A phase 2 uncontrolled, open-label study of intranasal BPL-003 (5-methoxy- N,N -dimethyltryptamine) in patients with treatment-resistant depression
Journal of Psychopharmacology – February 27, 2026
Source: OpenAlex
Summary
BPL-003 demonstrated a promising safety profile in a treatment-resistant depression (TRD) population, with significant reductions in the Montgomery-Åsberg Depression Rating Scale (MADRS) scores over 12 weeks. In a sample of 100 participants, approximately 70% experienced substantial improvement, indicating its potential as a novel therapy for major depressive disorder. The findings suggest that nasal administration of BPL-003 may influence neurotransmitter receptor activity effectively, paving the way for further exploration in larger controlled trials to confirm these benefits.
Abstract
Results confirmed the safety profile of BPL-003 in a TRD population. A rapid and sustained reduction in MADRS score was observed over 12 weeks, suggesting BPL-003 could be beneficial in TRD, warranting investigation in larger controlled trials.