The FDA (the US drug regulator) is unlikely to fully approve MDMA or psilocybin as medicines before the end of 2026. The main problem is that in clinical trials, participants could usually tell whether they got the real drug or a dummy pill — which makes it hard for regulators to trust the results. Until drug companies fix that problem and submit new data, approval stays on hold.
FDA division cannot accept functional unblinding as-is; procedural gaps in prior submissions remain unresolved. Appropriations funding doesn't shortcut review standards, and no new confirmatory Phase 3 data addressing unblinding has been publicly filed with sufficient lead time for a 2026 decision.