Nxera Pharma’s Daridorexant Shows Positive Phase III Results in South Korea

Nxera Pharma reported positive Phase III results for daridorexant 50mg in adult and elderly patients with insomnia in South Korea. The placebo-controlled, double-blind, randomized, multi-centre study assessed safety and efficacy over 28 days.

At day 28, daridorexant significantly improved subjective total sleep time versus placebo and showed benefits in secondary endpoints, including subjective wake after sleep onset (sWASO) and latency to sleep onset (sLSO). Adverse events were comparable between groups (13.41% vs 14.81% for placebo).

Daridorexant is marketed as Quviviq in Japan (Nxera/Shionogi partnership), in North America and Europe by Idorsia, and in Hong Kong/China by Simcere.

Nxera plans to submit a marketing authorisation application in Q1 2026, with approval expected by Q1 2027. Insomnia affects 15–25% of South Korean adults and is associated with significant physical and mental health impacts. Nxera aims to provide patients faster access to this treatment option.

20-01-2026