Definium Therapeutics announced on September 14, 2026, that its LSD-based treatment, DT120, has successfully reduced symptoms of generalized anxiety disorder (GAD) in a late-stage clinical trial. A single 100-microgram dose of DT120, a fast-dissolving lysergide tablet, demonstrated a reduction of 9.8 points in anxiety scale scores after 12 weeks. In comparison, the placebo group showed a 4.7-point decline.
Read More
The positive results from this trial mark Definium's second successful late-stage study for the treatment of GAD, which affects approximately 26 million adults in the United States. Current treatments typically include antidepressants, anti-anxiety medications, and psychotherapy.
Definium's shares have surged nearly threefold this year, reflecting increased investor interest in psychedelic-based therapies. The CEO, Robert Barrow, noted that these results may improve their chances of regulatory approval, especially in light of past failures by other programs seeking approval for GAD treatments.
The trial involved 245 participants who received either the 100-microgram dose, a lower 50-microgram dose, or a placebo. This lower dose was included to address potential functional unblinding, which occurs when participants can guess their treatment assignment. However, participants were reportedly able to accurately identify which group they were in.
The higher efficacy observed with the 100-microgram dose could facilitate discussions with regulators. Definium plans to file a marketing application with the US Food and Drug Administration in the first half of 2027.