{"id":"opc-34712-adt","safety":{"commonSideEffects":[{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Hot flashes"},{"rate":null,"effect":"Sexual dysfunction"},{"rate":null,"effect":"Nausea"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"OPC-34712 blocks the 5-HT7 receptor, which may enhance the efficacy of standard androgen deprivation therapy in prostate cancer by modulating serotonergic pathways involved in tumor progression. The combination approach aims to improve outcomes in hormone-sensitive or castration-resistant prostate cancer by targeting complementary mechanisms.","oneSentence":"OPC-34712 is a selective serotonin 5-HT7 receptor antagonist combined with androgen deprivation therapy (ADT) to treat prostate cancer.","_ai_confidence":"low"},"_scrapedAt":"2026-03-28T00:50:42.037Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prostate cancer (in combination with androgen deprivation therapy)"}]},"trialDetails":[{"nctId":"NCT04830215","phase":"PHASE4","title":"Brexpiprazole as Adjunctive Therapy in Adults With Major Depressive Disorder","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2021-04-01","conditions":"Major Depressive Disorder","enrollment":122},{"nctId":"NCT03538691","phase":"PHASE3","title":"A Trial to Evaluate the Efficacy, Safety & Tolerability of Brexpiprazole in the Maintenance Treatment of Adults With Major Depressive Disorder","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2018-07-13","conditions":"Major Depressive Disorder","enrollment":1149},{"nctId":"NCT02196506","phase":"PHASE3","title":"Study of the Safety and Efficacy of Fixed-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder With and Without Anxious Distress","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2014-07","conditions":"Depressive Disorder, Depression, Depressive Disorder, Major","enrollment":837},{"nctId":"NCT01727726","phase":"PHASE3","title":"A Study of Flexible-dose Brexpiprazole as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Delphinus Trial","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2012-12","conditions":"Depressive Disorder, Depression, Depressive Disorder, Major","enrollment":2182},{"nctId":"NCT00797966","phase":"PHASE2","title":"Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2009-05","conditions":"Major Depressive Disorder","enrollment":850},{"nctId":"NCT01360632","phase":"PHASE3","title":"Study of the Safety and Efficacy of Two Fixed Doses of OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder (the Polaris Trial)","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2011-06","conditions":"Depressive Disorder, Depression, Depressive Disorder, Major","enrollment":1539},{"nctId":"NCT01360645","phase":"PHASE3","title":"Study of the Safety and Efficacy of Fixed Dose OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder (the Pyxis Trial)","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2011-07","conditions":"Depressive Disorder, Depression, Depressive Disorder, Major","enrollment":826},{"nctId":"NCT01447576","phase":"PHASE2","title":"Study of Safety & Tolerability of OPC-34712 as Adjunctive Therapy in Treatment of Adult Patients With Major Depressive Disorder","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2009-09","conditions":"Major Depressive Disorder","enrollment":1036},{"nctId":"NCT01052077","phase":"PHASE2","title":"Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2010-03","conditions":"Major Depressive Disorder","enrollment":773}],"_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-34712 + ADT","genericName":"OPC-34712 + ADT","companyName":"Otsuka Pharmaceutical Development & Commercialization, Inc.","companyId":"otsuka-pharmaceutical-development-commercialization-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"OPC-34712 is a selective serotonin 5-HT7 receptor antagonist combined with androgen deprivation therapy (ADT) to treat prostate cancer. Used for Prostate cancer (in combination with androgen deprivation therapy).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}