{"id":"trileptal","safety":{"commonSideEffects":[{"rate":"25–50%","effect":"Dizziness"},{"rate":"20–40%","effect":"Somnolence"},{"rate":"15–30%","effect":"Diplopia (double vision)"},{"rate":"15–25%","effect":"Ataxia"},{"rate":"10–20%","effect":"Nausea"},{"rate":"2–3%","effect":"Hyponatremia"},{"rate":"1–2%","effect":"Rash"}]},"_chembl":{"chemblId":"CHEMBL1068","moleculeType":"Small molecule","molecularWeight":"252.27"},"_dailymed":{"setId":"4c5c86c8-ab7f-4fcf-bc1b-5a0b1fd0691b","title":"TRILEPTAL (OXCARBAZEPINE) TABLET, FILM COATED TRILEPTAL (OXCARBAZEPINE) SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]"},"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Oxcarbazepine is a prodrug that is rapidly metabolized to its active metabolite, 10-monohydroxy derivative (MHD), which inhibits voltage-dependent sodium channels and modulates high-voltage-activated calcium channels. This reduces the propagation of sodium-dependent action potentials in neurons, thereby decreasing seizure activity and abnormal electrical discharges in the brain.","oneSentence":"Oxcarbazepine blocks voltage-gated sodium channels in neuronal membranes, reducing repetitive neuronal firing and stabilizing hyperexcited neural tissue.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T04:49:39.478Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Partial-onset seizures (monotherapy and adjunctive therapy in adults and children)"},{"name":"Generalized tonic-clonic seizures (adjunctive therapy)"},{"name":"Bipolar disorder (off-label use)"}]},"trialDetails":[{"nctId":"NCT01679002","phase":"PHASE1","title":"Steady-state Pharmacokinetics of BIA 2-093 and Oxcarbazepine in Healthy Volunteers","status":"COMPLETED","sponsor":"Bial - Portela C S.A.","startDate":"2003-10","conditions":"Epilepsy","enrollment":12},{"nctId":"NCT00849797","phase":"PHASE1","title":"Oxcarbazepine 600 mg Tablets Under Non-Fasting Conditions","status":"COMPLETED","sponsor":"Teva Pharmaceuticals USA","startDate":"2005-07","conditions":"Healthy","enrollment":120},{"nctId":"NCT00850174","phase":"PHASE1","title":"Oxcarbazepine 600 mg Tablets Under Fasting Conditions","status":"COMPLETED","sponsor":"Teva Pharmaceuticals USA","startDate":"2005-04","conditions":"Healthy","enrollment":60},{"nctId":"NCT03567681","phase":"PHASE4","title":"Comparison of Two Forms of Oxcarbazepine for the Treatment of Bipolar Depression","status":"UNKNOWN","sponsor":"Collaborative Care Initiative, LLC","startDate":"2018-06-13","conditions":"Bipolar Depression, Treatment Effectiveness, Measure-based Guidance","enrollment":120},{"nctId":"NCT01678976","phase":"PHASE1","title":"Tolerability and Pharmacokinetics of a Single 900 mg Oral Dose of BIA 2-093 and Oxcarbazepine in Healthy Volunteers","status":"COMPLETED","sponsor":"Bial - Portela C S.A.","startDate":"2002-03","conditions":"Epilepsy","enrollment":13},{"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":"NCT00951847","phase":"NA","title":"Bioequivalence Study of Oxcarbazepine Oral Suspension 300 mg/5mL Under Fed Condition","status":"COMPLETED","sponsor":"Ranbaxy Laboratories Limited","startDate":"2006-10","conditions":"Healthy","enrollment":40},{"nctId":"NCT00951600","phase":"NA","title":"Bioequivalence Study of Oxcarbazepine Oral Suspension 300 mg/5 mL Under Fasting Conditions","status":"COMPLETED","sponsor":"Ranbaxy Laboratories Limited","startDate":"2006-09","conditions":"Healthy","enrollment":40}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":61,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Trileptal®","genericName":"Trileptal®","companyName":"Teva Pharmaceuticals USA","companyId":"teva-pharmaceuticals-usa","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Oxcarbazepine blocks voltage-gated sodium channels in neuronal membranes, reducing repetitive neuronal firing and stabilizing hyperexcited neural tissue. Used for Partial-onset seizures (monotherapy and adjunctive therapy in adults and children), Generalized tonic-clonic seizures (adjunctive therapy), Bipolar disorder (off-label use).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}