Definium Therapeutics reports its experimental LSD-based pill, DT120, significantly reduced symptoms of major depression in a late-stage trial. A single dose resulted in an 8.1-point greater improvement over placebo on a standard depression scale after six weeks. The drug was well-tolerated with no serious safety issues, moving it closer to a potential FDA submission amid growing interest in psychedelic treatments.
DT120 trial results
- ▪At 12 weeks, the placebo-adjusted improvement for patients on DT120 was 7.3 points
- ▪The trial enrolled 149 participants aged 18 to 74 with major depressive disorder
- ▪Six weeks after a single dose, patients taking DT120 had a 13.3-point drop on the MADRS depression scale, versus 5.2 points for placebo
- ▪Following the announcement on June 22, 2026, Definium Therapeutics' shares rose over 25% in premarket trading
- ▪The 8.1-point placebo-adjusted improvement on a standard depression scale at six weeks met the trial's main goal
- ▪Definium Therapeutics announced its LSD-based pill, DT120, significantly reduced major depression symptoms in a late-stage trial
- ▪Jefferies analysts previously noted that a 4 to 5 point placebo-adjusted improvement at week 6 would be a strong result
LSD pharmaceutical formulation
- ▪The drug functions by activating serotonin receptors in the brain
- ▪DT120 is classified as a classic psychedelic, a type of drug that temporarily alters perception, mood, and thinking
- ▪DT120 is a pharmaceutical formulation of lysergide, commonly known as LSD
Adverse events profile
- ▪The DT120 trial reported no serious safety issues or increase in suicidal thoughts
- ▪In the trial, 99% of adverse events were mild to moderate and primarily occurred on the day of dosing
Major depressive disorder prevalence
- ▪Major depressive disorder is a leading cause of disability, morbidity, and mortality
- ▪Approximately 21 million adults in the U.S. have experienced at least one episode of major depression, according to the National Institutes of Health
FDA submission timeline
- ▪In April, U.S. President Donald Trump signed an executive order to accelerate access to psychedelic drug research and treatment
- ▪Definium Therapeutics is currently conducting a second late-stage trial of DT120 for depression
- ▪The positive trial results bring Definium Therapeutics closer to a potential FDA submission
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