ONO Pharmaceutical Co. Ltd (OPHLF,4528.T) announced on Tuesday that it has applied for manufacturing and marketing approval of Cenobamate, also known as ONO-2017, in Japan for the treatment of partial-onset seizures with or without secondary generalized seizures.
The application is based on the results achieved in trial YKP3089C035, in which Cenobamate, along with adjunctive therapy, showed a significant improvement in the primary endpoint of percent change in seizure frequency compared to existing treatments and was well tolerated.
YKP3089C035 was a randomized, double-blind, placebo-controlled, multinational, Phase 3 clinical trial conducted in South Korea, China, and Japan. The trial evaluated the efficacy and safety of an adjunctive cenobamate therapy in adult patients aged 18-70 with focal seizures on one to three anti-seizure medications (ASMs).
All dosage groups of cenobamate achieved the primary efficacy endpoint, showing a significant reduction in the median percent change in seizure frequency compared to that in the placebo group during the 6-week maintenance phase. In the secondary endpoints for efficacy, all dosage groups of cenobamate showed significantly higher seizure-free rates compared to the placebo group. In 2024, the results of this trial were presented at the annual Meeting of the American Epilepsy Society.
Epilepsy is a chronic brain disorder that causes seizures due to abnormal brain activity. In Japan, about 1 million people have epilepsy, and around 30% do not achieve good seizure control with current medications.
Cenobamate is an oral, once-daily tablet used to treat partial-onset seizures in adults, marketed as Xcopri by SK Life Science Inc, a US subsidiary of South Korea-based SK Biopharmaceuticals Co Ltd (SKBP). As of September 2025, Cenobamate is commercialized as a treatment for partial-onset seizures in 25 countries, including in the United States and Europe.
In 2020, Ono entered into a licensing agreement with SK Biopharmaceuticals Co Ltd (SKBP) and obtained the rights to develop and commercialize their antiseizure medication, Cenobamate, in Japan.
In addition, in Japan, Ono is conducting a Phase 3 clinical trial of cenobamate for the treatment of primary generalized tonic-clonic (PGTC) seizures in adolescents and adults.
On Monday, the ONO shares had closed at 1700.00 Yen in the Tokyo Markets.
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