A Dose-Finding Study of MM120 (LSD D-Tartrate) for the Treatment of Anxiety Symptoms

Phase 2 Completed 198 enrolled Definium Therapeutics US, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a Phase 2, multi-center, randomized, double-blind, parallel-group, dose-finding study to assess the effect of 4 doses of MM120 (25, 50, 100 or 200 μg freebase-equivalent) for the treatment of anxiety symptoms in subjects diagnosed with generalized anxiety disorder (GAD).

Timeline

Start: 2022-08-24
Primary completion: 2023-10-06
Completion: 2023-11-27

Outcome

Mixed primary results

paper was statistically significant for the 100-µg and the 200-µg dose groups vs placebo PMID 40906494 ↗

paper but the 25-µg and 50-µg dose groups did not reach significance vs placebo PMID 40906494 ↗

Publications

Robison R, Barrow R, Conant C, Foster E, Freedman JM, Jacobsen PL, Jemison J, Karas SM, Karlin DR, Solomon TM, Halperin Wernli M, Fava M. Single Treatment With MM120 (Lysergide) in Generalized Anxiety Disorder: A Randomized Clinical Trial. JAMA. 2025 Oct 21;334(15):1358-1372. doi: 10.1001/jama.2025.13481.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MM120	Unknown	25 ug	—
Subject	MM120	Unknown	50 ug	—
Subject	MM120	Unknown	100 ug	—
Subject	MM120	Unknown	200 ug	—