SK Biopharmaceuticals' Cenobamate Successfully Suppresses Generalized Seizures by 71.9%

A groundbreaking epilepsy drug developed in Korea is making waves in the global medical community. The Phase 3 clinical trial results for Cenobamate (XCOPRI), announced by SK Biopharmaceuticals on September 16, 2025, were truly remarkable. In this study, conducted across 122 clinical trial sites in 12 countries involving 169 patients with primary generalized tonic-clonic (PGTC) seizures, Cenobamate demonstrated a 71.9% reduction in seizure frequency. This was an overwhelming difference compared to the 39.6% observed in the placebo group, securing a complete victory with statistical significance (p=0.003). PGTC seizures, in particular, are a critical symptom that increases the risk of sudden unexpected death in epilepsy (SUDEP), representing an unmet medical need with limited existing treatment options. With this achievement, Cenobamate has now conquered generalized seizures following partial-onset seizures, solidifying its status as a 'broad-spectrum' anticonvulsant. Donghoon Lee, CEO of SK Biopharmaceuticals, expressed confidence that "Cenobamate's position in the global anticonvulsant market will be significantly strengthened."

SK Biopharmaceuticals' Cenobamate Successfully Suppresses Generalized Seizures by 71.9% photo 1

The success of Cenobamate is a symbolic event demonstrating the innovative capabilities of the Korean bio-industry. Since receiving U.S. FDA approval in 2019, its annual sales have surged, surpassing 500 billion Korean Won in 2024, with projections for sales exceeding 700 billion Korean Won this year. Even more astonishing is the sharp rise in operating profit margins, making it possible for this domestically developed new drug to achieve the world's number one market share. In terms of safety, Cenobamate also demonstrated excellent tolerability, with adverse event rates of 60% in the Cenobamate group and 53% in the placebo group, mostly mild to moderate in severity. Based on these results, SK Biopharmaceuticals plans to pursue a supplemental New Drug Application (sNDA) to the FDA for an additional indication for PGTC seizures. Detailed results are expected to be unveiled at the American Epilepsy Society (AES) meeting in December, which is anticipated to draw even greater attention from the global medical community. Currently, 30% of the 50 million epilepsy patients worldwide are refractory to existing treatments, and the expanded indication for Cenobamate is expected to offer new hope to millions of patients. Cenobamate's success not only proves the global competitiveness of K-Bio but also signifies a new turning point for the domestic pharmaceutical industry. In particular, the fact that this clinical trial was conducted simultaneously in 12 countries, including Korea, demonstrates K-Bio's capability to lead global clinical trials. Industry experts evaluate that Cenobamate has a high probability of achieving blockbuster sales of over 1 billion USD annually. However, challenges remain, such as competition from global pharmaceutical companies and the formulation of strategies to prepare for patent expiration. Nevertheless, Cenobamate's latest achievement holds symbolic significance, announcing to the world that Korea is transitioning from a mere producer of generic drugs to a powerhouse of innovative new drugs. Once FDA approval is completed in the second half of 2025, it will be recorded as the most successful global new drug in Korean bio-history.