{"id":"eslicarbazepine-acetate","rwe":[{"pmid":"41885510","year":"2026","title":"Eslicarbazepine Use During Breastfeeding: A Case Report.","finding":"","journal":"Journal of human lactation : official journal of International Lactation Consultant Association","studyType":"Clinical Study"},{"pmid":"41722592","year":"2026","title":"Safety and efficacy of eslicarbazepine acetate for seizure prevention in patients with stroke at high risk of developing post-stroke epilepsy: a proof-of-concept, phase 2a, randomised, double-blind, placebo-controlled antiepileptogenesis trial.","finding":"","journal":"The Lancet. Neurology","studyType":"Clinical Study"},{"pmid":"41706289","year":"2026","title":"Antiseizure Medications in Older Adults with Epilepsy: Considerations in Pharmacology, Safety, Tolerability, and Effectiveness of Newer Agents.","finding":"","journal":"Drugs & aging","studyType":"Clinical Study"},{"pmid":"41560726","year":"2025","title":"Pharmacovigilance signal detection of psychiatric adverse events induced by third-generation antiepileptic drugs in children.","finding":"","journal":"Frontiers in pharmacology","studyType":"Clinical Study"},{"pmid":"41493949","year":"2026","title":"Bayesian-Based Pharmacokinetic Framework Integrated with Therapeutic Drug Monitoring for Assessing Adherence to Antiseizure Medications: A Clinical Trial Simulation Study.","finding":"","journal":"Journal of medical Internet research","studyType":"Clinical Study"}],"tags":[{"label":"eslicarbazepine acetate","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Sodium channel alpha subunit","category":"target"},{"label":"SCN10A","category":"gene"},{"label":"SCN11A","category":"gene"},{"label":"SCN1A","category":"gene"},{"label":"N03AF04","category":"atc"},{"label":"Oral","category":"route"},{"label":"Tablet","category":"form"},{"label":"Generic Available","category":"availability"},{"label":"LOE Approaching","category":"status"},{"label":"Partial seizure","category":"indication"},{"label":"Sumitomo Pharma Am","category":"company"},{"label":"Approved 2010s","category":"decade"},{"label":"Anticonvulsants","category":"pharmacology"},{"label":"Cardiovascular Agents","category":"pharmacology"},{"label":"Central Nervous System Agents","category":"pharmacology"},{"label":"Membrane Transport Modulators","category":"pharmacology"},{"label":"Sodium Channel Blockers","category":"pharmacology"},{"label":"Voltage-Gated Sodium Channel Blockers","category":"pharmacology"}],"phase":"marketed","safety":{"safetySignals":[{"llr":551.211,"date":"","count":217,"signal":"Seizure","source":"DrugCentral FAERS","actionTaken":"Reported 217 times (LLR=551)"},{"llr":218.82,"date":"","count":107,"signal":"Hyponatraemia","source":"DrugCentral FAERS","actionTaken":"Reported 107 times (LLR=219)"},{"llr":139.062,"date":"","count":25,"signal":"Drug dose titration not performed","source":"DrugCentral FAERS","actionTaken":"Reported 25 times (LLR=139)"},{"llr":109.917,"date":"","count":44,"signal":"Generalised tonic-clonic seizure","source":"DrugCentral FAERS","actionTaken":"Reported 44 times (LLR=110)"},{"llr":77.717,"date":"","count":65,"signal":"Somnolence","source":"DrugCentral FAERS","actionTaken":"Reported 65 times (LLR=78)"},{"llr":55.92,"date":"","count":18,"signal":"Partial seizures","source":"DrugCentral FAERS","actionTaken":"Reported 18 times (LLR=56)"},{"llr":48.679,"date":"","count":21,"signal":"Inappropriate antidiuretic hormone secretion","source":"DrugCentral FAERS","actionTaken":"Reported 21 times (LLR=49)"},{"llr":48.596,"date":"","count":26,"signal":"Irritability","source":"DrugCentral FAERS","actionTaken":"Reported 26 times (LLR=49)"},{"llr":42.127,"date":"","count":31,"signal":"Agitation","source":"DrugCentral FAERS","actionTaken":"Reported 31 times (LLR=42)"},{"llr":40.789,"date":"","count":10,"signal":"Impulse-control disorder","source":"DrugCentral FAERS","actionTaken":"Reported 10 times (LLR=41)"},{"llr":39.925,"date":"","count":98,"signal":"Off label use","source":"DrugCentral FAERS","actionTaken":"Reported 98 times (LLR=40)"},{"llr":37.961,"date":"","count":55,"signal":"Drug interaction","source":"DrugCentral FAERS","actionTaken":"Reported 55 times (LLR=38)"},{"llr":36.213,"date":"","count":13,"signal":"Multiple-drug resistance","source":"DrugCentral FAERS","actionTaken":"Reported 13 times (LLR=36)"},{"llr":34.646,"date":"","count":4,"signal":"Axillary lymphadenectomy","source":"DrugCentral FAERS","actionTaken":"Reported 4 times (LLR=35)"}],"commonSideEffects":[{"effect":"Dizziness","drugRate":"25%","severity":"common"},{"effect":"Somnolence","drugRate":"reported","severity":"unknown"},{"effect":"Nausea","drugRate":"reported","severity":"unknown"},{"effect":"Headache","drugRate":"reported","severity":"unknown"},{"effect":"Diplopia","drugRate":"reported","severity":"unknown"},{"effect":"Vomiting","drugRate":"reported","severity":"unknown"},{"effect":"Fatigue","drugRate":"reported","severity":"unknown"},{"effect":"Vertigo","drugRate":"reported","severity":"unknown"},{"effect":"Ataxia","drugRate":"reported","severity":"unknown"},{"effect":"Blurred vision","drugRate":"reported","severity":"unknown"},{"effect":"Tremor","drugRate":"reported","severity":"unknown"},{"effect":"Hyponatremia","drugRate":"13%","severity":"serious"},{"effect":"Asthenia","drugRate":"14%","severity":"common"},{"effect":"Rash","drugRate":"14%","severity":"common"},{"effect":"Dysarthria","drugRate":"14%","severity":"common"},{"effect":"Memory impairment","drugRate":"14%","severity":"common"},{"effect":"Nystagmus","drugRate":"14%","severity":"common"}],"specialPopulations":{"Pregnancy":"Based on animal data, may cause fetal harm. Limited available data with APTIOM use in pregnant women are insufficient to inform drug-associated risk of adverse developmental outcomes. In oral studies conducted in pregnant mice, rats, and rabbits, eslicarbazepine acetate demonstrated developmental toxicity, including increased incidence of malformations (mice), embryolethality (rats), and fetal growth retardation (all species), at clinically relevant doses. Advise pregnant woman of the potential risk to fetus. There is pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, such as APTIOM, during pregnancy. Encourage women who are taking APTIOM during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown.","Geriatric use":"There were insufficient numbers of patients >=65 years old enrolled in the controlled adjunctive epilepsy trials (N=15) to determine the efficacy of APTIOM in this patient population. The pharmacokinetics of APTIOM were evaluated in elderly healthy subjects (N=12) (Figure 1). Although the pharmacokinetics of eslicarbazepine are not affected by age independently, dose selection should take in consideration the greater frequency of renal impairment and other concomitant medical conditions.","Paediatric use":"Safety and effectiveness of APTIOM have been established in the age groups to 17 years. Use of APTIOM in these age groups is supported by evidence from adequate and well-controlled studies of APTIOM in adults with partial-onset seizures, pharmacokinetic data from adult and pediatric patients, and safety data from clinical studies in 393 pediatric patients to 17 years of age."}},"trials":[],"aliases":[],"company":"Sumitomo Pharma Am","patents":[{"applNo":"N022416","source":"FDA Orange Book","status":"Active","expires":"Sep 13, 2028","useCode":"U-2123","territory":"US","drugProduct":false,"patentNumber":"9763954","drugSubstance":false},{"applNo":"N022416","source":"FDA Orange Book","status":"Active","expires":"Aug 24, 2032","useCode":"U-2121","territory":"US","drugProduct":false,"patentNumber":"9750747","drugSubstance":false},{"applNo":"N022416","source":"FDA Orange Book","status":"Active","expires":"Apr 21, 2026","useCode":"","territory":"US","drugProduct":false,"patentNumber":"9206135","drugSubstance":true},{"applNo":"N022416","source":"FDA Orange Book","status":"Active","expires":"Apr 21, 2026","useCode":"","territory":"US","drugProduct":true,"patentNumber":"9643929","drugSubstance":false},{"applNo":"N022416","source":"FDA Orange Book","status":"Active","expires":"Oct 23, 2028","useCode":"","territory":"US","drugProduct":true,"patentNumber":"9566244","drugSubstance":false},{"applNo":"N022416","source":"FDA Orange Book","status":"Active","expires":"Oct 23, 2028","useCode":"","territory":"US","drugProduct":true,"patentNumber":"10912781","drugSubstance":false},{"applNo":"N022416","source":"FDA Orange Book","status":"Active","expires":"Apr 17, 2030","useCode":"","territory":"US","drugProduct":true,"patentNumber":"8372431","drugSubstance":false}],"pricing":[],"allNames":"aptiom","offLabel":[],"synonyms":["eslicarbazepine acetate","zebinix","exelief","aptiom","BIA 2-093","Sep-0002093"],"timeline":[{"date":"2013-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from SUNOVION PHARMS INC to Sumitomo Pharma Am"},{"date":"2013-11-08","type":"positive","source":"DrugCentral","milestone":"FDA approval (Sunovion Pharms Inc)"},{"date":"2023-08-03","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 2 manufacturers approved"},{"date":"2026-04-21","type":"negative","source":"FDA Orange Book","milestone":"Substance patent 9206135 expires"}],"approvals":[{"date":"2013-11-08","orphan":false,"company":"SUNOVION PHARMS INC","regulator":"FDA"}],"brandName":"Aptiom","ecosystem":[{"indication":"Partial seizure","otherDrugs":[{"name":"brivaracetam","slug":"brivaracetam","company":"Ucb Inc"},{"name":"cenobamate","slug":"cenobamate","company":"Sk Life Science Inc"},{"name":"perampanel","slug":"perampanel","company":"Eisai Inc"},{"name":"pregabalin","slug":"pregabalin","company":"Pf Prism Cv"}],"globalPrevalence":null}],"mechanism":{"target":"Sodium channel alpha subunit","novelty":"Follow-on","targets":[{"gene":"SCN10A","source":"DrugCentral","target":"Sodium channel alpha subunit","protein":"Sodium channel protein type 10 subunit alpha"},{"gene":"SCN11A","source":"DrugCentral","target":"Sodium channel alpha subunit","protein":"Sodium channel protein type 11 subunit alpha"},{"gene":"SCN1A","source":"DrugCentral","target":"Sodium channel alpha subunit","protein":"Sodium channel protein type 1 subunit alpha"},{"gene":"SCN2A","source":"DrugCentral","target":"Sodium channel alpha subunit","protein":"Sodium channel protein type 2 subunit alpha"},{"gene":"SCN3A","source":"DrugCentral","target":"Sodium channel alpha subunit","protein":"Sodium channel protein type 3 subunit alpha"},{"gene":"SCN4A","source":"DrugCentral","target":"Sodium channel alpha subunit","protein":"Sodium channel protein type 4 subunit alpha"},{"gene":"SCN5A","source":"DrugCentral","target":"Sodium channel alpha subunit","protein":"Sodium channel protein type 5 subunit alpha"},{"gene":"SCN7A","source":"DrugCentral","target":"Sodium channel alpha subunit","protein":"Sodium channel protein type 7 subunit alpha"},{"gene":"SCN8A","source":"DrugCentral","target":"Sodium channel alpha subunit","protein":"Sodium channel protein type 8 subunit alpha"},{"gene":"SCN9A","source":"DrugCentral","target":"Sodium channel alpha subunit","protein":"Sodium channel protein type 9 subunit alpha"}],"moaClass":"Cytochrome P450 2C19 Inhibitors","modality":"Small Molecule","drugClass":"eslicarbazepine acetate","explanation":"APTIOM is extensively converted to eslicarbazepine, which is considered to be responsible for therapeutic effects in humans. The precise mechanism(s) by which eslicarbazepine exerts anticonvulsant activity is unknown but is thought to involve inhibition of voltage-gated sodium channels.","oneSentence":"Aptiom works by blocking sodium channels in the brain to reduce the frequency of seizures.","technicalDetail":"Aptiom acts as a voltage-gated sodium channel blocker, specifically targeting the alpha subunit, to modulate the excitability of neurons and reduce the propagation of seizure activity."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Eslicarbazepine_acetate","title":"Eslicarbazepine acetate","extract":"Eslicarbazepine acetate (ESL), sold under the brand names Aptiom and Zebinix among others, is an anticonvulsant medication approved for use in Europe and the United States as monotherapy or as additional therapy for partial-onset seizures epilepsy.","wiki_history":"==History==\nEslicarbazepine acetate was developed by the Portuguese pharmaceutical company Bial. In early 2009, Bial sold the marketing rights in Europe to the Japanese company Eisai. The drug was approved in the European Union in April 2009 under the trade names Zebinix and Exalief, but was marketed only under the first name. In the US it is marketed by Sunovion (formerly Sepracor) and was approved in November 2013. This lowered the all-discounted retail cost from thousands of dollars to as little as $67.25 for the consumer - even more significant as alternative studied treatments such as trigeminal neuralgia are excluded from most US insurance coverage, due to Bial/Sunovion not submitting approval for additional treatments to the FDA."},"commercial":{"launchDate":"2013","_launchSource":"DrugCentral (FDA 2013-11-08, SUNOVION PHARMS INC)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4303","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=ESLICARBAZEPINE%20ACETATE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ESLICARBAZEPINE ACETATE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Eslicarbazepine_acetate","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T11:11:33.791465","biosimilars":[],"competitors":[{"drugName":"carbamazepine","drugSlug":"carbamazepine","fdaApproval":"1968-03-11","patentExpiry":"Nov 10, 2028","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"oxcarbazepine","drugSlug":"oxcarbazepine","fdaApproval":"2000-01-14","patentExpiry":"Apr 13, 2027","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"rufinamide","drugSlug":"rufinamide","fdaApproval":"2008-11-14","genericCount":11,"patentStatus":"Off-patent — generic available","relationship":"same-class"}],"genericName":"eslicarbazepine acetate","indications":{"approved":[{"name":"Partial seizure","source":"DrugCentral","snomedId":29753000,"regulator":"FDA","eligibility":"patients 2 years of age and older"}],"offLabel":[],"pipeline":[]},"currentOwner":"Sumitomo Pharma Am","drugCategory":"loe-approaching","labelChanges":[],"relatedDrugs":[{"drugId":"carbamazepine","brandName":"carbamazepine","genericName":"carbamazepine","approvalYear":"1968","relationship":"same-class"},{"drugId":"oxcarbazepine","brandName":"oxcarbazepine","genericName":"oxcarbazepine","approvalYear":"2000","relationship":"same-class"},{"drugId":"rufinamide","brandName":"rufinamide","genericName":"rufinamide","approvalYear":"2008","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT06597084","phase":"PHASE2","title":"Anti-epileptogenic Effects of Eslicarbazepine Acetate","status":"COMPLETED","sponsor":"Bial - Portela C S.A.","startDate":"2019-05-29","conditions":["Post Stroke Epilepsy"],"enrollment":129,"completionDate":"2023-09-11"},{"nctId":"NCT02283814","phase":"PHASE1","title":"A Open-label, Drug Interaction Study Between Eslicarbazepine Acetate and Topiramate","status":"COMPLETED","sponsor":"Bial - Portela C S.A.","startDate":"2007-01","conditions":["Epilepsy"],"enrollment":32,"completionDate":"2007-02"},{"nctId":"NCT02283788","phase":"PHASE1","title":"Trial to Evaluate the Effect of Eslicarbazepine Acetate on Cardiac Repolarization","status":"COMPLETED","sponsor":"Bial - Portela C S.A.","startDate":"2007-03","conditions":["Epilepsy"],"enrollment":67,"completionDate":"2007-06"},{"nctId":"NCT01879345","phase":"PHASE1","title":"A Study to Evaluate the Tolerability and Pharmacokinetics of Two Single and Multiple High Dose Regimens of BIA 2-093 In Healthy Volunteers","status":"COMPLETED","sponsor":"Bial - Portela C S.A.","startDate":"2004-10","conditions":["Epilepsy"],"enrollment":18,"completionDate":"2004-12"},{"nctId":"NCT02281591","phase":"PHASE1","title":"Disposition of Eslicarbazepine Acetate and Its Metabolites S-licarbazepine and R-licarbazepine","status":"COMPLETED","sponsor":"Bial - Portela C S.A.","startDate":"2006-06","conditions":["Epilepsy"],"enrollment":32,"completionDate":"2006-07"},{"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,"completionDate":"2003-12"},{"nctId":"NCT02172742","phase":"PHASE1","title":"The Effect of BIA 2-093 on the Steady-state Pharmacokinetics of Digoxin","status":"COMPLETED","sponsor":"Bial - Portela C S.A.","startDate":"2002-05","conditions":["Epilepsy"],"enrollment":13,"completionDate":"2002-07-25"},{"nctId":"NCT00957047","phase":"PHASE3","title":"Efficacy and Safety Study of BIA 2-093 in Combination With Other Anti-Epileptic Drugs to Treat Partial Epilepsy","status":"COMPLETED","sponsor":"Bial - Portela C S.A.","startDate":"2004-07","conditions":["Partial Epilepsy"],"enrollment":395,"completionDate":"2008-01"},{"nctId":"NCT00957684","phase":"PHASE3","title":"Efficacy and Safety of Eslicarbazepine Acetate as Adjunctive Therapy for Refractory Partial Seizures","status":"COMPLETED","sponsor":"Bial - 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Portela C S.A.","startDate":"2010-12","conditions":["Epilepsy"],"enrollment":815,"completionDate":"2016-09"},{"nctId":"NCT02171195","phase":"PHASE1","title":"A Single Centre, Phase I, Double-blind, Randomised, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetic Profile and Effects on EEG of Single Rising Oral Doses of BIA 2-093","status":"COMPLETED","sponsor":"Bial - Portela C S.A.","startDate":"2000-07","conditions":["Epilepsy"],"enrollment":64,"completionDate":"2000-10"},{"nctId":"NCT00980746","phase":"PHASE2","title":"Efficacy and Safety of Eslicarbazepine Acetate as Therapy for Patients With Painful Diabetic Neuropathy","status":"COMPLETED","sponsor":"Bial - Portela C S.A.","startDate":"2007-11","conditions":["Painful Diabetic Neuropathy"],"enrollment":557,"completionDate":"2008-11"},{"nctId":"NCT02777671","phase":"PHASE1","title":"Effect of Eslicarbazepine Acetate on the Pharmacokinetics of Gliclazide in Healthy Volunteers","status":"COMPLETED","sponsor":"Bial - 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