A Phase 3 Trial of DT120 for Generalized Anxiety Disorder (Voyage)

Phase 3 Active not recruiting 214 enrolled Definium Therapeutics US, Inc.

RandomizedParallel-groupTriple-blindTreatment

Summary

A Phase 3 Double-blind, Placebo-controlled Study (Part A) with an Open-label Extension (Part B) Evaluating DT120 Compared to Placebo in Generalized Anxiety Disorder - Voyage

Timeline

Start: 2024-12-11
Primary completion: 2026-07
Completion: 2026-11

Outcome

Met primary endpoint

release “Voyage met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement from baseline compared with placebo” definiumtx.com ↗

release “Participants receiving DT120 ODT achieved a statistically significant reduction in Hamilton Anxiety Rating Scale (HAM-A) score” definiumtx.com ↗

Publications

Jacobs E, Zahid Z, Hinkle J, Nayak S, Yaden DB. Psychedelic medicine: mechanisms, evidence, and translation to practice. BMJ. 2026 Feb 23;392:e081723. doi: 10.1136/bmj-2024-081723.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	DT120	Unknown	100 ug	Oral