Nxera Pharma Reports Positive Phase 3 Results for Daridorexant in South Korea Insomnia Trial

Nxera Pharma announced positive top-line results from a Phase 3 trial of daridorexant 50 mg for insomnia in adult and elderly patients in South Korea on January 19-20, 2026.2 3

The multicenter, randomized, double-blind, placebo-controlled trial met primary endpoint of subjective total sleep time (sTST) and secondary endpoints of subjective latency to sleep onset (sLSO) and wake after sleep onset (sWASO), all with p<0.0001 vs placebo after 28 days.2 3 6

Daridorexant was well-tolerated, with treatment-emergent adverse events in 13.41% of patients vs 14.81% on placebo.2 3

Nxera plans to file a marketing authorization application in South Korea in Q1 2026, with approval expected in Q1 2027.2 3 5

Daridorexant is a dual orexin receptor antagonist (DORA), marketed as QUVIVIQ in US, Europe, and Japan.3 6

Sources:

2. https://www.pharmanow.live/latest-news/nxera-daridorexant-phase3-korea

3. https://www.biospace.com/press-releases/nxera-pharma-reports-positive-results-from-phase-3-trial-of-daridorexant-in-south-korea

5. https://www.clinicaltrialsarena.com/news/nxera-positive-outcomes-daridorexant-study/

6. https://www.nasdaq.com/articles/nxera-pharma-daridorexant-phase-3-trial-insomnia-south-korea-meets-primary-secondary-goals

Sources:

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