Definium Therapeutics Announces Positive Phase 3 Voyage Trial Results for DT120 ODT in GAD

Author : Mary Brown | Published On : 14 Aug 2026

Definium Therapeutics announced positive topline results from its Phase 3 Voyage trial evaluating DT120 ODT (lysergide tartrate) in adult patients with generalized anxiety disorder (GAD). The findings mark the company's second consecutive late-stage success for DT120 ODT, following positive Phase 3 Emerge trial results in major depressive disorder (MDD) released in June.

The Voyage study achieved its primary efficacy endpoint and met all key secondary endpoints. Participants treated with a single 100 µg dose of DT120 ODT achieved statistically significant and clinically meaningful reductions in anxiety symptoms compared to placebo, as measured by the Hamilton Anxiety Rating Scale (HAM-A).

At Week 12, the DT120 ODT treatment group showed a least squares (LS) mean change of -11.6 on the HAM-A scale, compared to an LS mean change of -6.2 in the placebo group. This represents a placebo-adjusted LS mean difference of 5.4 points ($p < 0.0001$) and a standardized effect size of 0.81. Rapid onset of action was observed as early as Day 2 following administration, with therapeutic improvements sustained across all post-baseline evaluation points throughout Part A.

Rob Barrow, Chief Executive Officer of Definium Therapeutics, noted that the efficacy observed in the Voyage trial reinforces the drug's therapeutic potential across psychiatric conditions. He confirmed that the company remains on track to report topline data from its second Phase 3 GAD trial, Panorama, in September.

Safety and Tolerability Profile

DT120 ODT was generally well tolerated during the trial, with no new safety signals identified. Treatment-emergent adverse events (TEAEs) were predominantly mild to moderate, transient, and concentrated on the initial dosing day. Consistent with earlier clinical studies, researchers reported no suicidality signals or suicidal behaviors.

Post-dosing discharge readiness was monitored using a structured end-of-session checklist (EoSC), administered hourly starting five hours after dose administration. Key observations included:

Average Time to Resolution: Participants reached discharge criteria in an average of 6.4 hours (median 6.1 hours).
8-Hour Milestone: 92% of participants met the EoSC criteria within eight hours post-administration.

Transforming the Treatment Paradigm for GAD

Generalized anxiety disorder affects approximately 26 million adults in the United States, representing a significant burden of disease that has seen little pharmacological innovation over the past two decades. Current standard-of-care options often require daily oral dosing, take weeks to achieve therapeutic efficacy, and carry varying rates of treatment failure or non-adherence.

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