23 completed, 4 recruiting, 3 terminated, 1 active not recruiting. 14 Phase 3, 13 Phase 1, 6 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 14 | Completed 6, Recruiting 4, Terminated 3, Active not recruiting 1 |
| Phase 1 | 13 | Completed 13 |
| Phase 2 | 6 | Completed 5, Terminated 1 |
Follow SEP-363856: new trials by email Literature Review of SEP-363856 trials Research Report on SEP-363856
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Trial of the Safety and Tolerability of SEP-363856 in Adults With Generalized Anxiety Disorder SEP-363856 - Generalized Anxiety Disorder | Phase 3 | Recruiting | Otsuka Pharmaceutical Development & Commercialization, Inc. | 1120 | 2026-10-08 | 2026-10-20 |
| A Trial of the Efficacy and Safety of a Fixed Dose of SEP-363856 in Adults With Generalized Anxiety Disorder SEP-363856, Placebo - Generalized Anxiety Disorder | Phase 3 | Recruiting | Otsuka Pharmaceutical Development & Commercialization, Inc. | 384 | 2026-08-06 | 2026-10-20 |
| A Trial of the Efficacy and Safety of Fixed Doses of SEP-363856 in Adults With Generalized Anxiety Disorder SEP-363856, Placebo - Generalized Anxiety Disorder | Phase 3 | Recruiting | Otsuka Pharmaceutical Development & Commercialization, Inc. | 576 | 2026-07-28 | 2026-09-22 |
| A Long-term Administration Trial of SEP-363856 in Patients With Schizophrenia SEP-363856 - Schizophrenia | Phase 3 | Recruiting | Otsuka Pharmaceutical Co., Ltd. | 100 | 2025-12-22 | 2026-01-14 |
| A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia SEP-363856, Placebo - Schizophrenia | Phase 3 | Active not recruiting | Otsuka Pharmaceutical Development & Commercialization, Inc. | 538 | 2025-02-28 | 2026-10-05 |
| A Clinical Study to Learn if SEP-363856 Has Physical Dependence in Adults With Schizophrenia SEP-363856, Placebo - Schizophrenia | Phase 1 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 60 | 2023-06-21 | 2024-06-26 |
| An Extension Study to a Clinical Study That Will Continue to Evaluate the Effectiveness and Safety of SEP-363856 in People With Schizophrenia That Switch to SEP-363856 From Their From Their Current Antipsychotic Medication SEP-363856 - Schizophrenia | Phase 3 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 75 | 2023-03-31 | 2025-12-11 |
| A Clinical Study That Will Measure How Well SEP-363856 Works and How Safe it is in Adults With Generalized Anxiety Disorder SEP-363856, Placebo - Generalized Anxiety Disorder | Phase 2 / Phase 3 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 434 | 2023-03-08 | 2025-10-10 |
| A Clinical Study That Will Evaluate How Well SEP-363856 Works and How Safe it is in People With Schizophrenia That Switch to SEP-363856 From Their Current Antipsychotic Medication SEP-363856 - Schizophrenia | Phase 3 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 101 | 2022-12-19 | 2025-12-11 |
| A Clinical Study That Will Assess the Effect of SEP-363856 or Prior Antipsychotic (PA) Standard of Care on Body-weight Associated Parameters in Subjects With Schizophrenia SEP-363856, Prior antipsychotic (risperidone, olanzapine, quetiapine or aripiprazole) - Schizophrenia | Phase 1 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 19 | 2022-11-15 | 2024-06-26 |
| A Trial of the Safety and Efficacy of SEP-363856 in the Treatment of Adults With Major Depressive Disorder SEP-363856, Placebo - Major Depressive Disorder | Phase 2 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 929 | 2022-11-09 | 2026-02-18 |
| A Clinical Study That Will Assess the Effect of SEP-363856 and Prior Antipsychotic (PA) Standard of Care on Glucose and Regulation of Insulin in Patients With Schizophrenia SEP-363856 - Schizophrenia | Phase 1 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 15 | 2022-08-30 | 2024-06-26 |
| A Clinical Study That Will Assess How Food Moves Through the Stomach and Effects Blood Glucose Levels in Subjects With Schizophrenia Taking SEP-363856 or and Prior Antipsychotic (PA) Standard SEP-363856, Prior antipsychotic (risperidone, olanzapine, quetiapine or aripiprazole) - Schizophrenia | Phase 1 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 31 | 2022-06-13 | 2024-06-26 |
| A Clinical Trial to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Patients With Schizophrenia in Japan SEP-363856 - Schizophrenia | Phase 3 | Terminated | Sumitomo Pharma Co., Ltd. | 68 | 2022-05-16 | 2025-03-19 |
| A Clinical Trial Study to Determine the Effect of an Investigational Drug (SEP-363856) Has on the Way That the Drug Metformin Travels Through the Body in People With Schizophrenia. placebo, SEP-363856, metformin - Schizophrenia | Phase 1 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 21 | 2021-05-12 | 2024-06-26 |
| A Clinical Trial to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic People With Schizophrenia, Followed by an Open-label Extension Phase SEP-363856 50 mg, SEP-363856 75 mg, Placebo - Schizophrenia | Phase 2 / Phase 3 | Terminated | Sumitomo Pharma Co., Ltd. | 83 | 2021-03-29 | 2024-03-15 |
| A Clinical Study to Investigate the Effect of an Investigational Drug on Electrocardiogram Intervals in Adults With Schizophrenia. SEP363856 150 mg, Placebo, moxifloxacin 400 mg - Schizophrenia | Phase 1 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 150 | 2020-06-18 | 2024-06-26 |
| Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Japanese Male and Female Subjects With Schizophrenia SEP-363856, Placebo - Schizophrenia | Phase 1 | Completed | Sumitomo Pharma Co., Ltd. | 13 | 2020-03-31 | 2022-04-12 |
| A Study of the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia. SEP363856, quetiapine XR - Schizophrenia | Phase 3 | Completed | Otsuka Pharmaceutical Development & Commercialization, Inc. | 305 | 2019-11-21 | 2025-12-31 |
| A Clinical Study to Evaluate the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia SEP-363856 - Schizophrenia | Phase 3 | Terminated | Otsuka Pharmaceutical Development & Commercialization, Inc. | 463 | 2019-11-20 | 2024-12-16 |
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Schizophrenia (24) · Generalized Anxiety Disorder (4) · Anxiety Disorders (3) · Depression (1) · Depressive Disorder (1) · Depressive Disorder, Major (1) · Mental Disorders (1) · Narcolepsy (1) · Psychotic Disorders (1)
Otsuka Pharmaceutical Development & Commercialization, Inc. (26) · Sumitomo Pharma Co., Ltd. (4) · Otsuka Pharmaceutical Co., Ltd. (1)
United States (24) · Japan (7) · Russia (6) · Ukraine (6) · Bulgaria (5) · Hungary (3) · Romania (3) · Serbia (3) · Colombia (2) · Croatia (2) · Latvia (2) · United Kingdom (2) · Canada (1) · China (1) · Czechia (1)
Nobuhito Sanada (1)
PMID 36369028, PMID 32294346, PMID 37209427, PMID 37273942, PMID 37550314
2019 (5), 2016 (2)