{"id":"sep-363856","safety":{"commonSideEffects":[{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Insomnia"}]},"_chembl":{"chemblId":"CHEMBL4650337","moleculeType":"Small molecule","molecularWeight":"183.28"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"TAAR1 is a G-protein coupled receptor expressed on glutamatergic and dopaminergic neurons that acts as a negative feedback regulator of neurotransmitter release. By activating TAAR1, SEP-363856 reduces excessive glutamate and dopamine signaling, which is hypothesized to address core symptoms of schizophrenia and other psychiatric disorders without blocking dopamine D2 receptors like traditional antipsychotics.","oneSentence":"SEP-363856 is a trace amine-associated receptor 1 (TAAR1) agonist that modulates glutamatergic and dopaminergic neurotransmission in the brain.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:33:58.369Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Schizophrenia"},{"name":"Bipolar disorder (exploratory)"}]},"trialDetails":[{"nctId":"NCT05593029","phase":"PHASE2","title":"A Trial of the Safety and Efficacy of SEP-363856 in the Treatment of Adults With Major Depressive Disorder","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2022-11-09","conditions":"Major Depressive Disorder","enrollment":929},{"nctId":"NCT06894212","phase":"PHASE3","title":"A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia","status":"RECRUITING","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2025-02-28","conditions":"Schizophrenia","enrollment":522},{"nctId":"NCT07225712","phase":"PHASE3","title":"A Long-term Administration Trial of SEP-363856 in Patients With Schizophrenia","status":"RECRUITING","sponsor":"Otsuka Pharmaceutical Co., Ltd.","startDate":"2025-12-22","conditions":"Schizophrenia","enrollment":100},{"nctId":"NCT04115319","phase":"PHASE3","title":"A Study of the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia.","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2019-11-21","conditions":"Schizophrenia","enrollment":305},{"nctId":"NCT05628103","phase":"PHASE3","title":"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","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2022-12-19","conditions":"Schizophrenia","enrollment":101},{"nctId":"NCT05741528","phase":"PHASE3","title":"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","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2023-03-31","conditions":"Schizophrenia","enrollment":75},{"nctId":"NCT05729373","phase":"PHASE2, PHASE3","title":"A Clinical Study That Will Measure How Well SEP-363856 Works and How Safe it is in Adults With Generalized Anxiety Disorder","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2023-03-08","conditions":"Generalized Anxiety Disorder","enrollment":434},{"nctId":"NCT05359081","phase":"PHASE3","title":"A Clinical Trial to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Patients With Schizophrenia in Japan","status":"TERMINATED","sponsor":"Sumitomo Pharma Co., Ltd.","startDate":"2022-05-16","conditions":"Schizophrenia","enrollment":68},{"nctId":"NCT04038957","phase":"PHASE1","title":"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","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2019-08-07","conditions":"Schizophrenia","enrollment":22},{"nctId":"NCT04109950","phase":"PHASE3","title":"A Clinical Study to Evaluate the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia","status":"TERMINATED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2019-11-20","conditions":"Schizophrenia","enrollment":463},{"nctId":"NCT02969369","phase":"PHASE2","title":"A Study to Evaluate the Efficacy, Safety and Tolerability of SEP-363856 in Subjects With Parkinson's Disease Psychosis","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2016-12-31","conditions":"Parkinson Disease Psychosis","enrollment":39},{"nctId":"NCT02970929","phase":"PHASE2","title":"An Extension Study of Safety and Tolerability of SEP-363856 in Adult Subjects With Schizophrenia","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2017-01-31","conditions":"Schizophrenia","enrollment":157},{"nctId":"NCT02969382","phase":"PHASE2","title":"A Study to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Adults With Schizophrenia","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2016-12-05","conditions":"Schizophrenia","enrollment":245},{"nctId":"NCT04092686","phase":"PHASE3","title":"A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2019-09-30","conditions":"Schizophrenia","enrollment":464},{"nctId":"NCT05848700","phase":"PHASE1","title":"A Clinical Study to Learn if SEP-363856 Has Physical Dependence in Adults With Schizophrenia","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2023-06-21","conditions":"Schizophrenia","enrollment":60},{"nctId":"NCT05015673","phase":"PHASE1","title":"This is a Study to Determine the Effect of Multiple Doses of an Investigational Drug, Taken by Mouth, in People With Narcolepsy-cataplexy. Accepting Both Males and Females Ages of 18 Years to 55 Years. This Study Will be Conducted in the US and Will Require Approximately 13 Weeks Participation.","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2014-06-05","conditions":"Narcolepsy","enrollment":18},{"nctId":"NCT05402111","phase":"PHASE1","title":"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","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2022-06-13","conditions":"Schizophrenia","enrollment":31},{"nctId":"NCT04072354","phase":"PHASE3","title":"A Clinical Trial to Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2019-09-11","conditions":"Schizophrenia","enrollment":463},{"nctId":"NCT04865835","phase":"PHASE1","title":"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.","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2021-05-12","conditions":"Schizophrenia","enrollment":21},{"nctId":"NCT04369391","phase":"PHASE1","title":"A Clinical Study to Investigate the Effect of an Investigational Drug on Electrocardiogram Intervals in Adults With Schizophrenia.","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2020-06-18","conditions":"Schizophrenia","enrollment":150},{"nctId":"NCT01994473","phase":"PHASE1","title":"Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Male and Female Subjects With Schizophrenia","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2013-10","conditions":"Schizophrenia","enrollment":48},{"nctId":"NCT05542264","phase":"PHASE1","title":"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","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2022-11-15","conditions":"Schizophrenia","enrollment":19},{"nctId":"NCT01972711","phase":"PHASE1","title":"Study Assessing SEP-363856 in Male and Female Volunteers With High or Low Schizotype Characteristics","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2014-03","conditions":"Schizophrenia","enrollment":105},{"nctId":"NCT01940159","phase":"PHASE1","title":"A Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Male and Female Subjects With Schizophrenia","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2013-08","conditions":"Schizophrenia","enrollment":48},{"nctId":"NCT05463770","phase":"PHASE1","title":"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","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2022-08-30","conditions":"Schizophrenia","enrollment":15},{"nctId":"NCT04825860","phase":"PHASE2, PHASE3","title":"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","status":"TERMINATED","sponsor":"Sumitomo Pharma Co., Ltd.","startDate":"2021-03-29","conditions":"Schizophrenia","enrollment":83},{"nctId":"NCT03370640","phase":"PHASE1","title":"Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Japanese Male and Female Subjects With Schizophrenia in 2 Parts (Part 1 and 2).","status":"COMPLETED","sponsor":"Sumitomo Pharma Co., Ltd.","startDate":"2017-11-29","conditions":"Schizophrenia","enrollment":24},{"nctId":"NCT04325737","phase":"PHASE1","title":"Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Japanese Male and Female Subjects With Schizophrenia","status":"COMPLETED","sponsor":"Sumitomo Pharma Co., Ltd.","startDate":"2020-03-31","conditions":"Schizophrenia","enrollment":13}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":47,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"SEP-363856","genericName":"SEP-363856","companyName":"Otsuka Pharmaceutical Development & Commercialization, Inc.","companyId":"otsuka-pharmaceutical-development-commercialization-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"SEP-363856 is a trace amine-associated receptor 1 (TAAR1) agonist that modulates glutamatergic and dopaminergic neurotransmission in the brain. Used for Schizophrenia, Bipolar disorder (exploratory).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":8,"withResults":4},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}