Promising · not FDA-approved
MDMA in a clinic with extensive preparation, supervised dosing, and integration therapy. Not street “molly.”
Strongest PTSD-specific Phase 3 package in this family (MAPS / Lykos). FDA issued a complete response in 2024. In August 2026 a successor sponsor (Resilient) resubmitted an NDA without a new Phase 3. Still not approved. Does not work for everyone in the trials either.
Trials and limited expanded access. Not a neighborhood clinic.
Legal status is federal. Heart, meds, and psychosis history belong in a medical screen.
Evidence reviewed September 2026.