Nxera Pharma has announced positive top-line results from its Phase III study of daridorexant 50mg, aimed at treating insomnia in adult and elderly patients in South Korea.
The company intends to submit a marketing authorisation application for this treatment in the first quarter of 2026, with approval anticipated by the first quarter of 2027.
Approved as Quviviq in Japan, daridorexant is being marketed through a partnership between Nxera and Shionogi.
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Additionally, Idorsia Pharmaceuticals markets the therapy in Canada, the US, and multiple European countries while Simcere handles distribution in Hong Kong and China.
Insomnia affects both physical and mental health and is present in 15%-25% of the South Korean adult population.
The Phase III placebo-controlled, double-blind, randomised, multi-centre study is designed to assess the safety and efficacy of daridorexant.
Participants were assigned to receive either daridorexant 50mg or a placebo daily over 28 days. The study met both primary and secondary efficacy endpoints.
Results showed that at day 28, daridorexant significantly improved subjective total sleep time compared with placebo.
Improvements were also observed in secondary endpoints such as subjective wake after sleep onset (sWASO) and subjective latency to sleep onset (sLSO).
Adverse events were similar between groups, with treatment-emergent adverse events reported at 13.41% for the daridorexant group and 14.81% for the placebo.
Nxera Pharma Korea president and representative director MinBok Lee said: “Insomnia is highly prevalent in South Korea and represents a serious health condition. We are very encouraged by the positive results from this Phase III study, which represents a critical milestone as we prepare to submit a marketing authorisation application in the first quarter of 2026.
“This progress brings patients in South Korea suffering from insomnia one step closer to gaining access to an important new treatment option. With Quviviq already available in the US, Europe and Japan, we are committed to working towards making this medicine available to patients in South Korea as quickly as possible.”
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