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Drug

Eslicarbazepine acetate

Established medicine
ClassSodium channel alpha subunit blockerResearchOngoing clinical research

Also known as Aptiom, ESL.

RxNorm1482501ChEMBLCHEMBL87992UNIIBEA68ZVB2K
10
Protein targets
2
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Approval: ESLICARBAZEPINE ACETATE (ANDA216481)

Regulatory2026-08-05FDA

Prevention of Epilepsy in Stroke Patients at High Risk of Developing Unprovoked Seizures: Anti-epileptogenic Effects of Eslicarbazepine Acetate

Clinical trial2025-05-02Results posted · ClinicalTrials.gov

Efficacy and Safety of BIA 2-093 as Adjunctive Therapy for Refractory Partial Seizures in a Double-blind, Randomised, Placebo-controlled, Parallel-group, Multicentre Clinical Trial

Clinical trial2025-03-25Results posted · ClinicalTrials.gov

Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) as Adjunctive Therapy for Refractory Partial Seizures in a Double-blind, Randomised, Placebo-controlled, Parallel-group, Multicentre Clinical Trial.

Clinical trial2025-03-12Results posted · ClinicalTrials.gov

Efficacy and Safety of Eslicarbazepine Acetate as First Add-on to Levetiracetam or Lamotrigine Monotherapy or as Later Adjunctive Treatment for Subjects With Uncontrolled Partial-onset Seizures: A Multicenter, Open-label, Non-randomized Trial

Clinical trial2020-06-16Results posted · ClinicalTrials.gov

Efficacy and Safety Study of Eslicarbazepine Acetate (BIA 2 093) as Adjunctive Therapy for Refractory Partial Seizures in Children

Clinical trial2018-11-13Results posted · ClinicalTrials.gov

Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) as Monotherapy for Patients With Newly Diagnosed Partial-onset Seizures: a Double-blind, Randomized, Active-controlled, Parallel-group, Multicenter Clinical Study - Open-label ESL Extension

Clinical trial2018-09-11Completed · ClinicalTrials.gov

Long Term Eslicarbazepine Acetate Extension Study

Clinical trial2018-07-17Results posted · ClinicalTrials.gov

An Open-label Eslicarbazepine Acetate Long-term Safety and Tolerability Study in Children and Adolescents (4 - 17 Years)

Clinical trial2017-10-26Withdrawn · ClinicalTrials.gov

Safety and Efficacy of Eslicarbazepine Acetate (ESL) as Adjunctive Therapy for Partial Seizures in Elderly Patients

Clinical trial2017-08-07Results posted · ClinicalTrials.gov

A Single Center, Single Dose, Open Label, Laboratory Blind, Randomized, Three Period, Six Sequence, Crossover Study to Determine the Bioequivalence of Two Different Sources of Eslicarbazepine Acetate (800 mg) and to Assess the Dose Equivalence of Two Different Dose Strengths of Eslicarbazepine Acetate (200 and 800 mg) in Healthy Subjects

Clinical trial2017-01-05Completed · ClinicalTrials.gov

Approval: Zebinix (EMA)

Regulatory2009-04-21EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Eslicarbazepine acetate
Aliases & brands
AptiomESL
RxNorm CUI
1482501
ChEMBL ID
CHEMBL87992
UNII
BEA68ZVB2K
Primary mechanism
Sodium channel alpha subunit blocker
Regulatory jurisdictions
emafda

Pharmacology & targets

10 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Sodium channel protein type 1 subunit alpha
SCN1A · P35498
BLOCKERSodium channel alpha subunit blocker
Sodium channel protein type 5 subunit alpha
SCN5A · Q14524
BLOCKERSodium channel alpha subunit blocker
Sodium channel protein type 4 subunit alpha
SCN4A · P35499
BLOCKERSodium channel alpha subunit blocker
Sodium channel protein type 7 subunit alpha
SCN7A · Q01118
BLOCKERSodium channel alpha subunit blocker
Sodium channel protein type 2 subunit alpha
SCN2A · Q99250
BLOCKERSodium channel alpha subunit blocker
Sodium channel protein type 9 subunit alpha
SCN9A · Q15858
BLOCKERSodium channel alpha subunit blocker
Sodium channel protein type 3 subunit alpha
SCN3A · Q9NY46
BLOCKERSodium channel alpha subunit blocker
Sodium channel protein type 11 subunit alpha
SCN11A · Q9UI33
BLOCKERSodium channel alpha subunit blocker
Sodium channel protein type 8 subunit alpha
SCN8A · Q9UQD0
BLOCKERSodium channel alpha subunit blocker
Sodium channel protein type 10 subunit alpha
SCN10A · Q9Y5Y9
BLOCKERSodium channel alpha subunit blocker

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2009-04-21
Latest approval
2026-08-05
Authorities
FDA · EMA
Total events
2
fdaU.S. Food and Drug Administration· 1 event
2026-08-05Approval
Approval: ESLICARBAZEPINE ACETATE (ANDA216481)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2009-04-21Approval
Approval: Zebinix (EMA)

Indication: Zebinix is indicated as adjunctive therapy in adults, adolescents and children aged above 6 years, with partial-onset seizures with or without secondary generalisation.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

28 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
28
registered trials across all phases
LATEST COMPLETION 2023
14
Late-stage (III+)
23
Completed
5
Discontinued
PHASE DISTRIBUTIONn = 28
Phase 16Phase 28Phase 313Phase 41

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Efficacy and Safety of Eslicarbazepine Acetate as First Add-on to Levetiracetam or Lamotrigine Monotherapy or as Later Adjunctive Treatment for Subjects With Uncontrolled Partial-onset Seizures: A Multicenter, Open-label, Non-randomized Trial

CompletedPH IVSumitomo Pharma America, Inc.n=1022019

Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) as Monotherapy for Patients With Newly Diagnosed Partial-onset Seizures: a Double-blind, Randomized, Active-controlled, Parallel-group, Multicenter Clinical Study - Open-label ESL Extension

CompletedPH IIIBial - Portela C S.A.n=2062018

An Open-label Eslicarbazepine Acetate Long-term Safety and Tolerability Study in Children and Adolescents (4 - 17 Years)

WithdrawnPH IIISumitomo Pharma America, Inc.2017

Efficacy and Safety Study of Eslicarbazepine Acetate (BIA 2 093) as Adjunctive Therapy for Refractory Partial Seizures in Children

CompletedPH IIIBial - Portela C S.A.n=3042017

Long Term Eslicarbazepine Acetate Extension Study

CompletedPH IIISumitomo Pharma America, Inc.n=2742017

Recent completions

Trials that read out recently, adding to the completed evidence base.

Prevention of Epilepsy in Stroke Patients at High Risk of Developing Unprovoked Seizures: Anti-epileptogenic Effects of Eslicarbazepine Acetate

CompletedPH IIBial - Portela C S.A.n=1292023

Efficacy and Safety of Eslicarbazepine Acetate as First Add-on to Levetiracetam or Lamotrigine Monotherapy or as Later Adjunctive Treatment for Subjects With Uncontrolled Partial-onset Seizures: A Multicenter, Open-label, Non-randomized Trial

CompletedPH IVSumitomo Pharma America, Inc.n=1022019

Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) as Monotherapy for Patients With Newly Diagnosed Partial-onset Seizures: a Double-blind, Randomized, Active-controlled, Parallel-group, Multicenter Clinical Study - Open-label ESL Extension

CompletedPH IIIBial - Portela C S.A.n=2062018

Efficacy and Safety Study of Eslicarbazepine Acetate (BIA 2 093) as Adjunctive Therapy for Refractory Partial Seizures in Children

CompletedPH IIIBial - Portela C S.A.n=3042017

Long Term Eslicarbazepine Acetate Extension Study

CompletedPH IIISumitomo Pharma America, Inc.n=2742017

A Single Center, Single Dose, Open Label, Laboratory Blind, Randomized, Three Period, Six Sequence, Crossover Study to Determine the Bioequivalence of Two Different Sources of Eslicarbazepine Acetate (800 mg) and to Assess the Dose Equivalence of Two Different Dose Strengths of Eslicarbazepine Acetate (200 and 800 mg) in Healthy Subjects

CompletedPH IBial - Portela C S.A.n=242017
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.