No FDA psilocybin approval decision occurs within 18 months.

The FDA (the US drug regulator) will not approve any psilocybin-based medicine in the next 18 months. Most studies are still in early or mid stages — researchers haven't yet run the large, definitive trials the FDA requires before it will say a drug is safe and effective enough to prescribe.

Trials are earlier-stage; imaging and AUD/tobacco studies are promising but not pivotal. Rigor requires more Phase 3 data before any filing matures.