{"id":"sc-methylnaltrexone-mntx","safety":{"commonSideEffects":[{"rate":"15-30","effect":"Abdominal pain"},{"rate":"10-20","effect":"Diarrhea"},{"rate":"5-15","effect":"Nausea"},{"rate":"5-10","effect":"Flatulence"},{"rate":"5-10","effect":"Dizziness"}]},"_chembl":{"chemblId":"CHEMBL1186579","moleculeType":"Small molecule","molecularWeight":"356.44"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Methylnaltrexone is a quaternary amine derivative of naltrexone that selectively antagonizes mu-opioid receptors located in the peripheral nervous system of the gastrointestinal tract. Because it is highly polar and does not cross the blood-brain barrier, it blocks the constipating effects of opioids on the gut while preserving the analgesic and other central nervous system effects of opioid therapy. This mechanism allows patients on chronic opioid therapy to maintain pain relief while restoring normal bowel function.","oneSentence":"Methylnaltrexone is a peripheral mu-opioid receptor antagonist that blocks opioid receptors in the gastrointestinal tract without crossing the blood-brain barrier, thereby reversing opioid-induced constipation.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:33:36.768Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Opioid-induced constipation in patients with chronic non-cancer pain"},{"name":"Opioid-induced constipation in patients with advanced illness receiving palliative care"}]},"trialDetails":[{"nctId":"NCT06162377","phase":"PHASE4","title":"Methylnatrexone In Resectable Head and Neck Squamous Cell Carcinoma (MINK). A \"Window of Opportunity\" Pilot Study.","status":"RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2024-01-10","conditions":"Head and Neck Squamous Cell Carcinoma","enrollment":25},{"nctId":"NCT01367535","phase":"PHASE1","title":"Effects of MNTX on CYP450 2D6 in Metabolizers of Dextromethorphan","status":"COMPLETED","sponsor":"Bausch Health Americas, Inc.","startDate":"2006-03","conditions":"Healthy Adults","enrollment":54},{"nctId":"NCT01367600","phase":"PHASE3","title":"Open-Label Treatment Extension of Protocol MNTX 301","status":"COMPLETED","sponsor":"Bausch Health Americas, Inc.","startDate":"2003-02","conditions":"Terminal Illness","enrollment":27},{"nctId":"NCT01367496","phase":"PHASE1","title":"Pharmacokinetics and Bioavailability of Single Subcutaneous Doses of Methylnaltrexone Versus Intravenous Dose","status":"COMPLETED","sponsor":"Bausch Health Americas, Inc.","startDate":"2002-06","conditions":"Healthy Subjects","enrollment":6},{"nctId":"NCT01367509","phase":"PHASE1","title":"Pharmacokinetics, Safety, and Tolerability of Methylnaltrexone (MNTX) in Subjects With Impaired Renal Function","status":"COMPLETED","sponsor":"Bausch Health Americas, Inc.","startDate":"2004-03","conditions":"Renal Impairment","enrollment":32},{"nctId":"NCT01367574","phase":"PHASE2","title":"Methylnaltrexone in Patients With Opioid-Induced Bowel Dysfunction","status":"COMPLETED","sponsor":"Bausch Health Americas, Inc.","startDate":"2002-04","conditions":"Bowel Dysfunction","enrollment":39},{"nctId":"NCT01367522","phase":"PHASE1","title":"Pharmacokinetics, Safety, and Tolerability of Methylnaltrexone in Volunteers With Impaired Hepatic Function","status":"COMPLETED","sponsor":"Bausch Health Americas, Inc.","startDate":"2004-03","conditions":"Liver Dysfunction","enrollment":24},{"nctId":"NCT01367613","phase":"PHASE3","title":"Open-Label Treatment Extension of Protocol MNTX 302","status":"COMPLETED","sponsor":"Bausch Health Americas, Inc.","startDate":"2004-03","conditions":"Terminal Illness","enrollment":89},{"nctId":"NCT00402038","phase":"PHASE3","title":"Study of Methylnaltrexone (MNTX) for the Relief of Constipation","status":"COMPLETED","sponsor":"Bausch Health Americas, Inc.","startDate":"2004-02","conditions":"Advance Illness Patients With OIC","enrollment":134},{"nctId":"NCT00401362","phase":"PHASE3","title":"A a Single Dose Efficacy Study in Inducing Laxation in Advance Illness Patients","status":"COMPLETED","sponsor":"Bausch Health Americas, Inc.","startDate":"2003-02","conditions":"Advanced Illness Patients With Opioid Induced Constipation","enrollment":154},{"nctId":"NCT00804141","phase":"PHASE3","title":"Study Evaluating Long-Term Safety of MOA-728 in Participants With Opioid-Induced Constipation","status":"COMPLETED","sponsor":"Bausch Health Americas, Inc.","startDate":"2008-12-03","conditions":"Constipation","enrollment":1040},{"nctId":"NCT00640146","phase":"PHASE2","title":"Study of Subcutaneous Methylnaltrexone (MNTX) in the Treatment of Opioid-Induced Constipation During Rehabilitation After Orthopedic Procedures","status":"COMPLETED","sponsor":"Bausch Health Americas, Inc.","startDate":"2007-10-19","conditions":"Opioid-induced Constipation","enrollment":37},{"nctId":"NCT01368562","phase":"NA","title":"Compassionate Use Study of Methylnaltrexone","status":"COMPLETED","sponsor":"Bausch Health Americas, Inc.","startDate":"2003-01-24","conditions":"Opioid-induced Constipation","enrollment":26},{"nctId":"NCT01596777","phase":"PHASE1","title":"Effects of 500 mg Immediate Release and Extended Release Methylnaltrexone on Loperamide-induced Delay of the Oro-cecal and Whole-gut Transit Time in Healthy Subjects","status":"COMPLETED","sponsor":"University Medicine Greifswald","startDate":"2010-01","conditions":"Intestinal Obstruction","enrollment":15},{"nctId":"NCT01012960","phase":"PHASE4","title":"Opioids and Esophageal Function","status":"COMPLETED","sponsor":"Region Örebro County","startDate":"2009-11","conditions":"Pharyngeal Dysfunction, Esophageal Dysfunction","enrollment":13}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":13,"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":"SC Methylnaltrexone (MNTX)","genericName":"SC Methylnaltrexone (MNTX)","companyName":"Bausch Health Americas, Inc.","companyId":"bausch-health-americas-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Methylnaltrexone is a peripheral mu-opioid receptor antagonist that blocks opioid receptors in the gastrointestinal tract without crossing the blood-brain barrier, thereby reversing opioid-induced constipation. Used for Opioid-induced constipation in patients with chronic non-cancer pain, Opioid-induced constipation in patients with advanced illness receiving palliative care.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}