By Healthcare Brew Staff
less than 3 min read
Definition:
Psychedelic therapy includes a range of treatments for mental illnesses using psychedelic drugs. Psilocybin is being studied to treat depression, MDMA for post-traumatic stress disorder (PTSD), and LSD for generalized anxiety disorder.
Where is psychedelic therapy legal?
As of June 2025, most of these treatments are still considered Schedule I drugs, which is the Drug Enforcement Agency’s strictest designation and means they are illegal on the federal level.
But at the state level, Colorado and Oregon have led the charge. Denver was the first US city to decriminalize psilocybin in 2019, and the entire state of Oregon legalized the drug for therapeutic application in 2020. Then in March 2024, Utah’s governor created a bill to allow mental health patients in two health systems to receive psilocybin- and MDMA-based treatments.
The Department of Veterans Affairs has also been outspoken about its support for MDMA therapy to treat PTSD in particular.
How does FDA approval work for psychedelic therapies?
As of June 2025, the closest FDA-approved drug is Spravato, a ketamine-derived nasal spray, though there’s debate about whether ketamine is a psychedelic.
For much of 2024, however, Lykos Therapeutics was attempting to become the first psychedelic therapy developer to get FDA approval for its MDMA-based drug to treat PTSD. In early June, an advisory committee voted it down, though there was still hope the FDA would go against the recommendation (however unlikely that seemed).
But—spoiler—the FDA sided with the committee in early August. Lykos said at the time that it planned to meet with the FDA and adjust its strategy so it could try again in the future.
