BPL-003
Archives of Psychiatry Research December 29, 2025 Darko Vlahović, D. Vlahovic
A single intranasal dose of the investigational psychedelic BPL-003 (5-MeO-DMT) rapidly reduced depressive symptoms in a Phase 2b randomized controlled trial of 193 patients with treatment-resistant depression. The 8 mg and 12 mg doses produced statistically significant improvements on the Montgomery–Åsberg Depression Rating Scale as early as Day 2, sustained through Day 57. The 8 mg dose offered the best balance between efficacy and tolerability. Adverse effects were transient and mild. BPL-003 acts preferentially at 5-HT1A receptors and induces neuroplastic changes in frontal cortical regions, supporting its potential as a fast-acting, single-dose therapy for treatment-resistant depression.