Trump Signs Executive Order to Fast-Track Psychedelic Drug Reviews and Fund Research

President Donald Trump signed an executive order on Saturday, April 18, 2026, directing federal agencies to accelerate research and patient access to psychedelic drugs for the treatment of serious mental illness. The order establishes a fast-track review process for breakthrough therapies and allocates $50 million in federal funding to partner with state governments. This move marks a significant shift in federal policy toward substances that have historically been strictly controlled under Schedule I.

The Details

The executive order introduces 'Commissioner's National Priority Vouchers' for psychedelic drugs that have received a Breakthrough Therapy designation from the FDA. According to FDA Commissioner Marty Makary, these vouchers could reduce the standard review window of six to ten months down to just one to two months. Makary stated that the FDA will issue three such vouchers, with potential decisions on certain psychedelic treatments arriving as early as summer 2026.

To support clinical development, at least $50 million will be distributed through the Advanced Research Projects Agency for Health (ARPA-H). These funds are earmarked for partnerships with state governments that are already advancing psychedelic drug programs for serious mental health disorders.

In a notable shift for restricted substances, the order directs the FDA and DEA to create pathways for eligible patients to access psychedelic compounds, including ibogaine, via the Right to Try Act. This requires the issuance of necessary Schedule I handling authorizations to allow legal administration in clinical settings. Simultaneously, the Attorney General has been directed to review Schedule I substances that have completed Phase 3 clinical trials to determine if timely rescheduling is appropriate.

FDA Commissioner Makary also announced the first-ever clearance of an investigational new drug (IND) registration for noribogaine, a form of ibogaine, which will allow the compound to enter first-in-human trials. This announcement coincided with the signing ceremony, which was attended by Joe Rogan and former Navy SEAL Marcus Luttrell, who spoke about the life-changing impact of ibogaine.

Financial markets reacted immediately to the order, with shares of psychedelic developers seeing significant gains. Enveric BioSciences surged 140%, while Compass Pathways, AtaiBeckley, and GH Research rose by 37%, 28%, and 24%, respectively.

Context

Currently, no psychedelic drug is approved for medical use in the United States. Compounds such as psilocybin, MDMA, and LSD remain classified as Schedule I substances, meaning the federal government considers them to have no accepted medical use and a high potential for abuse. While states like Oregon and Colorado have legalized psilocybin therapy at the local level, federal restrictions have long hindered large-scale research.

Ibogaine, a compound derived from a West African shrub, has been particularly difficult to study due to known cardiovascular risks. Medical literature has linked the substance to irregular heart rhythms and over 30 deaths. Because of these toxicity concerns, the National Institutes of Health (NIH) discontinued ibogaine research in the 1990s. However, some proponents, including HHS Secretary Robert F. Kennedy Jr., have championed it as a viable alternative for treatment-resistant conditions.

The push for these therapies is driven by a crisis in veteran mental health. The administration's order cites that more than 6,000 veterans commit suicide annually, with the suicide rate for veterans being more than twice that of the non-veteran adult population. Commissioner Makary noted that 89% of veterans with PTSD are currently treated with SSRIs, which he described as having low effectiveness, while preliminary data suggests remission rates of 30–40% for PTSD when using certain psychedelics.

What's Next

The immediate focus will be the issuance of the three national priority vouchers and the subsequent FDA decisions expected by the end of summer 2026. The legal community is already scrutinizing the 'Right to Try' provisions; scholars from the Harvard Petrie-Flom Center have noted that ibogaine may not yet meet the basic safety requirements, such as the completion of Phase I trials, typically required for such eligibility.

Additionally, the FDA is reviewing the status of MDMA-assisted therapy. After a 2024 rejection based on protocol violations in clinical trials, Commissioner Makary indicated that if the company submits an audit of those violations, the results will be considered in due process.

As the Attorney General begins the review of substances that have cleared Phase 3 trials, the U.S. may see its first federal rescheduling of a psychedelic compound, potentially moving some therapies from Schedule I to a less restrictive category to facilitate wider medical adoption.