{"id":"subutex-sch-028444","safety":{"commonSideEffects":[{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Constipation"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Sweating"},{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Insomnia"}]},"_chembl":{"chemblId":"CHEMBL513136","moleculeType":"Small molecule","molecularWeight":"397.56"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Buprenorphine binds with high affinity to mu-opioid receptors in the central nervous system but produces only partial agonist effects, creating a 'ceiling effect' that limits respiratory depression and overdose potential. This pharmacological profile makes it suitable for opioid use disorder treatment, where it suppresses withdrawal symptoms and reduces illicit opioid use while maintaining a lower abuse liability compared to full mu-opioid agonists.","oneSentence":"Subutex (buprenorphine) is a partial mu-opioid receptor agonist that reduces opioid cravings and withdrawal symptoms while carrying lower overdose risk than full opioids.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:38:08.828Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Opioid use disorder (maintenance treatment)"},{"name":"Moderate to severe pain (analgesic use)"}]},"trialDetails":[{"nctId":"NCT00723697","phase":"","title":"Observational Study of Misuse of High Dose Buprenorphine (Subutex® or Generic) in Opiate-Addicted Patients in France (Study P05186AM1)(COMPLETED)","status":"COMPLETED","sponsor":"Indivior Inc.","startDate":"2007-05","conditions":"Buprenorphine, Naloxone, Opiate-related Disorders","enrollment":1307},{"nctId":"NCT00684073","phase":"PHASE4","title":"Preference for Subutex® (Buprenorphine) Versus Suboxone® (Buprenorphine/Naloxone) in Opioid Dependent Patients on Subutex® (Study P05094)(COMPLETED)","status":"COMPLETED","sponsor":"Indivior Inc.","startDate":"2007-07","conditions":"Opiate-related Disorders, Opiate Dependence, Drug Abuse","enrollment":60},{"nctId":"NCT00604188","phase":"PHASE4","title":"A Randomized Acceptability and Safety Study of Suboxone Induction in Heroin Users (P05042)(COMPLETED)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2008-02-22","conditions":"Opiate Dependence, Drug Dependence, Substance Dependence","enrollment":188}],"_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":["SCH 028444"],"phase":"marketed","status":"active","brandName":"Subutex (SCH 028444)","genericName":"Subutex (SCH 028444)","companyName":"Merck Sharp & Dohme LLC","companyId":"merck","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Subutex (SCH 028444) is a small molecule used to treat various conditions related to opiate dependence and substance dependence. It is a form of buprenorphine, a medication also found in Suboxone.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}