- The core, quadruple-masked, dose-finding study () aims to evaluate the efficacy and safety of a single dose of BPL-003 (intranasal 5-MeO-DMT benzoate) in patients with Treatment Resistant Depression (TRD).
- It is thought to be the largest controlled study, as well as the first and only blinded Phase II trial in the US, to investigate 5-MeO-DMT, with 196 patients enroled across 38 sites in 6 countries.
- An open-label extension of the study continues to enrol patients to evaluate the safety and efficacy of a second dose of BPL
