MDMA-assisted therapy pairs sessions with MDMA and a course of manualized psychotherapy. It is often grouped with psilocybin therapy, but MDMA is a different drug, which one research team describes as not a serotonergic psychedelic (Armstrong et al., 2026).
Two phase 3 trials tested it in PTSD. In the first, 90 people were randomized, and among completers a clinician-rated PTSD score fell 24.4 points with MDMA against 13.9 with placebo (Mitchell et al., 2021). In the second, with 104 people, scores fell 23.7 and 14.8 (Mitchell et al., 2023). At an FDA advisory committee on 4 June 2024, 2 members voted that the data showed effectiveness and 9 voted no, with functional unblinding among the concerns (FDA minutes, 2024).
In August 2024 the FDA declined approval and asked for another phase 3 trial, according to the sponsor (Lykos Therapeutics, 2024). In August 2026, MAPS responded to a report that the sponsor had resubmitted its application without a new phase 3 trial (MAPS, 2026). No FDA approval had been announced as of October 2026, as far as this site found.
Sources
- Mitchell et al., Nature Medicine, 2021
- Mitchell et al., Nature Medicine, 2023
- FDA advisory committee minutes, 4 June 2024
- Lykos Therapeutics press release, 9 August 2024
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