RFK, Jr., puts psychedelics on fast track to FDA review and approval
The U.S. Food and Drug Administration is seeking to accelerate the review process for three companies that are studying psilocybin and an MDMA-like drug as treatments for depression and PTSD
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On Friday the U.S. Food and Drug Administration announced it is fast-tracking the review and approval process for three companies studying psilocybin, the active psychedelic compound in magic mushrooms, and methylone, an MDMA-like molecule, as treatments for depression and post-traumatic stress disorder (PTSD).
Specifically, the companies are investigating psilocybin as a therapy for treatment-resistant depression and for major depressive disorder; methylone is being studied as a potential treatment for PTSD.
The FDA also approved a phase 1 clinical trial of noribogaine hydrochloride—a form of the psychoactive substance ibogaine. In a handful of preliminary trials, the drug has shown some efficacy in treating substance use disorders, and the new trial will investigate the drug’s use as a treatment for alcohol use disorder. Ibogaine is extremely difficult to study in the U.S. because it is classified as a Schedule I drug—the most restrictive category, reserved for drugs with the highest abuse potential, including heroin and LSD. The clinical trial does not mean the FDA has approved ibogaine or found it to be safe or effective for any condition, and the drug carries well-documented heart health risks.
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The FDA’s announcement comes days after President Donald Trump signed an executive order directing the agency to speed up the development and approval process for psychedelics; Secretary of Health and Human Services Robert F. Kennedy, Jr., further touted the promise of these drugs at a Senate hearing on Wednesday.
“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,” Kennedy said in a statement on Friday. The FDA will prioritize treatments with enough early evidence to suggest they are more effective than existing therapies for mental health conditions, he said.
There is some evidence that psilocybin may be useful to treat depression in some people, but there have been just a few clinical trials. Similarly, some research suggests methylone may be effective in treating PTSD, but no phase 3 clinical trials—large studies that confirm that medications work the way they are designed to and are safe—have been completed as of yet. The FDA gave the drug, which is being developed by Transcend Therapeutics, “breakthrough therapy” designation in 2025, which put it on an expedited path for FDA review.
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