Nxera Pharma Co., Ltd. has announced positive top-line results from a phase 3 study in South Korea evaluating daridorexant 50mg in adult and elderly patients with insomnia.
The company plans to submit a marketing authorization application for daridorexant in South Korea in the first quarter of 2026, with approval in South Korea expected in the first quarter of 2027.
Daridorexant is approved and being marketed in Japan as QUVIVIQ under a commercialisation agreement between Nxera and Shionogi. QUVIVIQ, discovered by Idorsia Pharmaceuticals, is marketed by Idorsia in the US, Canada, and multiple European countries, and marketed by Simcere in China and Hong Kong.
Insomnia, characterized by difficulties in sleep onset and/or sleep maintenance, impacts both physical and mental health. The condition is highly prevalent in South Korea, affecting 15-25% of the adult population, or approximately 6.5-11m people.
MinBok Lee, president and representative director of Nxera Pharma Korea, said: “I Insomnia is highly prevalent in South Korea and represents a serious health condition that significantly affects patients’ daily lives. 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 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.”
The successful phase 3 trial is a multicentre, randomised, double-blind, placebo-controlled, parallel-group trial designed to evaluate the efficacy and safety of daridorexant in adult and elderly patients with insomnia. Patients were randomized to receive daridorexant 50mg or placebo once daily for 28 days.
The study met both its primary and secondary efficacy endpoints. At Day 28, daridorexant significantly improved the primary efficacy endpoint, the change from baseline in subjective total sleep time (sTST), compared with placebo. Daridorexant also significantly improved the secondary efficacy endpoints, the change from baseline at Day 28 in subjective latency to sleep onset (sLSO) and subjective wake after sleep onset (sWASO), compared with placebo.
The incidence of adverse events was comparable between the daridorexant and placebo treatment groups. The rate of treatment-emergent adverse events (TEAEs) during the double-blind treatment period was comparable between placebo and daridorexant, reported in 13.41% of patients treated with daridorexant 50 mg and 14.81% for placebo.