In Korea, national health insurance now covers Xcopri, a medication for epilepsy developed by SK biopharmaceuticals, following its launch by Dong-A ST. This development makes the treatment accessible to patients in Korea who continue to experience seizures despite taking existing medications.
The Korean government approved Xcopri in November 2025 as the 41st domestically developed new drug, indicating its use as an adjunctive treatment for adults experiencing focal-onset seizures, which may or may not progress to bilateral tonic-clonic seizures and are not adequately controlled by other medications.
Global Availability and Clinical Trials
Xcopri has been available in the United States since receiving FDA approval in 2019. Its introduction in Korea marks the first time a drug originally developed by SK biopharmaceuticals for the global market has been launched domestically.
Clinical trials have demonstrated the effectiveness of Xcopri. In Study 017, a clinical trial involving 437 adults with uncontrolled focal-onset seizures, cenobamate reduced seizure frequency by approximately 55% from baseline in both the 200 mg and 400 mg groups. During the 12-week maintenance period, 11% of patients in the 200 mg group and 21% in the 400 mg group achieved complete freedom from seizures, compared to 1% in the placebo group.
A separate phase 3 trial involving 519 patients in Korea, China, and Japan also demonstrated seizure reduction. During the six-week maintenance period, seizure freedom rates reached 30.1% in the 200 mg group and 52.4% in the 400 mg group, compared with 2.6% in the placebo group.
Pricing and Market Expectations
The reimbursement ceiling for Xcopri ranges from 1,648 won per 12.5 mg tablet to 14,000 won per 200 mg tablet. However, the actual out-of-pocket costs for patients on a monthly basis remain unclear.
In January 2024, Dong-A ST acquired the licensing rights to Xcopri through an agreement with SK biopharmaceuticals, covering 30 countries, including Korea, Asia, Russia, Australia, New Zealand, and Türkiye.
According to the Korean Epilepsy Society, approximately 360,000 individuals in Korea receive treatment for epilepsy. About 30% of these patients continue to experience seizures despite medication, highlighting the need for additional treatment options like Xcopri.
Mechanism and Administration
Cenobamate works through a dual mechanism involving inhibition of persistent sodium currents and enhancement of gamma-aminobutyric acid (GABA)-mediated inhibitory signaling. This approach aims to reduce seizure activity in patients with epilepsy.
The medication is administered once daily, with doses gradually increased according to the prescribed titration schedule. Dong-A ST is responsible for regulatory approvals, commercialization, and finished-product manufacturing in the licensed territories, which include Korea and other countries in Asia, Russia, Australia, New Zealand, and Türkiye.