SK Biopharmaceuticals Submits Supplemental New Drug Application to U.S. FDA for Cenobamate
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SK Biopharmaceuticals submitted an FDA application for expanded cenobamate use after positive Phase 3 data in generalized tonic-clonic seizures.
PARAMUS, N.J., Nov. 4, 2026 -- SK Biopharmaceuticals today announced that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval of cenobamate (U.S. brand name: XCOPRI®) for the treatment of primary generalized tonic-clonic seizures (PGTC) and an expansion of the existing focal-onset seizure (FOS) indication to include pediatric patients.
"This submission represents an important step in our continued investment in cenobamate and our efforts to reach more people living with epilepsy," said Donghoon Lee, CEO of SK Biopharmaceuticals. "We are building on the foundation established with cenobamate in focal-onset seizures in adults by evaluating its potential in additional seizure types, age groups and formulations. Our goal is to continue advancing innovation that can provide physicians with more treatment options to address the diverse needs of people living with epilepsy."
The sNDA is supported by positive results from a global Phase 3 trial (NCT03678753) evaluating cenobamate in patients 12 years of age and older living with PGTC seizures. The trial enrolled 169 patients across 122 sites in 12 countries, including the U.S., South Korea and countries in Europe.
In the trial, patients treated with cenobamate experienced a median 71.9% reduction in PGTC seizure frequency from baseline compared with a 39.6% reduction among patients receiving placebo, a statistically significant difference (p=0.003). Most reported adverse events were mild to moderate, and the safety findings were consistent with the known safety profile of cenobamate, with no new safety signals observed.
If approved by the FDA, the new indication would expand the use of cenobamate beyond its current indication for focal-onset seizures in adults and provide an additional treatment option for eligible patients with PGTC seizures. The PGTC submission is part of SK Biopharmaceuticals' broader effort to evaluate cenobamate across additional patient populations and formulations.
SK Biopharmaceuticals also submitted a separate sNDA to the FDA in October seeking to expand the existing focal-onset seizure (FOS) indication to pediatric patients. The company confirmed cenobamate's safety in clinical trials in pediatric patients with FOS and is pursuing an expansion of the eligible age range on that basis.
The company also submitted a New Drug Application (NDA) to the FDA in March for an oral suspension formulation of cenobamate. The formulation would provide an alternative for patients who have difficulty swallowing tablets and was also used in the pediatric clinical trial program.
Since the launch of XCOPRI in the U.S. in 2020, SK Biopharmaceuticals has continued to invest in the development of cenobamate with the goal of addressing the needs of more people living with epilepsy. These efforts include evaluating cenobamate in additional seizure types and age groups, developing additional formulations and expanding its availability in markets around the world.
SK Life Science, Inc., based in Paramus, New Jersey, is a U.S. subsidiary of SK Biopharmaceuticals Co., Ltd., a global biopharmaceutical company headquartered in South Korea that focuses on developing and commercializing innovative treatments. Together, they are advancing innovative treatments for central nervous system (CNS) disorders and expanding into oncology through next-generation modalities, including radiopharmaceutical therapy (RPT) and targeted protein degradation (TPD), while leveraging AI-driven innovation to accelerate drug development and enhance patient care. For more information, visit sklifescienceinc.com.
SK Biopharmaceuticals Co., Ltd. is part of SK Group, South Korea's second-largest conglomerate. SK Group continues to grow in response to the rapidly changing global business environment, demonstrating leadership across key sectors such as semiconductors, energy, ICT and biotechnology. The group is strengthening its leadership position through strategic investments, technological innovation, and global collaboration. With assets of USD 299.1 billion and revenue of USD 171.6 billion in 2025, SK Group is listed in the Fortune Global 500 companies and has 579 subsidiaries and branches worldwide. As a key player in SK Group's biotechnology sector, SK Biopharmaceuticals plays a central role in advancing pharmaceutical innovation, leveraging its integrated capabilities spanning drug discovery, clinical development, regulatory approval, and commercialization to bring innovative treatments to patients worldwide.
