Definium says LSD-based pill reduces anxiety in late-stage study

The benefit emerged as early as two days after dosing and lasted throughout the 12-week study

Definium Therapeutics announced on Wednesday that its LSD-based experimental pill, DT120, significantly reduced anxiety symptoms in a late-stage study, meeting its primary goal and causing the company's shares to surge over 20% premarket. The 214-patient trial evaluated a single 100-microgram dose of DT120, a fast-dissolving tablet of lysergide, in adults with generalized anxiety disorder (GAD).

Participants who received the drug experienced an 11.6-point decline on a standard anxiety rating scale at week 12, compared to a 6.2-point decrease for those in the placebo group. The difference of 5.4 points between the two groups was deemed statistically and clinically significant by Definium. Analyst Brian Abrahams from RBC Capital Markets noted that the data outperformed Wall Street's expectations and demonstrated efficacy comparable to other treatments for the condition.

The positive results were evident as early as two days after dosing and persisted throughout the 12-week study. DT120 belongs to a class of compounds called psychedelic medicines, which have garnered regulatory and investor interest, driving Definium shares up more than three times this year. In April, U.S. President Donald Trump signed an executive order aimed at accelerating access to research and treatments derived from psychedelic drugs for serious mental health conditions.

GAD is characterized by persistent, excessive worry that can disrupt daily life and affects approximately 26 million U.S. adults. It is typically treated with antidepressants, anti-anxiety medications, and psychotherapy. No new drug has been approved for GAD in nearly two decades, according to Brian Barnett, a Cleveland Clinic psychiatrist involved in the study.

Unlike most anxiety medications, which are typically taken regularly, DT120 is intended to be administered as a single dose during a supervised dosing session. The drug functions by targeting brain receptors associated with mood and perception. Most side effects were mild to moderate and transient, primarily occurring on the day of dosing, with no rise in suicidal ideation.

This is Definium's second late-stage success for DT120, following a positive outcome in a depression study in June.

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