Product Description
Cenobamate is used to control partial-onset seizures (convulsions) in the treatment of epilepsy. Cenobamate belongs to a class of medicines called anticonvulsants. It acts in the brain to prevent seizures. However, this medicine cannot cure epilepsy and will only work to control seizures for as long as you continue to take it.
Mechanisms of Action: No Mechanism
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Approved
Approved Countries: Austria | Bangladesh | Belgium | Croatia | Czech | Denmark | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Ireland | Israel | Italy | Latvia | Lithuania | Luxembourg | Norway | Poland | Portugal | Romania | Slovakia | Spain | Sweden | Switzerland | United Kingdom | United States
Approved Indications: None
Known Adverse Events: None
Company: SK Life Science
Company Location:
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Bulgaria, China, Czech Republic, Georgia, Germany, Hungary, Japan, Korea, Poland, Slovakia, Spain, Ukraine, United States
Active Clinical Trial Count: 14
Recent & Upcoming Milestones
- PDUFA Summary: Arvelle plans to file an MAA for Cenobamate with a PDUFA date of November 21, 2019.
Highest Development Phases
Phase 3: Epilepsies, Partial|Epilepsy, Generalized|Seizures
Phase 2: Epilepsy
Phase 1: Healthy Volunteers
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
jRCT2031220198 |
jRCT2031220198 | P2 |
Recruiting |
Epilepsy |
2027-01-31 |
|||
2023-506687-13-00 |
YKP3089C025 | P3 |
Active, not recruiting |
Seizures |
2025-12-31 |
2025-05-02 |
Treatments |
|
NCT03678753 |
YKP3089C025 | P3 |
Completed |
Epilepsy, Generalized |
2025-05-26 |
44% |
2025-07-10 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT04903314 |
YKP3089C039 | P1 |
Recruiting |
Epilepsies, Partial |
2025-10-01 |
12% |
2024-12-21 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT06579573 |
ONO-2017-01 | P3 |
Recruiting |
Epilepsy, Generalized |
2027-01-31 |
14% |
2025-06-18 |
Patient Enrollment|Primary Endpoints|Treatments |
jRCT2031210624 |
jRCT2031210624 | P3 |
Recruiting |
Epilepsy, Generalized |
2027-01-31 |
14% |
||
2023-506688-32-00 |
YKP3089C033 | P3 |
Recruiting |
Seizures |
2026-12-01 |
2025-05-02 |
Treatments |
|
NCT03961568 |
YKP3089C033 | P3 |
Enrolling by invitation |
Epilepsy, Generalized |
2026-08-01 |
55% |
2024-12-14 |
Primary Endpoints |
NCT05067634 |
YKP3089C040 | P3 |
Recruiting |
Epilepsies, Partial |
2026-05-01 |
42% |
2023-03-25 |
Primary Endpoints|Treatments|Trial Status |
2023-506841-52-00 |
YKP3089C040 | P3 |
Recruiting |
Seizures |
2025-06-09 |
2025-05-02 |
Treatments |
|
jRCT2031200405 |
jRCT2031200405 | P3 |
Recruiting |
Seizures |
2024-10-20 |
|||
2024-514045-11-00 |
YKP3089C039 | P1 |
Recruiting |
Seizures |
2026-03-31 |
2025-05-02 |
Treatments |
|
NCT05572255 |
YKP3089C045 | P1 |
Completed |
Healthy Volunteers |
2023-01-28 |
88% |
2023-05-12 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT06590896 |
ONO-2017-02 | P2 |
Recruiting |
Epilepsies, Partial |
2027-01-31 |
12% |
2024-09-20 |
Primary Endpoints |