April 24, 2026
3 min read
Key takeaways:
- Three companies will receive national priority vouchers to study psilocybin and methylone.
- Industry and academia will collaborate to develop endpoints for validating drug efficacy.
Since President Donald J. Trump’s executive order to increase access to psychedelics and other alternative therapies for mental health, HHS has announced new regulatory actions and funding to support the development of these drugs.
“While there are a number of available therapies for various illnesses such as depression, substance use disorder and PTSD, many people do not respond well to these therapies,” Frederick S. Barrett, PhD, director of the Center for Psychedelic and Consciousness Research at Johns Hopkins Medicine, told Healio.
Many patients with depression, substance use disorder, PTSD and other mental illnesses do not respond well to current treatment, prompting a need for alternatives. Image: Adobe Stock
“The promise of psychedelic therapies is that they seem to have the potential for some people to rapidly address these psychiatric illnesses, and for some people these effects are very long lasting,” he said.
FDA will issue national priority vouchers to three companies that are studying psilocybin for treatment-resistant depression and major depressive disorder as well as methylone for post-traumatic stress disorder.
“The national priority voucher program has the potential to really speed up the review of new drug applications from companies that have conducted the appropriate trials to determine the safety and efficacy of these drugs,” Barrett said. “This could really push the most promising therapies to the front of the line for FDA review.”
Also, FDA has permitted DemeRx NB to begin a phase 1 clinical study of noribogaine hydrochloride in treating alcohol use disorder following its investigational new drug submission. HHS this the first time that FDA has allowed a clinical study of an ibogaine derivative.
“Ibogaine is the compound that we really know the least about out of all the psychedelic drugs, and it’s one of the only psychedelic drugs that has a real, known cardiotoxic risk,” Barrett said.
These risks require extensive screening and monitoring during treatment, and they have made ibogaine “nearly impossible to study” in the United States, with carefully controlled clinical trials.
“There’s a lot of excitement about ibogaine, but we need to temper that with the reality that it is a risky compound, and we still know quite little about it from a scientific perspective,” said.
The Advanced Research Projects Agency for Health (ARPA-H) has announced the first set of research teams participating in the Evidence-Based Validation & Innovation for Rapid Therapeutics in Behavioral Health (EVIDENT) initiative as well.
With up to $139.4 million in funding, EVIDENT will generate FDA-ready clinical endpoints to validate the effectiveness of digital interventions, neuromodulation, neuroplastogens such as psychedelics, and other rapid-acting therapies.
“ARPA-H is building the measurement science that can finally show what’s happening inside the body when someone is under treatment,” HHS Secretary Robert F. Kennedy Jr. said in a press release. “Through this data, we’ll be able to match the right treatment to the right person and know how an individual will respond before it begins.”
the researchers build the first generation of scalable, objective measures of behavioral health, providers will be able to move toward precise, personalized, data-driven care and away from trial-and-error approaches to validation. Additionally, these measures will accelerate approval and reduce development costs.
research teams will ask what should be used for objective measurement, what happens during treatment, who will respond to what treatment, and what the shared data foundation is.
“The EVIDENT program in parallel is promising to really help kickstart a much richer and more complete data collection and set of research projects to better understand how to target these therapies to the individuals for whom they might work most effectively,” Barrett said.
Participants so far include nine corporations and five universities.
- Attune Neurosciences will share findings from its studies of low-intensity focused ultrasound for chronic pain and depression.
- INVI MindHealth will contribute data about its platform for real-time objective biomarkers designed to serve as endpoints for rapidly determining the efficacy of neuromodulation and psychedelic treatment.
- The University of Wisconsin will offer results from three trials of psilocybinthe University of California will share findings from a trial of psilocybin therapy vs mindfulness trainingand Johns Hopkins University School of Medicine will share results from eight clinical trials investigating the use of psilocybin.
“We’re at the early stages of getting the project up and running, but over the next 2 years, we expect to collect a wide range of measurements and biomarkers from a number of people who are undergoing experimental clinical trials to basically help to better characterize who may respond well to these treatments,” Barrett said. “That will inform further research on what we might be able to do to optimize the delivery of these interventions.”
Barrett noted that psychedelics have not been approved for any indications and are only available as part of clinical trials, where their efficacy, safety and delivery are still being determined.
“It’s important that we let this process continue,” he . “If and when any of these compounds are approved as medicine, the next steps will be coming up with the right structure and infrastructure, really, to make these interventions available in a safe and responsible manner.”
For more information:
Frederick S. Barrett, PhD, can be reached at fbarrett@jhmi.edu.
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