At least one large final-stage clinical trial testing psilocybin for depression or MDMA (a related psychedelic) for PTSD will report that the drug actually works as hoped by the end of 2026. This matters because Phase 3 trials are the final hurdle before the FDA decides whether to approve a drug for doctors to prescribe. If one succeeds, it proves the drug works, brings approval closer, and validates the whole industry's approach.
COMPASS Pathways COMP360 Phase 3 MDD trial (COMP005) is actively enrolling with readout plausible in 2026. Usona Institute's psilocybin MDD trial is in Phase 3. Effect sizes in Phase 2 psilocybin MDD studies were large (Cohen's d ~0.8-1.0), giving meaningful probability of replication. Predicting 'at least one' across multiple active trials is more defensible than predicting all succeed. Excludes initial MDMA-PTSD NDA (already rejected) but includes supplemental or new sponsor trials. Falsifiable: trial reports published or announced with p-value on primary endpoint.