Phase 3 (FDA rejection Aug 2024, resubmission pending)
MDMA Therapy
MDMA-assisted therapy is pursuing FDA approval for PTSD treatment. After a Phase 3 FDA rejection in August 2024, sponsors are preparing a resubmission with additional safety data.
50Clinical Trials
1Companies
0Legal States
FDA StatusPhase 3 (FDA rejection Aug 2024, resubmission pending)
Legal PathwayFDA approval pathway (federal)
Also Known Asecstasy, molly, midomafetamine
Legal Status by State
View full legal tracker →Fully Operational
Legal, Launching
Decriminalized
Active Legislation
Research Only
No Activity
Clinical Trials
Phase 123
Phase 212
Phase 36
Active, Not Recruiting·Phase 3·MDMA
MDMA-assisted Massed Prolonged Exposure for PTSD
Healing Breakthrough
Post-Traumatic Stress Disorder
Active, Not Recruiting·Early Phase 1·MDMA
MDMA-Assisted Therapy for Pathological Narcissism
University of Washington
Narcissism
Completed·Phase 1·MDMA
Comparative Acute Effects of R-MDMA and S-MDMA in Healthy Participants
University Hospital, Basel, Switzerland
Healthy
Completed·Phase 2·MDMA
MDMA for AUD/PTSD Comorbidity
Carolina L Haass-Koffler
Alcohol Use DisorderPost Traumatic Stress Disorder
Completed·Phase 1·MDMA
Acute Effects of 3,4-methylenedioxymethamphetamine (MDMA) With and Without a Booster Dose
University Hospital, Basel, Switzerland
Healthy
Completed·Phase 3·MDMA
MDMA-assisted Brief Cognitive Behavioral Conjoint Therapy for PTSD
Dr. Leslie Morland
PTSDRelational Problems
Companies & Research
Organizations developing MDMA-based therapies