The Food and Drug Administration on Friday awarded fast-track review to three companies investigating psychedelic treatments for depression and post-traumatic stress disorder, marking the latest move by the Trump administration to push these therapies toward potential approval.
The agency declined to name the recipients of the priority review vouchers, but two of the companies are studying psilocybin—one for treatment-resistant depression and another for major depressive disorder. A third firm is researching methylone, a compound similar to MDMA, for PTSD.
“As this field moves forward, it is critical that their development is grounded in sound science and rigorous clinical evidence,” FDA Commissioner Marty Makaray said in a statement. “We owe it to our nation’s veterans and all Americans who are suffering from these conditions to evaluate these potential therapies with urgency.”
Companies selected for the voucher program will benefit from a shortened review period after filing a New Drug Application. Shortly after the FDA announcement, Compass Pathways disclosed it had received one of the vouchers for its psilocybin-based candidate COMP360, a synthetic formulation for treatment-resistant depression.
“We are honored and grateful to be selected for the CNPV, which is a clear validation of both the urgent unmet need facing millions of people living with treatment resistant depression and the innovative science of COMP360,” said Kabir Nath, CEO of Compass Pathways.
In addition, the administration approved an early-stage clinical study of a ibogaine derivative. DemeRx NB, based in Miami, will test noribogaine hydrochloride as a potential treatment for alcohol use disorder. This is the first time the FDA has allowed a U.S. clinical trial of any ibogaine derivative, a psychoactive compound from the African Tabernanthe iboga shrub. The authorization does not signify approval or a determination of safety or efficacy.
“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,” Health and Human Services Secretary Robert F. Kennedy Jr. said Friday.
The vouchers were awarded following President Trump’s executive order last Saturday, which directed federal agencies to ease restrictions and expedite research into psychedelic drugs. This order, sparked in part by a conversation with podcaster Joe Rogan, signals a significant shift in federal drug policy. Most psychedelics remain classified as Schedule I by the Drug Enforcement Administration, the most restrictive category for substances deemed to have “no currently accepted medical use and a high potential for abuse.”
The FDA's decision aligns with broader administration efforts to address mental health challenges, particularly among veterans. The move also comes amid other policy shifts, including Trump's psychedelics order and ongoing debates over drug policy reform.
