Accelerated FDA Action for Psychedelics: Insights From Daniel R. Karlin on DT120 ODT and FDA review timelines

Lysergide tartrate (DT120 ODT) development is positioned as aligned with an FDA and federal push to accelerate access to psychedelic-based treatments for serious mental illness. Daniel R. Karlin, MD, MA, Definium Therapeutics chief medical officer, says the April 2026 executive order and resulting regulatory attention do not change Definium’s plan, but any efficiencies from the review process are beneficial. DT120 ODT is Definium’s proprietary formulation of LSD, an ergoline derivative acting as a partial agonist at serotonin-2A receptors. DT120 ODT trials target major depressive disorder and generalized anxiety disorder and are expanding to posttraumatic stress disorder. The Emerge and Ascend studies cover MDD, Voyage and Panorama cover GAD, and the phase 3 Haven study in PTSD is planned with a primary endpoint using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) at week 8.