ESLICARBAZEPINE ACETATE
ESLICARBAZEPINE ACETATE is indicated for the treatment of Partial-Onset Seizures.
How ESLICARBAZEPINE ACETATE Works
Eslicarbazepine acetate is a prodrug that is extensively converted into eslicarbazepine, the active component responsible for its therapeutic effects. While the precise mechanism of action is not fully known, it is believed to involve the inhibition of voltage-gated sodium channels. By interacting with these channels, the drug exerts anticonvulsant activity to help regulate electrical signaling in the brain.
Details
- Status
- Prescription
- First Approved
- 2021-06-29
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
ESLICARBAZEPINE ACETATE Approval History
What ESLICARBAZEPINE ACETATE Treats
1 indicationsESLICARBAZEPINE ACETATE is approved for 1 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Partial-Onset Seizures
ESLICARBAZEPINE ACETATE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to ESLICARBAZEPINE ACETATE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03116828 results posted | 093-701 | Ph 4 | completed | A Study of a Drug to be Used in Addition With Another Drug to Treat Adults With Uncontrolled Partial-onset Seizures |
| NCT00910247 results posted | 093-050 | Ph 3 | completed | Eslicarbazepine Acetate Monotherapy Long Term Study |
| NCT03108729 | SEP-093-364 | Ph 3 | withdrawn | A Pediatric Drug Study to Determine the Long-term Safety and Tolerability in Children and Adolescents (4-17 Years in Age) Taking the Drug |
| NCT01422720 results posted | BIA-2093-401 0140BI17.MPB, 2009-012587-14 | Ph 3 | completed | Safety and Efficacy of Eslicarbazepine Acetate as Adjunctive Therapy for Partial Seizures in Elderly Patients |
| NCT00866775 results posted | 093-045 | Ph 3 | completed | Safety and Efficacy of Eslicarbazepine Acetate Monotherapy in Subjects With Partial Epilepsy Not Well Controlled by Current Antiepileptic Drugs |
| NCT00987558 results posted | BIA-2093-124 | Ph 1 | completed | Effect of Repeated Administration of Eslicarbazepine Acetate on the Pharmacokinetics of Simvastatin in Healthy Subjects |
| NCT00900237 results posted | BIA-2093-127 | Ph 1 | completed | Study to Evaluate Pharmacokinetics and Tolerability of Multiple Doses of Eslicarbazepine Acetate and Oxcarbazepine |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ESLICARBAZEPINE ACETATE FDA Label Details
Indications & Usage
ESLICARBAZEPINE ACETATE is indicated for the treatment of Partial-Onset Seizures.
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APTIOM
Full clinical data, patents, trials, and competitive landscape for eslicarbazepine acetate.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.