Overview
Eslicarbazepine acetate (ESL) is an anticonvulsant medication approved for use in Europe, the United States and Canada as an adjunctive therapy for partial-onset seizures that are not adequately controlled with conventional therapy. Eslicarbazepine acetate is a prodrug that is rapidly converted to eslicarbazepine, the primary active metabolite in the body. Eslicarbazepine's mechanism of action is not well understood, but it is known that it does exert anticonvulsant activity by inhibiting repeated neuronal firing and stabilizing the inactivated state of voltage-gated sodium channels, thus preventing their return to the activated state during which seizure activity can occur. Eslicarbazepine acetate is marketed as Aptiom in North America and Zebinix or Exalief in Europe. It is available in 200, 400, 600, or 800mg tablets that are taken once daily, with or without food. Eslicarbazepine acetate is associated with numerous side effects including dizziness, drowsiness, nausea, vomiting, diarrhea, headache, aphasia, lack of concentration, psychomotor retardation, speech disturbances, ataxia, depression and hyponatremia. It is recommended that patients taking eslicarbazepine acetate be monitored for suicidality.
Indication
Eslicarbazepine acetate is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.
Associated Conditions
- Partial-Onset Seizures
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/09/19 | Phase 2 | Completed | Bial - Portela C S.A. | ||
2020/01/09 | N/A | UNKNOWN | Centre Hospitalier Saint Joseph Saint Luc de Lyon | ||
2019/09/19 | Phase 1 | Completed | Whanin Pharmaceutical Company | ||
2017/04/17 | Phase 4 | Completed | |||
2017/04/11 | Phase 3 | Withdrawn | |||
2015/06/29 | Phase 3 | Completed | Bial - Portela C S.A. | ||
2014/11/05 | Phase 1 | Completed | Bial - Portela C S.A. | ||
2014/11/02 | Phase 1 | Completed | Bial - Portela C S.A. | ||
2013/12/27 | Phase 2 | Completed | Bial - Portela C S.A. | ||
2013/06/17 | Phase 1 | Terminated | Bial - Portela C S.A. |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Lupin Pharmaceuticals, Inc. | 68180-290 | ORAL | 200 mg in 1 1 | 4/3/2025 | |
| Sumitomo Pharma America, Inc. | 63402-206 | ORAL | 600 mg in 1 1 | 3/28/2019 | |
| Camber Pharmaceuticals, Inc. | 31722-429 | ORAL | 400 mg in 1 1 | 9/7/2023 | |
| Sumitomo Pharma America, Inc. | 63402-202 | ORAL | 200 mg in 1 1 | 3/28/2019 | |
| Sumitomo Pharma America, Inc. | 63402-204 | ORAL | 400 mg in 1 1 | 3/28/2019 | |
| Lupin Pharmaceuticals, Inc. | 68180-293 | ORAL | 800 mg in 1 1 | 4/3/2025 | |
| Lupin Pharmaceuticals, Inc. | 68180-292 | ORAL | 600 mg in 1 1 | 4/3/2025 | |
| Camber Pharmaceuticals, Inc. | 31722-428 | ORAL | 200 mg in 1 1 | 9/7/2023 | |
| Sumitomo Pharma America, Inc. | 63402-208 | ORAL | 800 mg in 1 1 | 3/28/2019 | |
| Lupin Pharmaceuticals, Inc. | 68180-291 | ORAL | 400 mg in 1 1 | 4/3/2025 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 4/21/2009 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| APTIOM | sumitomo pharma canada, inc. | 02426862 | Tablet - Oral | 200 MG | 8/7/2014 |
| APO-ESLICARBAZEPINE | 02537974 | Tablet - Oral | 800 MG | 5/6/2025 | |
| APO-ESLICARBAZEPINE | 02537966 | Tablet - Oral | 600 MG | 5/6/2025 | |
| AURO-ESLICARBAZEPINE | auro pharma inc | 02527448 | Tablet - Oral | 400 MG | 5/8/2025 |
| APO-ESLICARBAZEPINE | 02537931 | Tablet - Oral | 200 MG | 5/6/2025 | |
| AURO-ESLICARBAZEPINE | auro pharma inc | 02527456 | Tablet - Oral | 600 MG | 5/8/2025 |
| AURO-ESLICARBAZEPINE | auro pharma inc | 02527464 | Tablet - Oral | 800 MG | 5/8/2025 |
| APTIOM | sumitomo pharma canada, inc. | 02426870 | Tablet - Oral | 400 MG | 8/7/2014 |
| APTIOM | sumitomo pharma canada, inc. | 02426889 | Tablet - Oral | 600 MG | 8/7/2014 |
| APTIOM | sumitomo pharma canada, inc. | 02426897 | Tablet - Oral | 800 MG | 8/7/2014 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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