Clearmind Medicine Presents Non-Hallucinogenic Psychedelic Research at FDA Hearing

Key Points

• Clearmind Medicine’s Chief of Global Impact, Mary-Elizabeth Gifford, testified at the FDA’s September 14 hearing on the potential future therapeutic use of psychedelic drugs.
• Gifford addressed patient access and shared insights from Clearmind’s clinical trial involving Yale University and Johns Hopkins University.
• Clearmind is developing MEAI, a non-hallucinogenic, psychedelic-derived neuroplastogen for alcohol use disorder, or AUD.
• The company said its research suggests non-hallucinogenic neuroplastogens could potentially support more scalable treatment models without expensive supervised dosing.
• The FDA hearing also examined provider training, patient safety, data collection, and drug-standardization practices.

Clearmind Medicine (NASDAQ: CMND) said it participated in the FDA’s psychedelic drug hearing in Washington, D.C., after receiving an invitation from the agency.

Mary-Elizabeth Gifford, Clearmind’s Chief of Global Impact, spoke to a federal panel about patient access to future psychedelic-based treatments and the company’s work on non-hallucinogenic neuroplastogenic compounds.

Clearmind Discusses Patient Access at FDA Psychedelic Drug Hearing

The FDA hearing focused on considerations for the potential future therapeutic use of psychedelic drugs.

The event brought together FDA officials and federal representatives from the Substance Abuse and Mental Health Services Administration, the National Institutes of Health, and the Veterans Health Administration. Clearmind said approximately 1,800 participants attended in person or virtually.

Gifford was invited to discuss patient access. She said non-hallucinogenic psychedelic-derived neuroplastogens may help reduce the need for costly supervised dosing, potentially making treatment more accessible through existing healthcare systems.

Non-Hallucinogenic Neuroplastogens Could Support Scalable Treatment Models

Clearmind said its clinical work at Yale and Johns Hopkins has generated findings suggesting that a new category of psychedelic-derived compounds may retain neuroplasticity-related therapeutic benefits while avoiding hallucinogenic effects.

The company believes this approach could reduce barriers associated with supervised treatment settings and support a more scalable care model.

Gifford told the FDA panel that these treatments could potentially expand access for people with difficult-to-treat substance use disorders and other conditions. She said a future treatment model could potentially use existing primary-care and Veterans Affairs resources rather than require entirely new and costly delivery systems.

MEAI Is Being Studied for Alcohol Use Disorder

Clearmind’s lead candidate, MEAI, is being evaluated for alcohol use disorder in an FDA-approved clinical trial at Yale University Medical School and Johns Hopkins University.

The company said MEAI is among a limited number of non-hallucinogenic, psychedelic-derived neuroplastogen candidates to advance into a Phase 2a clinical trial.

Clearmind is developing MEAI as a potential treatment for AUD, a condition the company said affects one in 10 Americans and is a leading cause of preventable death among working-age adults.

MEAI remains an investigational drug candidate and has not been approved to treat alcohol use disorder or any other condition.

FDA Hearing Also Examines Safety and Provider Requirements

In addition to patient access, the FDA hearing sought input on provider training and credentialing, patient safety, data collection, and standardization of psychedelic medicines.

The federal listening panel included Tiffany R. Farchione, M.D., director of the Division of Psychiatry within the FDA’s Center for Drug Evaluation and Research Office of New Drugs. Senior representatives from SAMHSA, the National Institute on Drug Abuse, ARPA-H, and the Veterans Health Administration also participated.

Clearmind said the hearing reflects a broader federal discussion about how psychedelic-derived treatments could be studied, regulated, and potentially delivered within existing healthcare systems.