MDMA will not receive FDA approval in calendar year 2026 and will receive a second Complete Response Letter citing safety and abuse potential gaps.

The FDA (the US drug regulator) will reject MDMA as a treatment for PTSD in 2026 with a formal Complete Response Letter — a rejection that cites incomplete data on heart safety and addiction risk. This matters because MDMA's approval has been delayed repeatedly, and this prediction says the delays continue through all of next year.

Advisory committee skepticism is structural, not addressable by advocacy. Cardiovascular and abuse potential data files remain materially incomplete. Multi-agent consensus (fda_reviewer, dea_officer, neuropharmacologist) with only patient-advocacy voices dissenting. Resolution is clean: either an approval announcement or a CRL by December 31, 2026.