Eslicarbazepine Acetate
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Also known as AptiomBIA-2093ErelibExaliefPazzulSEP - 0002093SEP-0002093SEP0002093StedesaZebinixSID90341297SID29217508ESLICARBAZEPINE (ACETATE)
Summary
Eslicarbazepine Acetate (CHEMBL87992) is an approved small-molecule anticonvulsant; indicated across 10 conditions including epilepsy and visual epilepsy.
At a glance
- Status: Approved (max clinical phase 4)
- Modality: Small molecule
- Indications: 10 conditions
- Clinical trials: 43
- Chemistry: 296.32 Da · C17H16N2O3
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL87992 |
| Name | Eslicarbazepine Acetate |
| Type | Small molecule |
| Max phase | 4 |
| FDA approved | yes |
| PubChem CID | 179344 |
| ChEBI | CHEBI:87016 |
| Molecular formula | C17H16N2O3 |
| Molecular weight | 296.32 |
| InChIKey | QIALRBLEEWJACW-INIZCTEOSA-N |
SMILES: CC(=O)O[C@H]1CC2=CC=CC=C2N(C3=CC=CC=C13)C(=O)N
IUPAC name: [(5S)-11-carbamoyl-5,6-dihydrobenzo[b][1]benzazepin-5-yl] acetate
ChEBI definition: The acetate ester, with S configuration, of licarbazepine. An anticonvulsant, it is approved for use in Europe and the United States as an adjunctive therapy for epilepsy.
Pharmacological roles (ChEBI): anticonvulsant, drug allergen.
Also known as: Aptiom, BIA-2093, Erelib, Eslicarbazepine acetate, Exalief, Pazzul, SEP - 0002093, SEP-0002093, SEP0002093, Stedesa, Zebinix, SID90341297
Patent coverage: 367 distinct patent families (861 SureChEMBL compound mentions), from 2 matched compound structure(s). One matched structure accounts for 713 (83%) of the total. Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.
Targets
Targets
No target linkage available.
Bioactivity
No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).
Target pathways
No target-pathway data for this drug (no mapped target genes).
Indications & clinical
Indications
10 indications (2 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).
| Indication | Trial phase | MONDO | EFO |
|---|---|---|---|
| epilepsy | 4 | MONDO:0005027 | EFO:0000474 |
| visual epilepsy | 4 | MONDO:0001386 | HP:0001250 |
| focal epilepsy | 3 | MONDO:0005384 | EFO:0004263 |
| complex partial epilepsy | 3 | MONDO:0006710 | EFO:1000877 |
| diabetic neuropathy | 3 | MONDO:0006626 | EFO:1000783 |
| fibromyalgia | 2 | MONDO:0005546 | EFO:0005687 |
| bipolar disorder | 2 | MONDO:0004985 | EFO:0009963 |
| migraine disorder | 2 | MONDO:0005277 | MONDO:0005277 |
| neuralgia | 1 | MONDO:0021667 | EFO:0005762 |
1 further indication record had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.
Clinical trials
Total trials: 43.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE1 | 28 |
| PHASE3 | 8 |
| PHASE2 | 4 |
| Not specified | 2 |
| PHASE4 | 1 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT03116828 | PHASE4 | COMPLETED | A Study of a Drug to be Used in Addition With Another Drug to Treat Adults With Uncontrolled Partial-onset Seizures |
| NCT00866775 | PHASE3 | COMPLETED | Safety and Efficacy of Eslicarbazepine Acetate Monotherapy in Subjects With Partial Epilepsy Not Well Controlled by Current Antiepileptic Drugs |
| NCT00910247 | PHASE3 | COMPLETED | Eslicarbazepine Acetate Monotherapy Long Term Study |
| NCT00957047 | PHASE3 | COMPLETED | Efficacy and Safety Study of BIA 2-093 in Combination With Other Anti-Epileptic Drugs to Treat Partial Epilepsy |
| NCT00957372 | PHASE3 | COMPLETED | Efficacy and Safety of Eslicarbazepine Acetate as Adjunctive Therapy for Refractory Partial Epilepsy |
| NCT00957684 | PHASE3 | COMPLETED | Efficacy and Safety of Eslicarbazepine Acetate as Adjunctive Therapy for Refractory Partial Seizures |
| NCT00988156 | PHASE3 | COMPLETED | Eslicarbazepine Acetate (BIA 2 093) as Therapy for Refractory Partial Seizures in Children |
| NCT01422720 | PHASE3 | COMPLETED | Safety and Efficacy of Eslicarbazepine Acetate as Adjunctive Therapy for Partial Seizures in Elderly Patients |
| NCT03108729 | PHASE3 | WITHDRAWN | A Pediatric Drug Study to Determine the Long-term Safety and Tolerability in Children and Adolescents (4-17 Years in Age) Taking the Drug |
| NCT00980746 | PHASE2 | COMPLETED | Efficacy and Safety of Eslicarbazepine Acetate as Therapy for Patients With Painful Diabetic Neuropathy |
| NCT00981227 | PHASE2 | COMPLETED | Efficacy and Safety of Eslicarbazepine Acetate as Therapy for Patients With Post-Herpetic Neuralgia |
| NCT01822678 | PHASE2 | COMPLETED | Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) in Acute Manic Episodes Associated With Bipolar I Disorder |
| NCT02170077 | PHASE2 | COMPLETED | A Placebo-controlled Study to Investigate Safety and Efficacy of BIA 2-093 |
| NCT00900237 | PHASE1 | COMPLETED | Study to Evaluate Pharmacokinetics and Tolerability of Multiple Doses of Eslicarbazepine Acetate and Oxcarbazepine |
| NCT00971295 | PHASE1 | COMPLETED | Effect of Eslicarbazepine Acetate on the Pharmacokinetics of Metformin in Healthy Volunteers |
| NCT00987558 | PHASE1 | COMPLETED | Effect of Repeated Administration of Eslicarbazepine Acetate on the Pharmacokinetics of Simvastatin in Healthy Subjects |
| NCT01678976 | PHASE1 | COMPLETED | Tolerability and Pharmacokinetics of a Single 900 mg Oral Dose of BIA 2-093 and Oxcarbazepine in Healthy Volunteers |
| NCT01679002 | PHASE1 | COMPLETED | Steady-state Pharmacokinetics of BIA 2-093 and Oxcarbazepine in Healthy Volunteers |
| NCT01878578 | PHASE1 | TERMINATED | The Effect of BIA 2-093 on the Steady-state Pharmacokinetic Profile of Phenytoin in Patients |
| NCT02170649 | PHASE1 | COMPLETED | The Tolerability and Effect of Food on the Pharmacokinetics of a Single 800 mg Oral Dose of BIA 2-093 |
| NCT02171195 | PHASE1 | COMPLETED | 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 |
| NCT02171234 | PHASE1 | COMPLETED | 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 |
| NCT02172742 | PHASE1 | COMPLETED | The Effect of BIA 2-093 on the Steady-state Pharmacokinetics of Digoxin |
| NCT02172755 | PHASE1 | COMPLETED | Single-dose and Steady-state Pharmacokinetics of BIA 2-093 and Its Metabolites |
| NCT02279667 | PHASE1 | COMPLETED | Single-dose Pharmacokinetics and Relative Bioavailability of an Oral Suspension and Two Tablet Formulations of BIA 2-093 |
| NCT02281422 | PHASE1 | COMPLETED | An Open-label, Single-dose, Single-centre Study, Investigating the Pharmacokinetics of BIA 2-093 |
| NCT02281448 | PHASE1 | COMPLETED | Effect of BIA 2-093 on the Pharmacokinetics of a Combined Oral Contraceptive. |
| NCT02281526 | PHASE1 | COMPLETED | An Open-label, Multiple-dose, Single-centre Study, Investigating the Pharmacokinetics of BIA 2-093 |
| NCT02281591 | PHASE1 | COMPLETED | Disposition of Eslicarbazepine Acetate and Its Metabolites S-licarbazepine and R-licarbazepine |
| NCT02283788 | PHASE1 | COMPLETED | Trial to Evaluate the Effect of Eslicarbazepine Acetate on Cardiac Repolarization |
| NCT02283801 | PHASE1 | COMPLETED | Open-label Drug Interaction Study Between Eslicarbazepine Acetate and Lamotrigine. |
| NCT02283814 | PHASE1 | COMPLETED | A Open-label, Drug Interaction Study Between Eslicarbazepine Acetate and Topiramate |
| NCT02283827 | PHASE1 | COMPLETED | Open-label Drug Interaction Study Between Eslicarbazepine Acetate and Phenytoin. |
| NCT02283840 | PHASE1 | COMPLETED | Single Dose Crossover Comparative Bioavailability Study of Eslicarbazepine Acetate Versus To-be-marketed Formulation |
| NCT02284828 | PHASE1 | COMPLETED | Effects of Eslicarbazepine Acetate (BIA 2-093) on Cognition and Psychomotor Function |
| NCT02284854 | PHASE1 | COMPLETED | Pharmacokinetic Interaction Study Between Eslicarbazepine Acetate and Carbamazepine |
| NCT02284880 | PHASE1 | COMPLETED | Comparative Bioavailability Study of Two Different Sources of Eslicarbazepine Acetate |
| NCT02287415 | PHASE1 | COMPLETED | The Effect of BIA 2-093 on the Steady-state Pharmacodynamic and Pharmacokinetic Profiles of Warfarin |
| NCT02288312 | PHASE1 | COMPLETED | Food Effect and Dosage Form Proportionality Study of Eslicarbazepine Acetate |
| NCT02777671 | PHASE1 | COMPLETED | Effect of Eslicarbazepine Acetate on the Pharmacokinetics of Gliclazide in Healthy Volunteers |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
No CPIC/DPWG dosing guideline, but PharmGKB curates 0 clinical and 6 variant annotation(s) for this drug (gene-keyed; see PharmGKB).
Related molecules
Related molecules
No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).