President Donald Trump has signed an executive order directing the US Food and Drug Administration (FDA) to expedite regulatory review of psychedelic drugs, including ibogaine compounds, as treatments for serious mental illness.
The move could have significant implications for pharmaceutical developers and manufacturers working in this emerging therapeutic space.
The order mandates that the FDA issue Commissioner's National Priority Vouchers to psychedelic drug candidates that have already received Breakthrough Therapy designation.
FDA Commissioner Marty Makary confirmed that priority review vouchers will be awarded imminently to three serotonin 2a agonists — a class encompassing compounds such as LSD and psilocybin, the active molecule in magic mushrooms.
The executive order also directs the FDA and Drug Enforcement Administration (DEA) to establish an access pathway under the Right to Try Act for patients seeking investigational psychedelic therapies, including provisions for Schedule I handling authorisations for treating physicians and researchers.
Separately, the Attorney General has been directed to initiate rescheduling reviews for any Schedule I substance that successfully completes Phase III trials for a serious mental health disorder.
The process, if completed, would substantially alter the controlled substances framework governing manufacture and supply.
The White House is also allocating at least $50m via the Advanced Research Projects Agency for Health (ARPA-H) to support federal-state collaboration on psychedelic drug programmes.
The order additionally mandates data-sharing agreements between HHS, FDA and the Department of Veterans Affairs to accelerate real-world evidence generation and facilitate timely approvals.
For the pharmaceutical industry, the order could prove pivotal.
UK-headquartered Compass Pathways, which is developing COMP360 (a synthetic psilocybin candidate), welcomed the announcement.
The company reported a Phase III win in treatment-resistant depression in February and is currently completing a rolling approval submission with the FDA, on track for Q4 2026.
Definium Therapeutics, with three Phase III trials of an LSD formulation expected to report this year, also expressed support for the directive.
Ibogaine, which is derived from a West African shrub, has been a particular focus given its potential in treating opioid dependence, PTSD and depression in veterans with traumatic brain injuries.
The drug is currently unapproved in the US and cardiac safety concerns remain a key consideration for developers and regulators alike.
The order signals a broader regulatory acceleration under the current administration, with implications for API sourcing, GMP-compliant manufacturing of Schedule I-derived compounds and evolving CMC requirements as novel psychedelic formulations progress toward approval.