President Donald Trump has signed an executive order directing federal health agencies to dramatically accelerate research into and regulatory pathways for psychedelic therapies, aiming to make them available for patients with severe mental health conditions.
The order, signed Saturday, instructs the Food and Drug Administration to issue new guidance for clinical trials on substances like psilocybin, MDMA, LSD, and ibogaine. It also mandates improved data sharing between the FDA and the Department of Veterans Affairs and aims to facilitate the fast rescheduling of any psychedelic drugs that gain FDA approval. "In many cases, these experimental treatments have shown life-changing potential for those suffering from severe mental illness and depression—including our cherished veterans," President Trump said.
Health and Human Services Secretary Robert F. Kennedy, Jr. stated the order will "remove legal impediments" blocking research. A key component involves coordinating with the Drug Enforcement Administration to begin rescheduling reviews for any Schedule I psychedelic substance that successfully completes Phase 3 clinical trials. The FDA also announced it will issue three national priority vouchers for psychedelic therapies, which can shorten approval timelines to weeks. Furthermore, officials announced the first ibogaine investigational new drug clearance, paving the way for initial human trials in the U.S.
The administration is allocating $50 million to support state-level ibogaine research and creating a pathway for critically ill patients to access the substance under the federal Right to Try law. The move is framed as a direct response to a national mental health crisis, with particular emphasis on helping veterans. Representative Morgan Luttrell, who attended the signing, stated he can "personally attest to the significant benefits of this treatment" and that it changed his life.
Officials indicate the next steps involve rapidly developing the specific rules and protocols to enable therapeutic access. HHS Secretary Kennedy has previously expressed a goal of providing legal access to psychedelic therapies for military veterans within 12 months. While significant regulatory work remains, the executive order represents a concerted federal effort to transition promising psychedelic compounds from tightly restricted research into approved treatments for conditions like PTSD, depression, and addiction.