The Promise of Therapeutic Psilocybin: An Evaluation of the 134 Clinical Trials, 54 Potential Indications, and 0 Marketing Approvals on ClinicalTrials.gov.
Drug design, development and therapy January 1, 2024 Sarah A Norring, Michael G Spigarelli 22 citations
Psilocybin, a tryptamine psychedelic, has been promoted as a potential mental health therapeutic. An observational study of ClinicalTrials.gov data found 134 psilocybin trials over the past 20 years, typically unblinded studies with 10-20 participants at a single site. Only three advanced trials (1 Phase 2/3 and 2 Phase 3) have been submitted, all within the last two years. The authors argue that the large number of small, exploratory trials covering many indications may be slowing FDA approval and wasting capital. They conclude that little real progress has been made toward approval and the field lacks clear direction.