SK Biopharm Epilepsy New Drug 'Cenobamate', Phase 3 Clinical Trial Approval for Domestic Pediatric Patients

SK Biopharm's epilepsy new drug Cenobamate.

[Asia Economy Reporter Lee Gwan-joo] The domestic clinical trial subjects for SK Biopharm's epilepsy drug 'Cenobamate (YKP3089)' will be expanded to include children.

According to the Ministry of Food and Drug Safety's integrated drug information system 'Drug Safety Korea' on the 24th, SK Biopharm received approval the day before for a Phase 3 clinical trial to verify the public safety and efficacy of Cenobamate in pediatric subjects with partial onset (focal) seizures.

The clinical trial will be conducted at six locations: Severance Hospital, Chungbuk National University Hospital, Korea University Guro Hospital, Seoul Boramae Hospital, Ajou University Hospital, and Seoul National University Hospital.

Cenobamate is a treatment for partial seizures in patients with epilepsy. It received marketing authorization in the United States in November 2019 and in Europe in March of this year. This is the first case of a domestically developed new drug by a Korean pharmaceutical company entering the U.S. market by obtaining approval without technology export.

Following the U.S. and Europe, SK Biopharm is conducting Phase 3 clinical trials involving more than 500 epilepsy patients in Korea, China, and Japan to launch Cenobamate in Asia. The first patient for the Phase 3 trial was registered domestically in April last year, and with this clinical approval, the target subjects will be expanded to include children. An SK Biopharm official explained, "We have received clinical approval to expand the sites to include pediatric subjects."

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