{"id":"opc-34712fum-brexpiprazole-fumarate","safety":{"commonSideEffects":[{"rate":null,"effect":"Akathisia"},{"rate":null,"effect":"Weight gain"},{"rate":null,"effect":"Sedation"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Tremor"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Brexpiprazole modulates dopaminergic and serotonergic neurotransmission through multiple receptor interactions. As a partial agonist at D2 receptors, it reduces excessive dopamine signaling in psychotic states while maintaining baseline dopaminergic tone. Its 5-HT1A partial agonism and 5-HT2A antagonism contribute to anxiolytic and antidepressant effects, making it suitable for treating schizophrenia and major depressive disorder.","oneSentence":"Brexpiprazole is a serotonin-dopamine activity modulator (SDAM) that acts as a partial agonist at dopamine D2 and serotonin 5-HT1A receptors while antagonizing serotonin 5-HT2A receptors.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:24:26.180Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Schizophrenia"},{"name":"Major depressive disorder (adjunctive treatment)"}]},"trialDetails":[{"nctId":"NCT06036108","phase":"PHASE1","title":"Food Effect Study of Brexpiprazole Once-weekly (QW) Formulation in Patients With Schizophrenia","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Co., Ltd.","startDate":"2023-10-03","conditions":"Schizophrenia","enrollment":59},{"nctId":"NCT05325645","phase":"PHASE3","title":"Trial of Brexpiprazole Once-weekly (QW) Formulation in Patients With Acute Schizophrenia","status":"RECRUITING","sponsor":"Otsuka Pharmaceutical Co., Ltd.","startDate":"2022-07-21","conditions":"Acute Schizophrenia","enrollment":450},{"nctId":"NCT05326347","phase":"PHASE3","title":"A Long-term Administration Trial of Brexpiprazole Once-weekly (QW) Formulation in Patients With Schizophrenia","status":"ACTIVE_NOT_RECRUITING","sponsor":"Otsuka Pharmaceutical Co., Ltd.","startDate":"2022-05-31","conditions":"Schizophrenia","enrollment":190}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"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":"OPC-34712FUM/ Brexpiprazole fumarate","genericName":"OPC-34712FUM/ Brexpiprazole fumarate","companyName":"Otsuka Pharmaceutical Co., Ltd.","companyId":"otsuka","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Brexpiprazole is a serotonin-dopamine activity modulator (SDAM) that acts as a partial agonist at dopamine D2 and serotonin 5-HT1A receptors while antagonizing serotonin 5-HT2A receptors. Used for Schizophrenia, Major depressive disorder (adjunctive treatment).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}