Trial Profile

A Biomarker-Guided, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Liafensine in Patients With Treatment-Resistant Depression

Status: Completed

Phase of Trial: Phase II

Latest Information Update: 13 Sep 2025

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At a glance

11 Sep 2025 Results published in a Denovo Biopharma media release
11 Sep 2025 According to a Denovo Biopharma LLC media release, the success of this pivotal study resulted in the FDA granting Fast Track Designation for liafensine. The company noted that only one additional positive pivotal study would be required before submitting a New Drug Application (NDA) for the treatment of ANK3-positive treatment-resistant depression (TRD). This Phase 2b trial was conducted at 58 sites across the United States, Canada, and China.
11 Sep 2025 According to a Denovo Biopharma LLC media release, today announced that results from the pivotal ENLIGHTEN trial have been published as the feature article in JAMA Psychiatry.

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