Nxera Pharma has reported encouraging top-line data from a phase 3 clinical trial of its insomnia treatment daridorexant in South Korea, paving the way for a planned marketing submission in early 2026.
The study evaluated a 50 mg dose of daridorexant in both adult and elderly patients with insomnia. According to the company, the trial met all primary and secondary endpoints, showing significant improvements in subjective total sleep time, subjective latency to sleep onset and subjective wake after sleep onset when compared with placebo. The incidence of adverse events was similar across treatment and placebo groups.
Daridorexant is already approved and marketed in Japan under the brand name Quviviq through a commercialisation agreement between Nxera and Shionogi. It is also marketed by Idorsia in the US, Canada and several European countries, and by Simcere in China and Hong Kong.
Insomnia remains a widespread condition in South Korea, affecting an estimated 15–25% of adults, equivalent to roughly 6.5–11 million people. The company said the latest results represent a significant step toward expanding treatment options for this large patient population.
Mr MinBok Lee, President and Representative Director of Nxera Pharma Korea, said: “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 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 United States, Europe and Japan, we are committed to working towards making this medicine available to patients in South Korea as quickly as possible.”
Nxera expects regulatory approval in South Korea in the first quarter of 2027.
