Curie Brief
Turn on cookies to sign in
Signing in saves your progress to your Curie account. We can only do that with cookies on — turn them on to continue.
News
A single dose of DT120 (lysergide ODT), a proprietary LSD-based tablet, has earned FDA Breakthrough Therapy designation for major depressive disorder (MDD) — its second such designation after one for generalized anxiety disorder. In the phase 3 Emerge trial, one dose produced rapid, significant improvements in depression scores that lasted through 12 weeks, with no serious adverse events or suicidality signals.
DT120 (lysergide ODT), a proprietary orally disintegrating tablet formulation of LSD developed by Definium Therapeutics, has received its second FDA Breakthrough Therapy designation — now for major depressive disorder (MDD), following an earlier designation for generalized anxiety disorder (GAD). The designation was backed by data from the randomized, double-blind, placebo-controlled phase 3 Emerge trial involving 149 adults with moderate-to-severe MDD.
A single 100µg dose of DT120 produced rapid and durable antidepressant effects, with significant improvements in depression scores observed as early as week 1 and sustained through week 12 — all without any accompanying psychotherapy. The drug was well tolerated; nearly all adverse events were mild-to-moderate, most resolved on dosing day, and no serious adverse events or suicidality signals were reported.
Why it matters: With over 4 million patients failing current antidepressant options, a single-dose psychedelic therapy showing rapid, durable efficacy — and now FDA Breakthrough status — could represent a meaningful shift in how MDD is treated. A second pivotal trial (Ascend) is ongoing, with results expected in 2027.
