Cenobamate

Overview

Cenobamate, or YKP-3089, is an antiepileptic drug developed by SK Pharmaceuticals and used to treat partial onset seizures. The exact mechanism of action has not been described in the literature, though it positively modulates GABA and inhibits voltage gated sodium channels. Cenobamate was granted FDA approval on 21 November 2019.

Indication

Cenobamate is indicated for the treatment of partial onset seizures in adults.

Associated Conditions

Partial-Onset Seizures

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Real-world Clinical Response to Cenobamate Early Add-on in France, Germany and Spain	2024/12/04	NCT06716801	N/A	Not yet recruiting	Aziende Chimiche Riunite Angelini Francesco S.p.A
Safety of Cenobamate in Japanese Subjects With Partial Onset Seizures	2024/09/19	NCT06590896	Phase 2	Recruiting	Ono Pharmaceutical Co. Ltd
ONO-2017 Study Japanese Patients With Primary Generalized Tonic Clonic Seizures.	2024/08/30	NCT06579573	Phase 3	Recruiting	Ono Pharmaceutical Co. Ltd
Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy	2024/06/11	NCT06453213	Phase 4	Recruiting	SK Life Science, Inc.
Cenobamate in the Intensive Care Unit	2024/04/08	NCT06352723	Early Phase 1	Not yet recruiting	Brigham and Women's Hospital
A Randomized, Open-label, Three-way Crossover Study to Evaluate the Relative Bioavailability of 200 mg Cenobamate Administered Orally	2022/10/07	NCT05572255	Phase 1	Completed	SK Life Science, Inc.
Safety and Efficacy Study of Cenobamate in Pediatric Subjects 2-17 Years of Age With Partial-onset (Focal) Seizures	2021/10/05	NCT05067634	Phase 3	Recruiting	SK Life Science, Inc.
Dose-Escalation Study of Cenobamate (YKP3089) in Pediatric Subjects with Partial-Onset Seizures	2021/05/26	NCT04903314	Phase 1	Recruiting	SK Life Science, Inc.
Safety Study of Cenobamate in Subjects With Normal Hepatic Function and Subjects With Severe Hepatic Impairment	2021/03/10	NCT04791553	Phase 1	Completed	SK Life Science, Inc.
Bioavailability and Food Effect Study of Cenobamate as an Oral Suspension and Tablet	2020/12/31	NCT04690751	Phase 1	Completed	SK Life Science, Inc.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Xcopri	SK Life Science, Inc.	71699-050	ORAL	50 mg in 1 1	3/28/2024
Xcopri	SK Life Science, Inc.	71699-200	ORAL	200 mg in 1 1	3/28/2024
Xcopri	SK Life Science, Inc.	71699-025	ORAL	25 mg in 1 1	3/28/2024
Xcopri	SK Life Science, Inc.	71699-100	ORAL	100 mg in 1 1	3/28/2024
Xcopri	SK Life Science, Inc.	71699-150	ORAL	150 mg in 1 1	3/28/2024

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Ontozry	Angelini Pharma S.p.A,Angelini Pharma S.p.A,Viale Amelia 70, 00181,Rome – Italy	Authorised	3/26/2021

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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Korean Hospitals Secure Approval for SK Biopharmaceuticals' Cenobamate for Epilepsy Treatment

5 months ago

Two major Korean university hospitals have received therapeutic use approval for cenobamate in epilepsy treatment, marking the first medical team applications for this indication since SK Biopharmaceuticals' 2022 approval.

Cenobamate Shows Strong Efficacy in Northeast Asian Epilepsy Patients in Phase 3 Trial

7 months ago

Cenobamate demonstrated a significant reduction in seizure frequency in Northeast Asian epilepsy patients in a Phase 3 trial.

SK Biopharm and Eurofarma Seek Approval for Cenobamate in Brazil for Epilepsy Treatment

9 months ago

• SK Biopharm and Eurofarma have submitted a New Drug Application (NDA) to ANVISA for cenobamate, aiming to provide a new treatment option for epilepsy patients in Brazil. • Cenobamate, already available in the U.S., Europe, and Canada, is poised to address the significant unmet needs in Latin America, where over half of epilepsy patients lack adequate care. • Eurofarma will distribute cenobamate across 17 Latin American countries, including Brazil and Mexico, with SK Biopharm set to receive milestone payments and royalties upon approval and commercialization. • The partnership underscores SK Biopharm's strategy to broaden its global presence and commitment to ensuring rapid launches of cenobamate in regions where it is not yet available.

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