No full FDA approval of MDMA or psilocybin occurs in 2026; any progress is via REMS-gated pathways or resubmission.

Predicted 2026-07-17 · Resolves 2026-12-31 · regulation · USA

85%

ORACLE CONFIDENCE

⏳ Pending

Every outcome is scored publicly in the ledger.

Even with a full year on the clock, neither MDMA nor psilocybin will earn complete FDA approval as a medicine in 2026. Companies may make some progress — like resubmitting their applications or navigating special restricted-access programs — but the finish line is still out of reach. Real patients hoping for an approved prescription option will have to wait longer.

Resolution rule: YES if, as of 2026-12-31, the FDA has NOT granted full marketing approval (NDA/BLA) to any MDMA- or psilocybin-containing drug. Checked via the FDA Drugs@FDA database (accessdata.fda.gov/scripts/cder/daf) and FDA press releases (fda.gov/news-events). Any listed full approval of such a product before the check date resolves NO.

FDA approval requires durable efficacy and functional-unblinding resolution; resubmissions take quarters. No MDMA or psilocybin NDA/BLA is positioned for full approval within 2026's remaining months.

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