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The extended-release formulation provides sustained drug levels, allowing for once or twice daily dosing compared to immediate-release formulations.","oneSentence":"Extended-release phenytoin sodium blocks voltage-gated sodium channels in the brain to reduce neuronal excitability and prevent seizure propagation.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T04:30:08.969Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Generalized tonic-clonic seizures"},{"name":"Complex partial (temporal lobe) seizures"},{"name":"Simple partial seizures"},{"name":"Status epilepticus (parenteral formulation)"}]},"trialDetails":[{"nctId":"NCT07066722","phase":"PHASE1","title":"A Study to Evaluate VH4524184 Tablet Absorption, Effects of Food, and Interactions With Other Drugs in Healthy Adults","status":"COMPLETED","sponsor":"ViiV Healthcare","startDate":"2025-07-07","conditions":"HIV Infections","enrollment":126},{"nctId":"NCT06719557","phase":"PHASE1","title":"A Study of the Effect of Itraconazole and Phenytoin on Calderasib (MK-1084) in Healthy Adults (MK-1084-008)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2024-05-20","conditions":"Healthy","enrollment":28},{"nctId":"NCT07072624","phase":"PHASE4","title":"Early Post-Traumatic Seizures Prevention Trial (E-PTS Trial)","status":"RECRUITING","sponsor":"All India Institute of Medical Sciences, Jodhpur","startDate":"2025-07-23","conditions":"Seizures, Traumatic Brain Injuries, Traumatic Brain Injury (TBI) Patients","enrollment":1260},{"nctId":"NCT00647621","phase":"PHASE1","title":"Steady-State Study of Extended Phenytoin Sodium Capsules 100 mg and Dilantin® Kapseals® 100 mg","status":"COMPLETED","sponsor":"Mylan Pharmaceuticals Inc","startDate":"2005-10","conditions":"Healthy","enrollment":72},{"nctId":"NCT03325439","phase":"PHASE3","title":"A Study to Test the Pharmacokinetics, Efficacy, and Safety of Brivaracetam in Newborns With Repeated Electroencephalographic Seizures","status":"TERMINATED","sponsor":"UCB Biopharma SRL","startDate":"2019-05-07","conditions":"Electroencephalographic Neonatal Seizures","enrollment":9},{"nctId":"NCT04956627","phase":"PHASE1","title":"A Study to Assess the Effect of Itraconazole, Phenytoin and Gemfibrozil on the Drug Levels of BMS-986166 in Healthy Participants","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2021-07-28","conditions":"Healthy Participants","enrollment":15},{"nctId":"NCT01713946","phase":"PHASE3","title":"A Placebo-controlled Study of Efficacy & Safety of 2 Trough-ranges of Everolimus as Adjunctive Therapy in Patients With Tuberous Sclerosis Complex (TSC) & Refractory Partial-onset Seizures","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2013-04-29","conditions":"Tuberous Sclerosis Complex-associated Refractory Seizures","enrollment":366},{"nctId":"NCT00774306","phase":"NA","title":"Antiepileptic Drugs and Vascular Risk Markers","status":"TERMINATED","sponsor":"Thomas Jefferson University","startDate":"2009-04","conditions":"Subarachnoid Hemorrhage","enrollment":52}],"_emaApprovals":[],"_faersSignals":[{"count":33,"reaction":"CONVULSION"},{"count":18,"reaction":"ANTICONVULSANT DRUG LEVEL DECREASED"},{"count":16,"reaction":"ANTICONVULSANT DRUG LEVEL BELOW THERAPEUTIC"},{"count":16,"reaction":"GRAND MAL CONVULSION"},{"count":16,"reaction":"PHARMACEUTICAL PRODUCT COMPLAINT"},{"count":13,"reaction":"DRUG INEFFECTIVE"},{"count":11,"reaction":"STEVENS-JOHNSON SYNDROME"},{"count":8,"reaction":"FALL"},{"count":6,"reaction":"PRURITUS"},{"count":6,"reaction":"TOXIC EPIDERMAL NECROLYSIS"}],"_approvalHistory":[],"publicationCount":10,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Dilantin"],"phase":"marketed","status":"active","brandName":"Extended Phenytoin Sodium","genericName":"Extended Phenytoin Sodium","companyName":"Bristol-Myers Squibb","companyId":"bristol-myers-squibb","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Extended-release phenytoin sodium blocks voltage-gated sodium channels in the brain to reduce neuronal excitability and prevent seizure propagation. Used for Generalized tonic-clonic seizures, Complex partial (temporal lobe) seizures, Simple partial seizures.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}