{"id":"pxt3003-dose-1","safety":{"commonSideEffects":[{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Headache"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"PXT3003 combines baclofen, naltrexone, and sorbitol in a proprietary formulation designed to modulate immune responses and reduce inflammatory markers in the peripheral nervous system. The combination targets multiple pathways involved in demyelinating neuropathies, particularly Charcot-Marie-Tooth disease type 1A (CMT1A), by reducing neuroinflammation and potentially promoting myelin repair and axonal regeneration.","oneSentence":"PXT3003 is a fixed-dose combination of three active pharmaceutical ingredients that work synergistically to reduce neuroinflammation and promote nerve regeneration in peripheral neuropathies.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:30:52.249Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Charcot-Marie-Tooth disease type 1A (CMT1A)"}]},"trialDetails":[{"nctId":"NCT04762758","phase":"PHASE3","title":"Phase III Trial Assessing the Efficacy and Safety of PXT3003 in CMT1A Patients","status":"ACTIVE_NOT_RECRUITING","sponsor":"Pharnext S.C.A.","startDate":"2021-03-30","conditions":"Charcot-Marie-Tooth Disease","enrollment":350},{"nctId":"NCT03023540","phase":"PHASE3","title":"Assessing Long Term Safety and Tolerability of PXT3003 in Patients With Charcot-Marie-Tooth Disease Type 1A","status":"UNKNOWN","sponsor":"Pharnext S.C.A.","startDate":"2017-03-07","conditions":"Charcot-Marie-Tooth Disease, Type IA","enrollment":187},{"nctId":"NCT02579759","phase":"PHASE3","title":"Phase III Trial Assessing the Efficacy and Safety of PXT3003 in CMT1A Patients (PLEO-CMT)","status":"COMPLETED","sponsor":"Pharnext S.C.A.","startDate":"2015-12","conditions":"Charcot-Marie-Tooth Disease Type 1A","enrollment":323},{"nctId":"NCT01401257","phase":"PHASE2","title":"Phase II, Randomized, Placebo-controlled Trial in Patients With Charcot-marie-tooth Disease Type 1A","status":"COMPLETED","sponsor":"Pharnext S.C.A.","startDate":"2010-12","conditions":"Charcot-Marie-Tooth Disease, Hereditary Neuropathy With Liability to Pressure Palsies, Genetic Disorders","enrollment":80}],"_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":["DOSE 1","DOSE 2","(RS)-baclofen, naltrexone hydrochloride and D-sorbitol oral fixed dose combination","liquid oral solution"],"phase":"phase_3","status":"active","brandName":"PXT3003 dose 1","genericName":"PXT3003 dose 1","companyName":"Pharnext S.C.A.","companyId":"pharnext-s-c-a","modality":"Small molecule","firstApprovalDate":"","aiSummary":"PXT3003 is a fixed-dose combination of three active pharmaceutical ingredients that work synergistically to reduce neuroinflammation and promote nerve regeneration in peripheral neuropathies. Used for Charcot-Marie-Tooth disease type 1A (CMT1A).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}