& development


Midomafetamine (MDMA) capsules have not been approved by any regulatory agency. The safety and efficacy of midomafetamine have not been established for the treatment of PTSD.

Advancing medical and scientific knowledge in clinical research

We are committed to conducting research and development to determine the safety and efficacy of our investigational products to determine their potential to help address unmet needs in mental health. We have completed two Phase 3 trials for post-traumatic stress disorder (PTSD) and submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for midomafetamine (MDMA) capsules used in combination with psychological intervention, which includes talk therapy, and other supportive services provided by a qualified healthcare provider.

Investigational MDMA-assisted therapy is in development for individuals with PTSD and if approved, would be the first psychedelic-assisted therapy approved for PTSD. We have completed six Phase 2 and two Phase 3 studies examining the use of investigational MDMA-assisted therapy for PTSD. MDMA-assisted therapy is also being studied in other indications.

micrograph of crystalline structures with iridescent colors

Please email [email protected] with any questions about our investigator-initiated trials program.
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To learn more about ongoing studies with investigational MDMA-assisted therapy, please visit