14 completed, 4 recruiting, 1 active not recruiting, 1 approved for marketing. 7 Phase 3, 6 Phase 1, 4 Phase 2, 1 Early Phase 1, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 7 | Completed 5, Recruiting 2 |
| Phase 1 | 6 | Completed 6 |
| Phase 2 | 4 | Completed 3, Recruiting 1 |
| Early Phase 1 | 1 | Not yet recruiting 1 |
| Phase 4 | 1 | Active not recruiting 1 |
Follow Cenobamate: new trials by email Literature Review of Cenobamate trials Research Report on Cenobamate
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study to Evaluate the Safety, Efficacy, and PK of ONO-2017 in Japanese Patients With POS 2 to 17 Year Olds Cenobamate (tablet) for 12 to < 18 year olds, Cenobamate (syrup) for 2 to < 18 year olds - Partial Epilepsy | Phase 3 | Recruiting | Ono Pharmaceutical Co., Ltd. | 20 | 2026-06-10 | 2026-10-09 |
| Cenobamate in the Intensive Care Unit Cenobamate - Epilepsy, Neurologic Disorder | Early Phase 1 | Not yet recruiting | Brigham and Women's Hospital | 10 | 2026-06-01 | 2026-03-30 |
| Real-world Clinical Response to Cenobamate Early add-on in France, Germany and Spain Cenobamate - Focal Epilepsy With and Without Secondary Generalization | Recruiting | Aziende Chimiche Riunite Angelini Francesco S.p.A | 300 | 2024-12-19 | 2025-09-19 | |
| Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy Cenobamate - Focal Onset Seizure | Phase 4 | Active not recruiting | SK Life Science, Inc. | 49 | 2024-10-14 | 2026-10-27 |
| Safety of Cenobamate in Japanese Subjects With Partial Onset Seizures Cenobamate - Epilepsies, Partial | Phase 2 | Recruiting | Ono Pharmaceutical Co., Ltd. | 100 | 2022-11-04 | 2025-06-03 |
| A Randomized, Open-label, Three-way Crossover Study to Evaluate the Relative Bioavailability of 200 Mg Cenobamate Administered Orally Cenobamate - Healthy Volunteers | Phase 1 | Completed | SK Life Science, Inc. | 24 | 2022-09-27 | 2024-09-19 |
| ONO-2017 Study Japanese Patients With Primary Generalized Tonic Clonic Seizures. Cenobamate - Epilepsy, Generalized | Phase 3 | Recruiting | Ono Pharmaceutical Co., Ltd. | 15 | 2022-07-12 | 2025-06-17 |
| Safety and Efficacy Study of Cenobamate in Pediatric Subjects 2-17 Years of Age With Partial-onset (Focal) Seizures Xcopri - Partial Epilepsy | Phase 3 | Completed | SK Life Science, Inc. | 154 | 2022-01-10 | 2026-10-16 |
| Safety Study of Cenobamate in Subjects With Normal Hepatic Function and Subjects With Severe Hepatic Impairment Cenobamate - Hepatic Impairment | Phase 1 | Completed | SK Life Science, Inc. | 15 | 2021-06-17 | 2024-03-28 |
| Dose-Escalation Study of Cenobamate (YKP3089) in Pediatric Subjects With Partial-Onset Seizures Xcopri - Partial Epilepsy | Phase 1 | Completed | SK Life Science, Inc. | 26 | 2021-05-27 | 2026-03-31 |
| Randomized, Double-blind Study to Evaluate Efficacy and Safety of Cenobamate Adjunctive Therapy in POS Cenobamate, Placebo - Partial Seizure, Focal Seizure | Phase 3 | Completed | SK Life Science, Inc. | 519 | 2021-03-08 | 2026-06-03 |
| Bioavailability and Food Effect Study of Cenobamate as an Oral Suspension and Tablet Cenobamate 200Mg Tab Fasted, Cenobamate Oral Suspension Fed, Cenobomate Oral Suspension Fasted - Healthy | Phase 1 | Completed | SK Life Science, Inc. | 28 | 2020-12-21 | 2024-08-12 |
| Cenobamate Open-Label Extension Study for YKP3089C025 Cenobamate - Primary Generalized Tonic Clonic Seizures in the Setting of Idiopathic Generalized Epilepsy | Phase 3 | Completed | SK Life Science, Inc. | 147 | 2019-08-13 | 2026-06-26 |
| Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Cenobamate Adjunctive Therapy in PGTC Seizures Cenobamate, Placebo - Primary Generalized Epilepsy | Phase 3 | Completed | SK Life Science, Inc. | 169 | 2018-10-03 | 2026-07-02 |
| A Study of the Abuse Liability Potential of Cenobamate in Recreational Drug Users Alprazolam Placebo, Cenobamate placebo, Alprazolam - Healthy Volunteer | Phase 1 | Completed | SK Life Science, Inc. | 53 | 2017-03-08 | 2024-11-07 |
| Assess the Influence of Cenobamate on the PK of Cytochrome P450 (CYP) Probe Drugs As a Means of Predicting Drug-drug Interactions Cenobamate, midazolam, Warfarin Pill - Healthy | Phase 1 | Completed | SK Life Science, Inc. | 24 | 2017-02-22 | 2024-09-19 |
| Safety and Pharmacokinetic Study of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures YKP3089 - Partial Epilepsy | Phase 3 | Completed | SK Life Science, Inc. | 1345 | 2016-08-03 | 2024-05-14 |
| A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Trial of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures YKP3089, Placebo - Partial Epilepsy | Phase 2 | Completed | SK Life Science, Inc. | 437 | 2013-07-31 | 2025-06-24 |
| Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures YKP3089, Placebo - Partial Epilepsy | Phase 2 | Completed | SK Life Science, Inc. | 222 | 2011-07-06 | 2022-04-11 |
| Efficacy of YKP3089 in Patients With Photosensitive Epilepsy YKP3089, Placebo - Epilepsy | Phase 2 | Completed | SK Life Science, Inc. | 11 | 2007-08-01 | 2014-01-31 |
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Epilepsies, Partial (8) · Seizures (7) · Epilepsy (3) · Epilepsy, Idiopathic Generalized (2) · Epilepsy, Generalized (1) · Nervous System Diseases (1)
SK Life Science, Inc. (16) · Ono Pharmaceutical Co., Ltd. (3) · Aziende Chimiche Riunite Angelini Francesco S.p.A (1) · Brigham and Women's Hospital (1)
United States (14) · Poland (7) · South Korea (7) · Hungary (6) · Australia (4) · Bulgaria (4) · Czechia (4) · Germany (4) · Japan (4) · Spain (4) · Ukraine (4) · Slovakia (3) · France (2) · Serbia (2) · Thailand (2)
Sunita Misra, MD (4) · Marc Kamin, MD (3) · Project Leader (3) · Jacqueline French, M.D. (1) · Janice Laramy, PhD, PharmD (1) · Jong Woo Lee, MD, PhD (1) · Stephen Greene, PharmD (1) · Vijaykumar Vashi (1)
PMID 23219031, PMID 25769377, PMID 31292226, PMID 31734103, PMID 32409485, PMID 33662894, PMID 34254673, PMID 34633084, PMID 35605481, PMID 35705501, PMID 38446341, PMID 39087564, PMID 41101116, PMID 41428177