Legislation, Industry, and the Future of Psilocybin for PTSD
One of the most widely known psychedelic compounds in the world, psilocybin has been investigated in thousands in clinical trials focused mostly on treatments for depression and anxiety. That changed last month with the FDA’s announcement that it would approve a new proposal to study psilocybin assisted therapy for post-traumatic stress disorder (PTSD).
On January 7, 2026 the FDA accepted Compass Pathway’s Investigational New Drug Application for their COMP360 compound with a PTSD indication. Compass Pathways has been investigating COMP360, a synthetic psilocybin formulation, as a possible therapy for treatment resistant depression. With this recent approval, Compass Pathways will now expand their COMP360 drug to a PTSD indication and begin late-stage trials.
“The limited treatment options and the long absence of innovation in PTSD demands bold action,” Dr. Guy Goodwin, chief Medical Officer of Compass Pathways, said. “At Compass Pathways, we are prioritizing a PTSD program that could bring hope to millions of patients and their families. We are pleased that the FDA has accepted our IND application for COMP360 in PTSD, enabling the initiation of a late-stage trial.”
This IND application is in partnership with Radial Health – an organization working to build a national network of clinics to provide access to FDA-approved treatments for mental health conditions. The company works with a variety of medical-device and pharmaceutical companies to understand how these treatments are working in a clinical trial setting and optimize the delivery of these interventions to consumers post-approval.
“Our view is that psychiatry is undergoing this profound shift towards far more rapid acting treatments that include neuromodulation devices and rapid acting medications,” John Capecelatro, co-founder and CEO at Radial Health, said. “As we think about COMP360 and the broader psychedelic medicine pipeline we have a tremendous amount of interventions coming down. Our perspective is that in order to ensure those treatments are available to as broad a number of consumers, as safely and effectively as possible, we have to spend meaningful time upfront. This includes understanding how they’re expected to work in an outpatient setting such that we can build the right specific tooling and care protocols around each of these treatments.”
This Compass Pathways sponsored trial is only one of few clinical trials investigating a version of psilocybin for PTSD. The company’s investigation will be a multicenter, randomized, double-blind, controlled study with an open label extension to assess the efficacy, safety, and tolerability of COMP360 in participants with PTSD. The Compass Pathways trials differ from other psychedelic clinical trials in that they do not have a focus on psychological support or psychedelic-assisted therapy.
There are other studies assessing psilocybin as a possible treatment for PTSD, including one that was recently completed at Johns Hopkins University. This study was also a randomized controlled trial assessing the efficacy and safety of two doses of psilocybin for PTSD with psychological support.
“The results so far are very good and it appears safe,” said Dr. Sandeep Nayak, Assistant Professor at Johns Hopkins University. “In our trial, there has not been a clear added utility of the second dose. I suspect, and this is the basis for a new study we are setting up, that a single dose of psilocybin will be more effective than a single dose of MDMA.”
The Legal Landscape of Psilocybin Decriminalization
As the federal government moves psilocybin research forward, some state initiatives are also seeking to decriminalize the use of psilocybin mushrooms for those with PTSD. Earlier last year in Michigan, House Bill 4686 was introduced by District 14 Rep. Mike McFall (D), specifically to decriminalize psilocybin for those with a post-traumatic stress disorder (PTSD) diagnosis. This bill, along with many other local initiatives, have been pushing Michigan lawmakers to engage with advocates on decriminalization.
One such organization is the Decriminalize Psilocybin Michigan (DPMI) organization working to promote public education and policy changes through coalition building and creating educational materials at all levels. Currently, DPMI is working experts across the state and the state legislature to provide information on psilocybin that will hopefully inform lawmakers to pass decriminalization measures for more than just a PTSD diagnosis.
“One thing that unites all communities across all spectrums in the United States and even the broader global community is we all have trauma,” Michelle Donaldson, Co-Director of DPMI, said. “A bill like what Representative McFall put out, while it is limiting to PTSD, it’s a foot in the door. If we can prove concepts and dispel fears and stigmas around these medicines, then we can hopefully open up broader access.”
In December last year, lawmakers in Massachusetts voted to advance House Bill 2532, a bill establishing a framework for psilocybin therapy, alongside a new draft of House Bill 2506, a measure designed to legalize the use of psilocybin specifically for veterans, law enforcement officers and qualifying patients. House Bill 2506 was drafted by Graham Moore and Jamie Morey of the advocacy group Mass Healing, in collaboration with Rep. Steven Owens (D).
This group of bills establishes both a medical model for psilocybin therapy and a pathway for decriminalization. House Bill 2506 uses language that is largely missing from other bills, developed by collaborating with researchers to create a set of standards that can be adapted as more evidence is available.
“Uniquely, in terms of legislation across the country,” said Moore, “It’s [House Bill 2506] the only legislation that in statute defines a qualifying condition using objective scientific standards. I worked with a psychiatrist, doctors and pharmacists to do this intelligently and we came up with some disqualifying conditions and the need for diagnosis, and more.”
New Jersey is also following suit taking a standardized approach to psilocybin legislation, but instead of focusing on access, Senate Bill 2283 creates a pilot program strictly based on medicalization. The Psilocybin Behavioral Health Access and Services Act will work with hospital systems and allow psilocybin treatments that strictly follow FDA-guidelines and will report outcomes to lawmakers during a two-year period. This bill will likely allow for alignment with medical products, such as synthesized psilocybin, rather than natural mushroom products.
Why Psilocybin?
While there is a lack of empirical evidence supporting psilocybin-assisted therapy for PTSD, the data for psilocybin in other indications such as depression and anxiety is promising. Since 2018, psilocybin has been granted Breakthrough Therapy Designation for treatment resistant depression (TRD), specifically related to COMP360.
There are many reasons for the legislative momentum behind psilocybin therapies including the natural origins of the fungi, the data supporting other mental health indications, and possibly targeted information either from patient advocates, drug companies, or lobbyists.
The psychedelic field has largely focused on MDMA for treatment of PTSD largely in veteran populations. This is unsurprising given that according to the U.S. Department of Veterans Affairs, 29% of veterans will experience PTSD in their lifetime compared to just 6% of the general population. There has been debate over whether the data supports MDMA-assisted therapy for PTSD and the FDA denied an application for MDMA-assisted therapy from Lykos Therapeutics in 2024. Nevertheless, established clinical trials involving MDMA-assisted therapy for PTSD, supported for years by the MAPS nonprofit organization, established investigations into psychedelics as possible therapies for this condition..
“Politicians are not fully aware of the differences between various psychedelics,” said Dr. Berra Yazar-Klosinski, Founder & CEO at Yazar Lab and former Chief Scientific Officer at for-profit MAPS Public Benefit Corporation which carried the studies of MDMA-assisted therapy forward. “They are the recipient of targeted information from drug companies and patient advocates. However, scientists are not often involved in those conversations so they are not able to provide an assessment of the quality of evidence supporting claims.”
Yazar-Klosinki has first-hand experience in attempting to bring a drug to market. She also criticized the way drug companies communicate indications and scientific research. “Drug companies are communicating potential uses pre-approval and not always following the rules of scientific exchange,” she explained. “This includes the requirement to limit potentially promotional statements that lack balance between benefit-risk and also can overstate the status of the science in favor of raising money in order to actually do the science.”
On the other hand, many have criticized the U.S. drug policies for impeding progress on neurotherapeutic advancement. Psychedelics, including psilocybin, are classified as Schedule I meaning they have no FDA-approved medical value and high potential for abuse. Yet, these substances are increasingly difficult to research under provisions of the Controlled Substances Act. This act requires researchers to obtain specific registration to study these substances and comes with stringent regulations once that registration is obtained.
“You can’t say something has no known medical indication if you can’t test the medical indication because of the barriers of research access,” Victoria Cvitanovic, an attorney at Rudick Law Group who focuses on psychedelics and medical cannabis, said. “It gets massively easier to get data when things are legal or have a pathway to access. I don’t think the scientific community can have a complete answer to these questions in the environment of prohibition that we’re living in.”
Is Research Catching Up?
Anecdotal reports have a powerful impact on legislative decisions. Those who have used these compounds have described psychedelic experiences as the most impactful and meaningful experiences of their lives. The question remains: why hasn’t research caught up?
“The anecdotal reports from people should be an indicator we should be researching this,” Cvitanovic explained. “We need to start thinking about how we can get that data and provide evidence of whether or not these anecdotal stories are supported? Additionally, it’s incredibly challenging to be faced with the data we do have and the powerful anecdote from the person who is also a voter. Instead of criticizing an imperfect bill because the science isn’t there, scientists should be using it as an opportunity to find research gaps.”
Additional barriers impacting the ability of scientific research to play catch-up could be the stigma surrounding Schedule I substances and mental health. Many people, including some veterans, may not feel comfortable participating in clinical trials and would rather self-medicate without a public record of participation. For others, however, these trials are the only way that they can get the help they need which can increase participation.
“We have launched a new study exclusively for veterans called PAMVET, MDMA plus psilocybin for PTSD in veterans, and it has so far been our fastest enrolling clinical trial ever,” Dr. Nayak said. “There is quite a lot of anecdote and some observational research on other psychedelics, particularly ayahuasca, but I agree there’s little data on psilocybin for PTSD. Many people, including many participants who come to us, assume that it’s been very well studied and there’s lots of good evidence for it but it’s not true yet.”
The expectations surrounding these psychedelic-assisted treatments continue to arise in conversations surrounding data interpretation. With so much discussion about psilocybin legislation, breakthrough therapies and mental health treatments, many organizations are working to address this in their own day-to-day work.
“We’re about to start polling our decriminalized municipalities and counties for metrics of what’s happening in the hospital system, the emergency rooms, instances where arrests are being made,” said Donaldson of DPMI. “If we had these statistics right now, it would really lend to the argument people are trying to get across or what they are trying to portray [with psychedelics]. The more knowledge that we collect, the more statistics that we have, it just bolsters the legitimacy of decriminalization and access.”
Despite the lack of data supporting the use of psychedelic therapies for specific indications, people who use these substances continue to seek out practitioners and share their stories. Throughout history, the medical and legal landscape has promoted people who are most vulnerable as the face of their movements, but these individuals sometimes get left behind after the outcome is reached, often due to the cost of medicalized therapies.
This is why many advocates continue to promote decriminalization of naturally occurring psychedelics such as psilocybin mushrooms, whether or not the data is there to support it. By allowing psilocybin to be accessed without fear of criminalization, people that wouldn’t normally be able to access it via medical systems have an avenue for access.
“One thing we need to implement is a harm calculus,” Cvitanovic said. “How harmful is it really for a person with PTSD to have a guided psilocybin experience? If it’s not that harmful, the data for that indication not being there shouldn’t be that big of a deal. We need to take into consideration the fact that people are deeply deeply moved to advocate for this and haven’t experienced harm.”
While state legislation for access to psychedelics continues to gain momentum across the U.S., new studies investigating psilocybin for PTSD could provide the data needed to support access to a range of therapies.