NEW YORK, August 12, 2026
Definium Therapeutics, Inc. announced positive topline results from the Phase 3 Voyage study evaluating DT120 ODT (lysergide) 100 µg in adults with generalized anxiety disorder (GAD). The study met its primary endpoint and all key secondary efficacy endpoints, with DT120 ODT producing a statistically significant placebo-adjusted improvement of 5.4 points on the Hamilton Anxiety Rating Scale (HAM-A) at Week 12 (p<0.0001; Cohen’s d=0.81). The company reported that improvement was observed as early as Day 2 and remained sustained through subsequent assessments in Part A. DT120 ODT was generally well tolerated, with treatment-emergent adverse events primarily mild to moderate, transient and concentrated around the dosing day. The Voyage results represent the company’s second positive Phase 3 readout for DT120 ODT, following positive results from the Emerge study in major depressive disorder announced in June 2026.
DT120 ODT Demonstrates Significant Anxiety Reduction
The Voyage Phase 3 study enrolled 214 adults with DSM-5-confirmed GAD across approximately 35 U.S. clinical sites. Participants received either a single 100 µg dose of DT120 ODT or placebo and were followed during a 12-week double-blind treatment period. At Week 12, the least-squares mean HAM-A score change was -11.6 points with DT120 ODT compared with -6.2 points with placebo, producing a placebo-adjusted difference of -5.4 points (p<0.0001). The treatment also demonstrated significant effects across key secondary measures, including CGI-S improvement at Week 12, HAM-A change at Week 1 and CGI-S change as early as Day 2. At Week 12, 43% of DT120-treated participants achieved at least a 50% reduction in HAM-A, compared with 16% receiving placebo. HAM-A remission occurred in 14% versus 4%, while 51% of DT120 participants achieved mild or better anxiety severity compared with 23% on placebo. These results indicate a substantial treatment effect, although regulatory approval will depend on the complete clinical development package and FDA review..
Safety Profile Supports Continued DT120 Development
Definium reported that DT120 ODT was generally well tolerated in the Voyage study, with no new safety signals identified. Treatment-emergent adverse events were described as predominantly mild to moderate, transient and occurring on the day of dosing during Part A. The company also reported no suicidality signal or suicidal behavior. Participants were evaluated using a structured end-of-session checklist beginning five hours after dosing to determine when they met criteria for completing the acute dosing session. The average time to meeting the criteria was 6.4 hours, with a median of 6.1 hours, and 92% of participants meeting the criteria by hour eight. Voyage includes a 40-week open-label extension following the initial 12-week double-blind period, during which participants may be eligible for additional DT120 ODT doses based on symptom severity. Definium is also evaluating DT120 ODT in its second pivotal GAD study, Phase 3 Panorama, which includes 100 µg and 50 µg dose arms alongside placebo.
Advertisement
Definium Advances DT120 ODT Toward Additional Indications
The positive Voyage results strengthen the clinical development program for DT120 ODT, Definium’s proprietary orally disintegrating formulation of lysergide designed for psychiatric disorders. The company is developing DT120 ODT for GAD, major depressive disorder (MDD) and post-traumatic stress disorder (PTSD) and is exploring additional brain-health applications. DT120 has received FDA Breakthrough Therapy designation for GAD, providing an additional regulatory pathway for interactions during development but not guaranteeing approval. The company expects topline results from the Panorama Phase 3 GAD study in September 2026, creating another important clinical milestone. Voyage is therefore a significant result for Definium, particularly because the study demonstrated a large placebo-adjusted HAM-A effect and improvements across multiple secondary measures. However, the program still faces the need for confirmatory evidence, regulatory review and successful completion of the broader clinical development program before DT120 ODT could become an approved treatment for GAD.
Source:Definium Therapeutics press release
