TAIZHOU, Jiangsu, Sept. 21, 2025 — Recently, the pivotal Phase III clinical trial results for Fazamorexant, a pioneering new anti-insomnia drug developed in-house by Yangtze River Pharmaceutical Group, debuted globally at the World Sleep Congress 2025, held concurrently with the annual meeting of the Asian Society of Sleep Medicine (ASSM 2025). This announcement has attracted considerable interest within the international sleep medicine community.
This seminal development represents a major stride in the global advancement of innovative treatments for sleep disorders.
The World Sleep Congress, hosted this year in Singapore, stands as the premier academic gathering in the field of sleep medicine, convening leading international specialists and scholars. The unveiling of Fazamorexant’s trial results signifies a key advancement by China in novel pharmaceutical creation, enhancing its growing prominence on the global academic stage.
During the dedicated session, “Orexin/Hypocretin System: Clinical Use”, jointly chaired by Professor Han Fang, ex-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, Dr. Zhu Wenjun, a postdoctoral fellow at Peking University People’s Hospital, delivered a study report, offering an in-depth analysis of the Phase III clinical data for Fazamorexant, a dual orexin receptor antagonist.
The study, as reported, was a Phase III clinical trial, designed as multi-center, randomized, double-blind, and placebo-controlled. It involved 1,034 adult insomnia patients receiving the investigational drug to assess Fazamorexant’s efficacy and safety. The results demonstrated that Fazamorexant, operating as a dual orexin receptor antagonist (DORA), exhibited swift effectiveness and a commendable safety profile in adult patients suffering from insomnia.
Notably, Fazamorexant showed outstanding results in key sleep indicators. It demonstrated notably superior improvements in sleep efficiency, time to fall asleep, and reduction in nocturnal awakenings when compared with existing clinical data for other DORAs on the market, yielding more compelling data (Note: these comparisons are based on different clinical trial conditions and should not be directly referenced for clinical use). Furthermore, the drug also presented a positive safety and tolerability profile, with no instances of rebound insomnia or withdrawal symptoms observed post-discontinuation.
According to Professor Han Fang, as a fast-acting and short-half-life DORA, Fazamorexant not only addresses the therapeutic needs of patients struggling to fall asleep but also sustains sleep without impacting their daytime functions. For individuals experiencing difficulty maintaining sleep at night, the potential for a ‘twice nightly dosing’ strategy might even be investigated, offering an innovative avenue for personalized and targeted therapy, a concept that garnered broad approval from the congress’s attendees.
Subsequent to the congress, 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, conveyed his keen interest in Fazamorexant and prospective collaboration on additional studies.
Yangtze River Pharmaceutical confirmed that the company has formally filed the new drug application (NDA) for Fazamorexant with the National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE). Following the international presentation of its Phase III trial outcomes, the company anticipates a swift review and approval process to initiate commercial production, aiming to offer a safer, more effective, and novel treatment option for insomnia patients worldwide without delay.
Yangtze River Pharmaceutical Group
Yang wen
info@yangzijiang.com
https://en.yangzijiang.com/
0086 4009881999
Accompanying photos for this announcement are accessible at
