Clearmind Medicine Inc. (Nasdaq: CMND) has shipped its novel psychedelic-derived drug candidate, CMND-100, to the United States for its upcoming Phase I/IIa clinical trial targeting Alcohol Use Disorder (AUD). This trial, approved by the FDA, will be conducted at Yale School of Medicine, Johns Hopkins University School of Medicine, and IMCA in Israel. CMND-100, an oral MEAI-based drug, aims to reduce alcohol consumption and cravings through a novel mechanism of action.

The successful shipment of CMND-100 and the commencement of the clinical trial are critical steps for Clearmind as it tackles the substantial, underserved AUD market. The prevalence of AUD, impacting over 28 million adults in the U.S. alone, coupled with the limited effectiveness of existing treatments, creates a significant opportunity for innovative therapies like CMND-100. The selection of prestigious research institutions like Yale and Johns Hopkins underscores the potential of this drug candidate.

This Phase I/IIa trial will evaluate both the safety and efficacy of CMND-100 in reducing alcohol consumption. The trial’s initiation keeps Clearmind on track for its first-in-human study of this potentially groundbreaking AUD treatment. While financial details weren’t disclosed in the announcement, the pursuit of this large market suggests significant future revenue potential should the trial prove successful.

Positive clinical trial results could position Clearmind as a leader in the next generation of AUD treatments, potentially reshaping the landscape of addiction therapy. This progress may also attract further investment and partnerships, accelerating the development and commercialization of CMND-100. The upcoming clinical trial represents a crucial inflection point for Clearmind, the outcome of which will significantly influence the company’s future trajectory.

Source link: https://www.globenewswire.com/news-release/2025/03/21/3047090/0/en/Clearmind-Medicine-s-FDA-Approved-Clinical-Trial-for-CMND-100-Moves-Forward-as-Drug-Arrives-in-the-U-S-Advancing-Toward-Key-Milestones.html

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Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.