The FDA announced regulatory actions to support development of serotonin-2A agonists and psychedelic drugs on Friday, with President Donald Trump signing an executive order on Saturday to accelerate research on psychedelics for mental health disorders. “Today’s order will ensure that people suffering from debilitating symptoms might finally have a chance to reclaim their lives and lead a happier life,” Trump said during the signing.
FDA Priority Vouchers
The FDA issued national priority vouchers to three companies studying psilocybin for treatment-resistant depression and major depressive disorder, and methylone for post-traumatic stress disorder. The agency is also allowing an early-phase clinical study of noribogaine hydrochloride after an Investigational New Drug submission. DemeRx NB, the sponsor of the research, is investigating noribogaine as a possible treatment for substance use disorder and other conditions, allowing the company to begin a Phase I clinical study in the United States.
Addressing the Mental Health Crisis
Health and Human Services Secretary Robert F. Kennedy Jr. stated: “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.” FDA Commissioner Marty Makary added: “These medications have the potential to address the nation’s mental health crisis, including conditions like treatment-resistant depression, alcoholism and other serious mental health and substance abuse conditions. As this field moves forward, it is critical that their development is grounded in sound science and rigorous clinical evidence.”
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://www.upi.com/Top_News/US/2026/04/24/fda-psychadelics-mental-health/9451777053217/