Psychedelic Drugs

FDA is supporting the development of psychedelic drugs, including new treatments for serious mental health conditions.

In recent years, there has been growing interest in and active research on the therapeutic potential of psychedelic drugs, in particular for the treatment of serious mental health conditions.

In response, FDA has made significant advances in psychedelic drug development through the issuance of scientific guidance, engagement with federal partners and the public, and regulatory actions to support drug development.

Graphic with teal and dark blue background. Text on the left of the graphic in white letters reads Guidance for Industry.

Guidance for Psychedelic Drug Development

Read FDA’s finalized guidance on "Psychedelic Drugs: Considerations for Clinical Investigations."

FDA to Hold Public Meeting on Horizontal Approaches to Food Standards of Identity Modernization

September 2026 Part 15 Hearing

Register for FDA’s Part 15 hearing on "Considerations for Potential Future Therapeutic Use of Psychedelic Drugs."

Decorative image for Rare Disease Regulatory Science Research

Priority Vouchers and New Clinical Research

Learn about FDA’s issuance of priority vouchers for psychedelic medications and decision to allow an early phase clinical study of noribogaine to proceed.

Combat medics conduct an exercise at the Marine Corps Training Area Bellows, Hawaii, on Jan. 10, 2018. (U.S. Army photo by Staff Sgt. Armando R. Limon, 3rd Brigade Combat Team, 25th Infantry Division)

Collaboration with the Department of Veterans Affairs

Read the FDA/VA Memorandum of Understanding, which will facilitate data sharing on treatments for substance use disorder and mental health conditions.

Background

Additional scientific and public engagement efforts include the following:

Draft guidance on "Psychedelic Drugs: Considerations for Clinical Investigations," issued in June 2023
Public meeting on "Advancing Psychedelic Clinical Study Design," held in collaboration with the Reagan-Udall Foundation for the FDA in January 2024
Public meeting on "Advancing Treatments for Post-Traumatic Stress Disorder," held in collaboration with the Reagan-Udall Foundation for the FDA in September 2024

FDA’s ongoing efforts align with President Trump’s recent executive order aimed at accelerating research and expanding access to innovative psychedelic therapies for serious mental health conditions. The executive order underscores the Administration’s commitment to supporting rigorous scientific research into emerging treatments for conditions such as post-traumatic stress disorder, depression, and substance use disorders, while maintaining the FDA’s gold standard for safety and effectiveness.