MDMA
Late-stage trials · positive resultsTwo positive Phase 3 trials. Rejected by the FDA in 2024; resubmitted in 2026.
MDMA-assisted therapy met its main goal in two Phase 3 trials, in severe PTSD (90 people) and in moderate-to-severe PTSD (104 people). The comparison group got the same therapy with a placebo.12
In August 2024 the FDA declined to approve it. Its letter cites unreliable recording of side effects, no proof the benefit lasts beyond 18 weeks and possible selection bias (many participants had used MDMA before), and asks for a new trial.3
In August 2026, MAPS — the non-profit behind the original trials — said the sponsor, Resilient Pharmaceuticals, is resubmitting without a new Phase 3 trial. Resilient itself has not announced it.4
Australia allows authorised psychiatrists to prescribe MDMA for PTSD, and Switzerland grants patient-by-patient exceptional licences.56


