Nxera Pharma Reports Strong Phase 3 Results For Daridorexant 50 mg In South Korea, Plans Q1 2026 Approval Filing With Potential Launch By Early 2027

Nxera Pharma Co., Ltd. has announced positive top-line results from its Phase 3 clinical study in South Korea evaluating daridorexant 50 mg in adults and older patients with insomnia. With these encouraging results, the company plans to submit a marketing authorization application for daridorexant in the first quarter of 2026. If approved, daridorexant is expected to become available in South Korea in the first quarter of 2027.

Daridorexant is already approved and marketed in Japan under the brand name QUVIVIQ® through a commercialization agreement between Nxera and Shionogi. The medicine, originally discovered by Idorsia Pharmaceuticals, is also marketed by Idorsia in the United States, Canada, and several European countries, and by Simcere in China and Hong Kong.

Insomnia, which involves difficulties falling asleep or staying asleep, is a common condition in South Korea. It is estimated to affect 15–25% of adults—representing roughly 6.5 to 11 million people. The condition impacts daily functioning and overall physical and mental health, making effective treatment options especially important.

Commenting on the new results, MinBok Lee, President and Representative Director of Nxera Pharma Korea, said that insomnia remains a major health issue in the country. He stated that the positive Phase 3 data marks an important milestone as the company prepares to file for approval in early 2026. He added that this progress brings South Korean patients closer to accessing a new treatment option that has already been made available in the US, Europe, and Japan. He also reaffirmed the company’s commitment to delivering QUVIVIQ® to patients in South Korea as soon as possible.

The successful Phase 3 trial was conducted as a multicenter, randomized, double-blind, placebo-controlled, parallel-group study. It was designed to evaluate both the effectiveness and safety of daridorexant 50 mg taken once daily for 28 days. Participants were assigned to receive either daridorexant or a placebo throughout the treatment period.

The study achieved its primary and secondary efficacy goals. After 28 days, daridorexant significantly improved subjective total sleep time compared with placebo. It also showed meaningful improvements in secondary measures, including subjective latency to sleep onset and subjective wake after sleep onset. All improvements were statistically significant, with results showing p<0.0001 for the 50 mg dose.

The treatment was generally well tolerated. The incidence of adverse events was similar in both groups, with treatment-emergent adverse events reported in 13.41% of patients taking daridorexant and 14.81% of those receiving placebo. These findings indicate that daridorexant demonstrated a favorable safety profile in addition to its clinical benefits.