36 completed, 3 terminated, 2 recruiting, 1 active not recruiting. 16 Phase 2, 14 Phase 3, 13 Phase 1, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 16 | Completed 15, Terminated 1 |
| Phase 3 | 14 | Completed 11, Terminated 2, Recruiting 1 |
| Phase 1 | 13 | Completed 11, Recruiting 1, Terminated 1 |
| Phase 4 | 1 | Active not recruiting 1 |
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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 |
|---|---|---|---|---|---|---|
| SKL35501 With SKL35502 Imaging in Adults With NTSR1 Positive Advanced Solid Tumors SKL35501, SKL35502 - Selected Advanced Solid Tumors, Colorectal Cancer (CRC) | Phase 1 | Recruiting | SK Life Science, Inc. | 100 | 2026-08-19 | 2026-09-10 |
| 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 | 2026-08-27 |
| 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 |
| Safety, Tolerability, PK/PD & Preliminary Efficacy of SKL27969 in Advanced Solid Tumors Patients SKL27969 - Advanced Solid Tumor | Phase 1 / Phase 2 | Terminated | SK Life Science, Inc. | 15 | 2022-09-12 | 2025-05-04 |
| Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults Carisbamate - Seizures, Lennox Gastaut Syndrome | Phase 3 | Recruiting | SK Life Science, Inc. | 252 | 2022-04-28 | 2025-07-24 |
| 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 |
| Bioavailability and Food Effect Study of 3 Types of Carisbamate Carisbamate - Healthy Subjects | Phase 1 | Completed | SK Life Science, Inc. | 33 | 2020-08-27 | 2021-10-07 |
| Single-Dose Escalation Study Followed by a Multiple-Dose Escalation Study of SKL24741 in Healthy Subjects SKL24741, Placebo - Healthy | Phase 1 | Completed | SK Life Science, Inc. | 111 | 2020-02-13 | 2023-12-21 |
| 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 |
| Carisbamate Safety Study in Adult and Pediatric Subjects With Lennox-Gastaut Syndrome Carisbamate - Lennox Gastaut Syndrome | Phase 1 | Completed | SK Life Science, Inc. | 15 | 2019-05-03 | 2024-04-04 |
| Carisbamate in Adult & Pediatric Subjects With Lennox-Gastaut Syndrome Carisbamate - Lennox Gastaut Syndrome | Phase 1 | Completed | SK Life Science, Inc. | 18 | 2019-02-07 | 2023-05-30 |
| 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 Safety, Tolerability, PK and PD Study of Multiple Oral Doses of SKL15508 in Subjects With Stable Schizophrenia SKL15508, Placebo - Schizophrenia | Phase 1 / Phase 2 | Completed | SK Life Science, Inc. | 39 | 2014-07-01 | 2016-10-13 |
Showing 20 of 43. Sign in to see all of them.
Seizures (15) · Epilepsies, Partial (13) · Epilepsy (7) · Epilepsy, Complex Partial (5) · Lennox Gastaut Syndrome (4) · Diabetic Neuropathies (3) · Epilepsy, Idiopathic Generalized (2) · Epilepsy, Partial, Motor (2) · Biliary Tract Neoplasms (1) · Blister (1) · Carcinoma, Non-Small-Cell Lung (1) · Chickenpox (1) · Colorectal Neoplasms (1) · Diabetes Mellitus (1) · Drug Resistant Epilepsy (1)
S-2-O-carbamoyl-1-o-chlorophenyl-ethanol (20) · Cenobamate (16) · Alprazolam (1) · Bupropion (1) · Levetiracetam (1) · Midazolam (1) · Omeprazole (1) · Pregabalin (1) · Topiramate (1) · Warfarin (1) · carbamic acid 3-(4-((4-amino-5-chloro-2-methoxybenzoylamino)methyl)piperidin-1-yl)-1-(4-fluorophenyl)propyl ester (1)
United States (26) · Poland (9) · South Korea (9) · Hungary (8) · Spain (6) · Australia (5) · Germany (5) · Bulgaria (4) · Czechia (4) · Ukraine (4) · Argentina (3) · Serbia (3) · Slovakia (3) · Israel (2) · Mexico (2)
Marc Kamin, MD (6) · Sunita Misra, MD (4) · Vijaykumar Vashi, PhD (2) · Jacqueline French, M.D. (1) · Janice Laramy, PhD, PharmD (1) · Marc Kamin, M.D. (1) · Michael Camilleri, MD (1) · Ry R Forseth, Ph.D. (1) · Stephen Greene, PharmD (1) · Vijaykumar Vashi (1)
PMID 34870321, PMID 19863578, PMID 19001248, PMID 19222595, PMID 20201005, PMID 21320109, PMID 23219031, PMID 25148765, 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