Psychedelic Drug Reviews Accelerated by FDA Vouchers

The U.S. Food and Drug Administration (FDA) on Friday moved to speed up the development of new therapies for severe mental illness by issuing national priority review vouchers to three pharmaceutical companies, officials said. The step is designed to accelerate how quickly certain psychedelic-drug applications are evaluated by the agency.

The action follows an executive order signed by President Donald Trump on April 18 that directed the FDA to provide these vouchers for psychedelic drugs that have been granted “breakthrough therapy” status. Under the order’s framework, the goal is to shorten the FDA’s review timeline from the typical six to ten months to an expedited one to two months for eligible products.

Compass Pathways confirmed it received one of the vouchers for its psilocybin-based candidate, COMP360, which the company is developing for treatment-resistant depression. The FDA said the remaining two vouchers went to companies studying psilocybin for major depressive disorder and methylone for post-traumatic stress disorder, but the agency did not officially name the recipients beyond Compass Pathways.

The initiative is framed around the scale of mental health needs cited in the announcement. The source material states that 23.4% of U.S. adults were affected in 2024, and 17.6% of veterans were affected in 2023. The policy move links those figures to an effort to bring potential new treatment options through the regulatory process more quickly.

Officials described psychedelic treatments as working by activating proteins on nerve cells that influence brain reorganization and repair. Within the substances referenced, psilocybin and ibogaine are classified as Schedule I drugs. The source material notes that psilocybin has been studied more extensively and has shown potential to reduce depression symptoms.

Ibogaine, despite presidential support mentioned in the source material, was not part of this round of priority review vouchers. The reason given was that ibogaine’s clinical development is less advanced and its safety record is weaker compared with psilocybin.

For markets and policy stakeholders, the voucher program creates a faster regulatory pathway for a narrow set of drug candidates tied to “breakthrough therapy” designation, while leaving key details—such as the identities of two voucher recipients—unconfirmed by the FDA in this instance. S. review timelines can influence global development strategies, cross-border capital flows into biotech, and how quickly companies seek approvals in other jurisdictions.