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Global regulatory progress for MDMA-assisted therapy

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2026-09-04 12:33 UTC → 2026-09-05 06:09 UTC · added removed

Regulatory developments regarding MDMA-assisted therapy for post-traumatic stress disorder (PTSD) have progressed in both the United States and New Zealand. In the United States, Resilient Pharmaceuticals resubmitted a New Drug Application (NDA) to the FDA for MDMA-assisted therapy. This resubmission seeks to address previous regulatory concerns regarding safety characterization and bias mitigation using existing data, rather than conducting new Phase 3 trials. This follows the FDA’s July 2026 publication of final guidance on psychedelic drug clinical investigations. Concurrently, New Zealand’s Medsafe has authorized two psychiatrists to psychiatrists—Gary Wynn in Wellington and Tom Paterson in Auckland—to prescribe pharmaceutical-grade MDMA for severe PTSD. This decision makes New Zealand the second country to authorize such use, following Australia’s 2023 authorization. The treatment is restricted to authorized clinicians who must follow strict therapeutic protocols within a controlled clinical setting for patients aged 18 and older; patients are not permitted to take the substance home. Deputy Prime Associate Health Minister David Seymour supported the authorization, stating that ‘PTSD ruins lives and is difficult to treat’ and suggesting MDMA could be highly effective through psychedelic-assisted therapy. This move follows research, including Phase 3 trials by the Multidisciplinary Association for Psychedelic Studies, which indicated significant symptom reduction. This development stands in contrast to the U.S. Food and Drug Administration’s 2024 decision to reject MDMA for medical use due to insufficient evidence regarding safety and efficacy.

Versions

  1. 2026-09-05 06:09 UTC Global regulatory progress for MDMA-assisted therapy
  2. 2026-09-04 12:33 UTC Global regulatory progress for MDMA-assisted therapy
  3. 2026-09-04 03:54 UTC Global regulatory progress for MDMA-assisted therapy

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