Announcement of Manufacturing and Marketing Authorization Application for Daridorexant in South Korea

Overview of the Manufacturing and Marketing Authorization Application in South Korea

Nexera Pharma Corporation has submitted a manufacturing and marketing authorization application to the Ministry of Food and Drug Safety (MFDS) of South Korea for daridorexant, a dual orexin receptor antagonist, for the treatment of patients with insomnia. In the Phase III clinical trial conducted in South Korea, the primary endpoint of total sleep time (sTST) and secondary endpoints of sleep latency (sLSO) and wake time after sleep onset (sWASO) were all achieved, and safety was comparable to the placebo group.

Market Background and Future Outlook

In South Korea, 15–25% of the adult population, approximately 6.5 to 11 million people, suffer from insomnia, and the number of chronic insomnia patients is increasing. Daridorexant is marketed in Japan under the brand name "Quvivia® Tablets" and is also sold in the United States, Canada, Europe, China, and Hong Kong. Approval in South Korea is targeted for 2027, and the company will provide updates on the review progress as appropriate. The impact of this application on consolidated earnings for the fiscal year ending December 2026 is considered minimal.