MAPS / Lykos Therapeutics

Rule Changes

Pursuing revised MDMA therapy application after 2024 FDA rejection

For 55 years, the federal government classified psilocybin, MDMA, LSD, and ibogaine as Schedule I substances — drugs with no accepted medical use. On April 18, 2026, President Trump signed an executive order titled 'Accelerating Medical Treatments for Serious Mental Illness,' directing the Food and Drug Administration (FDA) to expedite clinical trials of those same substances for treating post-traumatic stress disorder (PTSD) in veterans. The order, whose signing ceremony included podcaster Joe Rogan and former Navy SEAL Marcus Luttrell, was driven substantially by Health and Human Services Secretary Robert F. Kennedy Jr. It makes $50 million in federal funding through the Advanced Research Projects for Health (ARPA-H) available for state-level ibogaine research — matched by state funds — and extends the Right to Try law to allow seriously ill patients to access psychedelics still under investigation. Within hours of the signing, FDA Commissioner Marty Makary announced that the agency would issue 'national priority' review vouchers for three psilocybin-class drugs, a first for any psychedelic substance, with decisions possible as early as summer 2026. The FDA also announced steps to clear the way for the first-ever US human trials of ibogaine.

Updated Apr 19