The FDA (the US drug regulator) will not approve psilocybin for treating cocaine addiction based on a single clinical trial. Instead, the agency will require independent researchers to replicate the results in a second study before it considers the drug effective enough. No completed Phase 3 trials (the gold-standard final stage) exist yet, so this means approval can't happen before 2029 at the earliest.
FDA's evidentiary standards for Schedule I compounds are well-documented and single-trial evidence has historically been insufficient. The cocaine use disorder indication is early-stage with no completed Phase 3 trials as of 2026. The replication burden is consistent with FDA's general posture and its specific caution around psychedelics. Resolve date of 2029-01-01 is appropriate given no NDA is expected before 2027-2028 at earliest. Confidence maintained.