APTIOM (eslicarbazepine acetate)
APTIOM is indicated for the treatment of Partial-Onset Seizures.
How APTIOM Works
APTIOM is extensively converted into its active metabolite, eslicarbazepine, which is responsible for the drug's therapeutic effects. While the precise mechanism of action is not fully established, it is thought to involve the inhibition of voltage-gated sodium channels. By interacting with these channels, the drug is believed to exert the anticonvulsant activity necessary to manage seizures.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2013-11-08
- Patent Cliff
- 2032
- Routes
- ORAL
- Dosage Forms
- TABLET
APTIOM Approval History
What APTIOM Treats
1 indicationsAPTIOM is approved for 1 conditions since its original approval in 2013. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Partial-Onset Seizures
APTIOM 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 APTIOM
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| NCT03108729 | SEP-093-364 | Ph 3 | withdrawn | A Pediatric Drug Study to Determine the Long-term Safety and Tolerability in Children and Adolescents (4-17 Years in Age) Taking the Drug |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.
APTIOM FDA Label Details
Indications & Usage
FDA Label (PDF)APTIOM is indicated for the treatment of Partial-Onset Seizures.
Pro Intelligence Preview
Deep insights for APTIOM
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2032
- • 128 active patents
Trial Analysis
- • 9 total trials
- • Stage: Declining
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment