{"id":"sabril","safety":{"commonSideEffects":[{"rate":"30-40","effect":"Visual field defects"},{"rate":"20-30","effect":"Fatigue"},{"rate":"15-25","effect":"Somnolence"},{"rate":"10-20","effect":"Weight gain"},{"rate":"5-15","effect":"Peripheral edema"},{"rate":"10-15","effect":"Headache"}]},"_chembl":{"chemblId":"CHEMBL89598","moleculeType":"Small molecule","molecularWeight":"129.16"},"_dailymed":{"setId":"a5d389d2-d0e1-4395-a2a2-b552808e7f98","title":"SABRIL (VIGABATRIN) TABLET, FILM COATED [LUNDBECK PHARMACEUTICALS LLC]"},"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"By inhibiting GABA transaminase, vigabatrin prevents the degradation of GABA, leading to sustained elevation of this inhibitory neurotransmitter in the central nervous system. This enhanced GABAergic inhibition reduces neuronal excitability and seizure activity. The mechanism is irreversible, meaning the enzyme inhibition persists until new enzyme is synthesized.","oneSentence":"Sabril (vigabatrin) irreversibly inhibits GABA transaminase, the enzyme that breaks down the neurotransmitter GABA, thereby increasing GABA levels in the brain.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:06:26.734Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Infantile spasms (West syndrome)"},{"name":"Refractory focal seizures as adjunctive therapy"}]},"trialDetails":[{"nctId":"NCT02220114","phase":"NA","title":"Acceptability Study of a New Paediatric Form of Vigabatrin in Infants and Children With Infantile Spasms or Pharmacoresistant Partial Epilepsy","status":"COMPLETED","sponsor":"Orphelia Pharma","startDate":"2014-05","conditions":"Infantile Spasms","enrollment":38},{"nctId":"NCT01073579","phase":"","title":"Sabril Patient Registry","status":"COMPLETED","sponsor":"Lundbeck LLC","startDate":"2009-08","conditions":"Infantile Spasms, Refractory Complex Partial Seizures in Adults","enrollment":9423},{"nctId":"NCT01278173","phase":"PHASE4","title":"A Study of the Structure and Function of the Retina in Adult Patients With Refractory Complex Partial Seizures Treated With Vigabatrin (Sabril®)","status":"COMPLETED","sponsor":"Lundbeck LLC","startDate":"2010-12","conditions":"Adult Refractory Complex Partial Seizures","enrollment":65},{"nctId":"NCT01390909","phase":"","title":"Clinical and Economic Burden of Uncontrolled Epilepsy: Analyses From a Medicaid Database and a Private Health Plan Database","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2010-05","conditions":"Epilepsy","enrollment":12386},{"nctId":"NCT01413711","phase":"PHASE4","title":"An Open-Label, Single and Multiple Oral Dose Pharmacokinetic Study of Vigabatrin in Infants With Infantile Spasms","status":"WITHDRAWN","sponsor":"Lundbeck LLC","startDate":"2012-06","conditions":"Infantile Spasms","enrollment":""}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":43,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Vigabatrin"],"phase":"marketed","status":"active","brandName":"Sabril®","genericName":"Sabril®","companyName":"Lundbeck LLC","companyId":"lundbeck-llc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Sabril (vigabatrin) irreversibly inhibits GABA transaminase, the enzyme that breaks down the neurotransmitter GABA, thereby increasing GABA levels in the brain. Used for Infantile spasms (West syndrome), Refractory focal seizures as adjunctive therapy.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}