SK Biopharm’s seizure medication Xcopri (cenobamate) launched in South Korea via Dong-A ST, backed by National Health Insurance coverage as of November 2026. The therapy targets adult partial-onset seizures poorly controlled by existing treatments, offering an advanced dual-action mechanism designed to reduce seizure frequency and achieve complete seizure freedom.
The Bottom Line
- Market Entry: Available in South Korea with National Health Insurance reimbursement, lowering cost barriers for an estimated 360,000 national epilepsy patients.
- Licensing Footprint: Dong-A ST holds manufacturing technology transfer rights for finished products and commercialization across 30 territories, including Russia, Australia, and South/Southeast Asia, following a January 2024 agreement with SK Biopharm.
- Clinical Efficacy: Pivotal trials demonstrated complete seizure freedom rates reaching up to 52.4% during maintenance periods in Asian cohorts, significantly outperforming placebo benchmarks.
Insurance Reimbursement and Pricing Structure
As reported by Hit News, six distinct dosage strengths of Xcopri entered the domestic reimbursement list following price negotiations with the National Health Insurance Service. Upper price limits established by health authorities are set at 1,648 KRW for the 12.5mg strength, 3,110 KRW for 25mg, 5,599 KRW for 50mg, 9,332 KRW for 100mg, 11,967 KRW for 150mg, and 14,000 KRW for the 200mg formulation. All listed formulations benefit from flexible pricing agreements.
According to Yonhap Infomax, the domestic introduction arrives six years after the medication first debuted in the United States in 2020. Dong-A ST secured local product approval as South Korea’s 41st domestically developed novel drug from the Ministry of Food and Safety in November 2025.
Clinical Trial Data and Mechanism of Action
Xcopri operates as a third-generation antiepileptic drug featuring a dual mechanism of action. It inhibits persistent sodium currents in brain neurons while simultaneously enhancing the activity of gamma-aminobutyric acid (GABA), an inhibitory neurotransmitter, to suppress abnormal electrical signaling.
| Clinical Trial | Patient Cohort | Dosage Group | Complete Seizure Freedom Rate |
|---|---|---|---|
| Study 017 (FDA Approval Trial) | 437 Adult Focal Seizure Patients | 200mg / 400mg | 11% (200mg) – 21% (400mg) vs. 1% (Placebo) |
| Study 035 (Asia Phase 3 Trial) | 519 Adult Patients (KR, CN, JP) | 200mg / 400mg | 30.1% (200mg) – 52.4% (400mg) vs. 2.6% (Placebo) |
As outlined by ETNews, approximately 30% of South Korea’s 360,000 diagnosed epilepsy patients experience drug-refractory conditions where standard regimens fail to control seizures. The Asian phase 3 trial (Study 035) tracked 519 adult patients across South Korea, China, and Japan, recording complete seizure freedom rates of 30.1% for the 200mg cohort and 52.4% for the 400mg cohort during their respective maintenance phases.
Global Licensing and Regional Expansion Strategy
Under the terms of the January 2024 licensing agreement between SK Biopharm and Dong-A ST, the commercialization scope extends far beyond the domestic market. Dong-A ST acquired finished pharmaceutical production technology to manage regulatory approvals, local manufacturing, and sales across 30 jurisdictions.
As detailed by Yonhap News Agency, the rollout aligns with broader international milestones for the brand, including regulatory clearance secured in Japan during September. SK Biopharm continues to pursue label expansions targeting broader age groups and additional neurological indications worldwide.
Corporate Statements and Access Impact
A Dong-A ST representative stated, We hope Xcopri will establish itself as a new treatment option for epilepsy patients, and we will continue contributing to help patients reduce difficulties in daily life caused by seizures and maintain stable treatment.
The company further noted that the drug’s National Health Insurance reimbursement reduces the economic burden for drug-refractory epilepsy patients and enhances treatment accessibility, helping patients reduce seizure-related restrictions and continue stable daily lives.
