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
Xenon's Azetukalner Shows Sustained Efficacy and Safety in Long-Term Focal Onset Seizure Study
• Xenon Pharmaceuticals' azetukalner demonstrates sustained reduction in seizure frequency and impressive seizure freedom rates in patients with focal onset seizures.
• Approximately one-third of patients treated with azetukalner for at least 36 months achieved seizure freedom for a year or longer, showcasing long-term efficacy.
• The X-TOLE open-label extension study highlights a consistent safety profile, suggesting azetukalner is generally well-tolerated over extended periods.
• Pre-clinical data indicates that Nav1.1 potentiators may offer protection against spontaneous seizures and SUDEP in a Dravet syndrome model.
Xenon Pharmaceuticals Advances Azetukalner Program for Epilepsy and MDD
• Xenon Pharmaceuticals is progressing its Phase 3 epilepsy program with azetukalner, anticipating topline data from the X-TOLE2 study in the second half of 2025.
• The company plans to initiate the X-NOVA2 Phase 3 trial for azetukalner in major depressive disorder (MDD) by the end of the year, expanding its therapeutic focus.
• Xenon is expanding its ion channel portfolio, with multiple candidates advancing towards IND filings in 2025, targeting Kv7, Nav1.7, and Nav1.1.
• Long-term data from the X-TOLE open-label extension study of azetukalner in focal onset seizures will be presented at the American Epilepsy Society (AES) annual meeting.
Drug Development Updates
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