SK Biopharm secures Japanese approval for epilepsy drug Cenobamate

SK Biopharm has secured regulatory approval in Japan for its epilepsy treatment, Cenobamate (brand name Xcopri), through its partner Ono Pharmaceutical. The approval from Japan’s Ministry of Health, Labour and Welfare follows successful multi-national Phase 3 clinical trials involving adult patients in South Korea, China, and Japan.

This milestone completes SK Biopharm’s regulatory coverage across the three major Northeast Asian markets, having previously obtained approvals in South Korea and China. Japan represents the world’s second-largest epilepsy market after the United States, with an estimated 1 million patients, approximately 30% of whom suffer from seizures that are difficult to control with existing medications.

Under the licensing agreement established in 2020, SK Biopharm will receive milestone payments and future royalties based on sales in Japan. The company is also pursuing expanded indications in the region, including ongoing Phase 3 trials for pediatric patients and adults with primary generalized tonic-clonic seizures.