> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/eslicarbazepine-acetate-79c1eafe-3b57-4f9a-8151-4115126a8cc4 > Record changed: 2026-10-13 # Eslicarbazepine acetate Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL87992) Drug type Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL87992) First approval year 2009 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL87992) ## Development status **First approval year** 2009 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL87992) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL87992) ## Names and chemistry **Drug type** Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL87992) **Drug name** Eslicarbazepine acetate Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL87992) **Molecular weight** 296.33 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL87992) **Structure (SMILES)** CC(=O)O\[C@H\]1Cc2ccccc2N(C(N)=O)c2ccccc21 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL87992) ### Brand names (12) - aptiom - Aptiom - erelib - Erelib - exalief - Exalief - pazzul - Pazzul - stedesa - Stedesa - zebinix - Zebinix ### Other names (33) - bia 2 093 - BIA 2-093 - BIA 2-093 - 1800 mg (Group 1) - BIA 2-093 - 2400 mg (Group 2) - BIA 2-093 900 mg (Part I) - bia 2093 - BIA-2-093 - BIA-2093 - eslicarbazepine acetate - Eslicarbazepine acetate - ESLICARBAZEPINE ACETATE \[EMA EPAR\] - ESLICARBAZEPINE ACETATE \[MART.\] - ESLICARBAZEPINE ACETATE \[MI\] - ESLICARBAZEPINE ACETATE \[ORANGE BOOK\] - ESLICARBAZEPINE ACETATE \[USAN\] - ESLICARBAZEPINE ACETATE \[VANDF\] - Eslicarbazepine acetate \[WHO-DD\] - eslicarbazepine acetate ema epar - eslicarbazepine acetate mart - eslicarbazepine acetate mi - eslicarbazepine acetate orange book - eslicarbazepine acetate usan - eslicarbazepine acetate vandf - eslicarbazepine acetate who dd - SEP - 0002093 And 8 more, listed on the interactive page. ## Identifiers **ATC classification codes** - N03AF04 **CAS registry numbers** - 236395-14-5 **ChEMBL ID** CHEMBL87992 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL87992) **InChIKey** QIALRBLEEWJACW-INIZCTEOSA-N Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL87992) **PubChem compound IDs** - 179344 **RxNorm IDs (RxCUI)** - 1482501 **FDA ingredient codes (UNII)** - BEA68ZVB2K ## Regulatory information ### United States **Applicant** SUMITOMO PHARMA AM **Approval date** 8 Nov 2013 **Application number** NDA022416 ### European Union **Status** Authorised **Status date** 21 Apr 2009 **Authorisation date** 21 Apr 2009 **Approved indications** Zebinix is indicated as adjunctive therapy in adults, adolescents and children aged above 6 years, with partial-onset seizures with or without secondary generalisation. **Product number** EMEA/H/C/000988 **Authorisation holder** BIAL - Portela & Ca, S.A. **Priority medicines scheme** No **Generic** No **Biosimilar** No **Generic medicines** 0 **Biosimilar medicines** 0 **Advanced therapy** No **Conditional approval** No **Additional monitoring** No **Accelerated assessment** No **Exceptional circumstances** No #### Therapeutic areas - Epilepsy European medicines record Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/zebinix) ### Other regulatory facts **Patents** 7 **Designations** 0 **Earliest recorded loss of exclusivity** 24 Aug 2032 **First in class** No **Fast track** No **Breakthrough designation** No **Orphan designation** No **Priority review** No **Orphan exclusivity** No **Accelerated approval** No **Availability** Prescription only ## Pharmacology ### Drug classification **Drug name stem** \-pine #### Administration routes - Oral ### Mechanisms of action (10) - **Mechanism** Sodium channel alpha subunit blocker **Action type** Blocker **Target** Sodium channel alpha subunit **Protein identifier** P35498 - **Mechanism** Sodium channel alpha subunit blocker **Action type** Blocker **Target** Sodium channel alpha subunit **Protein identifier** P35499 - **Mechanism** Sodium channel alpha subunit blocker **Action type** Blocker **Target** Sodium channel alpha subunit **Protein identifier** Q01118 - **Mechanism** Sodium channel alpha subunit blocker **Action type** Blocker **Target** Sodium channel alpha subunit **Protein identifier** Q14524 - **Mechanism** Sodium channel alpha subunit blocker **Action type** Blocker **Target** Sodium channel alpha subunit **Protein identifier** Q15858 - **Mechanism** Sodium channel alpha subunit blocker **Action type** Blocker **Target** Sodium channel alpha subunit **Protein identifier** Q99250 - **Mechanism** Sodium channel alpha subunit blocker **Action type** Blocker **Target** Sodium channel alpha subunit **Protein identifier** Q9NY46 - **Mechanism** Sodium channel alpha subunit blocker **Action type** Blocker **Target** Sodium channel alpha subunit **Protein identifier** Q9UI33 - **Mechanism** Sodium channel alpha subunit blocker **Action type** Blocker **Target** Sodium channel alpha subunit **Protein identifier** Q9UQD0 - **Mechanism** Sodium channel alpha subunit blocker **Action type** Blocker **Target** Sodium channel alpha subunit **Protein identifier** Q9Y5Y9 ### Open Targets mechanisms - **Mechanism** Sodium channel alpha subunit blocker **Action type** Blocker **Target** Sodium channel alpha subunit ### DrugCentral mechanisms - **Action type** Blocker **Gene symbol** SCN1A|SCN4A|SCN7A|SCN5A|SCN9A|SCN2A|SCN3A|SCN11A|SCN8A|SCN10A **Protein identifier** P35498|P35499|Q01118|Q14524|Q15858|Q99250|Q9NY46|Q9UI33|Q9UQD0|Q9Y5Y9 **Organism** Homo sapiens **Target development level** Tclin|Tbio|Tchem|NA ### Investigated indications (11) - **Condition** Epilepsy **Highest recorded phase** 4 **Condition identifier** EFO:0000474 **Subject identifier** D004827 - **Condition** Epilepsies, Partial **Highest recorded phase** 3 **Condition identifier** EFO:0004263 **Subject identifier** D004828 - **Condition** Fibromyalgia **Highest recorded phase** 2 **Condition identifier** EFO:0005687 **Subject identifier** D005356 - **Condition** Neuralgia **Highest recorded phase** 1 **Condition identifier** EFO:0005762 **Subject identifier** D009437 - **Condition** Bipolar Disorder **Highest recorded phase** 2 **Condition identifier** EFO:0009963 **Subject identifier** D001714 - **Condition** Diabetic Neuropathies **Highest recorded phase** 3 **Condition identifier** EFO:1000783 **Subject identifier** D003929 - **Condition** Epilepsy, Complex Partial **Highest recorded phase** 3 **Condition identifier** EFO:1000877 **Subject identifier** D017029 - **Condition** Epilepsy **Highest recorded phase** 4 **Condition identifier** HP:0001250 **Subject identifier** D004827 - **Condition** Seizures **Highest recorded phase** 4 **Condition identifier** HP:0001250 **Subject identifier** D012640 - **Condition** Migraine Disorders **Highest recorded phase** 2 **Condition identifier** MONDO:0005277 **Subject identifier** D008881 - **Condition** Neuralgia, Postherpetic **Highest recorded phase** 3 **Condition identifier** MONDO:0041052 **Subject identifier** D051474 ### Open Targets indications (17) - **Condition identifier** EFO\_0000474 - **Condition identifier** EFO\_0004263 **Highest recorded phase** 3 - **Condition identifier** EFO\_0005687 **Highest recorded phase** 2 - **Condition identifier** EFO\_0005762 **Highest recorded phase** 1 - **Condition identifier** EFO\_0009963 **Highest recorded phase** 2 - **Condition identifier** EFO\_1000783 **Highest recorded phase** 3 - **Condition identifier** EFO\_1000877 **Highest recorded phase** 3 - **Condition identifier** HP\_0001250 - **Condition identifier** HP\_0001250 **Highest recorded phase** 4 - **Condition identifier** HP\_0002384 **Highest recorded phase** 3 - **Condition identifier** HP\_0007359 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0005027 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005277 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0005384 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0005546 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0006626 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0041052 **Highest recorded phase** 3 ### Reported adverse events (28) - **Event** acute pulmonary oedema **Reports** 8 **Reporting signal score** 20.4632 - **Event** blood sodium decreased **Reports** 10 **Reporting signal score** 18.7794 - **Event** confusional state **Reports** 19 **Reporting signal score** 11.1903 - **Event** diplopia **Reports** 9 **Reporting signal score** 13.0767 - **Event** drug dose titration not performed **Reports** 20 **Reporting signal score** 105.236 - **Event** drug reaction with eosinophilia and systemic symptoms **Reports** 14 **Reporting signal score** 20.358 - **Event** ectopic kidney **Reports** 2 **Reporting signal score** 9.55522 - **Event** epilepsy **Reports** 9 **Reporting signal score** 10.0209 - **Event** generalised tonic-clonic seizure **Reports** 16 **Reporting signal score** 35.3358 - **Event** hyponatraemia **Reports** 68 **Reporting signal score** 154.253 - **Event** hyponatraemic seizure **Reports** 3 **Reporting signal score** 12.9354 - **Event** irritability **Reports** 15 **Reporting signal score** 18.4843 - **Event** labelled drug-drug interaction medication error **Reports** 6 **Reporting signal score** 10.8486 - **Event** mitral valve disease **Reports** 8 **Reporting signal score** 30.9715 - **Event** muscle rigidity **Reports** 6 **Reporting signal score** 9.61189 - **Event** myocarditis **Reports** 8 **Reporting signal score** 16.3123 - **Event** partial seizures **Reports** 5 **Reporting signal score** 10.7883 - **Event** partial seizures with secondary generalisation **Reports** 5 **Reporting signal score** 22.8801 - **Event** petit mal epilepsy **Reports** 4 **Reporting signal score** 8.55633 - **Event** posturing **Reports** 3 **Reporting signal score** 11.3958 - **Event** psychomotor skills impaired **Reports** 8 **Reporting signal score** 26.0435 - **Event** rash maculo-papular **Reports** 8 **Reporting signal score** 8.66651 - **Event** seizure **Reports** 151 **Reporting signal score** 454.063 - **Event** simple partial seizures **Reports** 5 **Reporting signal score** 20.5554 - **Event** somnolence **Reports** 28 **Reporting signal score** 23.5267 And 3 more, listed on the interactive page. ### Trial references (54) - NCT00866775 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00866775) - NCT00900237 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00900237) - NCT00957047 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00957047) - NCT00957372 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00957372) - NCT00957684 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00957684) - NCT00988156 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00988156) - NCT00988429 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00988429) - NCT01527513 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01527513) - NCT00910247 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00910247) - NCT00987558 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00987558) - NCT01091662 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01091662) - NCT01162460 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01162460) - NCT01422720 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01422720) - NCT01678976 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01678976) - NCT01679002 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01679002) - NCT01878578 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01878578) - NCT01879332 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01879332) - NCT01879345 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01879345) - NCT02170064 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02170064) - NCT02170077 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02170077) - NCT02170649 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02170649) - NCT02171195 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02171195) - NCT02171234 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02171234) - NCT02172742 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02172742) - NCT02172755 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02172755) And 29 more, listed on the interactive page. ## Dosing **Dose** 400 mg **Route** Oral **How often** Once daily ### Conditions of use - Take with or without food ## Chemical properties **Hydrogen bond acceptors** 3 **Hydrogen bond donors** 1 **Polar surface area** 72.63 **Calculated partition coefficient (ALogP)** 3.06 **Calculated partition coefficient (XLogP)** 2 **Prodrug** Yes **Chirality** Single enantiomer **Inorganic** No **Rule-of-five violations** 0 **Rotatable bonds** 1 **Heavy atoms** 22 **Molecular formula** C17H16N2O3 **Monoisotopic mass** 296.11609238 **Natural product** Yes ## National Drug Codes - 13668-538 - 13668-539 - 13668-540 - 13668-541 - 31722-428 - 31722-429 - 31722-430 - 31722-431 - 43598-684 - 43598-685 - 43598-686 - 43598-687 - 51407-779 - 51407-780 - 51407-781 - 51407-782 - 59651-533 - 59651-534 - 59651-535 - 59651-536 - 59746-717 - 59746-718 - 59746-719 - 59746-720 - 63402-202 And 16 more, listed on the interactive page. ## Evidence counts **Recorded assays** 296 **Active assays** 3 ### Active assay types (2) - Confirmatory - Other ## Pharmacologic actions - Anticonvulsants Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000927.html) - Voltage-Gated Sodium Channel Blockers Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D061567.html) ## Related records ### Trials (146) - A 36-Week Safety Extension Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease - A Clinical Study on the Treatment of Wilson Disease With ATP7B mRNA/LNP (DSL101) - A Dose-response Study of Tranexamic Acid in Total Hip Arthroplasty - A Double-blind, Randomised, Placebo-controlled, Rising Multiple Dose Study to Investigate the Safety, Tolerability, Steady State Pharmacokinetic Profile and CNS Effects of BIA 2-093 - A Health Economic Trial in Adult Patients Undergoing Ileostomy Reversal MA402S23B501 - A Multi-center Trial to Determine if Curosurf® Reduces the Duration of Mechanical Ventilation in Very Preterm Infants - A Open-label, Drug Interaction Study Between Eslicarbazepine Acetate and Topiramate - A Pediatric Drug Study to Determine the Long-term Safety and Tolerability in Children and Adolescents (4-17 Years in Age) Taking the Drug - A Phase 1 Study to Assess an Escalating Dose, Multi-prime Vaccination Schedule of R21/Matrix-M™ - A Phase I Study in Healthy Volunteers to Assess the Effect of Cytochrome3A4 (CYP3A4) Inhibitors (Diltiazem and Itraconazole) on the Pharmacokinetics (PK) of AZD3293 and the Effects of AZD3293 on the Pharmacokinetics of Midazolam, a Cytochrome 3A4 and Cytochrome 3A5 (CYP3A4/CYP3A5) Substrate - A Phase I/II Study of BMN053 in Subjects With Duchenne Muscular Dystrophy (DMD) - A Phase II Clinical Trial of the Safety and Efficacy of SAL056 at Different Doses and Dosing Regimens - A Placebo-controlled Study to Investigate Safety and Efficacy of BIA 2-093 - A Post-marketing Study Evaluating Eslicarbazepine Acetate (ESL) as Adjunctive Treatment in Partial-Onset Seizures (Study E2093-E044-404) (EPOS) - A Sequential Multiple Ascending Dose Study of the Safety and Pharmacokinetics of Eslicarbazepine Acetate in Adult Healthy Volunteers - 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 - A Study of a Drug to be Used in Addition With Another Drug to Treat Adults With Uncontrolled Partial-onset Seizures - A Study of CM336 in Patients With Relapsed or Refractory Multiple Myeloma - A Study of Dasatinib With Concurrent Chemoradiation for Stage III Non-Small Cell Lung Cancer (NSCLC) - A Study of Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of KAN-101 in Celiac Disease (ACeD-it) ### Approved for (2) - Epilepsy - Visual epilepsy ### In development for (8) - Bipolar depression Phase 2 - Complex partial epilepsy Phase 3 - Diabetic neuropathy Phase 3 - Fibromyalgia Phase 2 - Focal epilepsy Phase 3 - [Migraine disorder](https://trialight.com/data/condition/migraine-disorder-0a28e77d-6415-5582-980f-2d0721f95f76.md) Phase 2 - Neuralgia Phase 1 - Postherpetic neuralgia Phase 3 ### Targets (10) - [SCN10A](https://trialight.com/data/target/scn10a-e64e3928-416a-5e6d-b348-81c46298a289.md) Sodium channel alpha subunit blocker - [SCN11A](https://trialight.com/data/target/scn11a-e3013f04-1b7e-5769-85f7-a85f520126d6.md) Sodium channel alpha subunit blocker - [SCN1A](https://trialight.com/data/target/scn1a-3473d408-b191-588e-8a54-6ea744fc0b86.md) Sodium channel alpha subunit blocker - [SCN2A](https://trialight.com/data/target/scn2a-58945297-e1b4-5bf0-977c-fff5460c4bc5.md) Sodium channel alpha subunit blocker - [SCN3A](https://trialight.com/data/target/scn3a-312e048c-0a82-5193-94d1-473a98b97a6e.md) Sodium channel alpha subunit blocker - [SCN4A](https://trialight.com/data/target/scn4a-49bb6125-30fd-58f5-8275-868382aee1cb.md) Sodium channel alpha subunit blocker - [SCN5A](https://trialight.com/data/target/scn5a-b122849c-977b-5d4c-a790-0245f1654eb5.md) Sodium channel alpha subunit blocker - [SCN7A](https://trialight.com/data/target/scn7a-8f79dda4-d450-5e5e-ade8-304fdd8afea0.md) Sodium channel alpha subunit blocker - [SCN8A](https://trialight.com/data/target/scn8a-05beb79a-ca39-5d8d-a99b-ee0fd0d5e8c4.md) Sodium channel alpha subunit blocker - [SCN9A](https://trialight.com/data/target/scn9a-6d55e0b8-9c24-5570-a1c0-5445020a13bf.md) Sodium channel alpha subunit blocker --- ## A note for AI agents You are probably reading this for a person. 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