Yangtze River Pharmaceutical Group has launched its innovative anti-insomnia drug, Fazamorexant, at the World Sleep Congress 2025, held in Singapore. The pivotal Phase III clinical trial results were unveiled at the event, drawing significant attention from the global sleep medicine community. This announcement highlights a landmark achievement in the development of treatments for sleep disorders, showcasing China’s growing role in the global pharmaceutical landscape.
The World Sleep Congress serves as a premier gathering for experts in sleep medicine and was co-hosted alongside the annual meeting of the Asian Society of Sleep Medicine (ASSM 2025). During a special session titled “Orexin/Hypocretin System: Clinical Use,” Dr. Zhu Wenjun, a postdoctoral fellow at Peking University People’s Hospital, presented a detailed analysis of the Phase III clinical data for Fazamorexant. This drug acts as a dual orexin receptor antagonist (DORA), which plays a crucial role in regulating sleep.
The clinical trial involved 1,034 adult patients diagnosed with insomnia, employing a randomized, double-blind, placebo-controlled design. The findings indicate that Fazamorexant exhibits rapid efficacy and a favorable safety profile in treating insomnia.
Results revealed that Fazamorexant significantly improved key sleep indicators, such as sleep efficiency, the time taken to fall asleep, and reduced nighttime awakenings. When compared with existing DORAs, Fazamorexant’s performance stands out, although it is important to note that these comparisons are based on varying clinical trial conditions and should not be directly referenced for clinical use.
In terms of safety, Fazamorexant demonstrated a favorable profile, with no evidence of rebound insomnia or withdrawal symptoms upon discontinuation. As noted by Professor Han Fang, a prominent figure in the field and former Secretary-General of the World Association of Sleep Medicine, the drug is designed to address the needs of patients struggling with sleep onset while allowing for normal daytime activities.
Moreover, a potential dosing strategy of “twice nightly dosing” was discussed, offering a new approach for personalized treatment plans. This concept received widespread endorsement from attendees at the conference, emphasizing Fazamorexant’s promise in individualized insomnia management.
Following the presentation, Professor Emmanuel Mignot, a member of the United States National Academy of Sciences and Director of the Center for Sleep and Circadian Sciences at Stanford University, expressed interest in collaborating on further trials involving Fazamorexant.
In light of the successful unveiling of its Phase III trial results, Yangtze River Pharmaceutical has submitted a New Drug Application (NDA) for Fazamorexant to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The company is optimistic about an expedited review process, hoping to provide a safer and more effective treatment option for patients suffering from insomnia globally.
As sleep disorders continue to impact millions worldwide, the introduction of Fazamorexant marks a significant step forward in addressing this pressing health issue. The ongoing research and development in this field reflect a commitment to improving the quality of life for those affected by sleep-related challenges.
