XCOPRI (cenobamate)
XCOPRI is indicated for the treatment of Partial-Onset Seizures.
How XCOPRI Works
While the precise mechanism of action is unknown, cenobamate is demonstrated to reduce repetitive neuronal firing by inhibiting voltage-gated sodium currents. It also acts as a positive allosteric modulator of the γ-aminobutyric acid (GABA A) ion channel. These combined actions help regulate electrical activity in the brain to produce its therapeutic effects.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2019-11-21
- Patent Cliff
- 2039
- Routes
- ORAL
- Dosage Forms
- TABLET
XCOPRI Approval History
What XCOPRI Treats
1 indicationsXCOPRI is approved for 1 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Partial-Onset Seizures
XCOPRI 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 XCOPRI
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
11 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05067634 | YKP3089C040 | Ph 3 | active not recruiting | Safety and Efficacy Study of Cenobamate in Pediatric Subjects 2-17 Years of Age With Partial-onset (Focal) Seizures |
| NCT04903314 | YKP3089C039 | Ph 1 | completed | Dose-Escalation Study of Cenobamate (YKP3089) in Pediatric Subjects With Partial-Onset Seizures |
| NCT06453213 | YKP3089C049 | Ph 4 | active not recruiting | Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy |
| NCT03961568 | YKP3089C033 | Ph 3 | enrolling by invitation | Cenobamate Open-Label Extension Study for YKP3089C025 |
| NCT03678753 | YKP3089C025 | Ph 3 | completed | Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Cenobamate Adjunctive Therapy in PGTC Seizures |
| NCT06579573 | ONO-2017-01 jRCT2031210624 | Ph 3 | recruiting | ONO-2017 Study Japanese Patients With Primary Generalized Tonic Clonic Seizures. |
| NCT06590896 | ONO-2017-02 jRCT2031220198 | Ph 2 | recruiting | Safety of Cenobamate in Japanese Subjects With Partial Onset Seizures |
| NCT03509285 | YKP3089C024 | Ph 1 | completed | A Study of the Abuse Liability Potential of Cenobamate in Recreational Drug Users |
| NCT05572255 | YKP3089C045 | Ph 1 | completed | A Randomized, Open-label, Three-way Crossover Study to Evaluate the Relative Bioavailability of 200 Mg Cenobamate Administered Orally |
| NCT03234699 | YKP3089C026 | Ph 1 | completed | Assess the Influence of Cenobamate on the PK of Cytochrome P450 (CYP) Probe Drugs As a Means of Predicting Drug-drug Interactions |
| NCT04791553 | YKP3089C038 | Ph 1 | completed | Safety Study of Cenobamate in Subjects With Normal Hepatic Function and Subjects With Severe Hepatic Impairment |
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.
XCOPRI FDA Label Details
Indications & Usage
FDA Label (PDF)XCOPRI is indicated for the treatment of Partial-Onset Seizures.
XCOPRI Patents & Exclusivity
Patents (2 active)
Pro Intelligence Preview
Deep insights for XCOPRI
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2039
- • 72 active patents
Trial Analysis
- • 9 total trials
- • Stage: Expansion
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