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MDMA: what the evidence shows

Two positive Phase 3 trials for PTSD — and a rejection the field is still working through. In trials, MDMA is never given on its own: every positive result comes from MDMA given within a full course of therapy.

Not an approved treatment for any condition yet.

Last reviewed 23 October 2026Re-checked every month5 conditions with published evidence

Is MDMA legal where you live?See country-by-country rules on our Psychedelic Therapy Legality Map

Condition by condition

One card per condition, strongest evidence first. Hover or tap a label to see what it means; the numbers link to sources at the bottom of the page.

PTSD

Late-stage trials · positive results

Two 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

Compare every substance for PTSD →

Anxiety disorders

Early research

Small trials in social anxiety, including a version of MDMA without the therapy.

In a 12-person randomised pilot, MDMA-assisted therapy reduced social anxiety in autistic adults more than placebo.7

In a 71-person Phase 2a trial, two doses of R-MDMA (EMP-01) without psychotherapy improved social anxiety scores by about 12 points more than placebo. The trial wasn't powered for significance. Eli Lilly agreed to buy the developer in July 2026.89

Compare every substance for anxiety disorders →

Safety and who it's not for

The FDA's 2024 rejection letter found that side effects weren't reliably recorded in the trials, including effects people experienced as positive, so the safety picture is incomplete.3

Phase 3 trials excluded people with significant heart disease, and every dose was given in a clinic with therapists present.12

Keep reading

EMDR Therapy in the UK, and How It Compares with Psychedelic TherapyHow EMDR works in the UK, what it costs, and how it compares with MDMA-assisted therapy.Read the article How to Choose a Psychedelic Therapy ProviderWhat credentials, safety checks and red flags to look for before you book.Read the article Advocating For Veteran Psychedelic Therapy in UkraineA Ukrainian war veteran on why he is campaigning for psychedelic-assisted therapy for veterans with PTSD.Read the article Research databaseNew studies, summarisedHundreds of papers on psychedelics and mental health, each with a plain-language summary and key facts.Browse the database

Looking for care in Europe?

PsyAccess, our sister project, lists verified licensed providers and trial sites.

Sources

Numbered in the order they appear above. We only use peer-reviewed papers, official company announcements (for trial status and topline results), regulators and trial registries.

  1. Mitchell JM et al. MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Nat Med. 2021Journal
  2. Mitchell JM et al. MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial. Nat Med. 2023Journal
  3. US FDA Complete Response Letter, NDA 215455 (midomafetamine), 8 August 2024Regulator
  4. Multidisciplinary Association for Psychedelic Studies (MAPS), statement, 10 August 2026Company release
  5. Therapeutic Goods Administration (Australia), 2023Regulator
  6. Swiss Federal Office of Public Health (FOPH/BAG)Regulator
  7. Danforth AL et al. Reduction in social anxiety after MDMA-assisted psychotherapy with autistic adults: a randomized, double-blind, placebo-controlled pilot study. Psychopharmacology. 2018Journal
  8. AtaiBeckley press release, 26 February 2026Company release
  9. Eli Lilly and Company press release, 16 July 2026Company release
  10. Sessa B et al. First study of safety and tolerability of MDMA-assisted psychotherapy in patients with alcohol use disorder. J Psychopharmacol. 2021Journal
  11. Wolfson PE et al. MDMA-assisted psychotherapy for treatment of anxiety and other psychological distress related to life-threatening illnesses: a randomized pilot study. Sci Rep. 2020Journal
  12. Kvam TM et al. MDMA-assisted therapy as a treatment for major depressive disorder: proof of principle study. Br J Psychiatry. 2025Journal