TAIZHOU, Jiangsu, Sept. 21, 2025 (GLOBE NEWSWIRE) — 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 discontinuation.
As pointed out by Professor Han Fang, as a fast-acting and short-half-life DORA, Fazamorexant can not only meets the treatment needs of patients with difficulty falling asleep but also maintains sleep without affecting their daytime activities. For people who have difficulty maintaining sleep at night, a new strategy of ‘twice nightly dosing’ could even be explored, providing a new path for individualized and precise treatment, which was widely recognized by the scholars at the conference.
Following the conference, Professor Emmanuel Mignot, Academician of the United States National Academy of Sciences and Director of the Center for Sleep and Circadian Sciences at Stanford University, expressed his interest in Fazamorexant and possible cooperation in further trials.
A representative from Yangtze River Pharmaceutical stated that the company has officially submitted the new drug application (NDA) for Fazamorexant to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). With the debut release of the phase III trial results on the international stage, the company is looking forward to an accelerated review and registration to kick off the industrialization process, so as to provide a safer, more effective and innovative option for global insomnia patients as soon as possible.
Yangtze River Pharmaceutical Group
Yang wen
https://en.yangzijiang.com/
0086 4009881999
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