Cenobamate

Generic Name
Cenobamate
Brand Names
Ontozry, XCopri, Xcopri 250 Mg Maintenance Pack, Xcopri Titration Pack - 12.5 Mg (14), 25 Mg (14) 28 Count
Drug Type
Small Molecule
Chemical Formula
C10H10ClN5O2
CAS Number
913088-80-9
Unique Ingredient Identifier
P85X70RZWS
Background

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
Associated Therapies
-
Clinical Trials
Related News

Real-world Clinical Response to Cenobamate Early Add-on in France, Germany and Spain

First Posted Date
2024-12-04
Last Posted Date
2024-12-04
Lead Sponsor
Aziende Chimiche Riunite Angelini Francesco S.p.A
Target Recruit Count
300
Registration Number
NCT06716801

Safety of Cenobamate in Japanese Subjects With Partial Onset Seizures

Phase 2
Recruiting
Conditions
Epilepsies, Partial
Interventions
Drug: Cenobamate
First Posted Date
2024-09-11
Last Posted Date
2024-09-11
Lead Sponsor
Ono Pharmaceutical Co. Ltd
Target Recruit Count
100
Registration Number
NCT06590896
Locations
🇯🇵

Ehime University Hospital, Ehime, Japan

🇯🇵

Department of Neurology and Stroke Center, Southern Tohoku Clinic., Fukushima, Japan

🇯🇵

Hiroshima University Hospital, Hiroshima, Japan

and more 26 locations

ONO-2017 Study Japanese Patients With Primary Generalized Tonic Clonic Seizures.

Phase 3
Recruiting
Conditions
Epilepsy, Generalized
Interventions
Drug: Cenobamate
First Posted Date
2024-08-30
Last Posted Date
2024-08-30
Lead Sponsor
Ono Pharmaceutical Co. Ltd
Target Recruit Count
12
Registration Number
NCT06579573
Locations
🇯🇵

Aichi Medical University Hospital, Aichi, Japan

🇯🇵

Hospital of the University of Occupational and Environmental Health, Japan, Fukuoka, Japan

🇯🇵

Hokkaido University Hospital, Hokkaido, Japan

and more 22 locations

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

Phase 4
Recruiting
Conditions
Focal Onset Seizure
Interventions
Drug: Cenobamate
First Posted Date
2024-06-11
Last Posted Date
2024-11-28
Lead Sponsor
SK Life Science, Inc.
Target Recruit Count
90
Registration Number
NCT06453213
Locations
🇺🇸

Arizona Neuroscience Research, Phoenix, Arizona, United States

🇺🇸

Center For Neurosciences, Tucson, Arizona, United States

🇺🇸

Clinical Trials Inc, Little Rock, Arkansas, United States

and more 37 locations

Cenobamate in the Intensive Care Unit

Early Phase 1
Not yet recruiting
Conditions
Epilepsy
Neurologic Disorder
Interventions
Drug: Cenobamate
First Posted Date
2024-04-08
Last Posted Date
2024-04-08
Lead Sponsor
Brigham and Women's Hospital
Target Recruit Count
10
Registration Number
NCT06352723
Locations
🇺🇸

Brigham and Women's Hospital, Boston, Massachusetts, United States

A Randomized, Open-label, Three-way Crossover Study to Evaluate the Relative Bioavailability of 200 mg Cenobamate Administered Orally

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
Drug: Cenobamate
First Posted Date
2022-10-07
Last Posted Date
2023-05-10
Lead Sponsor
SK Life Science, Inc.
Target Recruit Count
24
Registration Number
NCT05572255
Locations
🇺🇸

Worldwide Clinical Trials, San Antonio, Texas, United States

Safety and Efficacy Study of Cenobamate in Pediatric Subjects 2-17 Years of Age with Partial-onset (focal) Seizures

Phase 3
Recruiting
Conditions
Partial Epilepsy
Interventions
Drug: Xcopri
First Posted Date
2021-10-05
Last Posted Date
2024-12-19
Lead Sponsor
SK Life Science, Inc.
Target Recruit Count
140
Registration Number
NCT05067634
Locations
🇺🇸

Cincinnati Children's Hospital, Cincinnati, Ohio, United States

🇺🇸

Phoenix Children's Hospital, Phoenix, Arizona, United States

🇺🇸

Lucile Packard Children's Hospital Stanford, Palo Alto, California, United States

and more 51 locations

Dose-Escalation Study of Cenobamate (YKP3089) in Pediatric Subjects with Partial-Onset Seizures

Phase 1
Recruiting
Conditions
Partial Epilepsy
Interventions
Drug: Xcopri
First Posted Date
2021-05-26
Last Posted Date
2024-12-20
Lead Sponsor
SK Life Science, Inc.
Target Recruit Count
24
Registration Number
NCT04903314
Locations
🇺🇸

Cincinnati Children's Hospital, Cincinnati, Ohio, United States

🇺🇸

Phoenix Children's Hospital, Phoenix, Arizona, United States

🇺🇸

Mid-Atlantic Epilepsy and Sleep Center, Bethesda, Maryland, United States

and more 8 locations

Safety Study of Cenobamate in Subjects With Normal Hepatic Function and Subjects With Severe Hepatic Impairment

Phase 1
Completed
Conditions
Hepatic Impairment
Interventions
Drug: Cenobamate
First Posted Date
2021-03-10
Last Posted Date
2024-03-28
Lead Sponsor
SK Life Science, Inc.
Target Recruit Count
15
Registration Number
NCT04791553
Locations
🇸🇰

Summit Clinical Research s.r.o., Bratislava, Slovakia

🇵🇱

Centrum Badan Klinicznych Piotr Napora lekarze sp.p.,, Wrocław, Poland

Randomized, Double-blind Study to Evaluate Efficacy and Safety of Cenobamate Adjunctive Therapy in POS

Phase 3
Active, not recruiting
Conditions
Partial Seizure
Focal Seizure
Interventions
Drug: Placebo
Drug: Cenobamate
First Posted Date
2020-09-21
Last Posted Date
2023-10-10
Lead Sponsor
SK Life Science, Inc.
Target Recruit Count
540
Registration Number
NCT04557085
Locations
🇨🇳

Site 3, Shanghai, China

🇯🇵

Site 2, Tokyo, Japan

🇰🇷

Site 1, Seoul, Korea, Republic of

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