| ulotaront (SEP-363856) / Otsuka |
| Completed | 3 | 305 | Europe, US, RoW | SEP363856, quetiapine XR, Seroquel XR | Otsuka Pharmaceutical Development & Commercialization, Inc. | Schizophrenia | 12/22 | 12/22 | | |
NCT04072354 / 2019-000470-36: A Clinical Trial to Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia |
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| Completed | 3 | 463 | Europe, US, RoW | SEP-363856 50mg, SEP-363856 75mg, Placebo | Otsuka Pharmaceutical Development & Commercialization, Inc. | Schizophrenia | 05/23 | 09/23 | | |
NCT04092686 / 2019-000697-37: A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia |
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| Completed | 3 | 464 | Europe, US, RoW | SEP-363856 75mg, SEP-363856 100mg, Placebo | Otsuka Pharmaceutical Development & Commercialization, Inc., Sunovion Pharmaceuticals Inc. | Schizophrenia | 06/23 | 06/23 | | |
NCT05628103: 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 |
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| Completed | 3 | 101 | US | SEP-363856 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Schizophrenia | 04/24 | 04/24 | | |
NCT04109950 / 2019-000696-16: A Clinical Study to Evaluate the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia |
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| Terminated | 3 | 463 | Europe, US, RoW | SEP-363856 | Otsuka Pharmaceutical Development & Commercialization, Inc., Sunovion Pharmaceuticals Inc. | Schizophrenia | 11/23 | 11/23 | | |
NCT05741528: 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 |
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| Completed | 3 | 75 | US | SEP-363856 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Schizophrenia | 09/24 | 09/24 | | |
NCT06894212: A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia |
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| Recruiting | 3 | 522 | Japan, US | SEP-363856, Placebo | Otsuka Pharmaceutical Development & Commercialization, Inc. | Schizophrenia | 10/26 | 10/26 | | |
NCT05359081: A Clinical Trial to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Patients With Schizophrenia in Japan |
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| Terminated | 3 | 68 | Japan | SEP-363856 | Sumitomo Pharma Co., Ltd. | Schizophrenia | 03/24 | 03/24 | | |
NCT07225712: A Long-term Administration Trial of SEP-363856 in Patients With Schizophrenia |
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| Recruiting | 3 | 100 | Japan | SEP-363856 | Otsuka Pharmaceutical Co., Ltd. | Schizophrenia | 03/28 | 03/28 | | |
CTR20213353: A clinical study on the treatment of schizophrenia |
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| Terminated | 2/3 | 111 | China | 1. Chinese Generic Name: SEP-363856; English Generic Name: SEP-363856; Trade Name: NA; 2. Chinese Generic Name: SEP-363856; English Generic Name: SEP-363856; Trade Name: NA; 3. Chinese Generic Name: SEP-363856; English Generic Name: SEP-363856; Trade Name: NA; 1. Chinese Generic Name: SEP-363856 Placebo; English Generic Name: SEP-363856 Placebo; Trade Name: NA; 2. Chinese Generic Name: SEP-363856 Placebo; English Generic Name: SEP-363856 Placebo; Trade Name: NA | Sunovion Pharmaceuticals Inc. / UPM Pharmaceuticals, Inc. / Kanae Co., Ltd. / Sumitomo Pharmaceutical (Suzhou) Co., Ltd. | Indications: Acute psychotic disorders of schizophrenia | | | | |
NCT05729373: A Clinical Study That Will Measure How Well SEP-363856 Works and How Safe it is in Adults With Generalized Anxiety Disorder |
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| Completed | 2/3 | 434 | Europe, Japan, US | SEP-363856, Placebo | Otsuka Pharmaceutical Development & Commercialization, Inc. | Generalized Anxiety Disorder | 09/25 | 09/25 | | |
NCT04825860 / 2022-503006-20-00: 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 |
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| Terminated | 2/3 | 83 | Japan, RoW | SEP-363856 50 mg, SEP-363856 75 mg, Placebo | Sumitomo Pharma Co., Ltd., Sumitomo Pharma Co. Ltd. | Schizophrenia | 10/23 | 10/23 | | |
DA801201, 2022-503006-20-00: 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 |
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| Completed | 2/3 | 32 | Europe | SEP-363856, SEP-363856 matching placebo | Sumitomo Pharma Co. Ltd., Sumitomo Pharma Co. Ltd. | Acutely Psychotic Patients with Schizophrenia | | | | |
NCT05593029: A Trial of the Safety and Efficacy of SEP-363856 in the Treatment of Adults With Major Depressive Disorder |
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| Completed | 2 | 929 | Europe, Canada, US, RoW | SEP-363856, Placebo | Otsuka Pharmaceutical Development & Commercialization, Inc., Sumitomo Pharma Co., Ltd., Sumitomo Pharma America, Inc. | Major Depressive Disorder | 11/25 | 11/25 | | |
CTR20213168: SEP-363856 PK study in healthy adult male subjects in China |
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| Terminated | 1 | 42 | China | 1. Chinese Generic Name: SEP-363856 Tablets; English Generic Name: SEP-363856 Tablets; Product Name: NA; | Sunovion Pharmaceuticals Inc. / UPM Pharmaceuticals, Inc. / Kanae Co., Ltd. / Sumitomo Pharmaceutical (Suzhou) Co., Ltd. | Indications: Schizophrenia | | | | |
NCT04038957: A Clinical Study to Investigate the Effect of an Investigational Drug as an Added Medication to an Antipsychotic, in Adults With Schizophrenia, as Measured Positron Emission Tomography (PET) Imaging |
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| Completed | 1 | 22 | Europe | SEP-363856 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Schizophrenia | 06/23 | 06/23 | | |
NCT05402111: 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 |
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| Completed | 1 | 31 | US | SEP-363856, Prior antipsychotic (risperidone, olanzapine, quetiapine or aripiprazole) | Otsuka Pharmaceutical Development & Commercialization, Inc. | Schizophrenia | 09/23 | 09/23 | | |
NCT05542264: 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 |
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| Completed | 1 | 19 | US | SEP-363856, Prior antipsychotic (risperidone, olanzapine, quetiapine or aripiprazole) | Otsuka Pharmaceutical Development & Commercialization, Inc. | Schizophrenia | 02/24 | 02/24 | | |
NCT05463770: 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 |
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| Completed | 1 | 15 | US | SEP-363856 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Schizophrenia | 08/23 | 08/23 | | |
NCT05848700: A Clinical Study to Learn if SEP-363856 Has Physical Dependence in Adults With Schizophrenia |
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| Completed | 1 | 60 | US | SEP-363856, Placebo | Otsuka Pharmaceutical Development & Commercialization, Inc. | Schizophrenia | 03/24 | 03/24 | | |
