{"id":"biib041-fampridine-sr","safety":{"commonSideEffects":[{"rate":null,"effect":"Seizures"},{"rate":null,"effect":"Urinary tract infection"},{"rate":null,"effect":"Insomnia"},{"rate":null,"effect":"Dizziness"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Asthenia/fatigue"}]},"_chembl":{"chemblId":"CHEMBL4591082","moleculeType":"Unknown","molecularWeight":"622.79"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Fampridine (4-aminopyridine) blocks voltage-gated potassium channels on demyelinated axons, prolonging action potentials and increasing the probability of action potential propagation across demyelinated segments. The sustained-release (SR) formulation allows for twice-daily dosing with improved tolerability compared to immediate-release formulations. This mechanism restores conduction in partially demyelinated nerve fibers, leading to improved walking speed and motor function in MS patients.","oneSentence":"Fampridine-SR is a potassium channel blocker that enhances nerve impulse conduction by blocking potassium efflux, thereby improving motor function in patients with multiple sclerosis.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:04:17.018Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Multiple sclerosis (MS) — to improve walking speed and motor function"}]},"trialDetails":[{"nctId":"NCT01480063","phase":"","title":"An Observational Study to Collect Information on Safety and to Document the Drug Utilization of Fampyra (BIIB041) When Used In Routine Medical Practice","status":"COMPLETED","sponsor":"Biogen","startDate":"2012-04-16","conditions":"Multiple Sclerosis","enrollment":4734},{"nctId":"NCT02219932","phase":"PHASE3","title":"Efficacy and Safety Study of Prolonged-Release Fampridine in Participants With Multiple Sclerosis","status":"COMPLETED","sponsor":"Biogen","startDate":"2014-09","conditions":"Multiple Sclerosis","enrollment":646},{"nctId":"NCT01917019","phase":"PHASE3","title":"A Safety and Efficacy Study of Oral Prolonged-Release Fampridine (BIIB041) in Japanese Participants With Multiple Sclerosis","status":"COMPLETED","sponsor":"Biogen","startDate":"2013-08","conditions":"Multiple Sclerosis, Remittent Progressive, Multiple Sclerosis, Primary Progressive, Relapsing-Remitting Multiple Sclerosis","enrollment":101},{"nctId":"NCT01480076","phase":"PHASE4","title":"Open-Label Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) on Quality of Life as Reported by Participants With Multiple Sclerosis","status":"COMPLETED","sponsor":"Biogen","startDate":"2012-02","conditions":"Multiple Sclerosis","enrollment":901},{"nctId":"NCT01597297","phase":"PHASE2","title":"Exploratory Study to Assess the Effect of Fampridine (BIIB041) on Walking Ability and Balance in Participants With Multiple Sclerosis.","status":"COMPLETED","sponsor":"Biogen","startDate":"2012-08","conditions":"Multiple Sclerosis","enrollment":132},{"nctId":"NCT01532154","phase":"","title":"Fampridine Pregnancy Exposure Registry","status":"TERMINATED","sponsor":"Biogen","startDate":"2015-08","conditions":"Multiple Sclerosis, Pregnancy","enrollment":1},{"nctId":"NCT01215084","phase":"PHASE1","title":"A Pharmacokinetics (PK) and Safety Study of Oral Fampridine-PR 10 mg in Chinese, Japanese, and Caucasian Adult Healthy Volunteers","status":"COMPLETED","sponsor":"Biogen","startDate":"2010-10","conditions":"Healthy","enrollment":36},{"nctId":"NCT01235221","phase":"PHASE3","title":"Open Label Extension Study to Evaluate the Safety and Tolerability of Oral Fampridine-Sustained Release (SR) in Canadian Participants With Multiple Sclerosis Who Participated in Acorda Extension Trials.","status":"COMPLETED","sponsor":"Biogen","startDate":"2010-12","conditions":"Multiple Sclerosis","enrollment":38}],"_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":["Dalfampridine","Fampridine-ER","Ampyra","Fampyra","Fampridine-PR"],"phase":"phase_3","status":"active","brandName":"BIIB041 (Fampridine-SR)","genericName":"BIIB041 (Fampridine-SR)","companyName":"Biogen","companyId":"biogen","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Fampridine-SR is a potassium channel blocker that enhances nerve impulse conduction by blocking potassium efflux, thereby improving motor function in patients with multiple sclerosis. Used for Multiple sclerosis (MS) — to improve walking speed and motor function.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}