The Latest Data on Psychedelic DT120 ODT With Daniel R. Karlin, MD, MA

Definium Therapeutics’ novel candidate, lysergide tartrate (DT120 ODT) is now under study for major depressive disorder (MDD) and generalized anxiety disorder (GAD), and posttraumatic stress disorder (PTSD).¹ DT120 ODT is Definium’s proprietary and pharmaceutically optimized formulation of LSD and an ergoline derivative belonging to the group of classic serotonergic psychedelics, which acts as a partial agonist at serotonin-2A receptors.

Daniel R. Karlin, MD, MA, the chief medical officer of Definium Therapeutics, shared some more information about the data on DT120 and what separates it from other psychedelics, including the new information shared at their Investor and Analyst Day.¹

DT120 ODT Trials

MDD

DT120 ODT for the treatment of MDD is currently being evaluated in the Emerge study, which is fully enrolled with 149 participants randomly assigned 1:1 to receive DT120 ODT 100 µg or placebo. Topline data are anticipated in quarter 2 of 2026. It is also being evaluated in the upcoming Ascend study; sites are activated and first dosing is anticipated to begin soon. Investigators will enroll 175 participants randomly assigned 2:1:2 to DT120 ODT 100 µg, DT120 ODT 50 µg control, or placebo.

GAD

DT120 ODT for the treatment of GAD is currently being evaluated in Voyage study, which is also fully enrolled. The 214 participants are randomly assigned 1:1 to receive DT120 ODT 100 µg or placebo. Topline data are anticipated early in quarter 3 of 2026. Additionally, in the Panorama study, investigators have enrolled over 200 participants and screening is now closed. Participants will be randomly assigned 2:1:2 to receive DT120 ODT 100 µg, DT120 ODT 50 µg control, or placebo, with topline data now anticipated in late quarter 3 of 2026.

PTSD

Lastly, the phase 3 Haven study of DT120 ODT for the treatment of PTSD is expected to enroll approximately 200 participants, who will be randomly assigned 1:1 to receive DT120 ODT or placebo. The study’s primary endpoint is the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) at week 8. The study is expected to initiate in 2027.²

Updates Following the Psychedelic Executive Order

On April 18, 2026, President Trump issued an Executive Order directing the US Department of Health and Human Services to accelerate access to treatments for patients with serious mental illness—specifically psychedelics.² As Karlin shared with Psychiatric Times, this news will not slow or shift Definium’s scientific enterprise, but the efficiencies generated in the review process are welcome. Definium will remain committed to research that demonstrates the conditions for safe and efficacious use of these drugs across the conditions of study.

You can hear more of Karlin’s thoughts following the executive order in this video: “Accelerated FDA Action for Psychedelics: Insights From Daniel R. Karlin, MD, MA.”

Dr Karlin is the chief medical officer of Definium Therapeutics.

References

1. Definium Therapeutics highlights DT120 ODT (lysergide tartrate) clinical advancements and commercial strategy at Investor and Analyst Day. News release. April 22, 2026. Accessed April 24, 2026. https://ir.definiumtx.com/news-events/press-releases/detail/223/definium-therapeutics-highlights-dt120-odt-lysergide-tartrate-clinical-advancements-and-commercial-strategy-at-investor-and-analyst-day

2. Accelerating medical treatments for serious mental illness. The White House. April 18, 2026. Accessed April 24, 2026. https://www.whitehouse.gov/presidential-actions/2026/04/accelerating-medical-treatments-for-serious-mental-illness/