Clearmind Advances Dialogue with U.S. Federal Government on Psychedelic Therapies, Submitting Recommendations to FDA
Key Highlights
- ➤Clearmind submitted psychedelic-therapy recommendations to the FDA under Docket No. FDA-2026-N-7542
- ➤Recommendations seek self-administration guidance and streamlined pathways for non-hallucinogenic neuroplastogens
- ➤Yale and Johns Hopkins trials generated data supporting reduced need for expensive supervised dosing
- ➤Clearmind urged collaborations with VA, DoW, and HHS on at-home-potential AUD therapies
- ➤Mary-Elizabeth Gifford briefed an FDA-convened federal panel on September 14, 2026
Expert Statements
Dr. Adi Zuloff-Shani, Chief Executive Officer of Clearmind Medicine
“Clearmind has been dedicating substantial resources and effort to advancing awareness of non-hallucinogenic neuroplastogens and their potential role in addressing significant unmet needs in addiction and mental health”
Dr. Adi Zuloff-Shani, Chief Executive Officer of Clearmind Medicine
“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.”
Dr. Adi Zuloff-Shani, Chief Executive Officer of Clearmind Medicine
“We believe that continued engagement with federal agencies, alongside rigorous clinical research, is important to advancing new treatment options for patients who currently have limited access to care.”
Company Calls for Consideration of New Regulatory Pathways and Cost Saving of Non-Hallucinogenic Neuroplastogens for Alcohol Use Disorder
Vancouver, Canada, Oct. 07, 2026 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND) (the “Company”), a clinical-stage biopharmaceutical company advancing non-hallucinogenic psychedelic-derived neuroplastogens for scalable treatment of neuropsychiatric, metabolic, and addiction disorders including Alcohol Use Disorder (“AUD”), today announced that it has submitted recommendations to the U.S. Food and Drug Administration (“FDA”) in response to the agency’s public hearing and request for comments on “Considerations for Potential Future Therapeutic Use of Psychedelic Drugs.”
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