Cenobamate Clinical Trials (2026): 14 Studies for Healthy & Epilepsy
Hipa.ai Research · Source: ClinicalTrials.gov / AACT
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14 Cenobamate clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 13 indications (including Healthy & Epilepsy) and 1,473 total planned enrollment. 5 Phase 3 Cenobamate trials and 1 Phase 2, 1 Phase 4 are listed. 5 Cenobamate clinical trials are actively recruiting. Most recent activity: NCT07594158 (Dec 2029).
Cenobamate clinical trials at a glance: phase × recruitment status
| Phase | recruiting | active not recruiting | completed | not yet recruiting | Total |
|---|---|---|---|---|---|
| Early P1 | 1 | 1 | |||
| P1 | 5 | 5 | |||
| P2 | 1 | 1 | |||
| P3 | 2 | 3 | 5 | ||
| P4 | 1 | 1 | |||
| N/A | 1 | 1 |
Recruiting Cenobamate clinical trials (5)
Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).
| NCT ID | Title | Phase | Indication | Enrollment | Started |
|---|---|---|---|---|---|
| NCT07594158 | A Study to Evaluate the Safety, Efficacy, and PK of ONO-2017 in Japanese Patients With POS 2 to 17 Year Olds | P3 | Partial Epilepsy | 20 | May 2026 |
| NCT06352723 | CENOBITECenobamate in the Intensive Care Unit | Early P1 | Epilepsy | 10 | Jun 2026 |
| NCT06716801 | Real-world Clinical Response to Cenobamate Early add-on in France, Germany and Spain | — | Focal Epilepsy With and Without Secondary Generalization | 300 | Dec 2024 |
| NCT06590896 | Safety of Cenobamate in Japanese Subjects With Partial Onset Seizures | P2 | Epilepsies, Partial | 100 | Nov 2022 |
| NCT06579573 | ONO-2017 Study Japanese Patients With Primary Generalized Tonic Clonic Seizures. | P3 | Epilepsy, Generalized | 15 | Jul 2022 |
Cenobamate clinical trials by indication
Healthy (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04690751 | — | P1 | completed | Bioavailability and Food Effect Study of Cenobamate as an Oral Suspension and Tablet |
| NCT03234699 | CYP | P1 | completed | Assess the Influence of Cenobamate on the PK of Cytochrome P450 (CYP) Probe Drugs As a Means of Predicting Drug-drug Interactions |
Epilepsy (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06352723 | CENOBITE | Early P1 | not yet recruiting | Cenobamate in the Intensive Care Unit |
Partial Epilepsy (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07594158 | — | P3 | recruiting | A Study to Evaluate the Safety, Efficacy, and PK of ONO-2017 in Japanese Patients With POS 2 to 17 Year Olds |
Focal Epilepsy With and Without Secondary Generalization (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06716801 | — | N/A | recruiting | Real-world Clinical Response to Cenobamate Early add-on in France, Germany and Spain |
Focal Onset Seizure (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06453213 | — | P4 | active not recruiting | Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy |
Epilepsies, Partial (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06590896 | — | P2 | recruiting | Safety of Cenobamate in Japanese Subjects With Partial Onset Seizures |
Healthy Volunteers (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05572255 | — | P1 | completed | A Randomized, Open-label, Three-way Crossover Study to Evaluate the Relative Bioavailability of 200 Mg Cenobamate Administered Orally |
Epilepsy, Generalized (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06579573 | — | P3 | recruiting | ONO-2017 Study Japanese Patients With Primary Generalized Tonic Clonic Seizures. |
Hepatic Impairment (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04791553 | — | P1 | completed | Safety Study of Cenobamate in Subjects With Normal Hepatic Function and Subjects With Severe Hepatic Impairment |
Partial Seizure (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04557085 | — | P3 | completed | Randomized, Double-blind Study to Evaluate Efficacy and Safety of Cenobamate Adjunctive Therapy in POS |
Primary Generalized Tonic Clonic Seizures in the Setting of Idiopathic Generalized Epilepsy (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03961568 | — | P3 | completed | Cenobamate Open-Label Extension Study for YKP3089C025 |
Primary Generalized Epilepsy (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03678753 | — | P3 | completed | Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Cenobamate Adjunctive Therapy in PGTC Seizures |
Healthy Volunteer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03509285 | — | P1 | completed | A Study of the Abuse Liability Potential of Cenobamate in Recreational Drug Users |
All Cenobamate trials (14)
Sorted by most recent activity (completion → start → posted date). Each row links to the trial detail page on Hipa.ai.
| NCT ID | Acronym | Title | Phase | Status | Enrollment | Sponsor | Started |
|---|---|---|---|---|---|---|---|
| NCT07594158 | A Study to Evaluate the Safety, Efficacy, and PK of ONO-2017 in Japanese Patients With POS 2 to 17 Year Olds | P3 | recruiting | 20 | Ono Pharmaceutical Co., Ltd. | May 2026 | |
| NCT06352723 | CENOBITE | Cenobamate in the Intensive Care Unit | Early P1 | not yet recruiting | 10 | Brigham and Women's Hospital | Jun 2026 |
| NCT06453213 | Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy | P4 | active not recruiting | 49 | SK Life Science, Inc. | Oct 2024 | |
| NCT06716801 | Real-world Clinical Response to Cenobamate Early add-on in France, Germany and Spain | — | recruiting | 300 | Aziende Chimiche Riunite Angelini Francesco S.p.A | Dec 2024 | |
| NCT06590896 | Safety of Cenobamate in Japanese Subjects With Partial Onset Seizures | P2 | recruiting | 100 | Ono Pharmaceutical Co., Ltd. | Nov 2022 | |
| NCT06579573 | ONO-2017 Study Japanese Patients With Primary Generalized Tonic Clonic Seizures. | P3 | recruiting | 15 | Ono Pharmaceutical Co., Ltd. | Jul 2022 | |
| NCT03961568 | Cenobamate Open-Label Extension Study for YKP3089C025 | P3 | completed | 147 | SK Life Science, Inc. | Aug 2019 | |
| NCT03678753 | Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Cenobamate Adjunctive Therapy in PGTC Seizures | P3 | completed | 169 | SK Life Science, Inc. | Oct 2018 | |
| NCT04557085 | Randomized, Double-blind Study to Evaluate Efficacy and Safety of Cenobamate Adjunctive Therapy in POS | P3 | completed | 519 | SK Life Science, Inc. | Mar 2021 | |
| NCT04791553 | Safety Study of Cenobamate in Subjects With Normal Hepatic Function and Subjects With Severe Hepatic Impairment | P1 | completed | 15 | SK Life Science, Inc. | Jun 2021 | |
| NCT05572255 | A Randomized, Open-label, Three-way Crossover Study to Evaluate the Relative Bioavailability of 200 Mg Cenobamate Administered Orally | P1 | completed | 24 | SK Life Science, Inc. | Sep 2022 | |
| NCT04690751 | Bioavailability and Food Effect Study of Cenobamate as an Oral Suspension and Tablet | P1 | completed | 28 | SK Life Science, Inc. | Dec 2020 | |
| NCT03509285 | A Study of the Abuse Liability Potential of Cenobamate in Recreational Drug Users | P1 | completed | 53 | SK Life Science, Inc. | Mar 2017 | |
| NCT03234699 | CYP | Assess the Influence of Cenobamate on the PK of Cytochrome P450 (CYP) Probe Drugs As a Means of Predicting Drug-drug Interactions | P1 | completed | 24 | SK Life Science, Inc. | Feb 2017 |
Cenobamate clinical trials: frequently asked questions
- How many Cenobamate clinical trials are there?
- 14 Cenobamate clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 4 are actively recruiting participants. 8 are marked completed.
- Are Cenobamate clinical trials recruiting in 2026?
- Yes — 4 Cenobamate trials are actively recruiting in 2026. See the recruiting trials and the per-state site list further down this page.
- What conditions is Cenobamate being studied for?
- Cenobamate is being studied for Healthy, Epilepsy, Epilepsy, Generalized, Focal Epilepsy With and Without Secondary Generalization, Focal Onset Seizure and 10 more. The trials are grouped by indication on this page.
- What phase is Cenobamate in?
- Cenobamate clinical trials span 1 Phase 4, 5 Phase 3, 1 Phase 2, 5 Phase 1. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
- Who sponsors Cenobamate clinical trials?
- The lead sponsor across the most Cenobamate trials is SK Life Science, Inc., with 3 additional lead sponsors listed in the data. Each trial row links to the full study detail page including sponsor information.
Sources and methodology
Trial inventory derived from the AACT mirror of ClinicalTrials.gov. Trials are filtered to those naming Cenobamateas an intervention. Phase, status, enrollment, sponsor, and dates are taken from the source `studies` table; primary indication is the first listed condition. Acronyms are extracted from each trial's brief title where present. PubMed links are populated for trials whose published primary outcomes have been indexed in our evidence cache.
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