Nxera Pharma Files South Korea Approval For Insomnia Drug Daridorexant After Successful Phase III Trial

Nxera Pharma Co., Ltd. has submitted a marketing authorization application (MAA) to the Ministry of Food and Drug Safety (MFDS) in South Korea seeking approval for daridorexant, a dual orexin receptor antagonist designed to treat adults suffering from insomnia. The regulatory submission follows encouraging results from a Phase III clinical trial conducted in South Korea, in which the therapy met both its primary and secondary efficacy endpoints.

Insomnia is a common sleep disorder characterized by difficulty falling asleep or staying asleep, often leading to significant effects on both mental and physical well-being. In South Korea, the condition is estimated to affect 15–25% of the adult population, representing approximately 6.5 to 11 million individuals, highlighting the substantial unmet need for effective treatment options.

Mr. MinBok Lee, President and Representative Director of Nxera Pharma Korea, commented: “This submission represents a key milestone in our efforts to expand access to daridorexant in South Korea. With the medicine already approved and marketed in Japan, we look forward to sharing further progress as it advances through the regulatory review process in South Korea towards anticipated approval in 2027.”

Daridorexant is already commercially available in Japan under the brand name QUVIVIQ through a commercialization agreement between Nxera and Shionogi & Co., Ltd.. The drug was originally discovered by Idorsia Pharmaceuticals and is currently marketed by Idorsia across several international markets, including the United States, Canada, and multiple European countries.

In addition, daridorexant has expanded its global presence through partnerships, with Simcere Pharmaceutical Group responsible for commercialization in China and Hong Kong. With the latest regulatory filing in South Korea, Nxera aims to broaden the availability of this insomnia treatment across Asia, potentially improving sleep health outcomes for millions of patients in the region.