Drugs / Cenobamate
Cenobamate
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Ontozry | — | 2021-03-26 | europa.eu ↗ |
| Approved | US (FDA) | XCOPRI | — | 2019-11-21 | fda.gov ↗ |
Trials 20
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT06352723 | Jun 2026 → Jun 2028 expected | epilepsy | Brigham and Women's Hospital | Not yet recruiting | No outcome recorded |
| Phase 16 trials | ||||||
| Phase 1 | NCT05572255 | Sep 2022 → Jan 2023 | — | SK Life Science, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04791553 | Jun 2021 → Nov 2022 | — | SK Life Science, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04903314 | May 2021 → Nov 2025 | focal epilepsy | SK Life Science, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04690751 | Dec 2020 → May 2021 | — | SK Life Science, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03509285 | Mar → Nov 2017 | — | SK Life Science, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03234699 | Feb → Jul 2017 | — | SK Life Science, Inc. | Completed | No outcome recorded |
| Phase 24 trials · 2 met primary | ||||||
| Phase 2 | NCT06590896 | Nov 2022 → Jan 2027 expected | focal epilepsy | Ono Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT01866111 | Jul 2013 → Apr 2021 | focal epilepsy | SK Life Science, Inc. | Completed | Met primary |
| Phase 2 | NCT01397968 | Jul 2011 → Jun 2013 | focal epilepsy | SK Life Science, Inc. | Completed | Met primary |
| Phase 2 | NCT00616148 | Aug 2007 → Jan 2009 | epilepsy | SK Life Science, Inc. | Completed | No outcome recorded |
| Phase 37 trials · 1 met primary | ||||||
| Phase 3 | NCT07594158 | Jun 2026 → Mar 2028 expected | focal epilepsy | Ono Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT06579573 | Jul 2022 → Jan 2027 expected | generalized epilepsy | Ono Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT05067634 | Jan 2022 → Nov 2026 expected | focal epilepsy | SK Life Science, Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04557085 | Mar 2021 → Feb 2024 | focal epilepsy | SK Life Science, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03961568 | Aug 2019 → Jun 2026 | epilepsy with generalized tonic-clonic seizures | SK Life Science, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03678753 | Oct 2018 → May 2025 | generalized epilepsy | SK Life Science, Inc. | Completed | Met primary |
| Phase 3 | NCT02535091 | Aug 2016 → Mar 2021 | epilepsy | SK Life Science, Inc. | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT06453213 | Oct 2024 → May 2027 expected | focal epilepsy | SK Life Science, Inc. | Active not recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04513860 | — | focal epilepsy | SK Life Science, Inc. | Approved for marketing | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2026-09-16 | Ono Pharmaceutical Co., Ltd. | Regulatory Ono Received Manufacturing and Marketing Approval in Japan for XCOPRI ® Tablets for the Treatment of Patients with Partial-onset Seizures, With or Without Secondary Generalized Seizures ono-pharma.com ↗ |
| 2026-03-10 | Eurofarma Laboratorios S.A. | Regulatory Eurofarma é a primeira farmacêutica com registro no Brasil para o cenobamato, tratamento inovador para epilepsia eurofarma.com.br ↗
O produto acaba de obter registro junto à Agência Nacional de Vigilância Sanitária (Anvisa) , marcando um novo capítulo na estratégia da companhia para o fortalecimento de seu portfólio em sistema nervoso central. |
| 2025-12-09 | Ignis Therapeutics (Suzhou) Limited | Regulatory 抗癫痫发作新药西诺氨酯片（商品名：翼弗瑞®）正式获批上市，开启中国癫痫治疗新篇章 ignistherapeutics.com ↗
北京时间2025年12月9日，翼思生物宣布，国家药品监督管理局批准抗癫痫发作新药西诺氨酯片（商品名：翼弗瑞®）上市，用于成人癫痫患者部分性发作的治疗。 |
| 2025-09-30 | Ono Pharmaceutical Co., Ltd. | Regulatory Ono Submits an Application for Approval of Cenobamate (ONO-2017), Antiseizure Medications in Japan ono-pharma.com ↗ |
| 2025-09-01 | Aziende Chimiche Riunite Angelini Francesco S.p.A | Results Angelini Pharma Presents Data Demonstrating Benefits of Cenobamate▼ for Adults Living with Uncontrolled Epilepsy angelinipharma.com ↗
Findings from a post-hoc analysis of the phase 3 open label clinical trial demonstrated that cenobamate sustained seizure freedom, specifically freedom from focal to bilateral tonic-clonic seizures, led to a reduction in the risk of sudden unexpected death in epilepsy (SUDEP). |
| 2024-12-10 | Ono Pharmaceutical Co., Ltd. | Results SK Biopharmaceuticals’ Cenobamate Demonstrates Clinical Efficacy and Safety in Epilepsy Patients across Korea, China and Japan ono-pharma.com ↗
SK Biopharmaceuticals a biotech unveiled the Phase 3 clinical trial results of cenobamate (U.S. brand name: XCOPRI®) in Northeast Asian epilepsy patients through a poster presentation at the 2024 American Epilepsy Society (AES) Annual Meeting in Los Angeles, USA. |
| 2024-09-09 | Aziende Chimiche Riunite Angelini Francesco S.p.A | Results Angelini Pharma presents long-term data for cenobamate demonstrating sustained benefit in adults living with Epilepsy angelinipharma.com ↗
Findings from a post-hoc analysis of the C017 open-label extension (OLE) study demonstrated sustained long-term reduction in seizure frequency with cenobamate, approved as adjunctive treatment in patients with focal onset seizures, after five years across eight different etiology categories |
| 2023-09-04 | Aziende Chimiche Riunite Angelini Francesco S.p.A | Results Angelini Pharma Presents Long-Term Data for cenobamate (ONTOZRY®) Demonstrating Sustained Benefit in Adults with Epilepsy Experiencing Uncontrolled Focal Seizures angelinipharma.com ↗
In a post-hoc analysis of the C017 open-label extension (OLE) study (abstract #1324), seizure freedom for at least one year was achieved by 23.6% of the patients with 19% achieving seizure freedom from the first day of treatment in the OLE. |
| 2021-03-30 | Aziende Chimiche Riunite Angelini Francesco S.p.A | Regulatory ONTOZRY® (cenobamate) receives European Commission approval for the treatment of drug-resistant focal-onset seizures in adults angelinipharma.com ↗ |
All press releases naming this drug 12 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 22 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | cenobamate | “The primary objective of this study is to assess the pharmacokinetics of cenobamate (YKP3089) in pediatric subjects with partial-onset (focal) seizures following single and...” NCT04903314 ↗15“Cenobamate (YKP3089), an investigational antiepileptic drug, has shown broad-spectrum anticonvulsant activity in preclinical studies and seizure models.” PMID 31734103 ↗ Nov 2019 “Suppression of the photoparoxysmal response in photosensitive epilepsy with cenobamate (YKP3089).” PMID 31292226 ↗ Jul 2019 |
| Known as | Cenobamato | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989949 ↗ |
| Known as | Ontozry | ChEMBL registry synonym — accepted as the source's own label CHEMBL3989949 ↗ |
| Known as | Xcopri | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05067634 ↗ |
| Known as | YKP3089 | “Cenobamate (YKP3089) is a small molecule approved in the United States (US), Europe and several other countries around the world for the treatment of Partial-Onset (focal)...” NCT06453213 ↗7“The primary objective of this study is to assess the pharmacokinetics of cenobamate (YKP3089) in pediatric subjects with partial-onset (focal) seizures following single and...” NCT04903314 ↗ “Cenobamate (YKP3089), an investigational antiepileptic drug, has shown broad-spectrum anticonvulsant activity in preclinical studies and seizure models.” PMID 31734103 ↗ Nov 2019 “Multiple Doses of Cenobamate (YKP3089)” NCT03234699 ↗ |
| Modality | Small molecule | “Cenobamate (YKP3089) is a small molecule approved in the United States (US) for the treatment of partial onset seizures (POS) in adult patients.” NCT04690751 ↗ |
| Route | Oral | “single oral dose of YKP3089” NCT00616148 ↗ |