott) | ABT-126 | — | COMPLETED | 2014-03 | NCT01678755 |
| Novartis | AQW051 | — | COMPLETED | 2013-12 | NCT01730768 |
| Targacept Inc. | TC-5619 | — | COMPLETED | 2013-11 | NCT01488929 |
| Jiangsu Hansoh Pharmaceutical Co., Ltd. | iloperidone | Atypical Antipsychotic [EPC] | COMPLETED | 2013-10 | NCT01623713 |
| Intra-Cellular Therapies, Inc. | ITI-007 | — | COMPLETED | 2013-08 | NCT01499563 |
| Indivior Inc. | Risperidone | Atypical Antipsychotic [EPC] | COMPLETED | 2013-04 | NCT01677377 |
| Reviva Pharmaceuticals | RP5063 | — | COMPLETED | 2013-03 | NCT01490086 |
| Biomedisyn Corporation | huperzine 0.2 mg BID | — | COMPLETED | 2012-12 | NCT00963846 |
| PharmaNeuroBoost N.V. | Pipamperone | — | COMPLETED | 2012-11 | NCT01450514 |
| Johnson & Johnson | JNJ-40411813 | — | COMPLETED | 2012-11 | NCT01323205 |
| Roche | bitopertin [RO4917838] | — | COMPLETED | 2012-09 | NCT01234779 |
| Amarantus BioScience Holdings, Inc. | Eltoprazine | — | COMPLETED | 2012-09 | NCT01266174 |
| Novartis | Iloperidone crystalline formulation | — | COMPLETED | 2012-07 | NCT01348100 |
| Denovo Biopharma LLC | LY2140023 | — | COMPLETED | 2012-06 | NCT01052103 |
| Eli Lilly | Risperidone | Atypical Antipsychotic [EPC] | COMPLETED | 2012-05 | NCT01086748 |
| H. Lundbeck A/S | Zicronapine open-label lead-in 10 mg daily | — | COMPLETED | 2012-02 | NCT01377233 |
| Novartis | AQW051 | — | COMPLETED | 2011-11 | NCT00825539 |
| Novartis | AQW051 2 mg (single and multiple doses) | — | COMPLETED | 2011-09 | NCT01163227 |
| GSK | GSK239512 | — | COMPLETED | 2011-08-10 | NCT01009060 |
| AbbVie (prior sponsor, Abbott) | ABT-126 | — | COMPLETED | 2011-08 | NCT01095562 |
| Pfizer | PF-02545920 | — | COMPLETED | 2011-08 | NCT01175135 |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | OPC-34712 | — | COMPLETED | 2011-08 | NCT01649557 |
| AbbVie (prior sponsor, Abbott) | ABT-288 Low Dose | — | COMPLETED | 2011-07 | NCT01077700 |
| cerbomed GmbH | — | — | COMPLETED | 2011-07 | NCT01176721 |
| Takeda | SPD489 (lisdexamfetamine dimesylate) | — | COMPLETED | 2011-01-20 | NCT00922272 |
| FORUM Pharmaceuticals Inc | EVP-6124 | — | COMPLETED | 2011-01 | NCT00968851 |
| Targacept Inc. | TC-5619 | — | COMPLETED | 2010-11 | NCT01003379 |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | OPC-34712 | — | COMPLETED | 2010-09 | NCT00905307 |
| Forest Laboratories | Cariprazine | — | COMPLETED | 2010-08-31 | NCT00839852 |
| Denovo Biopharma LLC | LY2140023 | — | COMPLETED | 2010-05 | NCT00845026 |
| Cyrenaic Pharmaceuticals | CYR-101 | — | COMPLETED | 2010-05 | NCT00861796 |
| AstraZeneca | AZD 8529 | — | COMPLETED | 2010-05 | NCT00921804 |
| Merck | MK-8998 | — | COMPLETED | 2010-04 | NCT00827918 |
| Cephalon | armodafinil | DAT | COMPLETED | 2010-03 | NCT00772005 |
| Roche | RO4917838 | — | COMPLETED | 2010-02 | NCT00616798 |
| Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | JNJ-37822681 | — | COMPLETED | 2010-02 | NCT00728195 |
| H. Lundbeck A/S | Lu AE58054 | — | COMPLETED | 2010-01 | NCT00810667 |
| Sponsor | Asset | MoA | Status | Primary Completion | NCT |
|---|---|---|---|---|---|
| Sichuan Kelun Pharmaceutical Co., Ltd | Brexpiprazole long-acting injection | — | RECRUITING | 2026-06-30 | NCT06674694 |
| Vigonvita Life Sciences | VV119 (in healthy adult subjects) | — | RECRUITING | 2026-07-01 | NCT06504290 |
| Bristol-Myers Squibb | KarXT | — | RECRUITING | 2027-06-21 | NCT07061288 |
| BioXcel Therapeutics Inc | BXCL501 80 Micrograms | — | RECRUITING | 2027-07-31 | NCT05025605 |
| Luye Pharma Group Ltd. | LY03020 | — | RECRUITING | 2025-12-31 | NCT07230652 |
| Vigonvita Life Sciences | VV119(SAD) | — | RECRUITING | 2025-12 | NCT06105151 |
| Luye Pharma Group Ltd. | LY03020 | — | ACTIVE NOT RECRUITING | 2025-08-27 | NCT07292233 |
| Jiangxi Kvvit Pharmaceutical Co., Ltd. | KR23248 | — | NOT YET RECRUITING | 2026-11 | NCT07585383 |
| Anxo Pharmaceutical Co., Ltd. | AX251 LAI 45 mg | — | NOT YET RECRUITING | 2028-07 | NCT07484204 |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | 14C-SEP-380135 | — | NOT YET RECRUITING | 2026-04-10 | NCT07455084 |
| Luye Pharma Group Ltd. | LY03017 | — | NOT YET RECRUITING | 2025-10-31 | NCT06793995 |
| Luye Pharma Group Ltd. | LY03017 | — | NOT YET RECRUITING | 2025-10 | NCT06980207 |
| Intra-Cellular Therapies, Inc. | Lumateperone Capsule | — | COMPLETED | 2025-11-20 | NCT06627413 |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | SEP-380135 | — | COMPLETED | 2025-09-12 | NCT07549581 |
| Teva Branded Pharmaceutical Products R&D LLC | TV-44749 | — | COMPLETED | 2025-08-14 | NCT06315283 |
| Humanis Saglık Anonim Sirketi | Brexpiprazole Film Coated Tablets | — | COMPLETED | 2025-08-04 | NCT07266792 |
| Rovi Pharmaceuticals Laboratories | Oral risperidone; QUAR F1/2, Dose 1 - Gluteal | — | COMPLETED | 2025-07-07 | NCT06276361 |
| Teva Branded Pharmaceutical Products R&D, Inc. | TV-44749 | — | COMPLETED | 2025-06-12 | NCT06253546 |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | SEP-380135 | — | COMPLETED | 2025-05-03 | NCT07305779 |
| Otsuka Pharmaceutical Co., Ltd. | OPC-34712FUM/ Brexpiprazole fumarate | — | COMPLETED | 2025-03-18 | NCT06036108 |
| Luye Pharma Group Ltd. | LY03020 | — | COMPLETED | 2025-02-13 | NCT06556966 |
| Teva Branded Pharmaceutical Products R&D LLC | Olanzapine Extended Release | — | COMPLETED | 2025-01-15 | NCT06319170 |
| Vanda Pharmaceuticals | VHX-896 and iloperidone | — | COMPLETED | 2024-10-24 | NCT06494397 |
| Kynexis B.V. | KYN-5356 | — | COMPLETED | 2024-10-07 | NCT06225115 |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | SEP-363856 | — | COMPLETED | 2024-03-15 | NCT05848700 |
| Merck | Elpipodect | — | COMPLETED | 2024-02-22 | NCT05893862 |
| Merck | MK-5720 | — | COMPLETED | 2024-02-15 | NCT05953740 |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | SEP-363856 | — | COMPLETED | 2024-02-12 | NCT05542264 |
| Minerva Neurosciences | Roluperidone 64 mg | — | COMPLETED | 2024-01-12 | NCT06107803 |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | SEP-363856 | — | COMPLETED | 2023-09-27 | NCT05402111 |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | SEP-363856 | — | COMPLETED | 2023-08-22 | NCT05463770 |
| Cerevel Therapeutics, LLC | CVL-231 | — | COMPLETED | 2023-07-14 | NCT04787302 |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | SEP-363856 | — | COMPLETED | 2023-06-06 | NCT04038957 |
| Merck | Elpipodect | — | COMPLETED | 2023-02-24 | NCT05406440 |
| Cerevel Therapeutics, LLC | CVL-231 | — | COMPLETED | 2022-10-19 | NCT05245539 |
| CF Pharma, LLC | VLT-015 | — | COMPLETED | 2022-09-30 | NCT05516121 |
| Merck | Nicotine patch | — | COMPLETED | 2022-09-23 | NCT05136690 |
| Luye Pharma Group Ltd. | LY03010 156 mg treatment group, deltoid | — | COMPLETED | 2022-09-23 | NCT05321602 |
| Vanda Pharmaceuticals | Iloperidone | Atypical Antipsychotic [EPC] | COMPLETED | 2022-08-30 | NCT04712734 |
| Whanin Pharmaceutical Company | Clozaril 100 mg (Clozapine) | — | COMPLETED | 2022-08-14 | NCT04849026 |
| Intra-Cellular Therapies, Inc. | Lumateperone 42 mg | — | COMPLETED | 2022-07-30 | NCT04779177 |
| Intra-Cellular Therapies, Inc. | Lumateperone Long-Acting Injectable | — | COMPLETED | 2022-05-23 | NCT04709224 |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | SEP-363856 | — | COMPLETED | 2022-05-03 | NCT04865835 |
| Tisento Therapeutics | CY6463 | — | COMPLETED | 2022-04-18 | NCT04972227 |
| Merck | Elpipodect | — | COMPLETED | 2022-03-22 | NCT04506905 |
| Luye Pharma Group Ltd. | LY03010; paliperidone palmitate | — | COMPLETED | 2022-03-15 | NCT04922593 |
| Cerevel Therapeutics, LLC | 10 mg CVL-231 as IR formulation | — | COMPLETED | 2022-02-24 | NCT05106309 |
| Cadent Therapeutics | CAD-9303 | — | COMPLETED | 2021-09-22 | NCT04306146 |
| LB Pharmaceuticals Inc. | LB-102 | — | COMPLETED | 2021-09-17 | NCT04588129 |
| Rovi Pharmaceuticals Laboratories | Risperidone ISM® 100 mg | — | COMPLETED | 2021-09-17 | NCT05179525 |
| Cerevel Therapeutics, LLC | CVL-231 | — | COMPLETED | 2021-05-07 | NCT04136873 |
| Sirtsei Pharmaceuticals, Inc. | SP-624 | — | COMPLETED | 2021-04-15 | NCT04510298 |
| Otsuka Pharmaceutical Co., Ltd. | 2mg conventional tablet, once-weekly tablets | — | COMPLETED | 2021-02-16 | NCT04118127 |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | SEP363856 150 mg | — | COMPLETED | 2020-11-10 | NCT04369391 |
| Sumitomo Pharma Co., Ltd. | SEP-363856 | — | COMPLETED | 2020-08-07 | NCT04325737 |
| LB Pharmaceuticals Inc. | LB-102 | — | COMPLETED | 2020-07-01 | NCT04187560 |
| Luye Pharma Group Ltd. | Paliperidone Palmitate | 5HT2A/D2 | COMPLETED | 2020-06-26 | NCT04572685 |
| Merck | MK-8189 | — | COMPLETED | 2020-04-03 | NCT03565068 |
| Cerevance Alpha, Inc. | CVN058 | — | COMPLETED | 2020-03-06 | NCT03669250 |
| Vanda Pharmaceuticals | Iloperidone | Atypical Antipsychotic [EPC] | COMPLETED | 2019-11-27 | NCT04127058 |
| Otsuka Beijing Research Institute | Aripiprazole IM Depot | — | COMPLETED | 2019-11-08 | NCT03287505 |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | Seroquel IR 300mg | — | COMPLETED | 2019-10-30 | NCT03872596 |
| Otsuka Beijing Research Institute | Aripiprazole IM Depot | — | COMPLETED | 2019-10-14 | NCT03285503 |
| Neurocrine Biosciences | TAK-041 | — | COMPLETED | 2019-09-22 | NCT02748694 |
| Roche | Ralmitaront | — | COMPLETED | 2019-09-04 | NCT06880328 |
| BioXcel Therapeutics Inc | Sublingual film containing BXCL501 (Dexmedetomidine) | — | COMPLETED | 2019-07-31 | NCT04010305 |
| Luye Pharma Group Ltd. | LY03010 | — | COMPLETED | 2019-07-24 | NCT03751488 |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | Aripiprazole | Atypical Antipsychotic [EPC] | COMPLETED | 2019-04-05 | NCT03854409 |
| Autifony Therapeutics Limited | AUT00206 | — | COMPLETED | 2019-04-03 | NCT03164876 |
| Sumitomo Pharma America, Inc. | DSP-1349M | — | COMPLETED | 2019-03-29 | NCT03627195 |
| Rovi Pharmaceuticals Laboratories | Risperidone ISM® 100 mg | — | COMPLETED | 2019-03-23 | NCT03527186 |
| Sumitomo Pharma Co., Ltd. | SEP-363856 | — | COMPLETED | 2018-09-20 | NCT03370640 |
| Astellas Pharma Global Development, Inc. | ASP6981 | — | COMPLETED | 2018-05-30 | NCT03356639 |
| H. Lundbeck A/S | Lu AF35700 (10 mg/day) | — | COMPLETED | 2018-04-18 | NCT02901587 |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | Aripiprazole | Atypical Antipsychotic [EPC] | COMPLETED | 2018-04-18 | NCT03150771 |
| Autifony Therapeutics Limited | Low dose AUT00206 800mg | — | COMPLETED | 2017-11 | NCT02935725 |
| Boehringer Ingelheim | BI 409306 25 mg | — | COMPLETED | 2017-08-03 | NCT02392468 |
| Astellas Pharma Global Development, Inc. | ASP4345 | — | COMPLETED | 2017-06-08 | NCT02720263 |
| Roche | RO5545965 | — | COMPLETED | 2017-04-24 | NCT02824055 |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | Brexpiprazole (OPC-34712) | — | COMPLETED | 2017-01-01 | NCT02411695 |
| Cycle Pharmaceuticals Ltd. | Chlorpromazine Hydrochloride | — | COMPLETED | 2016-12 | NCT02943213 |
| Karuna Therapeutics, Inc., a Bristol Myers Squibb company | xanomeline tartrate | — | COMPLETED | 2016-10-28 | NCT02831231 |
| Pfizer | PF-06412562 3mg BID | — | COMPLETED | 2016-10 | NCT02418819 |
| Braeburn Pharmaceuticals | ATI-9242 | — | COMPLETED | 2016-09-06 | NCT02824666 |
| Alkermes, Inc. | ALKS 3831 | — | COMPLETED | 2016-08 | NCT02804568 |
| Autifony Therapeutics Limited | AUT00206 | — | COMPLETED | 2016-07 | NCT02589262 |
| Alkermes, Inc. | Aripiprazole Lauroxil | 5-HT1A receptor/5-HT2A receptor/D2 receptor | COMPLETED | 2016-06 | NCT02636842 |
| Indivior Inc. | RBP-7000 | — | COMPLETED | 2016-05 | NCT02687984 |
| Alkermes, Inc. | Aripiprazole Lauroxil | 5-HT1A receptor/5-HT2A receptor/D2 receptor | COMPLETED | 2016-04 | NCT02320032 |
| H. Lundbeck A/S | Lu AF35700 | — | COMPLETED | 2016-02-11 | NCT02333487 |
| CMG Pharmaceutical Co. Ltd | Aripiprazole | Atypical Antipsychotic [EPC] | COMPLETED | 2016-02 | NCT02501109 |
| Amgen | AMG 581 | — | COMPLETED | 2016-02 | NCT02504476 |
| CoMentis | APN1125 | — | COMPLETED | 2015-11 | NCT02331433 |
| Amgen | AMG 581 | — | COMPLETED | 2015-10 | NCT02567370 |
| Zogenix, Inc. | ZX003 (Risperidone-SABER®) | — | COMPLETED | 2015-09 | NCT02411526 |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | SEP-363856 | — | COMPLETED | 2015-07 | NCT01972711 |
| Takeda | Roflumilast | Phosphodiesterase 4 Inhibitor [EPC] | COMPLETED | 2015-06 | NCT02079844 |
| Merck | Elpipodect | — | COMPLETED | 2015-04-23 | NCT02181803 |
| Biogen | PF-04958242 | — | COMPLETED | 2015-04-15 | NCT02332798 |
| Otsuka Pharmaceutical Co., Ltd. | OPC-14597 IMD | — | COMPLETED | 2015-04 | NCT02220712 |
Novel Drugs by Company (New molecular entities)
Reformulations (30 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.
Drug Targets
Generic Drugs (11 ANDA approved) Click to expand
Generic drugs contain the same active ingredient as the brand-name drug and are approved via ANDA (Abbreviated New Drug Application).
Drug Categories:
- Novel Drugs: NDA Type 1/2 (new molecular entity) or original BLA
- Reformulations: NDA Type 3/5 (new dosage form of existing molecule)
- Biosimilars: BLA-approved biologics highly similar to reference products
- Generics: ANDA-approved copies of small molecule drugs