Clearmind MedicineNasdaq: CMND

Cohort 3 recruitment advancing at Yale, Johns Hopkins, and Tel Aviv Sourasky; 80mg dose level; 18 total participants completed treatment and follow-up

Why it matters: Cohort 3 at the escalated 80mg dose will provide critical dose-response data. Ongoing treatment at U.S. sites with no SAEs reported through March 2026.

Watch next: Cohort 3 completion; full Phase I/IIa data readout; Phase 2 dose selection

Actual: Feb 23, 2024

FDA approval received to commence Phase I/IIa clinical trial of CMND-100 for AUD

Why it matters: MEAI (5-methoxy-2-aminoindane) is a novel non-hallucinogenic entactogen distinct from both MDMA and classical psychedelics. FDA clearance for AUD positions CMND-100 in a large unmet need market with no approved psychedelic/entactogenic treatments.

Actual: Apr 10, 2025

First U.S. clinical site initiated for CMND-100 Phase I/IIa trial

Why it matters: U.S. site activation at Yale and Johns Hopkins provides world-class AUD research infrastructure and KOL credibility.

Actual: Jun 5, 2025

First patient enrolled in Phase I/IIa trial

Why it matters: Marks transition from site activation to active dosing. Multinational trial with sites at Yale, Johns Hopkins, Tel Aviv Sourasky Medical Center, and Hadassah Medical Center.

Actual: Nov 18, 2025

Positive Cohort 1 topline safety data: no SAEs, good tolerability, high treatment adherence across 6 patients

Why it matters: Clean safety profile in first human dosing cohort de-risks the programme. Non-hallucinogenic mechanism means CMND-100 could potentially be prescribed for home use without intensive monitoring — a major commercial advantage over psilocybin for AUD.

Actual: Nov 24, 2025

Data Safety Monitoring Board (DSMB) unanimously recommended trial continuation after Cohort 1 review

Why it matters: Independent safety board endorsement strengthens confidence in CMND-100's safety margin.

Actual: Feb 9, 2026

Cohort 2 completed (6 additional patients): no SAEs, reinforcing favorable safety profile

Why it matters: 12 total patients treated safely across two cohorts. Consistent tolerability supports dose escalation.

Actual: Mar 4, 2026

Second DSMB review cleared; approved dose escalation to 80mg for Cohort 3

Why it matters: DSMB approval of dose escalation to 80mg indicates clean safety at lower doses and allows exploration of potentially more efficacious dosing.