Drug

Cenobamate

Approved · EMA

Late-stage development

Also known as Xcopri, Cenobamato, Cenobamatum.

RxNorm2265690 ChEMBLCHEMBL3989949UNIIP85X70RZWS

Active clinical trials

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Cenobamate Adjunctive Therapy in Subjects With PGTC Seizures

Clinical trial2026-07-02Results posted · ClinicalTrials.gov

A Multicenter Open-Label Extension Study to Evaluate the Long-Term Safety of Cenobamate Adjunctive Therapy in Subjects With Primary Generalized Tonic-Clonic Seizures

Clinical trial2026-06-10Completed · ClinicalTrials.gov

Open-Label Safety and Efficacy Study of Cenobamate in Pediatric Subjects 2-17 Years of Age With Partial-onset (Focal) Seizures

Clinical trial2026-04-03Results expected Q4 2026 · ClinicalTrials.gov

Use of Cenobamate in the Intensive Care Unit for Acute Frequent Seizures and Status Epilepticus

Clinical trial2026-03-30Results expected Q2 2028 · ClinicalTrials.gov

Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy

Clinical trial2026-02-27Results expected Q2 2027 · ClinicalTrials.gov

A Phase I, Open-Label, Pharmacokinetic, Dose-Escalation Study of Cenobamate (YKP3089) in Pediatric Subjects With Partial-Onset Seizures

Clinical trial2025-11-06Completed · ClinicalTrials.gov

ONO-2017 Phase III Study A Multicenter, Open-label Study in Japanese Patients With Primary Generalized Tonic Clonic Seizures.

Clinical trial2025-06-17Results expected Q1 2027 · ClinicalTrials.gov

A Phase 2, Multicenter Open-Label Extension Study to Evaluate the Long-term Safety of Cenobamate in Japanese Subjects With Partial Onset Seizures

Clinical trial2025-06-03Results expected Q1 2027 · ClinicalTrials.gov

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Cenobamate Adjunctive Therapy in Subjects With Partial Onset Seizures, With Optional Open-Label Extension

Clinical trial2025-03-21Completed · ClinicalTrials.gov

A Phase 1, Open-Label, Pharmacokinetic, Safety and Tolerability Study of a Single Oral Dose of Cenobamate (YKP3089) in Subjects With Normal Hepatic Function and Subjects With Severe Hepatic Impairment

Clinical trial2023-08-11Completed · ClinicalTrials.gov

A Randomized, Open-label, Three-way Crossover Study to Evaluate the Relative Bioavailability of 200 Mg Cenobamate Administered Orally As a Crushed Tablet or a Crushed Tablet Via a Naso-gastric Tube Compared with an Intact 200 Mg Cenobamate Tablet

Clinical trial2023-01-28Completed · ClinicalTrials.gov

Approval: Ontozry (EMA)

Regulatory2021-03-26EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Cenobamate

Aliases & brands

XcopriCenobamatoCenobamatum

RxNorm CUI

2265690

ChEMBL ID

CHEMBL3989949

UNII

P85X70RZWS

Regulatory jurisdictions

ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2021-03-26

Latest approval

2021-03-26

Authorities

EMA

Total events

emaEuropean Medicines Agency· 1 event

2021-03-26Approval

Approval: Ontozry (EMA)

Indication: Adjunctive treatment of focal-onset seizures with or without secondary generalisation in adult patients with epilepsy who have not been adequately controlled despite a history of… Show full indication

Adjunctive treatment of focal-onset seizures with or without secondary generalisation in adult patients with epilepsy who have not been adequately controlled despite a history of treatment with at least 2 anti-epileptic medicinal products.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.