Nxera Begins Phase 3 Clinical Trial For Daridorexant To Treat Insomnia

Nxera Pharma Co., Ltd. has announced the randomisation of the first patient in its Phase 3 clinical trial evaluating daridorexant, a dual orexin receptor antagonist, for treating insomnia in adults in South Korea. Insomnia, affecting 15-25% of South Korea's adult population, approximately 6.5 to 11 million people, leads to difficulties in falling and staying asleep, impacting overall health.

This Phase 3 study is a double-masked, placebo-controlled trial aimed at recruiting adult and elderly participants across multiple centres in South Korea. The trial will gather additional efficacy and safety data, complementing the substantial data from earlier North American, European, and Japanese trials. These data are crucial for obtaining marketing approval from South Korea's Ministry of Food and Drug Safety (MFDS). Results are anticipated in the first half of 2026.

Daridorexant, available in 25 mg and 50 mg doses, was approved in Japan in September 2024, based on solid clinical data, including a Phase 3 trial that met all endpoints. Nxera holds the Japanese and APAC rights for daridorexant, which will be marketed in Japan as QUVIVIQ™ under a collaboration with Shionogi, with a launch expected in Q4 2024. The drug is also approved in the U.S., Europe, and other regions where Idorsia Pharmaceuticals markets it.

Mr. MinBok Lee, President and Representative Director of Nxera Pharma Korea, said in a statement, “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.”