MindMed Phase 2b LSD for GAD: breakdown of JAMA trial results, protocol details, and FDA Breakthrough Therapy designation

LSD is being evaluated by MindMed as a lysergide D-tartrate (MM120) candidate for treating moderate to severe generalised anxiety disorder (GAD) in a Phase 2b trial. The study reported results in JAMA for 198 adults who received a single dose of 25 to 200 micrograms LSD or placebo across 22 outpatient research sites in the US between August 2022 and 2023, with dose-dependent improvement in HAM-A scores at week 4. The wider context includes MindMed’s earlier topline readout (including the 100 microgram arm HAM-A reduction and reported response and remission rates) and subsequent FDA Breakthrough Therapy Designation, framing the published protocol and additional data as supportive of a favourable efficacy and safety profile.