Clearmind Medicine Inc. (CMND) has announced that CMND-100 has met the primary endpoint in its FDA-approved Phase I/IIa clinical trial for Alcohol Use Disorder, marking a key milestone for the company's non-hallucinogenic MEAI-based drug program.
Alcohol Use Disorder remains a major unmet medical need, with limited effective treatment options and significant impact on health, behavior, and quality of life. Clearmind is developing CMND-100 as a novel, non-hallucinogenic therapeutic designed to address this gap.
The Phase I/IIa trial is a multinational, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of CMND-100 in adults with moderate to severe AUD. The study uses a dose-escalation design, with each cohort receiving progressively higher doses of the drug candidate.
Clearmind announced that results from the third cohort- the highest dose tested so far- demonstrated a high safety profile, reinforcing the findings from earlier cohorts.
According to the company, results from the third cohort showed:
-CMND-100 was well tolerated at the highest dose administered so far.
-No serious adverse events were reported. -Safety outcomes remained consistent with earlier cohorts, indicating stable tolerability across dose levels.
Meeting the primary safety and tolerability endpoint at this stage supports continued advancement of CMND-100 as a potential non-hallucinogenic treatment option for AUD.
The successful completion of the third cohort strengthens the overall safety package for CMND-100 and provides momentum for further clinical development. As a non-hallucinogenic MEAI-based oral therapy, CMND-100 represents a differentiated approach compared to traditional AUD treatments, which often have limited efficacy or challenging side-effect profiles.
The company implemented a 1-for-40 reverse stock split on December 15, 2025.
CMND is currently trading at $0.84, down 41.26%.
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