Phase III Clinical Study of Daridorexant Achieved the Full Patient Enrollment in China
On March 15, 2024, the Chinese Phase III clinical study of Daridorexant Hydrochloride Tablets (Daridorexant), achieved the enrollment of all 205 patients. Daridorexant is a novel sleep medication collaborated between Simcere Pharmaceutical Group Limited (Simcere; 2096.HK) and Idorsia Pharmaceutials Ltd. (Idorsia), for the treatment of adult patients with insomnia and considerable impact on daytime functioning.
This study is led by Professor Yuping Wang at Xuanwu Hospital of Capital Medical University and conducted in 33 centers across China. It is a local pivotal registry study of Daridorexant in China. On December 17, 2023, the Chinese Phase III clinical study of Daridorexant completed the first patient enrollment.
Overseas phase III data has been published in The Lancet Neurology[1]: 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, which is significantly different from those reported with benzodiazepines.
In addition to improving the nighttime sleep of adults with chronic insomnia disorder, Daridorexant is also the only DORA approved by the European Medicines Agency (EMA) that has an impact on daytime functioning.
On November 15, 2022, Simcere entered into an exclusive license agreement with Idorsia and was granted an exclusive right to develop and commercialize Daridorexant in the Greater China region (Mainland China, Hong Kong, and Macau). Currently, Daridorexant has been approved in the United States, United Kingdom, European Union, Switzerland, and Canada. A New Drug Application ("NDA") has been filed in Japan. So far there is no DORA-type sleep medication available in China.
Reference
1.Mignot E, Mayleben D, Fietze I, Leger D, Zammit G, Bassetti CLA, et al. Safety and efficacy of daridorexant in patients with insomnia disorder: results from two multicentre, randomised, double-blind, placebo-controlled, phase 3 trials. Lancet Neurol. 2022 Feb;21(2):125-139. Erratum in: Lancet Neurol. 2022 Jan 20; PMID: 35065036.