LSD Anxiety Drug Targets 2027 FDA Approval — SkimNews
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- Definium Therapeutics reported that the 100-microgram LSD group saw a 9.8-point average reduction on a 56-point anxiety scale after three months, compared with 4.7 points for placebo—a 'meaningful' improvement, per independent commentator Greg Cooper of University College London.
- FDA approval is expected within 12 to 24 months according to Cooper and Jules Evans of the Challenging Psychedelic Experiences Project, with Cooper noting this 'would set a precedent for approval elsewhere, such as the UK and Europe.'
- The trial enrolled more than 200 US adults with moderate-to-severe generalized anxiety disorder who had already tried standard therapies—a condition affecting nearly 3% of US adults annually.
- Unlike most psychedelic trials, participants received no post-dose psychotherapy—only limited psychological support on the dosing day—to isolate the drug-only effect, said team member Dan Karlin.
- Researchers carefully screened out anyone with a history of psychosis or suicidal behavior, and both Cooper and Evans warned that unsupervised home use would be dangerous given LSD trips lasting 6 to 12 hours.
- Psilocybin and MDMA are already approved for severe depression and PTSD in Australia and Switzerland, leaving the US lagging on psychedelic therapeutics despite this latest LSD data.
Why it matters: The Definium trial is the first major LSD study to strip out post-dose psychotherapy and still show meaningful anxiety reduction, attributing the effect to the drug itself rather than the therapy context. That matters for the nearly 3% of US adults affected by generalized anxiety disorder each year—a condition with no new treatments in decades. Experts warn the 6-12 hour trip duration and risk of panic mean unsupervised use would be genuinely dangerous, so any approval would require tight clinical controls.
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