CENOBAMATE
Development Insights
Details
- Status
- Prescription
- First Approved
- 2019-11-21
- Routes
- N/A
- Dosage Forms
- TABLET
CENOBAMATE Approval History
Clinical Trial Registry
10 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| 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 | completed | 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 |
| NCT04557085 | YKP3089C035 | Ph 3 | completed | Randomized, Double-blind Study to Evaluate Efficacy and Safety of Cenobamate Adjunctive Therapy in POS |
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.
CENOBAMATE FDA Label Details
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Full clinical data, patents, trials, and competitive landscape for cenobamate.
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