Cenobamate: First Approval
- 59 Downloads
Cenobamate (XCOPRI®) is an oral, small molecule neurotherapeutic azole compound that is being developed by SK Life Science Inc. and Arvelle Therapeutics for the treatment of epilepsy. Based on results of two pivotal phase 2 trials, cenobamate was recently approved in the USA for use in the treatment of partial-onset seizures in adult patients. This article summarizes the milestones in the development of cenobamate leading to this first approval.
Compliance with Ethical Standards
The preparation of this review was not supported by any external funding.
Conflict of interest
During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Susan Keam is a salaried employee of Adis International Ltd/Springer Nature, is responsible for the article content and declares no relevant conflicts of interest.
- 1.SK Biopharmaceuticals. SK Biopharmaceuticals and Arvelle Therapeutics announce agreement to develop and commercialize cenobamate in Europe [media release]. 2019. http://www.skbp.com.
- 2.U.S. Food and Drug Administration. FDA approves new treatment for adults with partial-onset seizures [media release]. 2019. https://www.fda.gov.
- 3.SK Biopharmaceuticals. Cenobamate (XCOPRI): US prescribing information. 2019. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212839s000lbl.pdf. Accessed 27 Nov 2019.
- 4.SK Biopharmaceuticals. SK Biopharmaceuticals drug program wins funding support from Korean government [media release]. 2012. http://www.skbp.com.
- 5.World Intellectual Property Organization. Neurotherapeutic azole compounds. 2006. https://patentimages.storage.googleapis.com/cf/e2/9c/8cb63ba5150ea9/WO2006112685A1.pdf. Accessed 3 Dec 2019.
- 6.United States Patent. Neurotherapeutic azole compounds. 2009. https://patentimages.storage.googleapis.com/2c/74/81/0377b9c4d274c7/US7598279.pdf. Accessed 3 Dec 2019.
- 7.European Patents Office. Neurotherapeutic azole compounds. 2013. https://patentimages.storage.googleapis.com/b4/26/d6/34276d54049f3d/EP1879873B1.pdf. Accessed 3 Dec 2019.
- 8.Korean Intellectual Property Office. Neutrotherapeutic azole compounds. 2013. https://patentimages.storage.googleapis.com/eb/b0/0d/368d2b1a1829f3/KR101286499B1.pdf. Accessed 3 Dec 2019.
- 9.Google Patents. Neurotherapeutic azole compounds. 2019. https://patents.google.com/patent/EP1879873B1/en?oq=+WO+2006%2f112685±. Accessed 3 Dec 2019.
- 11.Sharma R, Song WS, Nakamura M, et al. Effects of cenobamate on GABA-A receptor modulation [abstract no. P1.5-033]. Neurology. 2019;92(15 Suppl).Google Scholar
- 13.Vernillet L, Kamin M. Pharmacokinetics of cenobamate (YKP3089): results from single and multiple oral rising-dose studies in healthy subjects [abstract no. P5.280]. Neurology. 2018;90(15 Suppl).Google Scholar
- 14.Greene S, Orlinski L, Streicher C, et al. The pharmacokinetics of cenobamate in special populations [abstract no. P1.5-034]. Neurology. 2019;92(15 Suppl).Google Scholar
- 15.Vernillet L, Kamin M. Drug–drug interactions between cenobamate and other antiepileptic drugs: results from phase I studies with carbamazepine, phenobarbital, phenytoin, and divalproex sodium [abstract no. PII-135]. Clin Pharmacol Ther. 2018;103(Suppl 1):S91.Google Scholar
- 16.Krauss GL, Klein P, Brandt C, et al. Safety and efficacy of adjunctive cenobamate (YKP3089) in patients with uncontrolled focal seizures: a multicentre, double-blind, randomised, placebo-controlled, dose-response trial. Lancet Neurol. 2019;13:13.Google Scholar
- 17.French JA, Kowalski J, Maciejowski M, et al. YKP3089 in partial-onset seizures: a randomized, double-blind, placebo-controlled study [abstract no 044]. Epilepsia. 2014;55(Suppl 2):19.Google Scholar
- 18.Kamin M, Ferrari L. Time to onset of efficacy in seizure reduction with cenobamate (YKP3089) in patients with uncontrolled partial seizures from 2 randomized clinical trials [abstract no P1.5-032]. Neurology. 2019;92(15 Suppl).Google Scholar
- 19.Sperling M, Klein P, Kamin M. Safety of cenobamate (YKP3089) as adjunctive treatment for uncontrolled focal seizures in a large, multicenter, open-label study [abstract no. P1.5-019]. Neurology. 2019;92(15 Suppl).Google Scholar