Yangtze River Pharmaceutical Group (YRPG): Fazamorexant Tablets Class 1 new anti-insomnia drug approved for market
On May 21, the NMPA website announced that Yangtze River Pharmaceutical Group (YRPG)’s Class 1 new drug Fazamorexant Tablets had been approved for marketing in China for the treatment of insomnia. This is the first domestic dual orexin receptor antagonist approved in China.
Fazamorexant (development code: YZJ-1139) is a potent antagonist of both orexin type 1 and type 2 receptors (OX1R and OX2R). It improves sleep by inhibiting orexin receptors, including accelerating sleep onset and prolonging sleep duration. Additionally, Fazamorexant has the advantages of rapid absorption and a moderate half-life, enabling fast onset of action and low next day residual effects.
This approval is based on positive results from a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial (registration numbers: NCT05525637 / CTR20212685). The study aimed to evaluate the efficacy and safety of Fazamorexant. The results were presented globally for the first time at the World Sleep 2025 congress (World Sleep 2025) and the Asian Society of Sleep Medicine Annual Meeting (ASSM 2025). The results showed that Fazamorexant, as a dual orexin receptor antagonist, demonstrated rapid onset of action and a favorable safety profile in adult patients with insomnia.
In terms of safety, Fazamorexant was well tolerated, with a low discontinuation rate due to adverse events (0.6%). No rebound insomnia or withdrawal symptoms were observed after treatment cessation.
