Phase 3 DT120 Trial Reports Early and Sustained MDD Improvement

Key Clinical Summary

• DT120 produced an 8.1-point placebo-adjusted improvement in depression scores at week 6 in the 149-participant Emerge trial.
• Depression improvements appeared by week 1 and persisted through week 12; no serious adverse events were reported in Emerge.
• The separate trial Voyage, DT120 for generalized anxiety disorder (GAD) met its primary endpoint, while safety findings across 3 trials supported continued development.

A single 100µ dose of DT120 (lysergide), a classic serotonergic psychedelic that acts as a partial agonist at serotonin-2A receptors, significantly reduced major depressive disorder (MDD) symptoms compared with placebo in the phase 3 Emerge trial.

The findings were part of 3 posters presented at the Neuroscience Education Institute Fall Congress, November 5–8, 2026, in Colorado Springs, Colorado, which together described the investigational formulation’s efficacy in MDD, in GAD, and its safety across the development program.

MDD Study Findings

Emerge randomized 149 adults to DT120 orally disintegrating tablets or placebo for 12 weeks, followed by a 40-week extension. Eligible participants had Montgomery–Åsberg Depression Rating Scale (MADRS) scores of at least 26, a Clinical Global Impressions-Severity (CGI-S) score of at least 4, and were experiencing a major depressive episode lasting 8 weeks to 24 months. Based on that scale, 83% of participants had severe depression at baseline.

DT120 met the trial’s primary endpoint, producing an 8.1-point placebo-adjusted improvement at week 6 (P < .0001). At week 12, the placebo-adjusted improvement was 7.3 points (P < .0001).

“Significant improvements in MADRS total score were observed by week 1 and sustained through week 12,” wrote first author John G. Sonnenberg, PhD, Uptown Research Institute and Northwestern University’s Feinberg School of Medicine, Chicago, and coauthors.

CGI-S scores also improved significantly, showing -1.0 from baseline at day 2, -1.2 at week 6, and -1.0 at week 12 (P < .0001). Response and remission rates were significantly higher with DT120 at week 6, “supporting the clinical relevance of the observed effects,” the investigators wrote.

In Emerge, 99% of adverse events (AEs) were mild to moderate. No serious AEs or AEs leading to withdrawal were reported; common dosing-day events included illusion (64%), euphoric mood (29%), and nausea (27%). The most common AE reported after dosing day was headache.

DT120 for Generalized Anxiety Disorder

The Voyage trial randomized 214 adults with GAD to a single 100µ dose or placebo. DT120 produced a 5.4-point placebo-adjusted improvement in Hamilton Anxiety Rating Scale scores at week 12 (P < .0001), meeting the primary endpoint. At week 12, response rates were 43% versus 16% with placebo, and remission rates were 14% versus 4% with placebo.

Clinical Implications

The Emerge results document symptom improvement over 12 weeks after a single administration. Monitoring lasted several hours: mean time to End-of-Session Checklist clearance was 5.8 hours, and all DT120 recipients met clearance criteria within 8 hours.

Across the Emerge, Voyage, and Panorama trials, investigators reported no treatment-related serious adverse events or suicidality signal at analysis. The safety poster described findings as “supporting continued development of DT120 as a potential treatment option for patients with MDD or GAD.”

References

Jacobsen PL, Solomon TM, Jemison J, et al. DT120 (lysergide) safety from phase 3 studies in major depressive disorder and generalized anxiety disorder. Poster presented at: Neuroscience Education Institute Fall Congress; November 5–8, 2026; Colorado Springs, Colorado.

Jacobsen PL, Solomon TM, Jemison J, et al. Phase 3 topline results of DT120 (lysergide) in generalized anxiety disorder. Poster presented at: Neuroscience Education Institute Fall Congress; November 5–8, 2026; Colorado Springs, Colorado.

Sonneberg JG, Solomon TM, Jacobsen PL, et al. Phase 3 topline results of DT120 (lysergide) in major depressive disorder. Poster presented at: Neuroscience Education Institute Fall Congress; November 5–8, 2026; Colorado Springs, Colorado.