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# Breakthrough Status for Anxiety Disorder Drug
- URL: https://www.fdaweb.com/breakthrough-status-for-anxiety-disorder-drug/
- Published: 2024-03-13T12:00:00.000Z
- Updated: 2026-09-14T14:25:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156544

FDA has granted MindMed a breakthrough designation for its MM120 (lysergide d-tartrate) program for treating generalized anxiety disorder (GAD). The designation comes as the company is announcing results from a Phase 2b study of MM120 in GAD that met its key secondary endpoint. Data also “demonstrated clinically and statistically significant durability of activity observed through Week 12,” it says. MindMed previously announced “rapid, clinically meaningful, and statistically significant improvements on the Hamilton Anxiety rating scale (HAM-A) compared to placebo at Week 4, which was the trial’s primary endpoint.”

The designation for the therapy is based on the “significant unmet medical need in the treatment of GAD — especially in patients who do not respond to or tolerate currently available medications — along with the initial clinical data from Phase 2b and other research conducted by MindMed,” the company says. It is planning to hold an end-of-Phase 2 meeting with FDA before July, and a Phase 3 clinical program should be initiated in the second half of the year.

MindMed describes lysergide as a “synthetic ergotamine belonging to the group of classic, or serotonergic, psychedelics, which acts as a partial agonist at human serotonin-2A (5-hydroxytryptamine-2A \[5-HT2A\]) receptors.”