Clearmind Medicine Testifies at FDA Hearing on Psychedelic Therapies

Clearmind Medicine Inc, a clinical-stage biopharmaceutical company, recently testified before the U.S. Food and Drug Administration (FDA) at a historic hearing on the potential future therapeutic use of psychedelic drugs. The hearing, held on September 14, 2026, in Washington, D.C., was convened by the FDA to gather public input on the subject, with participation from senior officials from various federal agencies, including SAMHSA, the National Institutes of Health, and the Veterans Health Administration.

At the hearing, Mary-Elizabeth Gifford, Clearmind’s Chief of Global Impact, addressed the question of patient access. Gifford highlighted the findings from Clearmind’s clinical trials at Yale and Johns Hopkins, which suggest that a new category of psychedelics, neuroplastogenic compounds, may offer therapeutic benefits without the hallucinogenic effects of traditional psychedelics. These compounds, according to Gifford, could potentially reduce the need for expensive supervised dosing, making treatment more accessible and scalable.

Gifford emphasized that this next-generation approach could mitigate health disparities and provide a replicable treatment model for a wide range of neuropsychiatric, metabolic, and addiction disorders, including Alcohol Use Disorder (AUD). She noted that Clearmind’s proprietary drug candidate, MEAI, is currently being evaluated in FDA-approved clinical trials at Yale University Medical School and Johns Hopkins University. MEAI is one of a limited number of non-hallucinogenic, psychedelic-derived neuroplastogen candidates to have advanced to a Phase 2a clinical trial.

Adi Zuloff-Shani, Ph.D., Clearmind’s Chief Executive Officer, expressed gratitude to the FDA and federal health officials for leading this important national conversation.

The hearing also addressed provider training and credentialing, patient safety, and best practices for data collection and standardization. Approximately 1,800 participants attended the hearing in person and virtually. The FDA’s vision of responsible biopharma innovation in addiction treatment, including AUD, was underscored by the event. Clearmind’s participation in the hearing is seen as a significant step toward advancing the development and regulatory approval of neuroplastogenic compounds.

Clearmind Medicine Inc’s intellectual portfolio includes nineteen patent families, with 32 granted patents. The company aims to continue researching and developing psychedelic-based compounds and commercializing them as regulated medicines, foods, or supplements. MEAI, the company’s primary objective, is focused on treating AUD, a condition that affects one in ten Americans and is considered a leading cause of preventable deaths among working-age adults.

The company’s commitment to rigorous evidence-based research and federal policy alignment is evident in its approach to accelerating improved care for patients across the United States and globally. Clearmind’s efforts to bridge clinical research with federal policy are seen as crucial in the ongoing debate about the potential therapeutic benefits of psychedelic drugs.