Most recently, the Phase III pivotal clinical trial results of Fazamorexant, a first-class innovative anti-insomnia drug independently developed by Yangtze River Pharmaceutical Group,were globally unveiled for the first time at the World Sleep Congress 2025 combined with the annual meeting of the Asian Society of Sleep Medicine (ASSM 2025). The announcement has garnered widespread attention within the international sleep medicine community.
This groundbreaking achievement marks a significant milestone in the global development of innovative treatments for sleep disorders.
The World Sleep Congress, held in Singapore this year, is the highest-level academic event in the field of sleep medicine gathering top international experts and scholars. The release of the trial results of Fazamorexant marks an important breakthrough made by China in original new drugs, with increasing influence in the global academic stage.
At the “Orexin/Hypocretin System: Clinical Use”, a special session co-chaired by Professor Han Fang, former Secretary-General of the World Association of Sleep Medicine and former President of the ASSM from Peking University People’s Hospital, and Professor Seung-Chul Hong, President of the Korean Society of Sleep Research, a study report was given by Dr. Zhu Wenjun, a postdoctoral fellow at Peking University People’s Hospital, providing a detailed interpretation of the Phase III clinical data of Fazamorexant, the dual orexin receptor antagonist.
According to reports, this study is a multi-center, randomized, double-blind, and placebo-controlled phase III clinical trial, with a total of 1,034 adult patients with insomnia being administered the trial drug, aiming to evaluate the efficacy and safety of Fazamorexant. The results show that Fazamorexant, as an dual orexin receptor antagonist (DORA), demonstrates rapid efficacy and a favorable safety profile in adult patients with insomnia.
It is particularly worth noting that Fazamorexant exhibits exceptional performance in key sleep indicators. In terms of improved sleep efficiency, shortened period of falling asleep, and decreased nighttime awakening are significantly greater compared to the publicly available clinical data of other DORAs, the trial of Fazamorexant provides more significant data (Note: these comparisons are based on different clinical trial conditions and should not be directly referenced for clinical use). Additionally, the drug demonstrated a favorable safety and tolerability profile, with no observed rebound insomnia or withdrawal symptoms following
