Definium Therapeutics (NASDAQ: DFTX) is set to present findings from three positive Phase 3 clinical trials of its LSD-based drug candidate, DT120 ODT, at the 2026 Neuroscience Education Institute (NEI) Fall Congress in Colorado Springs, running from 5 to 8 November.
The presentations will cover the company’s late-stage clinical development programme for generalised anxiety disorder (GAD) and major depressive disorder (MDD), including the first medical congress presentation of results from its Panorama study.
Definium announced on 4 November that four scientific posters will be presented on Saturday, 7 November, bringing together findings from its Panorama, Voyage and Emerge trials.
All three studies have previously reported positive topline results, although the treatment remains investigational and has not received regulatory approval.
Three Phase 3 Studies Across Anxiety and Depression
Definium is developing DT120 ODT, a proprietary orally disintegrating tablet containing lysergide (LSD), as a potential treatment for psychiatric conditions.
Its Phase 3 programme includes two studies investigating generalised anxiety disorder and one examining major depressive disorder.
Panorama enrolled 245 adults with GAD, while Voyage involved 214 participants with the same condition. Both studies evaluated whether DT120 could reduce anxiety symptoms compared with placebo.
The Emerge study enrolled 149 adults with major depressive disorder, assessing the effects of a single 100-microgram dose of DT120 on depressive symptoms.
Each trial has reported positive topline findings, supporting the company’s continued development of the treatment.
At the congress, Definium will also present a combined assessment of safety data across all three studies, giving clinicians a broader view of the drug’s reported tolerability and adverse effects.
Moving Towards Regulatory Review
DT120 has received Breakthrough Therapy designation from the US Food and Drug Administration (FDA) for both GAD and MDD.
The designation is intended to accelerate the development and regulatory review of treatments for serious conditions where preliminary clinical evidence suggests a substantial improvement over existing therapies. It does not constitute FDA approval.
Definium is seeking to develop an LSD-based medicine that can be administered within a structured clinical treatment model.
Unlike conventional daily psychiatric medications, DT120 is being investigated as a treatment involving supervised dosing sessions, with patients monitored during the acute psychedelic effects.
The company will use the NEI Fall Congress to present its clinical findings to psychiatrists and other mental healthcare professionals as it advances towards potential regulatory submissions.
While the three positive Phase 3 readouts represent progress for LSD-based drug development, further regulatory assessment will determine whether DT120 can become an approved treatment for anxiety or depression.
