Schizophrenia
CNS 1 original drugsCNS indication. Schizophrenia has 1 FDA-approved novel treatment, led by ALKERMES INC, with 114 active industry clinical trials across 22 drug targets. Explore market leaders, treatments by mechanism, the clinical pipeline, and drug targets below.
Schizophrenia Market Leaders
Companies with the most FDA-approved novel Schizophrenia drugs.
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.
Schizophrenia 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.
Schizophrenia Clinical Pipeline by Phase
568 industry-sponsored trials across 129 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 |
| 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 |
| Newron Pharmaceuticals SPA | Evenamide 15 mg bid | — | RECRUITING | 2026-12-31 | NCT07184619 |
| 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 |
| LB Pharmaceuticals Inc. | LB-102 | — | NOT YET RECRUITING | 2028-12 | NCT07369154 |
| Qilu Pharmaceutical Co., Ltd. | 3-6mg QLM1016 | — | NOT YET RECRUITING | 2026-07 | NCT06799559 |
| Chengdu Kanghong Pharmaceutical Group Co., Ltd. | Hydrochloride Carliprazine capsules | — | NOT YET RECRUITING | 2026-06 | NCT06589817 |
| 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 |
|---|---|---|---|---|---|
| Kynexis B.V. | KYN-5356 low dose | — | RECRUITING | 2026-10 | NCT07191483 |
| Mapi Pharma Ltd. | Cariprazine Depot | — | RECRUITING | 2026-12-31 | NCT07185815 |
| Boryung Pharmaceutical Co., Ltd | BR5402A | — | RECRUITING | 2027-05 | NCT06821945 |
| Novartis | GXV813 | — | RECRUITING | 2027-07-29 | NCT07467993 |
| 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 |
| 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 |
| Shanghai Zhongze Therapeutics Co., Ltd. | SIPI6398 Tablets | — | NOT YET RECRUITING | 2027-10 | NCT07626034 |
| 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 | 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 |
| Sponsor | Asset | MoA | Status | Primary Completion | NCT |
|---|---|---|---|---|---|
| Bristol-Myers Squibb | KarXT | — | RECRUITING | 2027-06-21 | NCT07061288 |
| Johnson & Johnson | Aticaprant | — | RECRUITING | 2027-06-21 | NCT07615426 |
| BioXcel Therapeutics Inc | BXCL501 80 Micrograms | — | RECRUITING | 2027-07-31 | NCT05025605 |
| Vigonvita Life Sciences | VV119 (in healthy adult subjects) | — | RECRUITING | 2026-07-01 | NCT06504290 |
| Sichuan Kelun Pharmaceutical Co., Ltd | Brexpiprazole long-acting injection | — | RECRUITING | 2026-06-30 | NCT06674694 |
| 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 | 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 | 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 |
Novel Schizophrenia Drugs by Company (New molecular entities)
1 company has an FDA-approved novel drug for Schizophrenia.
Reformulations (31 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.
Schizophrenia Drug Targets
Molecular targets of approved and investigational Schizophrenia drugs — 22 targets tracked.
Generic Drugs (12 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