Clearmind submits psychedelic therapy recommendations to FDA

Clearmind Medicine Inc. (NASDAQ: CMND), a clinical-stage biopharmaceutical company, submitted recommendations to the U.S. Food and Drug Administration in response to the agency's public hearing on the potential future therapeutic use of psychedelic drugs, according to a press release.

The submission, filed under FDA Docket No. FDA-2026-N-7542, focuses on non-hallucinogenic psychedelic-derived compounds the company refers to as neuroplastogens, with a particular focus on alcohol use disorder. Clearmind recommends the FDA consider new guidance for self-administration and at-home therapies, streamlined regulatory pathways, expanded clinical trial access, and use of Breakthrough Designation.

The company also called for research collaborations with the U.S. Department of Veterans Affairs, U.S. Department of Health and Human Services, and the U.S. Department of War to pilot neuroplastogenic candidates for alcohol use disorder and other conditions.

Clearmind cited ongoing clinical trials at Yale University and Johns Hopkins University, stating data suggests its compounds may retain neuroplasticity benefits while eliminating hallucinogenic effects, potentially reducing the need for expensive supervised dosing sessions.

"Our engagement with the U.S. federal government reflects our commitment to contributing to the dialogue around patient access, responsible development, and the potential future use of psychedelic-derived therapies," said Dr. Adi Zuloff-Shani, Chief Executive Officer of Clearmind Medicine.

The submission follows a series of prior government engagements. In July, Clearmind responded to a Department of Health and Human Services request for information under the Great American Recovery Initiative. On Sept. 14, 2026, the company's Chief of Global Impact briefed an FDA-convened federal panel on patient access and clinical trial findings from Yale and Johns Hopkins.

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