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A Multicenter, Randomized, Double-blind, Placebo-controlled Phase Ⅲ Study to Evaluate the Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets in Participants With Generalized Anxiety Disorder.

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Trial Profile

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase Ⅲ Study to Evaluate the Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets in Participants With Generalized Anxiety Disorder.

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 02 Feb 2026

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At a glance

  • Drugs Toludesvenlafaxine (Primary)
  • Indications Generalised anxiety disorder
  • Focus Registrational; Therapeutic Use
  • Sponsors Luye Pharma Group

Most Recent Events

  • 08 Jan 2026 Accoridng to a Luye Pharma media release, based on results from this trial, the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for Ruoxinlin (Toludesvenlafaxine Hydrochloride Sustained-Release Tablets) for the new indication of Generalized Anxiety Disorder (GAD).
  • 18 Aug 2025 Accoridng to a Luye Pharma media release, company expects to complete the trial and submit the marketing authorization application for this indication in China by the end of this year.
  • 18 Aug 2025 Accoridng to a Luye Pharma media release, all patients have been enrolled in this phase 3 trial in China for the treatment of Generalized Anxiety Disorder (GAD).

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