{"id":"asc-01","safety":{"commonSideEffects":[{"rate":null,"effect":"Acne"},{"rate":null,"effect":"Hair loss"},{"rate":null,"effect":"Elevated liver enzymes"},{"rate":null,"effect":"Mood changes"}]},"_chembl":{"chemblId":"CHEMBL1778796","moleculeType":"Small molecule","molecularWeight":"757.00"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"ASC-01 binds to the androgen receptor with high selectivity, promoting anabolic effects in muscle and bone while minimizing androgenic side effects in other tissues. This tissue-selective activation aims to provide the therapeutic benefits of androgens without the adverse effects associated with traditional androgen replacement therapy or non-selective androgens.","oneSentence":"ASC-01 is a selective androgen receptor modulator (SARM) that activates androgen signaling in a tissue-selective manner.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:02:36.046Z","_scrapedBy":"cloudflare-swarm","_wikipedia":{"url":"https://en.wikipedia.org/wiki/Aripiprazole%2Fsertraline","title":"Aripiprazole/sertraline","extract":"Aripiprazole/sertraline is a combination formulation of aripiprazole (Abilify), an atypical antipsychotic, and sertraline (Zoloft), a selective serotonin reuptake inhibitor (SSRI), which was under development by Otsuka Pharmaceutical for the treatment of major depressive disorder (MDD). It combines serotonin reuptake inhibition from sertraline and modulation of dopamine and serotonin receptors from aripiprazole. In July 2017, it was in preregistration in Japan for the treatment of MDD. However, in September 2018, the regulatory submission in Japan for MDD was withdrawn."},"indications":{"approved":[{"name":"Muscle wasting and weakness in older adults"},{"name":"Age-related decline in muscle mass and function"}]},"trialDetails":[{"nctId":"NCT02088697","phase":"PHASE1","title":"A Bioequivalence Study of ASC-01 Placebo (Aripiprazole 0 mg/Sertraline 100 mg) and Sertraline Tablet in Healthy Male Subjects","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Co., Ltd.","startDate":"2013-12","conditions":"Healthy Volunteers","enrollment":50},{"nctId":"NCT03342963","phase":"PHASE1","title":"Bioequivalence Between Single Administration of ASC-01 (Aripiprazole/Sertraline Combination Drug) and Concomitant Single Administration of Aripiprazole and Sertraline, and Food Effect on Pharmacokinetics of ASC-01 in Healthy Male Adults","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Co., Ltd.","startDate":"2017-11-21","conditions":"Healthy Male Adults","enrollment":74},{"nctId":"NCT02046564","phase":"PHASE3","title":"Assess the Efficacy and Safety of ASC-01 in Patients With Major Depressive Disorder","status":"COMPLETED","sponsor":"Otsuka Pharmaceutical Co., Ltd.","startDate":"2014-02","conditions":"Major Depressive Disorder","enrollment":412}],"_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":"ASC-01","genericName":"ASC-01","companyName":"Otsuka Pharmaceutical Co., Ltd.","companyId":"otsuka-pharmaceutical-co-ltd","modality":"Small molecule","firstApprovalDate":"","aiSummary":"ASC-01 is a selective androgen receptor modulator (SARM) that activates androgen signaling in a tissue-selective manner. Used for Muscle wasting and weakness in older adults, Age-related decline in muscle mass and function.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}