{"id":"ntx-bup","safety":{"commonSideEffects":[{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Constipation"},{"rate":null,"effect":"Insomnia"},{"rate":null,"effect":"Withdrawal symptoms (if inadequately dosed)"}]},"_chembl":{"chemblId":"CHEMBL195316","moleculeType":"Small molecule","molecularWeight":"355.43"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Buprenorphine acts as a partial agonist at mu-opioid receptors, providing sufficient opioid activity to prevent withdrawal and reduce cravings, while naltrexone competitively blocks opioid receptors to prevent euphoria from additional opioid use. The combination is designed to improve treatment adherence and reduce the abuse potential compared to buprenorphine alone by discouraging attempts to augment the effect with additional opioids.","oneSentence":"NTX/BUP is a fixed-dose combination of naltrexone (an opioid antagonist) and buprenorphine (a partial opioid agonist) that reduces opioid cravings and withdrawal symptoms while blocking euphoric effects of additional opioid use.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:50:30.002Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Opioid use disorder (maintenance treatment)"}]},"trialDetails":[{"nctId":"NCT06233799","phase":"PHASE3","title":"Trial of Naltrexone/Bupropion for the Treatment of Methamphetamine Use Disorder","status":"RECRUITING","sponsor":"National Institute on Drug Abuse (NIDA)","startDate":"2024-07-01","conditions":"Methamphetamine-dependence, Methamphetamine Abuse","enrollment":360},{"nctId":"NCT04464980","phase":"PHASE2","title":"Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD)","status":"ACTIVE_NOT_RECRUITING","sponsor":"NYU Langone Health","startDate":"2021-06-08","conditions":"Opioid Use Disorder (OUD)","enrollment":1516},{"nctId":"NCT05262270","phase":"PHASE2","title":"Extended-Release Naltrexone and Monthly Extended-Release Buprenorphine for Cocaine Use Disorder (CURB-2)","status":"COMPLETED","sponsor":"University of Texas Southwestern Medical Center","startDate":"2023-04-18","conditions":"Cocaine Use Disorder","enrollment":427},{"nctId":"NCT02543944","phase":"PHASE2, PHASE3","title":"Improving Treatment Outcomes for Prescription Opioid Dependence","status":"COMPLETED","sponsor":"University of Arkansas","startDate":"2016-02","conditions":"Drug Dependence","enrollment":117},{"nctId":"NCT02294253","phase":"PHASE2, PHASE3","title":"Buprenorphine/Naloxone Stabilization and Induction Onto Injection Naltrexone","status":"COMPLETED","sponsor":"New York State Psychiatric Institute","startDate":"2014-09","conditions":"Opioid Dependence","enrollment":30},{"nctId":"NCT02537574","phase":"PHASE3","title":"Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Prior to First Dose of VIVITROL® (Naltrexone for Extended-Release Injectable Suspension)","status":"COMPLETED","sponsor":"Alkermes, Inc.","startDate":"2015-08","conditions":"Opioid Use Disorder","enrollment":380},{"nctId":"NCT02696434","phase":"PHASE3","title":"Evaluating Naltrexone for Use in Conjunction With Buprenorphine in Adults With Opioid Use Disorder Transitioning From Buprenorphine Maintenance Prior to First Dose of VIVITROL","status":"COMPLETED","sponsor":"Alkermes, Inc.","startDate":"2016-04","conditions":"Opioid Use Disorder","enrollment":101}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":12,"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":"NTX/BUP","genericName":"NTX/BUP","companyName":"Alkermes, Inc.","companyId":"alkermes-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"NTX/BUP is a fixed-dose combination of naltrexone (an opioid antagonist) and buprenorphine (a partial opioid agonist) that reduces opioid cravings and withdrawal symptoms while blocking euphoric effects of additional opioid use. Used for Opioid use disorder (maintenance treatment).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}