Nxera Pharma Co., Ltd.
Positive Results Reported in Phase III Trial of Daridorexant in South Korea
Achieved primary endpoints in the Phase III trial of Daridorexant in South Korea; manufacturing and marketing approval application planned for Q1 2026, with approval expected in Q1 2027.
Key Figures
- Significant improvement in primary endpoint total sleep time (sTST) with p<0.0001
- Significant improvements in secondary endpoints sleep latency (sLSO) and wake time after sleep onset (sWASO) with p<0.0001
- Adverse event incidence rate: Daridorexant group 13.41%, placebo group 14.81%
- Planned manufacturing and marketing approval application in South Korea: Q1 2026
- Expected approval in South Korea: Q1 2027
AI要約
Phase III Trial Results and Future Outlook
Nexera Pharma Co., Ltd. reported favorable results from the randomized, double-blind, placebo-controlled Phase III trial of the dual orexin receptor antagonist Daridorexant 50mg conducted in South Korea. The study significantly improved the primary endpoint of total sleep time (sTST) and the secondary endpoints of sleep latency (sLSO) and wake time after sleep onset (sWASO). The incidence of adverse events was comparable to the placebo group, confirming safety. The company plans to file for manufacturing and marketing approval in South Korea in Q1 2026, with approval expected in Q1 2027.
Product Market Deployment and Company Overview
Daridorexant is marketed in Japan as “Quviviq® Tablets” through a partnership with Shionogi & Co., Ltd. It is also available in the United States, Canada, Europe, China, and Hong Kong. Insomnia affects approximately 6.5 to 11 million adults, representing 15–25% of the adult population in South Korea. Nexera Pharma’s subsidiary, Nxera Pharma Korea, is preparing for manufacturing and marketing approval acquisition in the South Korean market. Nexera Pharma is a biopharmaceutical company developing numerous pipelines leveraging its “NxWave™” drug discovery platform.
