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Phase III Clinical Study of Daridorexant Reached the Primary Endpoint

Release time:2024-06-03

On May 30, 2024, Simcere Pharmaceutical Group Limited (Simcere; 2096.HK) announced that the Chinese Phase III clinical study of Daridorexant Hydrochloride Tablets (Daridorexant), for the treatment of insomnia patients in China, has met the primary study endpoint. Daridorexant is a novel insomnia drug collaborated between Simcere and Idorsia Pharmaceuticals Ltd.(Idorsia).


The multicenter, randomized, double-blind, placebo-controlled Phase III clinical study was led by Professor Yuping Wang of Xuanwu Hospital of Capital Medical University. The study was designed to evaluate the efficacy and safety of Daridorexant in Chinese patients with insomnia, with a total of 206 patients enrolled in the study covering 33 research centers nationwide. The primary endpoint was the reduction of nighttime awakening time in insomnia patients.


The results demonstrated that, as compared to placebo, one tablet of Daridorexant taken before bedtime each night significantly improved various sleep-related indicators, including nocturnal awakenings, in patients with insomnia. The results also demonstrated that Daridorexant is safe and well-tolerated.


According to the “2024 Chinese National Healthy Sleep White Paper”, 59% of Chinese residents surveyed suffer from insomnia, and less than 1/5 of the population have no sleep disorders. The results of this Phase III study further validate the efficacy and safety of Daridorexant on the Chinese insomnia patients, which is expected to meet the clinical needs of the majority of insomnia patients in China.


Overseas phase III data has been published in The Lancet Neurology[2]: the pivotal studies demonstrated that Daridorexant significantly improved sleep onset, sleep maintenance, and self-reported total sleep time at the first and third month of treatment compared to placebo without altering the sleep architecture. The studies also showed that Daridorexant is safe and well-tolerated with no evidence of dependency, rebound insomnia, withdrawal symptoms, or drug abuse, showing great safety tolerability and support for long-term use.


About Daridorexant

Daridorexant is a potential Best-in-Class innovative drug for the treatment of insomnia. Rather than inducing sleep through broad inhibition of brain activity, Daridorexant antagonizes only the activation of orexin receptors and consequently, Daridorexant decreases the wake drive, helping patients fall asleep and stay asleep with no hangover or drowsiness the next day. Daridorexant is the only DORA approved by the European Medicines Agency (EMA) that has an impact on daytime functioning.


Currently, Daridorexant has been approved in the United States, United Kingdom, European Union, Switzerland, and Canada. On May 20, 2024, Daridorexant was issued the certificate of drug/product registration by the Pharmacy and Poisons Board of Hong Kong, which allowed two specifications of daridorexant tablets, namely QUVIVIQ TABLETS 50MG and QUVIVIQ TABLETS 25MG, to be sold, offered for sale, distributed and possessed in Hong Kong.