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 1,471 total planned enrollment. 5 Phase 3 Cenobamate trials and 1 Phase 2, 1 Phase 4 are listed. 6 Cenobamate clinical trials are actively recruiting. Most recent activity: NCT07594158 (Dec 2029).

Cenobamate clinical trials at a glance: phase × recruitment status

Phaserecruitingactive not recruitingenrolling by invitationcompletednot yet recruitingTotal
Early P111
P155
P211
P32125
P411
N/A11

Recruiting Cenobamate clinical trials (6)

Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).

NCT IDTitlePhaseIndicationEnrollmentStarted
NCT07594158A Study to Evaluate the Safety, Efficacy, and PK of ONO-2017 in Japanese Patients With POS 2 to 17 Year OldsP3Partial Epilepsy20May 2026
NCT06352723CENOBITECenobamate in the Intensive Care UnitEarly P1Epilepsy10Jun 2026
NCT06716801Real-world Clinical Response to Cenobamate Early add-on in France, Germany and Spain—Focal Epilepsy With and Without Secondary Generalization300Dec 2024
NCT06590896Safety of Cenobamate in Japanese Subjects With Partial Onset SeizuresP2Epilepsies, Partial100Nov 2022
NCT06579573ONO-2017 Study Japanese Patients With Primary Generalized Tonic Clonic Seizures.P3Epilepsy, Generalized15Jul 2022
NCT03961568Cenobamate Open-Label Extension Study for YKP3089C025P3Primary Generalized Tonic Clonic Seizures in the Setting of Idiopathic Generalized Epilepsy145Aug 2019

Cenobamate clinical trials by indication

Healthy (2)

NCTAcronymPhaseStatusTitle
NCT04690751—P1completedBioavailability and Food Effect Study of Cenobamate as an Oral Suspension and Tablet
NCT03234699CYPP1completedAssess the Influence of Cenobamate on the PK of Cytochrome P450 (CYP) Probe Drugs As a Means of Predicting Drug-drug Interactions

Epilepsy (1)

NCTAcronymPhaseStatusTitle
NCT06352723CENOBITEEarly P1not yet recruitingCenobamate in the Intensive Care Unit

Partial Epilepsy (1)

NCTAcronymPhaseStatusTitle
NCT07594158—P3recruitingA 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)

NCTAcronymPhaseStatusTitle
NCT06716801—N/ArecruitingReal-world Clinical Response to Cenobamate Early add-on in France, Germany and Spain

Focal Onset Seizure (1)

NCTAcronymPhaseStatusTitle
NCT06453213—P4active not recruitingOpen-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy

Epilepsies, Partial (1)

NCTAcronymPhaseStatusTitle
NCT06590896—P2recruitingSafety of Cenobamate in Japanese Subjects With Partial Onset Seizures

Healthy Volunteers (1)

NCTAcronymPhaseStatusTitle
NCT05572255—P1completedA Randomized, Open-label, Three-way Crossover Study to Evaluate the Relative Bioavailability of 200 Mg Cenobamate Administered Orally

Epilepsy, Generalized (1)

NCTAcronymPhaseStatusTitle
NCT06579573—P3recruitingONO-2017 Study Japanese Patients With Primary Generalized Tonic Clonic Seizures.

Hepatic Impairment (1)

NCTAcronymPhaseStatusTitle
NCT04791553—P1completedSafety Study of Cenobamate in Subjects With Normal Hepatic Function and Subjects With Severe Hepatic Impairment

Partial Seizure (1)

NCTAcronymPhaseStatusTitle
NCT04557085—P3completedRandomized, 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)

NCTAcronymPhaseStatusTitle
NCT03961568—P3enrolling by invitationCenobamate Open-Label Extension Study for YKP3089C025

Primary Generalized Epilepsy (1)

NCTAcronymPhaseStatusTitle
NCT03678753—P3completedRandomized, Double-Blind Study to Evaluate Efficacy and Safety of Cenobamate Adjunctive Therapy in PGTC Seizures

Healthy Volunteer (1)

NCTAcronymPhaseStatusTitle
NCT03509285—P1completedA 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 IDAcronymTitlePhaseStatusEnrollmentSponsorStarted
NCT07594158A Study to Evaluate the Safety, Efficacy, and PK of ONO-2017 in Japanese Patients With POS 2 to 17 Year OldsP3recruiting20Ono Pharmaceutical Co., Ltd.May 2026
NCT06352723CENOBITECenobamate in the Intensive Care UnitEarly P1not yet recruiting10Brigham and Women's HospitalJun 2026
NCT06453213Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset EpilepsyP4active not recruiting49SK Life Science, Inc.Oct 2024
NCT06716801Real-world Clinical Response to Cenobamate Early add-on in France, Germany and Spain—recruiting300Aziende Chimiche Riunite Angelini Francesco S.p.ADec 2024
NCT06590896Safety of Cenobamate in Japanese Subjects With Partial Onset SeizuresP2recruiting100Ono Pharmaceutical Co., Ltd.Nov 2022
NCT06579573ONO-2017 Study Japanese Patients With Primary Generalized Tonic Clonic Seizures.P3recruiting15Ono Pharmaceutical Co., Ltd.Jul 2022
NCT03961568Cenobamate Open-Label Extension Study for YKP3089C025P3enrolling by invitation145SK Life Science, Inc.Aug 2019
NCT03678753Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Cenobamate Adjunctive Therapy in PGTC SeizuresP3completed169SK Life Science, Inc.Sep 2018
NCT04557085Randomized, Double-blind Study to Evaluate Efficacy and Safety of Cenobamate Adjunctive Therapy in POSP3completed519SK Life Science, Inc.Mar 2021
NCT04791553Safety Study of Cenobamate in Subjects With Normal Hepatic Function and Subjects With Severe Hepatic ImpairmentP1completed15SK Life Science, Inc.Jun 2021
NCT05572255A Randomized, Open-label, Three-way Crossover Study to Evaluate the Relative Bioavailability of 200 Mg Cenobamate Administered OrallyP1completed24SK Life Science, Inc.Sep 2022
NCT04690751Bioavailability and Food Effect Study of Cenobamate as an Oral Suspension and TabletP1completed28SK Life Science, Inc.Dec 2020
NCT03509285A Study of the Abuse Liability Potential of Cenobamate in Recreational Drug UsersP1completed53SK Life Science, Inc.Mar 2017
NCT03234699CYPAssess the Influence of Cenobamate on the PK of Cytochrome P450 (CYP) Probe Drugs As a Means of Predicting Drug-drug InteractionsP1completed24SK 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. 5 are actively recruiting participants. 7 are marked completed.
Are Cenobamate clinical trials recruiting in 2026?
Yes — 5 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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Related pages on Hipa.ai:

Cenobamate overviewCenobamate evidence & publications