The world’s first Phase 3 psilocybin clinical trial is about to commence

Research into clinical uses for psychedelics has proliferated in recent years, but despite the constant stream of “psychedelic renaissance” news, the vast majority of studies remain in early, preliminary stages. Apart from one notable modality (MDMA-assisted psychotherapy for post-traumatic stress disorder), no psychedelic clinical trial has progressed further than Phase 2.

A recent announcement from Compass Pathways is set to change that, with the world’s first Phase 3 human trial for day psilocybin therapy with psychological support due to commence by the end of 2022. The trial will enroll close to 1,000 participants and Compass is looking to FDA approval by the end of 2025.

By Rich Haridy