5-methoxy-N,N-dimethyltryptamine (BMND08) / Biomind - LARVOL DELTA

Safety and tolerability of multiple sublingual microdoses of 5-MeO-DMT in adults with moderate symptoms of depression and/or anxiety: a randomized, double-blind, placebo-controlled study. (PubMed, Neuropsychopharmacology) - P1/2 | "These findings provide critical groundwork for future trials targeting psychiatric populations, positioning 5-MeO-DMT as a novel, fast-acting therapeutic strategy with broad clinical relevance. TRIAL REGISTRATION: ClinicalTrials.gov: NCT06816667."

Clinical • Journal • CNS Disorders • Depression • Mental Retardation • Mood Disorders • Pain • Psychiatry

Efficacy of Sublingual 5-MeO-DMT for Reducing Anxiety and Depression in MCI (clinicaltrials.gov) - P1/2 | N=20 | Completed | Sponsor: Biomind Labs Inc. | Active, not recruiting ➔ Completed

Trial completion • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Depression • Mood Disorders • Psychiatry

Safety, Tolerability, and Efficacy of Sublingual Microdoses of 5-MeO-DMT for Depression and Anxiety (clinicaltrials.gov) - P1/2 | N=40 | Completed | Sponsor: Biomind Labs Inc. | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Depression • Mood Disorders • Psychiatry

Safety, Tolerability, and Efficacy of Sublingual Microdoses of 5-MeO-DMT for Depression and Anxiety (clinicaltrials.gov) - P1/2 | N=40 | Active, not recruiting | Sponsor: Biomind Labs Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Depression • Mood Disorders • Psychiatry

Safety, Tolerability, and Efficacy of Sublingual Microdoses of 5-MeO-DMT for Depression and Anxiety (clinicaltrials.gov) - P1/2 | N=40 | Recruiting | Sponsor: Biomind Labs Inc.

New P1/2 trial • CNS Disorders • Depression • Mood Disorders • Psychiatry

Efficacy of Sublingual 5-MeO-DMT for Reducing Anxiety and Depression in MCI (clinicaltrials.gov) - P1/2 | N=20 | Active, not recruiting | Sponsor: Biomind Labs Inc.

New P1/2 trial • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Depression • Mood Disorders • Psychiatry

Biomind Labs Announces Unprecedented Positive Results of Phase 2 Clinical Trial of BMND08 for Depression & Anxiety in Alzheimer's Disease (Financial Post) - P2 | N=NA | "Biomind Labs Inc...today announced the successful conclusion of the Phase 2 clinical trial of its proprietary 5-Metoxi-N,N-dimethyltryptamine ('5-MeO-DMT')-based BMND08, a sublingual formulation designed for the treatment of depression and anxiety in Alzheimer’s disease....Clinical findings support the safety and efficacy of BMND08 at a maximum dosage of 12mg, administered once weekly over four consecutive weeks. These doses, while subpsychedelic, have been shown to significantly enhance mood states, as evidenced in Group 1 (n=4). Throughout the trial, 100% of the participants responded to treatment and 100% were in remission from depression, anxiety, and stress by the end of the treatment period (week 5). In Group 2 (n=9)...demonstrating a significant enhancement in participants’ overall well-being compared to those who received Placebo (Group P, n=6)."

P2 data • Alzheimer's Disease • CNS Disorders • Depression • Mood Disorders

Biomind Labs Announces the Start of the First-Ever Clinical Trial Targeting Depression and Anxiety in Alzheimer’s Disease With a Proprietary formulation Based On 5-MeO-DMT (Businesswire) - "Biomind Labs Inc...is pleased to announce that it has commenced a Phase II clinical trial for its proprietary 5-Metoxi-N,N-dimethyltryptamine ('5-MeO-DMT')-based BMND08 candidate, a sublingual formulation for the potential treatment of anxiety and depression in Alzheimer’s disease....'The Phase IIa, double-blind, randomized, placebo-controlled, repeated single dose trial, is being led by our Clinical Advisor Neuroscientist Dr. Martín Bruno, includes 40 subjects (50-75 years old) and is being carried out at Dr. Marcial Quiroga Hospital in Argentina...'"

Trial status • Alzheimer's Disease • CNS Disorders • Depression

Biomind Labs Announces the Completion of the First Sublingual Psychedelic Formulation for Its Drug Candidate BMND08 for Depression and Anxiety in Alzheimer’s Disease (Businesswire) - “Biomind Labs Inc…is pleased to announce that it has successfully completed the development of a novel sublingual formulation to be used in the Phase II trial for its 5-Metoxi-N,N-dimethyltryptamine ('5-MeO-DMT')-based BMND08 candidate for the potential treatment of depression and anxiety in Alzheimer’s disease….‘Our scientific team has completed the challenging development of our proprietary sublingual formulation containing 5-MeO-DMT and the production of the first batch to be used in the Phase II trial.’”

Clinical • Alzheimer's Disease • CNS Disorders • Depression • Mood Disorders • Psychiatry

Biomind Labs Receives Approval for a Third Phase II Clinical Trial for Its 5-MeO-DMT Based BMND08 Candidate for Treatment of Depression and Anxiety in Alzheimer’s Disease (Businesswire) - “Biomind Labs Inc…is pleased to announce that a third Phase II clinical trial for its BMND08 candidate based on 5-Methoxy-N,N-dimethyltryptamine (‘5-MeO-DMT’) for treatment of depression and anxiety in patients with Alzheimer’s-type cognitive impairment has been approved by the Argentinian Institutional Review Board.”

New P2 trial • Alzheimer's Disease • CNS Disorders