FDA Supports Psychedelic-Based Medicines for Treatment-Resistant Depression, PTSD, and Substance Use Disorders

The U.S. Food and Drug Administration has accelerated the development of psychedelic-based medicines for serious mental health conditions following an executive order from President Donald Trump, issuing priority review vouchers to three companies studying treatments for depression, PTSD, and alcohol use disorder.

The FDA announced on April 24, 2026, that it is issuing national priority vouchers to companies researching psilocybin for treatment-resistant depression, psilocybin for major depressive disorder, and methylone for post-traumatic stress disorder (PTSD). The agency also cleared an early-phase clinical study of noribogaine hydrochloride, a derivative of ibogaine, to proceed after an Investigational New Drug (IND) submission for potential use in treating alcohol use disorder.

“Under President Trump’s leadership, we are accelerating the research, approval, and responsible access to promising mental health treatments—including psychedelic therapies like ibogaine—to confront our nation’s mental health crisis head-on, especially for our veterans,” said Health and Human Services Secretary Robert F. Kennedy, Jr. The FDA emphasized that these actions build directly on the executive order issued by President Trump on April 18, 2026, directing the Department of Health and Human Services to expand access to emerging therapies for serious mental illness.

FDA Commissioner Marty Makary, M.D., M.P.H., stated that the medications under review have the potential to address conditions such as treatment-resistant depression, alcoholism, and other serious mental health and substance abuse disorders. He stressed that while the agency is moving forward with urgency, development must be grounded in sound science and rigorous clinical evidence.

The priority vouchers are designed to expedite the FDA review process without altering scientific or regulatory standards. A spokesperson for Usona Institute, which received a voucher for its work with psilocybin to treat major depressive disorder, noted that the voucher shortens the timeline but does not change the requirements for approval. Similarly, Transcend Therapeutics confirmed it received a priority review voucher for its experimental drug methylone for PTSD, with the company’s CEO stating the move supports faster advancement of clinical trials.

Compass Pathways, a UK-based biotech company, also announced it received an expedited review for its synthetic psilocybin formulation targeting treatment-resistant depression, citing positive data from two large phase 3 studies. The FDA clarified that allowing these studies to proceed does not indicate that the drugs are approved or proven safe and effective, and that data must be closely monitored throughout the research process.

The actions represent a significant shift in federal policy toward supporting psychedelic-based medicines for conditions including treatment-resistant depression, PTSD, and substance use disorders. The FDA noted that this comes amid broader administrative efforts to reassess access to emerging therapies, including recent developments involving state-licensed medical marijuana.

As of the announcement date, the FDA has not approved any psychedelic substance for medical use, and all studies remain under investigational status. The agency reiterated its commitment to evaluating these therapies with scientific rigor while responding to the public health need for innovative mental health treatments.