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No FDA final approval of any psychedelic-assisted therapy (psilocybin, MDMA) will occur before 2026-08-02.

Predicted 2026-07-03 · Resolves 2026-08-02 · regulatory · USA

97%

ORACLE CONFIDENCE

⏳ Pending

Every outcome is scored publicly in the ledger.

The FDA (the US drug regulator) has not approved any therapy using psilocybin (the active ingredient in magic mushrooms) or MDMA (ecstasy) as a medicine. The FDA already rejected MDMA-assisted therapy in 2024 and asked the company to do more work. Psilocybin is still in earlier stages of review. Neither drug will clear the full approval process in the next few weeks.

Resolution rule: YES if, as of 2026-08-02, the FDA has not published approval of any MDMA- or psilocybin-assisted therapy product. Verified via the FDA Novel Drug Approvals / Drugs@FDA database on fda.gov on 2026-08-02.

MDMA-assisted therapy received a CRL in 2024 and no resubmission has completed review; psilocybin Phase 3 programs are not yet at NDA-decision stage. A final approval within the next 30 days is effectively ruled out by current review timelines.

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