DeepMed Research

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: C_₁₀H_₁₀ClN_₅O_₂

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

Clinical Trials

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

Not yet recruiting

Conditions: Focal Epilepsy with and Without Secondary Generalization

Interventions: Drug: Cenobamate

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: 2025-04-29

Lead Sponsor: SK Life Science, Inc.

Target Recruit Count: 90

Registration Number: NCT06453213

Locations: 🇺🇸
Consultants In Epilepsy and Neurology, Boise, Idaho, United States
🇺🇸
RUSH Neurology Epilepsy, Chicago, Illinois, United States
🇺🇸
Arizona Neuroscience Research, Phoenix, Arizona, 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: 2025-03-24

Lead Sponsor: SK Life Science, Inc.

Target Recruit Count: 140

Registration Number: NCT05067634

Locations: 🇩🇪
Diakonie Kork, Kehl, Germany
🇺🇸
Phoenix Children's Hospital, Phoenix, Arizona, United States
🇺🇸
Lucile Packard Children's Hospital Stanford, Palo Alto, California, United States

and more 52 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: 2025-03-06

Lead Sponsor: SK Life Science, Inc.

Target Recruit Count: 24

Registration Number: NCT04903314

Locations: 🇭🇺
I. Sz. Gyermekgyógyászati Klinika, Budapest, Hungary
🇺🇸
Phoenix Children's Hospital, Phoenix, Arizona, United States
🇺🇸
Mid-Atlantic Epilepsy and Sleep Center, Bethesda, Maryland, United States

and more 10 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

Bioavailability and Food Effect Study of Cenobamate as an Oral Suspension and Tablet

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Cenobamate 200Mg Tab Fasted
Drug: Cenobomate Oral Suspension Fasted
Drug: Cenobamate Oral Suspension Fed

First Posted Date: 2020-12-31

Last Posted Date: 2024-08-12

Lead Sponsor: SK Life Science, Inc.

Target Recruit Count: 28

Registration Number: NCT04690751

Locations: 🇺🇸
PRA Health Sciences Salt Lake City, Millcreek, Utah, United States

Drug Development Updates

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