Clearmind Medicine Successfully Completed First Cohort Treatment in its FDA-Approved Phase I/IIa Clinical Trial for Alcohol Use Disorder
Clearmind Medicine (Nasdaq: CMND) announced completion of treatment for the first patient cohort in its ongoing FDA-approved Phase I/IIa trial of CMND-100 for Alcohol Use Disorder (AUD) on November 10, 2025. Six patients have been enrolled and treated to date, with two sites at Johns Hopkins and four at Yale, and two additional sites in Israel activated.
The multinational, multicenter single- and multiple-dose study will assess safety, tolerability, and pharmacokinetics and explore preliminary efficacy signals such as reductions in alcohol cravings and consumption among treatment-seeking and non-treatment-seeking heavy drinkers. The company highlighted the commercial context, citing a market projected to reach about $20 billion by 2032.
Clearmind Medicine (Nasdaq: CMND) ha annunciato il completamento del trattamento per la prima coorte di pazienti nel suo attuale trial di fase I/IIa approvato dalla FDA di CMND-100 per il disturbo da uso di alcol (AUD) il 10 novembre 2025. A oggi sono stati arruolati e trattati sei pazienti, in due siti presso Johns Hopkins e quattro presso Yale, e sono stati attivati due ulteriori siti in Israele. Lo studio multinazionale, multicentro, unico e a dosi singole e multiple valuterà la sicurezza, la tollerabilità e la farmacocinetica e esplorerà segnali di efficacia preliminari quali riduzioni di craving e consumo di alcol tra pazienti in trattamento e bevitori pesanti non in trattamento. L'azienda ha evidenziato il contesto commerciale, citando un mercato previsto arrivare a circa $20 miliardi entro il 2032.
Clearmind Medicine (Nasdaq: CMND) anunció la finalización del tratamiento para la primera cohorte de pacientes en su ensayo de Fase I/IIa, aprobado por la FDA, de CMND-100 para el trastorno por uso de alcohol (AUD) el 10 de noviembre de 2025. Hasta la fecha se han inscrito y tratado seis pacientes, con dos sitios en Johns Hopkins y cuatro en Yale, y se activaron dos sitios adicionales en Israel. El estudio multinacional, multicentro, de dosis única y múltiple evaluará seguridad, tolerabilidad y farmacocinética y explorará señales de eficacia preliminares como reducciones en los antojos y el consumo de alcohol entre quienes buscan tratamiento y entre bebedores pesados no buscan tratamiento. La empresa destacó el contexto comercial, citando un mercado proyectado de alrededor de $20 mil millones para 2032.
Clearmind Medicine(Nasdaq: CMND)가 2025년 11월 10일 FDA가 승인한 1상/2상 초의 임상시험에서 CMND-100에 대한 알코올 사용 장애(AUD) 치료의 첫 환자 코호트 치료를 완료했다고 발표했습니다. 지금까지 6명의 환자들이 등록되어 치료를 받았으며, 두 개의 사이트는 존스홉킨스에서, 네 곳은 예일에서 운영되었고 이스라엘의 추가 두 개 사이트가 활성화되었습니다. 다국적 다기관 단일 및 다용량 연구는 안전성, 내약성 및 약물동력학을 평가하고 치료를 받는 환자와 치료를 원하지 않는 과다 음주자 사이에서 알코올 갈망과 섭취 감소와 같은 초기 유효성 신호를 탐색할 것입니다. 회사는 2032년까지 약 200억 달러에 이를 것으로 전망되는 시장을 인용하며 상업적 맥락을 강조했습니다.
Clearmind Medicine (Nasdaq: CMND) a annoncé l’achèvement du traitement de la première cohorte de patients dans son essai de phase I/IIa, approuvé par la FDA, pour CMND-100 dans le trouble lié à l’usage d’alcool (AUD) le 10 novembre 2025. Six patients ont été enrôlés et traités à ce jour, dans deux sites à Johns Hopkins et quatre à Yale, et deux sites supplémentaires en Israël ont été activés. L’étude multinationales, multicentrique, à dose unique et à doses multiples évaluera la sécurité, la tolérance et la pharmacocinétique et explorera des signaux d’efficacité préliminaires tels que des réductions des cravings et de la consommation d’alcool chez les personnes cherchant un traitement et les buveurs lourds non en traitement. L’entreprise a mis en avant le contexte commercial, citant un marché projeté d’environ 20 milliards de dollars américains d’ici 2032.
Clearmind Medicine (Nasdaq: CMND) gab am 10. November 2025 die Fertigstellung der Behandlung der ersten Patientenkohorte in seiner laufenden FDA-genehmigten Phase I/IIa-Studie von CMND-100 für Alkoholgebrauchsstörung (AUD) bekannt. Bis heute wurden sechs Patienten rekrutiert und behandelt, mit zwei Standorten an Johns Hopkins und vier an Yale, und zwei zusätzliche Standorte in Israel wurden aktiviert. Die multinationale, multizentrische Ein- und Mehrdosenstudie wird Sicherheit, Verträglichkeit und Pharmakokinetik bewerten und erste Wirksamkeitssignale wie Verringerungen von Alkoholcraving und -konsum bei behandlungswilligen und nicht behandlungswilligen Starktrinkern untersuchen. Das Unternehmen hob den kommerziellen Kontext hervor und verwies auf einen Markt, der voraussichtlich bis 2032 rund 20 Milliarden US-Dollar erreichen wird.
أعلنت شركة Clearmind Medicine (بورصة ناسداك: CMND) إتمام العلاج للدفعة الأولى من المرضى في تجربتها من المرحلة I/IIa المعتمدة من FDA من CMND-100 لاضطراب استخدام الكحول (AUD) في 10 نوفمبر 2025. حتى الآن تم تسجيل وعلاج ستة مرضى، بموقعين في جونز هوبكنز و4 في ييل، وتم تفعيل موقعين إضافيين في إسرائيل. ستقيّم الدراسة متعددة الجنسيات ومتعددة المراكز ذات الجرعات المفردة والمتعددة السلامة والتحمل والصيدلانية الحركية وتستكشف إشارات فاعلية أولية مثل تقليل اشتياق الكحول واستهلاكه بين المرضى الباحثين عن العلاج وشاربي الكحول الثقيلة غير الباحثين عن العلاج. أبرزت الشركة السياق التجاري، مستشهدة بسوق من المتوقع أن يصل إلى نحو $20 مليار بحلول 2032.
- First cohort completed with six patients treated
- Top research sites activated: Johns Hopkins and Yale enrollment
- Two additional sites in Israel activated for the trial
- Study scope includes single- and multiple-dose safety, tolerability, and PK
- Very small sample: only six patients treated to date
- Early-phase data limits conclusions on efficacy and commercial viability
- Selective enrollment requires participants to want to reduce/stop drinking, which may limit generalizability
Insights
Clearmind completed treatment of the first cohort in its FDA‑approved Phase I/IIa AUD trial, enrolling six patients across top centres.
**Clearmind** advanced CMND-100 by dosing the first cohort of six patients, with two at **Johns Hopkins** and four at **Yale**, and activating two sites in Israel. The trial is a multinational, single- and multiple-dose Phase I/IIa study authorized under an FDA IND to assess safety, tolerability, and pharmacokinetics, while exploring early efficacy signals such as reductions in alcohol cravings and consumption.
Key dependencies and risks include the upcoming safety, tolerability, and PK readouts; absence of safety or tolerability data keeps outcomes uncertain. Early enrolment across reputable centres supports credibility but does not demonstrate efficacy until predefined endpoints are met. Monitor cohort safety summaries, PK data, and any reported changes in alcohol consumption or craving metrics over the next reporting milestones; subsequent dose cohorts and Phase II expansion timelines will materially affect program momentum.
Milestone advances MEAI-based therapy targeting a global Alcohol Use Disorder treatment market projected to surpass
Vancouver, Canada, Nov. 10, 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, recently announced that it has successfully completed treatment of the first patient cohort in its ongoing Phase I/IIa clinical trial evaluating CMND-100 for the treatment of Alcohol Use Disorder (AUD).
To date, six patients have been successfully enrolled and treated in the trial, with two patients enrolled at Johns Hopkins University School of Medicine and four patients enrolled at Yale School of Medicine’s Department of Psychiatry- two of the world’s leading centers for neuropsychiatric and addiction research, highlighting the high scientific and clinical standards guiding the study In addition, two additional sites in Israel have been activated for the Phase I/IIa clinical trial.
The multinational, multicenter Phase I/IIa trial is designed as a single- and multiple-dose study to assess the safety, tolerability, and pharmacokinetic profile of CMND-100. It will also explore preliminary efficacy signals, such as reductions in alcohol cravings and consumption, among participants who are either non-treatment-seeking individuals reporting heavy binge drinking or treatment-seeking individuals diagnosed with AUD per DSM-5 criteria. All participants must express a desire to reduce or stop drinking.
Following FDA Investigational New Drug (IND) approval, the trial represents a critical step in advancing CMND-100 as a potential innovative therapy for the hundreds of millions worldwide affected by AUD, a condition where current treatments often fall short. The need for more effective AUD treatments remains urgent. According to Data Bridge Market Research, the global alcohol-dependency treatment market was valued at approximately
“Completing the first cohort is an important milestone as we progress toward demonstrating the potential clinical benefits of CMND-100 for people living with alcohol use disorder,” said Dr. Adi Zuloff-Shani, Chief Executive Officer of Clearmind Medicine.
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 the expected growth of the global alcohol-dependency treatment market and its progress toward demonstrating the potential clinical benefits of CMND-100 for people living with alcohol use disorder. 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
How many patients has Clearmind (CMND) treated in its Phase I/IIa CMND-100 AUD trial as of November 10, 2025?
Which research centers enrolled patients in Clearmind's CMND-100 AUD trial (CMND)?
What endpoints is the CMND-100 Phase I/IIa trial (CMND) designed to assess?
Does Clearmind's CMND-100 AUD trial have FDA clearance (CMND)?
What is the significance of completing the first cohort in Clearmind's CMND-100 trial (CMND)?
