• Daridorexant is a dual orexin receptor antagonist being developed by Nxera for the treatment of adult patients with insomnia
• QUVIVIQ™ (daridorexant) 25 and 50 mg was recently approved and is expected to launch in Japan in Q4 2024

Nxera Pharma Co. formerly known as Sosei Group or Sosei Heptares –announces 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.

Insomnia, characterized by difficulties in sleep onset and/or sleep maintenance, impacts both physical and mental health. The condition is highly prevalent in South Korea, affecting 15-25% of the adult population, or approximately 6.5-11 million people.

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 substantial data already generated in earlier trials completed in North America, Europe and Japan, that are required by the Ministry of Food and Drug Safety (MFDS) to grant marketing authorization for the drug in South Korea. The trial is expected to run for approximately 12 months with results expected during 1H 2026.

Daridorexant 25mg and 50mg was approved in Japan in September 2024 based on robust 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.

Mr. MinBok Lee, President and Representative Director of Nxera Pharma Korea, commented: “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. 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.”