Novel LSD Formulation Significantly Improves Anxiety Symptoms

 

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Post stroke anxiety(20% chance).  

Novel LSD Formulation Significantly Improves Anxiety Symptoms

 Single-dose DT120 ODT achieved significant, sustained reductions in HAM-A anxiety scores vs placebo at week 12, with clinical efficacy observed as early as day 2.Positive topline data were announced from a phase 3 trial evaluating DT120 (lysergide) orally disintegrating tablets (ODT) in adults with generalized anxiety disorder (GAD).  DT120 ODT is a proprietary tartrate salt form of lysergide, a semi-synthetic psychedelic that acts as a partial agonist at serotonin-2A receptors. The randomized, double-blind, placebo-controlled, phase 3 Voyage trial (ClinicalTrials.gov Identifier: NCT06741228) evaluated the safety and efficacy of DT120 ODT in adults with GAD and a baseline Hamilton Anxiety Rating Scale (HAM-A) total score of 20 or greater.  Study participants (N=214) were randomly assigned to receive a single 100µg dose of DT120 ODT (n=107) or placebo (n=107) during a 12-week double-blind treatment period (Part A). Eligible participants were then allowed to transition into a 40-week open-label extension phase (Part B), during which up to 4 additional doses of the semi-synthetic psychedelic could be administered based on symptom severity.   The primary endpoint was the change from baseline in HAM-A total score at week 12. The total score ranges from 0 to 56, with higher scores indicating more severe symptoms.  Findings showed treatment with DT120 ODT significantly improved HAM-A total score from baseline compared with placebo at week 12 (least squares [LS] mean change, -11.6 vs -6.2; placebo-adjusted difference, -5.4; P <.0001; effect size, d =.81). Clinical improvement was seen starting from day 2 and was sustained throughout the double-blind treatment period.  Notably, at week 1, the LS mean change from baseline in HAM-A total score (key secondary endpoint) was -11.9 in the psychedelic treatment arm vs -4.2 in the placebo arm (placebo-adjusted difference, -7.7; P <.0001).  Patients treated with D120 ODT also demonstrated significantly greater improvements in Clinical Global Impression–Severity (CGI-S) Scale scores compared with placebo as early as day 2 (LS mean change, -1.0 vs -0.2; placebo-adjusted difference, -0.8; P <.0001) and maintained through week 12 (LS mean change, -1.0 vs -0.4; placebo-adjusted difference, -0.6; P <.0001). DT120 ODT was well tolerated, with no new safety signals observed. No suicidality signal or suicidal behavior was reported in Part A of the trial. “The unprecedented efficacy demonstrated in Voyage should raise the bar for what patients and clinicians expect from GAD treatments and reinforces our belief that DT120 has the potential to redefine care for the millions of patients in need,” said Rob Barrow, Chief Executive Officer of Definium Therapeutics. “Importantly, the consistent, large effect size we’ve now observed across three studies underscores the potential of DT120 to transform psychiatry and usher in a new era of mental health care.” DT120 ODT is also being evaluated in adults with GAD in the ongoing, 3-arm, phase 3 Panorama trial (ClinicalTrials.gov Identifier: NCT06809595).

References:

Definium Therapeutics announces positive topline results from phase 3 Voyage study of DT120 ODT in generalized anxiety disorder. News release. Definium. August 12, 2026. https://www.businesswire.com/news/home/20260812579720/en/Definium-Therapeutics-Announces-Positive-Topline-Results-from-Phase-3-Voyage-Study-of-DT120-ODT-in-Generalized-Anxiety-Disorder