Trial Profile

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of YZJ-1139 Tablets in the Treatment of Insomnia Disorder

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 29 May 2026

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At a glance

Drugs Fazamorexant (Primary)
Indications Insomnia
Focus Registrational; Therapeutic Use
Sponsors Shanghai Haiyan Pharmaceutical Technology

Most Recent Events

29 May 2026 Status changed from recruiting to completed.
22 Sep 2025 Results presented in a Jiangsu media release
21 Sep 2025 According to a Yangtze River Pharmaceutical Group media release, 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).

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