The FDA (the US drug regulator) won't approve any psychedelic medicine next year unless companies completely redo their applications to fix a specific problem: participants in trials can usually tell whether they got the real drug or a placebo, which muddies the results. No company has fixed this yet, so approval is off the table for now. This delays access to potentially life-changing treatments for people with depression, PTSD, and addiction.
Functional unblinding is a known, documented threat to efficacy data integrity in psychedelic trials. RWE can supplement but cannot substitute for blinded controlled evidence under current FDA standards. No pending NDA has resolved this, making a 2026 approval unlikely.