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Definium’s LSD-Based Drug Lowers Anxiety in Second Successful Late-Stage Study

The 100-microgram dose cut anxiety scores by 9.8 points in 245 patients, and Definium plans a U.S. filing in 2027.

  • On Monday, Definium Therapeutics reported that its LSD-based treatment, DT120, reduced symptoms of generalized anxiety disorder in a second successful late-stage trial, sending shares soaring nearly 20% in premarket trading.
  • Generalized anxiety disorder affects about 26 million U.S. adults and typically requires weeks for traditional treatments to take effect, but Definium noted patients in the latest trial experienced significant anxiety reduction as early as the second day.
  • The 245-patient trial compared 100-microgram doses of DT120 against placebo, finding patients experienced a 9.8-point drop on the Hamilton Anxiety Rating Scale while placebo users saw a 4.7-point decline.
  • CEO Robert Barrow said the two successful studies answer "questions around the attribution of what's driving drug effect," as the company now looks for FDA approval in the first half of next year.
  • Regulatory and investor enthusiasm has helped Definium shares nearly triple this year, though Barrow noted that about a dozen programs have attempted approval for GAD in the last 20 years and have failed.
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STAT broke the news in Boston, United States on Monday, September 14, 2026.
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