Clearmind Medicine Accelerate FDA-Approved Alcohol Use Disorder Clinical Trial by Activating Fifth Elite Global Medical Site
Clearmind Medicine (Nasdaq: CMND) announced activation of Hadassah Medical Center as the fifth global site in its FDA‑approved Phase I/IIa trial of CMND‑100, a proprietary non‑hallucinogenic MEAI‑based oral candidate for Alcohol Use Disorder (AUD).
The multinational study evaluates safety, tolerability, pharmacokinetics and preliminary efficacy in moderate to severe AUD. Hadassah activated the site after final approval earlier in November 2025.
Top‑line data from the trial's first cohort reported a favorable safety profile with no serious adverse events and high participant adherence, supporting continued evaluation of CMND‑100.
Clearmind Medicine (Nasdaq: CMND) ha annunciato l'attivazione del Hadassah Medical Center come quinto sito globale nel suo trial di fase I/IIa approvato dalla FDA di CMND‑100, una candidata orale proprietaria non allucinogena basata su MEAI per Alcohol Use Disorder (AUD).
Lo studio multinazionale valuta sicurezza, tollerabilità, farmacocinetica ed efficacia preliminare in soggetti con disturbo da uso di alcol da moderato a grave. Hadassah ha attivato il sito dopo l'approvazione finale all'inizio di novembre 2025.
I dati principali della prima coorte dello studio hanno riportato un profilo di sicurezza favorevole senza eventi avversi gravi e con alta aderenza dei partecipanti, a supporto della continua valutazione di CMND‑100.
Clearmind Medicine (Nasdaq: CMND) anunció la activación del Hadassah Medical Center como el quinto sitio global en su ensayo de Fase I/IIa aprobado por la FDA de CMND‑100, una candidata oral propietaria basada en MEAI no alucinogénica para Alcohol Use Disorder (AUD).
El estudio multinacional evalúa seguridad, tolerabilidad, farmacocinética y eficacia preliminar en AUD de moderado a grave. Hadassah activó el sitio tras la aprobación final a principios de noviembre de 2025.
Los datos de línea superior de la primera cohorte del ensayo reportaron un perfil de seguridad favorable sin eventos adversos graves y una alta adherencia de los participantes, respaldando la continuación de la evaluación de CMND‑100.
Clearmind Medicine (Nasdaq: CMND)가 FDA 승인 1상/2상(IM/IIa) 시험에서 CMND‑100의 다섯 번째 글로벌 사이트로 Hadassah Medical Center를 활성화했다고 발표했습니다. 이는 비환각성 MEAI 기반의 독점적 경구 후보물질로 Alcohol Use Disorder (AUD)를 대상으로 합니다.
이 다국적 연구는 중등도에서 중증 AUD에서의 안전성, 내약성, 약물동력학 및 예비 효능을 평가합니다. Hadassah는 2025년 11월 초 최종 승인을 받은 후 사이트를 가동했습니다.
첫 코호트의 상위 라인 데이터는 안전성 프로필이 우수하다고 보고되었고 중대한 부작용 없이 참가자의 높은 순응도가 나타나 CMND‑100의 추가 평가를 뒷받침합니다.
Clearmind Medicine (Nasdaq : CMND) a annoncé l’activation du Hadassah Medical Center en tant que cinquième site mondial dans son essai de phase I/IIa approuvé par la FDA de CMND‑100, une candidate orale propriétaire non hallucinogène à base de MEAI pour Alcohol Use Disorder (AUD).
L’étude multinationale évalue la sécurité, la tolérance, la pharmacocinétique et l’efficacité préliminaire chez des patients souffrant d’un AUD modéré à sévère. Hadassah a activé le site après l’approbation finale début novembre 2025.
Les données principales de la première cohorte de l’essai ont montré un profil de sécurité favorable sans événements indésirables graves et une adhérence élevée des participants, soutenant la poursuite de l’évaluation de CMND‑100.
Clearmind Medicine (Nasdaq: CMND) gab die Aktivierung des Hadassah Medical Center als fünfte globale Studie in ihrer FDA- genehmigten Phase-I/IIa-Studie von CMND-100 bekannt, einer proprietären nicht-halluzinogenen MEAI-basierten oralen Kandidaten für Alcohol Use Disorder (AUD).
Die multinationale Studie bewertet Sicherheit, Verträglichkeit, Pharmakokinetik und vorläufige Wirksamkeit bei moderatem bis schwerem AUD. Hadassah aktivierte die Studie nach der endgültigen Genehmigung Anfang November 2025.
Top-Line-Daten aus der ersten Kohorte der Studie zeigten ein attraktives Sicherheitsprofil ohne schwere unerwünschte Ereignisse und eine hohe Teilnehmeradhärenz, was die weitere Bewertung von CMND‑100 unterstützt.
Clearmind Medicine (Nasdaq: CMND) أعلنت تفعيل مركز هداسا الطبي كخامس موقع عالمي في تجربتها من المرحلة I/IIa المعتمدة من إدارة الغذاء والدواء لـ CMND‑100، وهي مرشح فموي قائم على MEAI غير هلوسي ملكية لشركة هدفه اضطراب استخدام الكحول (AUD).
تقيّم الدراسة متعددة الجنسيات السلامة والتحمل والصيدلة الحركية والفعالية الأولية في AUD من معتدل إلى شديد. قامت هداسا بتفعيل الموقع بعد الموافقة النهائية في أوائل نوفمبر 2025.
أظهرت بيانات الخط العلوي من المجموعة الأولى من التجربة ملف سلامة غير سلبي بدون أحداث سلبية خطيرة وبامتثال عالٍ من المشاركين، مما يدعم الاستمرار في تقييم CMND‑100.
- FDA‑approved Phase I/IIa clinical trial initiated at fifth global site
- Top‑line cohort showed no serious adverse events
- High treatment adherence reported in first cohort
- Efficacy remains preliminary; no definitive efficacy results reported yet
Insights
FDA‑approved Phase I/IIa expands to Hadassah; early cohort shows favorable safety and high adherence.
Clearmind has activated a fifth global site following final approval to expand its FDA‑approved Phase I/IIa study of CMND‑100, a non‑hallucinogenic MEAI‑based oral candidate for Alcohol Use Disorder, with Hadassah Medical Center joining Yale, Johns Hopkins, Tel Aviv Sourasky and IMCA on
Initial top‑line results from the first cohort report a favorable safety profile with no serious adverse events and generally good tolerability, plus strong treatment adherence. These facts support feasibility and operational execution but do not establish efficacy or larger‑population safety; conclusions should remain conditional on subsequent cohorts and predefined endpoints.
Key dependencies include continued enrollment across sites, complete pharmacokinetic and efficacy readouts, and any future safety signals as sample size grows. Monitor upcoming cohort data releases and protocol‑specified endpoints over the coming months for clearer efficacy and safety signals; near‑term milestones are additional cohort results and multi‑site enrollment progress.
Prestigious Hadassah Medical Center Joins Yale, Johns Hopkins, Tel Aviv Sourasky and IMCA, in Evaluating the Company’s proprietary non-hallucinogenic MEAI-based oral drug candidate
Vancouver, Canada, Nov. 20, 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 neuroplastogen-derived therapeutics to solve major under-treated health problems, today announced the initiation of its FDA-approved Phase I/IIa clinical trial for CMND-100 at Hadassah Medical Center in Jerusalem, Israel. This milestone expands the trial to another leading global medical center, emphasizing the potential and growing momentum behind CMND-100—a proprietary non-hallucinogenic MEAI-based oral drug candidate designed to address the unmet needs of millions suffering from Alcohol Use Disorder (AUD).
The multinational, multi-center study evaluates the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of CMND-100 in reducing alcohol cravings and consumption among individuals with moderate to severe AUD. Following final approval received earlier this month, Hadassah—a leading Israeli institution, has swiftly activated the site. The activation follows the company’s previous announcement in June 2025 that Hadassah Medical Center was being added as an additional clinical site for its ongoing Phase I/IIa clinical trial.
The company recently announced top-line data from the first cohort of the clinical trial that demonstrated a favorable safety profile, with no serious adverse events reported and the treatment was generally well-tolerated across all participants. Additionally, the cohort showed strong treatment observance, with high adherence to the dosing regimen and protocol requirements, underscoring the feasibility and patient acceptability of CMND-100 in a clinical setting. These encouraging early findings support the ongoing evaluation of CMND-100 as a potential breakthrough therapy for AUD, a condition affecting millions worldwide where effective treatments remain limited.
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 potential and growing momentum behind CMND-100 and the he ongoing evaluation of CMND-100 as a potential breakthrough therapy for AUD. The Company cannot assure that any patent will issue as a result of a pending patent application or, if issued, whether it will issue in a form that will be advantageous to the Company. 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 announce about the CMND-100 trial on November 20, 2025?
What endpoints is the CMND-100 Phase I/IIa trial (CMND) evaluating?
What did the first cohort topline data for CMND-100 report for CMND?
When did Hadassah receive approval to activate as a CMND-100 clinical site?
How does the Hadassah site addition affect CMND-100’s global trial enrollment?
