Clearmind Medicine Receives Final Approval to Expand its FDA Regulated Phase 1/2a Clinical Trial for Alcohol Use Disorder at Hadassah Medical Center

Rhea-AI Summary

Clearmind Medicine (Nasdaq: CMND) received final approval on Nov 13, 2025 for Hadassah Medical Center in Jerusalem to join its ongoing Phase 1/2a trial of CMND-100, an oral MEAI-based candidate for Alcohol Use Disorder (AUD).

The trial is multinational and multicenter, includes Yale, Johns Hopkins and Tel Aviv Sourasky, and has completed treatment of its first cohort. The study will assess safety, tolerability, pharmacokinetics and preliminary efficacy for reducing alcohol cravings and consumption. The company expects continued patient enrollment and data collection across sites.

Positive

• Final site approval obtained from Hadassah Medical Center (Nov 13, 2025)
• First cohort treatment in the Phase 1/2a trial was completed
• Multicenter trial includes Yale, Johns Hopkins, Tel Aviv Sourasky, Hadassah

Negative

• None.

Insights

Clinical Trial Strategist

Final site approval at Hadassah expands enrollment capacity for the Phase 1/2a CMND-100 trial and keeps the program on a multinational clinical path.

The approval allows Hadassah Medical Center in Jerusalem to join the ongoing Phase 1/2a study of CMND-100, increasing the trial's geographic and investigator diversity alongside sites at Yale, Johns Hopkins, and Tel Aviv Sourasky. The study remains focused on safety, tolerability, pharmacokinetics and preliminary efficacy for Alcohol Use Disorder; the company reports the first cohort treatment completed and now expects broader patient enrollment.

Key dependencies and risks include timely enrollment across sites, consistency of protocol execution between centers, and clean safety/pharmacokinetic readouts; none of these are resolved by site approval alone. The release cites the global mortality burden of AUD at 4.7%, which frames clinical relevance but does not change trial outcomes or regulatory paths.

Watch for enrollment milestones, interim safety/pharmacokinetic data, and any site-specific start dates in the coming quarters; the approval dated Nov 13, 2025 primarily signals operational progress rather than efficacy evidence in the near term.

Vancouver, Canada, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the "Company"), a clinical-stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, today announced that it has received final approval from the Hadassah Medical Center, Jerusalem, Israel, for its ongoing Phase 1/2a clinical trial evaluating CMND-100, a proprietary MEAI-based oral drug candidate, for the treatment of Alcohol Use Disorder (AUD). This approval will enable Hadassah Medical Center, a leading clinical site in Israel, to join the Company’s clinical trial, of which the first cohort treatment was successfully completed. 

The trial includes other first-in-class institutions, such as Yale School of Medicine’s Department of Psychiatry, Johns Hopkins University School of Medicine and Tel Aviv Sourasky Medical Center, Israel. The study at Hadassah-University Medical Center will be led by Prof. Joseph Caraco, Director of Clinical Pharmacology Unit in the Department of Medicine.

Clearmind’s clinical trial is a critical step in addressing the global burden of AUD, which accounts for 4.7% of all deaths worldwide, according to the World Health Organization. The Company anticipates further progress in patient enrollment and data collection across its clinical sites, with the goal of delivering a breakthrough solution for those affected by AUD and their families. The Phase 1/2a clinical trial, a multinational, multi-center study, is designed to assess the safety, tolerability, and pharmacokinetic profile of CMND-100, while also evaluating its preliminary efficacy in reducing alcohol cravings and consumption in patients with AUD.

About Clearmind Medicine Inc.

Clearmind is a clinical-stage psychedelic pharmaceutical biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve widespread and underserved health problems, including alcohol use disorder. Its primary objective is to research and develop psychedelic-based compounds and attempt to commercialize them as regulated medicines, foods or supplements.

The Company’s intellectual portfolio currently consists of nineteen patent families including 31 granted patents. The Company intends to seek additional patents for its compounds whenever warranted and will remain opportunistic regarding the acquisition of additional intellectual property to build its portfolio.

Shares of Clearmind are listed for trading on Nasdaq under the symbol "CMND" and the Frankfurt Stock Exchange under the symbol “CWY0.”

For further information visit: https://www.clearmindmedicine.com or contact:

Investor Relations
invest@clearmindmedicine.com

Telephone: (604) 260-1566
US: CMND@crescendo-ir.com

General Inquiries
Info@Clearmindmedicine.com
www.Clearmindmedicine.com

Forward-Looking Statements:

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses how its clinical trial is a critical step in addressing the global burden of alcohol user disorder, its anticipation regarding further progress in patient enrollment and data collection across its clinical sites and its goal of delivering a breakthrough solution for those affected by alcohol user disorder and their families. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (“SEC”), including, but not limited to, the risks detailed in the Company’s annual report on Form 20-F for the fiscal year ended October 31, 2024 and subsequent filings with the SEC. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Clearmind is not responsible for the contents of third-party websites.

FAQ

What did Clearmind (CMND) announce on November 13, 2025 about its CMND-100 trial?

Clearmind announced final approval for Hadassah Medical Center to join its Phase 1/2a CMND-100 trial and noted the first cohort treatment was completed.

Which clinical sites are participating in Clearmind's Phase 1/2a CMND-100 study (CMND)?

The study includes Yale School of Medicine, Johns Hopkins School of Medicine, Tel Aviv Sourasky Medical Center and Hadassah Medical Center.

What will Clearmind's Phase 1/2a CMND-100 trial (CMND) evaluate?

The trial is designed to assess safety, tolerability, pharmacokinetics and preliminary efficacy in reducing alcohol cravings and consumption.

Who will lead the Hadassah site for Clearmind's CMND-100 trial (CMND)?

The Hadassah study will be led by Prof. Joseph Caraco, Director of the Clinical Pharmacology Unit in the Department of Medicine.

How does Clearmind describe the public health need targeted by CMND-100 (CMND)?

The company cited WHO data that Alcohol Use Disorder accounts for 4.7% of all deaths worldwide to contextualize the trial's goal.