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
Randomized, Double-blind Study to Evaluate Efficacy and Safety of Cenobamate Adjunctive Therapy in POS
- Conditions
- Partial SeizureFocal Seizure
- Interventions
- Drug: Placebo
- 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
Cenobamate Expanded Access Program (EAP)
- Conditions
- Partial Epilepsy
- First Posted Date
- 2020-08-14
- Last Posted Date
- 2022-01-26
- Lead Sponsor
- SK Life Science, Inc.
- Registration Number
- NCT04513860
Cenobamate Open-Label Extension Study for YKP3089C025
- Conditions
- Primary Generalized Tonic Clonic Seizures in the Setting of Idiopathic Generalized Epilepsy
- Interventions
- First Posted Date
- 2019-05-23
- Last Posted Date
- 2024-12-13
- Lead Sponsor
- SK Life Science, Inc.
- Target Recruit Count
- 145
- Registration Number
- NCT03961568
- Locations
- 🇺🇦
Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council, Zaporozhye, Zaporizhzhya, Ukraine
🇺🇦Communal Institution "Dnipropetrovsk Regional Clinical Hospital n.a. I.I. Mechnikov", Regional Center, Dnipropetrovs'k, Ukraine
🇺🇦Regional Psyconeurology Hospital #3, Ivano-Frankivs'k, Ukraine
Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Cenobamate Adjunctive Therapy in PGTC Seizures
- Conditions
- Primary Generalized Epilepsy
- Interventions
- Drug: Placebo
- First Posted Date
- 2018-09-20
- Last Posted Date
- 2025-01-14
- Lead Sponsor
- SK Life Science, Inc.
- Target Recruit Count
- 169
- Registration Number
- NCT03678753
- Locations
- 🇺🇸
Phoenix Children's Hospital, Phoenix, Arizona, United States
🇺🇸Center for Neurosciences, Tucson, Arizona, United States
🇺🇸Neuro Pain Medical Center, Fresno, California, United States
A Study of the Abuse Liability Potential of Cenobamate in Recreational Drug Users
- Conditions
- Healthy Volunteer
- Interventions
- First Posted Date
- 2018-04-26
- Last Posted Date
- 2024-11-07
- Lead Sponsor
- SK Life Science, Inc.
- Target Recruit Count
- 53
- Registration Number
- NCT03509285
- Locations
- 🇺🇸
Vince & Associates Clinical Research, Inc, Overland Park, Kansas, United States
🇨🇦INC Research, Inc., Toronto, Ontario, Canada
Assess the Influence of Cenobamate on the PK of Cytochrome P450 (CYP) Probe Drugs as a Means of Predicting Drug-drug Interactions
- Conditions
- Healthy
- Interventions
- First Posted Date
- 2017-07-31
- Last Posted Date
- 2017-08-08
- Lead Sponsor
- SK Life Science, Inc.
- Target Recruit Count
- 24
- Registration Number
- NCT03234699
- Locations
- 🇺🇸
Vince and Associates Clinical Research, Inc., Overland Park, Kansas, United States
Safety and Pharmacokinetic Study of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures
- First Posted Date
- 2015-08-28
- Last Posted Date
- 2024-05-14
- Lead Sponsor
- SK Life Science, Inc.
- Target Recruit Count
- 1345
- Registration Number
- NCT02535091
- Locations
- 🇺🇸
Blue Sky Neurology, Englewood, Colorado, United States
🇺🇸Comprehensive Epilepsy Care Center for Children and Adults PC, Chesterfield, Missouri, United States
🇺🇸Northeast Regional Epilepsy Group, Hackensack, New Jersey, United States
A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Trial of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures
- First Posted Date
- 2013-05-31
- Last Posted Date
- 2022-04-29
- Lead Sponsor
- SK Life Science, Inc.
- Target Recruit Count
- 437
- Registration Number
- NCT01866111
- Locations
- 🇺🇸
Clinical Trials, Inc., Little Rock, Arkansas, United States
🇺🇸Bradenton Research Center, Inc., Bradenton, Florida, United States
🇺🇸Lovelace Scientific Resources, Inc., Sarasota, Florida, United States
Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures
- First Posted Date
- 2011-07-20
- Last Posted Date
- 2022-04-11
- Lead Sponsor
- SK Life Science, Inc.
- Target Recruit Count
- 222
- Registration Number
- NCT01397968
- Locations
- 🇮🇳
Max Super Specialty Hospital, Saket, New Delhi, India
🇵🇱SPSK Nr 7 SUM w Katowicach, Gornoslaskie CM im. Prof. Leszka Gieca, Katowice, Poland
🇺🇸Kaiser Permanente, Anaheim, California, United States
Efficacy of YKP3089 in Patients With Photosensitive Epilepsy
- First Posted Date
- 2008-02-15
- Last Posted Date
- 2014-01-31
- Lead Sponsor
- SK Life Science, Inc.
- Target Recruit Count
- 11
- Registration Number
- NCT00616148
- Locations
- 🇺🇸
Cornell Medical Center, New York, New York, United States
🇺🇸University of Pennsylvania Epilepsy Center, Philadelphia, Pennsylvania, United States
🇺🇸Johns Hopkins Medical Center, Baltimore, Maryland, United States
Drug Development Updates
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