The US Food and Drug Administration has awarded three additional Commissioner’s National Priority Vouchers under its accelerated regulatory framework, targeting companies developing psychedelic-based therapies. The move follows President Donald Trump’s April 18 executive order aimed at advancing mental health treatment innovation. While the agency did not officially disclose the recipients, industry sources identified them as Compass Pathways, Transcend Therapeutics and Usona Institute. Among them, Compass Pathways has publicly confirmed its inclusion. Each of the companies has previously secured Breakthrough Therapy Designations, positioning them within the FDA’s accelerated review ecosystem under the Priority Voucher initiative.
The announcement underscores a broader federal push to expand access to emerging psychiatric treatments. “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,” HHS Secretary Robert F. Kennedy Jr. said in a statement. “The FDA will prioritise therapies with Breakthrough Therapy designation, where early evidence shows meaningful improvement over existing options for serious mental illness.” Compass Pathways, currently advancing two Phase 3 trials of its synthetic psilocybin candidate COMP360, is widely viewed as one of the most advanced players in the field. “We are honoured 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 CEO Kabir Nath. “As the most advanced company in the classic psychedelics field, Compass has generated positive data from two large, well controlled Phase 3 clinical trials. Based on the strength of our data, the FDA granted us a rolling NDA submission and review. Importantly, while the CNPV may provide process efficiencies and accelerated review timelines, an NDA submission must still meet FDA’s established standards of clinical evidence, scientific rigour, and regulatory compliance. We are confident we meet these standards.”
Further insight into Compass Pathways’ regulatory engagement highlights continuity within the agency. “Some of the turnover in FDA leadership and other changes within FDA notwithstanding, the psychiatry division, which is the division that we work with, has remained intact over the years,” said Steve Levine. “The people we meet with today are the same people we were meeting with a few years ago. We have a very good relationship with the psychiatry division. They’ve been very responsive, very supportive. So again, whatever other noise or chaos there may be out there, we feel very good about the relationship that we have with the psychiatry division.” The company expects to submit Phase 3 data by early Q3 and is targeting a potential commercial launch by year-end under the Priority Voucher pathway.
Meanwhile, Transcend Therapeutics is progressing its methylone-based PTSD treatment TSND-201, which is also included in the voucher allocation and currently undergoing Phase 3 studies. The company recently confirmed its acquisition by Otsuka Therapeutics. The Usona Institute is similarly advancing late-stage trials, focusing on chemically synthesised psilocybin for major depressive disorder. Separately, the FDA confirmed approval of an investigational new drug submission for DemeRx, which is developing noribogaine for alcohol use disorder, aligning with policy emphasis on ibogaine-based treatments.
