FDA issues no new psilocybin-specific guidance before year-end; the smokers/cancer/AUD trials read out only feasibility, not efficacy.

The FDA (the US drug regulator) is not expected to release any new official guidelines specifically for psilocybin before the end of 2026. The ongoing clinical trials on smoking, cancer distress, and alcohol problems are only testing whether psilocybin is safe enough to study further — not yet proving it actually works. Until companies run larger, tightly controlled trials showing real results, the FDA has no strong reason to act.

Phase 1/2 rite-of-passage and chronic-pain designs are safety-tier. No pivotal package exists to prompt guidance. I won't fast-track absent controlled efficacy data.