Regulatory PathRegulatory requirements compared

Active substance

Cenobamate

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
XCOPRI12.5MG; 25MG; 50MG; 100MG; 150MG; 200MGtablet · oralSK LIFEPrescription21 Nov 2019

EMA European Union — centrally authorised medicines

Ontozry Angelini Pharma S.p.A · Authorised · authorised 26 Mar 2021 · ATC N03AX

Therapeutic indication (EMA)

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.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
XCOPRI0253865212.5 MGTABLET · ORALKNIGHT THERAPEUTICS INC.
XCOPRI0253866025 MGTABLET · ORALKNIGHT THERAPEUTICS INC.
XCOPRI0253872550 MGTABLET · ORALKNIGHT THERAPEUTICS INC.
XCOPRI02538733100 MGTABLET · ORALKNIGHT THERAPEUTICS INC.
XCOPRI02538741150 MGTABLET · ORALKNIGHT THERAPEUTICS INC.
XCOPRI02538768200 MGTABLET · ORALKNIGHT THERAPEUTICS INC.
XCOPRI0253877625 MG; 12.5 MGKIT; TABLET · ORALKNIGHT THERAPEUTICS INC.
XCOPRI02538784100 MG; 50 MGKIT; TABLET · ORALKNIGHT THERAPEUTICS INC.

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACXCOPRI 100 MG TABLET$39.87152per EA23 Sep 2026
US NADACXCOPRI 12.5-25 MG TITRATION PK$3.91043per EA23 Sep 2026
US NADACXCOPRI 150 MG TABLET$39.8629per EA23 Sep 2026
US NADACXCOPRI 150-200 MG TITRATION PK$42.9098per EA23 Sep 2026
US NADACXCOPRI 200 MG TABLET$39.8775per EA23 Sep 2026
US NADACXCOPRI 25 MG TABLET$39.88192per EA23 Sep 2026
US NADACXCOPRI 250 MG DAILY DOSE PACK$21.36879per EA23 Sep 2026
US NADACXCOPRI 350 MG DAILY DOSE PACK$42.69935per EA23 Sep 2026
US NADACXCOPRI 50 MG TABLET$39.85674per EA23 Sep 2026
US NADACXCOPRI 50-100 MG TITRATION PAK$42.71457per EA23 Sep 2026
NHS Drug TariffCenobamate 100mg tablets£87.3614 tablet1 Oct 2026
NHS Drug TariffCenobamate 100mg tablets£136.5028 tablet1 Oct 2026
NHS Drug TariffCenobamate 12.5mg tablets and Cenobamate 25mg tablets£165.6228 tablet1 Oct 2026
NHS Drug TariffCenobamate 150mg tablets£89.1814 tablet1 Oct 2026
NHS Drug TariffCenobamate 150mg tablets£182.0028 tablet1 Oct 2026
NHS Drug TariffCenobamate 200mg tablets£91.0014 tablet1 Oct 2026
NHS Drug TariffCenobamate 200mg tablets£182.0028 tablet1 Oct 2026
NHS Drug TariffCenobamate 50mg tablets£85.5414 tablet1 Oct 2026
NHS Drug TariffCenobamate 50mg tablets£91.0028 tablet1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

  • US FDA 18 Aug 2025 XCOPRI — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for cenobamate →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.