Summary: Nxera Pharma has initiated a phase 3 clinical trial in South Korea to evaluate daridorexant, a dual orexin receptor antagonist, for treating insomnia in adults. The trial aims to provide the additional data required by South Korea’s Ministry of Food and Drug Safety for marketing authorization. Daridorexant has already been approved in Japan (where it will be marketed as Quviviq) and other regions, including the US and Europe, under a separate commercialization agreement.
Key Takeaways:
- Phase 3 Trial Underway in South Korea: Nxera Pharma has begun a double-blind, placebo-controlled phase 3 trial to meet regulatory requirements for daridorexant’s approval in South Korea.
- Daridorexant Approval in Other Markets: Daridorexant has been approved in Japan, where it will launch as Quviviq, and is also approved in North America, Europe, and certain other countries.
- Focus on South Korea’s Insomnia Population: The trial highlights the need to address insomnia’s high prevalence and health impact in South Korea, with results expected in early 2026.
Nxera Pharma Co Ltd, formerly known as Sosei Group or Sosei Heptares, announced the randomization of the first patient in a phase 3 clinical trial evaluating daridorexant, its novel dual orexin receptor antagonist, for the treatment of adult patients in South Korea with insomnia.
The randomized, double-blind, placebo-controlled phase 3 study aims to recruit adult and elderly subjects with insomnia at multiple centers in South Korea. The purpose of the trial is to provide additional efficacy and safety data, alongside the data already generated in earlier trials completed in North America, Europe, and Japan that are required by the Ministry of Food and Drug Safety to grant marketing authorization for the drug in South Korea. The trial is expected to run for approximately 12 months with results expected during the first half of 2026.
Daridorexant 25 mg and 50 mg was approved in Japan in September based on clinical efficacy and safety data, including from a phase 3 trial in Japan that met all primary and secondary endpoints.
Nxera owns the Japanese and APAC (ex-China) rights for daridorexant, which will be marketed in Japan as Quviviq under a commercialization agreement between Nxera and Shionogi. Quviviq is expected to be launched in Japan in Q4 2024. Quviviq is also approved in the US, Europe, and certain other countries where it is marketed by Idorsia Pharmaceuticals.
“Insomnia is highly prevalent in South Korea and is associated with several significant comorbidities, underscoring the point that this disorder is more than just a lack of sleep; it is a serious health concern that impacts the daily life of millions of people,” says MinBok Lee, president and representative director of Nxera Pharma Korea, in a release. “Following the approvals of Quviviq in various markets, including the US, Europe, and most recently Japan, we are committed to conducting this new trial and providing the additional data necessary to make this drug available to the many insomnia patients in South Korea.”
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