Nxera Pharma Reports Positive Results From Phase 3 Trial of Daridorexant in South Korea

Executive Summary

• Nxera Pharma announced positive top‑line Phase 3 results for daridorexant 50 mg in adult and elderly South Korean patients with insomnia, meeting both primary (subjective total sleep time) and secondary (latency to sleep onset, wake after sleep onset) efficacy endpoints.
• The company plans to file a marketing authorization application in South Korea in Q1 2026, targeting regulatory approval in Q1 2027.
• Safety profile was comparable to placebo, with treatment‑emergent adverse events reported in 13.41% of daridorexant patients versus 14.81% on placebo.

Key Details

• Study Design: Multicenter, randomized, double‑blind, placebo‑controlled, parallel‑group trial; 28‑day treatment period; patients received daridorexant 50 mg or matching placebo once daily.
• Efficacy Results:
• Primary endpoint – change from baseline in subjective total sleep time (sTST) at Day 28: statistically significant improvement vs. placebo (p < 0.0001).
• Secondary endpoints – changes from baseline in subjective latency to sleep onset (sLSO) and subjective wake after sleep onset (sWASO) at Day 28: both significantly improved vs. placebo (p < 0.0001).
• Safety: Incidence of treatment‑emergent adverse events (TEAEs) was 13.41% for daridorexant versus 14.81% for placebo; no new safety signals identified.
• Regulatory Timeline: Marketing authorization application to be submitted in South Korea Q1 2026; anticipated approval in South Korea Q1 2027.
• Commercial Status: Daridorexant is already approved and marketed in Japan as QUVIVIQ® under a commercialization agreement with Shionogi; QUVIVIQ® is also marketed by Idorsia (US, Canada, Europe) and Simcere (China, Hong Kong).
• Market Opportunity: Insomnia prevalence in South Korea estimated at 15‑25% of adults (~6.5–11 million people), representing a sizable unmet need.

Notable Quotes

“We are very encouraged by the positive results from this Phase 3 study, which represents a critical milestone as we prepare to submit a marketing authorization application… This progress brings patients in South Korea suffering from insomnia one step closer to gaining access to an important new treatment option.” – Mr. MinBok Lee, President and Representative Director, Nxera Pharma Korea.