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Xcopri (CENOBAMATE)
Xcopri works by enhancing the activity of a neurotransmitter called GABA, which helps calm down abnormal electrical activity in the brain.
At a glance
| Generic name | CENOBAMATE |
|---|---|
| Sponsor | Sk Life |
| Target | Gamma-aminobutyric acid receptor subunit alpha-4 |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 2019 |
Mechanism of action
The precise mechanism by which cenobamate exerts its therapeutic effects in patients with partial-onset seizures is unknown. Cenobamate has been demonstrated to reduce repetitive neuronal firing by inhibiting voltage-gated sodium currents. It is also positive allosteric modulator of the -aminobutyric acid (GABAA) ion channel.
Approved indications
- Epilepsy having focal-onset seizures
- Partial seizure
Common side effects
- Somnolence
- Dizziness
- Fatigue
- Diplopia
- Headache
- Nausea
- Constipation
- Diarrhea
- Vomiting
- Dry Mouth
- Abdominal Pain
- Dyspepsia
Key clinical trials
- Safety and Efficacy Study of Cenobamate in Pediatric Subjects 2-17 Years of Age With Partial-onset (Focal) Seizures (PHASE3)
- Cenobamate Efficacy in Individuals With Autoimmune Epilepsy
- Dose-Escalation Study of Cenobamate (YKP3089) in Pediatric Subjects With Partial-Onset Seizures (PHASE1)
- Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy (PHASE4)
- Cenobamate Open-Label Extension Study for YKP3089C025 (PHASE3)
- REACH: RWE Retrospective Study to Evaluate Cenobamate Impact on Health Care Resource Utilization
- Real-world Clinical Response to Cenobamate Early add-on in France, Germany and Spain
- Adjunctive Anti-seizure Medication (ASM) Real World Evidence (RWE) Study
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Xcopri CI brief — competitive landscape report
- Xcopri updates RSS · CI watch RSS
- Sk Life portfolio CI