Japan's Nxera Pharma Co., Ltd. (SOLTF) announced Monday positive top-line results from a Phase 3 study conducted in South Korea evaluating daridorexant 50 mg in adult and elderly patients with insomnia.
The company said it plans to submit a marketing authorization application for daridorexant in South Korea in the first quarter of 2026, with approval expected in the first quarter of 2027.
Insomnia disorder, characterized by difficulties in sleep onset and/or sleep maintenance, impacts both physical and mental health. It causes clinically significant distress or impairment in important areas of daytime functioning. In South Korea, the condition affects 15-25% of the adult population, or around 6.5-11 million people.
Daridorexant is a dual orexin receptor antagonist being developed in South Korea by Nxera for the treatment of adult patients with insomnia.
The company noted that the multicenter, randomized, double-blind, placebo-controlled, parallel-group trial met both its primary and secondary efficacy endpoints. In the trial to evaluate the efficacy and safety of daridorexant in adult and elderly patients with insomnia, patients were randomized to receive daridorexant 50 mg or placebo once daily for 28 days.
At Day 28, daridorexant significantly improved the primary efficacy endpoint, the change from baseline in subjective total sleep time, compared with placebo.
Daridorexant also significantly improved the secondary efficacy endpoints, the change from baseline at Day 28 in subjective latency to sleep onset and subjective wake after sleep onset, compared with placebo.
Daridorexant, marketed as QUVIVIQ, is already available in the United States, Europe and Japan.
QUVIVIQ, discovered by Idorsia Pharmaceuticals, is marketed by Idorsia in the US, Canada, and multiple European countries. The drug is marketed by Simcere in China and Hong Kong. In Japan, it is marketed under a commercialization agreement between Nxera and Shionogi.
MinBok Lee, President and Representative Director of Nxera Pharma Korea, stated, "Insomnia is highly prevalent in South Korea and represents a serious health condition that significantly affects patients' daily lives.... This progress brings patients in South Korea suffering from insomnia one step closer to gaining access to an important new treatment option."
In Japan, Nxera Pharma shares were trading at 812.00 yen, up 0.37%
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