The U.S. Food and Drug Administration announced on Friday, April 18, 2026, that it is fast-tracking research into psychedelic treatments for mental illness following an executive order signed by President Donald Trump on Saturday, April 19, 2026.
FDA prioritizes breakthrough therapies for depression and PTSD
The agency will issue national priority vouchers to companies studying psilocybin for treatment-resistant depression and methylone for post-traumatic stress disorder, according to the announcement. It also cleared an early-stage clinical trial for noribogaine hydrochloride, a derivative of ibogaine, as a potential treatment for alcohol use disorder — the first such authorization in the United States.
Officials stress science-based development despite accelerated pace
FDA Commissioner Marty Makary said the medications have potential to address the nation’s mental health crisis but emphasized that allowing studies to proceed does not mean the drugs are approved or proven safe and effective. Robert F. Kennedy Jr., secretary of the U.S. Department of Health and Human Services, stated the FDA will prioritize therapies with Breakthrough Therapy designation where early evidence shows meaningful improvement.
Research moves forward under strict monitoring
Officials said data will be closely monitored as research advances, and if approved, the medications will come with certain conditions and will not be available for standard pharmacy prescription. The announcement follows the Trump administration’s statement that it would ease restrictions on state-licensed medical cannabis operators.
What conditions are the psychedelic treatments being studied for?
Psilocybin is being studied for treatment-resistant depression, methylone for post-traumatic stress disorder, and noribogaine hydrochloride for alcohol use disorder.
Does fast-tracking mean the drugs are approved?
No, the FDA said allowing these studies to proceed does not mean the drugs are approved or proven safe and effective, and any future approval would come with certain conditions.
