Nxera Pharma has announced the enrollment of the first patient in a Phase 3 clinical trial of daridorexant for the treatment of insomnia in South Korea. This randomized, double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of daridorexant in adult and elderly patients with insomnia, addressing a significant health concern in the country.
The trial aims to recruit adult and elderly subjects with insomnia at multiple centers in South Korea. The primary objective is to provide additional efficacy and safety data required by the Ministry of Food and Drug Safety (MFDS) to potentially grant marketing authorization for daridorexant in South Korea. The study is expected to last approximately 12 months, with topline results anticipated in the first half of 2026.
Daridorexant: A Dual Orexin Receptor Antagonist
Daridorexant is a dual orexin receptor antagonist that blocks the binding and activity of orexins, neuropeptides that promote wakefulness. By inhibiting orexin receptors OX1R and OX2R, daridorexant helps to reduce overactive wake signaling, a key factor in insomnia. The drug is available in 25mg and 50mg doses.
Mr. MinBok Lee, President and Representative Director of Nxera Pharma Korea, emphasized the significance of this trial, stating, "Insomnia is highly prevalent in South Korea and is associated with several significant comorbidities, underscoring the point that this disorder is more than just a lack of sleep; it is a serious health concern that impacts the daily life of millions of people."
Insomnia in South Korea
Insomnia is characterized by difficulties in initiating or maintaining sleep, leading to clinically significant distress or impairment in daytime functioning. In South Korea, it affects approximately 15% to 25% of the adult population, equating to roughly 6.5 to 11 million people. The condition is more prevalent among women and older adults.
According to data from Korea’s Health Insurance Review and Assessment Service (HIRA), the number of chronic insomnia patients treated has increased by 21% from 597,529 in 2018 to 722,440 in 2022. Of these patients, 50% are aged 60 or above, and 61% are women.
QUVIVIQ™: Daridorexant's Brand Name
Daridorexant has already been approved in Japan and will be marketed as QUVIVIQ™ under a commercialization agreement between Nxera and Shionogi. QUVIVIQ™ is expected to launch in Japan in Q4 2024. It is also approved in the US, Europe, and certain other countries, where it is marketed by Idorsia Pharmaceuticals.
The Phase 3 trial in South Korea is entitled “A randomized, double-blind, multi-center, placebo-controlled, parallel, Phase 3 study to evaluate the efficacy and safety of daridorexant in adult and elderly subjects with insomnia disorder.” The primary endpoint is the evaluation of daridorexant's efficacy on subjective total sleep time (sTST) based on an electronic sleep diary (eDiary) over a 4-week period. Secondary endpoints include assessing the efficacy and safety of daridorexant on subjective latency to sleep onset (sLSO) and subjective wake after sleep onset (sWASO).
Participants will be randomly assigned to receive either a 50mg dose of daridorexant or a placebo once daily for a maximum of 12 weeks.
