Nxera Pharma Submits Marketing Authorization Application for Daridorexant in South Korea

Executive Summary

• Nxera Pharma submitted a Marketing Authorisation Application (MAA) to South Korea’s Ministry of Food and Drug Safety for daridorexant, the dual orexin receptor antagonist already approved in Japan as QUVIVIQ®.
• The submission follows positive Phase 3 data from a multicenter, double‑blind, placebo‑controlled trial that met its primary endpoint (subjective total sleep time) and secondary endpoints (subjective latency to sleep onset and subjective wake after sleep onset).
• Successful regulatory approval in South Korea is anticipated in 2027, expanding market access for daridorexant in the APAC region.

Key Details

• Product: Daridorexant (dual orexin receptor antagonist), marketed in Japan as QUVIVIQ®.
• Regulatory Action: Marketing authorisation application filed with South Korea’s MFDS on 4 Mar 2026.
• Phase 3 Trial Design: Multicenter, randomized, double‑blind, placebo‑controlled; patients received daridorexant 50 mg or placebo once daily for 28 days.
• Primary Efficacy Endpoint: Change from baseline in subjective total sleep time (sTST) at Day 28 – statistically significant improvement vs. placebo (p < 0.0001).
• Secondary Endpoints:
• Subjective latency to sleep onset (sLSO) – significant improvement vs. placebo (p < 0.0001).
• Subjective wake after sleep onset (sWASO) – significant improvement vs. placebo (p < 0.0001).
• Safety: Treatment‑emergent adverse events reported in 13.41% of daridorexant‑treated patients vs. 14.81% for placebo; safety profile comparable between groups.
• Market Context: Insomnia prevalence in South Korea estimated at 15–25% of adults (≈6.5–11 million people).
• Commercialisation Agreement: QUVIVIQ® marketed in Japan under a partnership with Shionogi; Idorsia holds rights for US, Canada, Europe; Simcere markets in China and Hong Kong.
• Future Outlook: Company expects regulatory review to conclude with approval anticipated in 2027, enabling launch in the South Korean market.

Notable Quotes

“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.” – Mr. MinBok Lee, President and Representative Director, Nxera Pharma Korea