Michael Mithoefer

Senior Medical Director for Medical Affairs at MAPS PBC

Data updated

Papers

28 publications

Trials

0 clinical trials

Research Footprint

Michael Mithoefer appears in 28 tracked papers (2010–2024), most studied alongside MDMA, Psilocybin and Placebo, across PTSD, Anxiety Disorders and Depressive Disorders.

Most-cited paper: MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study (942 citations).

Frequent co-authors: Rick Doblin, Berra Yazar-Klosinski and Lisa Jerome.

Background & Research

Michael Mithoefer is a psychiatrist and researcher world-renowned for his work with MDMA. Together with Annie Mithoefer, he has led foundational Phase 2 and Phase 3 trials investigating MDMA-assisted psychotherapy for treatment-resistant PTSD. His approach integrates internal family systems and experiential therapy, focusing on the patient's innate capacity for self-healing.

Affiliations

Institutions, companies, and organisations Michael Mithoefer is associated with.

MAPS

nonprofit

MAPS, the Multidisciplinary Association for Psychedelic Studies, is a U.S.-based 501(c)(3) nonprofit research and educational organization founded in 1986. It works nationally and with a broader global audience to develop medical, legal, and cultural contexts for the careful use of psychedelics and marijuana. Its core activities include research, education, advocacy, and convening the field through large public events. In psychedelic medicine and policy, MAPS positions itself as an advocate for legal access, drug policy reform, harm reduction, and health equity. Its Policy & Advocacy work includes legislative advocacy, community organizing, and impact litigation, and it has also launched work on access for system-impacted people and broader health equity in the legal psychedelic ecosystem. Current documented initiatives include the Psychedelic Science conference series, the Health Equity Program, The Zendo Project, and Ask MAPS, which handles public inquiries about therapy, research, and policy reform.

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Resilient Pharmaceuticals

biotech

Resilient Pharmaceuticals (formerly Lykos Therapeutics, formerly MAPS PBC) is a US-based public benefit corporation developing MDMA-assisted therapy for PTSD. It was founded in 2014 by MAPS as a commercial spinout to carry MAPS MDMA research through late-stage trials and regulatory approval. After two Phase 3 trials and an NDA filing, FDA issued a Complete Response Letter in August 2024 and requested an additional Phase 3 trial before approval. The company subsequently restructured and rebranded, while the public Lykos web presence continues to describe the organisation as pursuing FDA approval for MDMA-assisted therapy. As of the June 2026 review, no public company announcement of a new pivotal trial start or NDA resubmission date was found. VA/DoD-backed MDMA/PTSD research is proceeding in the broader field, but it should not be treated as direct support for Resilient/Lykos NDA resubmission unless linked by company or FDA evidence.

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Medical University of South Carolina

The Medical University of South Carolina (MUSC) is a public academic health sciences center in Charleston, South Carolina, founded in 1824. It comprises multiple colleges (Medicine, Dental Medicine, Health Professions, Nursing, Pharmacy, and Graduate Studies) and provides education, biomedical research, and clinical care across the state.

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