Federal Support for U.S. Psychedelic Research Accelerates 5-MeO-DMT Clinical Trials
During the last few weeks of 2025, President Trump officially signed a major executive order rescheduling cannabis as a Schedule III substance under U.S. federal law. This sweeping reform finally allows for cannabis and its potential medical applications to be more comprehensively studied through clinical trials. Trump’s rescheduling of marijuana may kick off a red letter year for not just medical cannabis reform and research, but also for more extensive research into psychedelic compounds with medical potential.
In previous years, local municipalities across the U.S. have decriminalized psilocybin and progressive states such as Oregon have authorized psilocybin for therapeutic use. Several other states are moving toward, or have already filed legislation to reschedule or start psilocybin therapy pilot programs and clinics.
Within the first few days of 2026, another significant reform occurred when the U.S. Food and Drug Administration lifted the two-year clinical hold on an Investigational New Drug (IND) application for a potential inhalable medicine produced from 5-MeO-DMT. Made by the Dublin-based GH Research, their DMT-based formulation GH001 is being investigated as a possible treatment for a condition known as Treatment-Resistant Depression.
Even prior to the groundbreaking decision by the FDA, GH001 had already seemed promising from a research standpoint. In a phase 2b clinical trial that started in 2023 structured as a randomized, double-blind, placebo-controlled investigation, GH001 “demonstrated a -15.5 point reduction on the Montgomery-Åsberg Depression Rating Scale (MADRS) compared to placebo on Day 8, with 57.5% of patients in remission” according to the findings.
Similar to Trump’s executive order on cannabis, the lifting of the clinical hold on GH001 is monumental and may create ripple effects that stretch beyond just another form or application being approved by the FDA.
“The progression of the GH001 clinical trial represents an important step forward for psychedelic-assisted medicine, particularly for conditions like depression where conventional approaches sometimes fall short,” explained Kim Anzarut, Founder of Allay Consulting, a cannabis and psychedelics-based consulting firm in Oregon.
Expansion of Clinical Trials Rests on Bipartisan Initiatives
Together with other compliance advisors observing these shifts, Anzarut says the clinical trials that are now permitted are vital for gathering information about the potential medical efficacy of GH001 and possibly other 5-MeO-DMT-based substances.
“This kind of controlled research gives regulators, clinicians, and patients credible data to evaluate safety and efficacy,” says Anzarut. “If supported by further evidence, trials could help normalize psychedelics as legitimate therapeutic options rather than just fringe experiments.”
“Seeing the FDA lift clinical holds to allow advanced trials like GH001 demonstrates how psychedelic research is finally being upgraded to conventional regulatory pathways. It shows the need for companies in this space to invest early in compliance, quality systems, and documentation. These are the key foundations that support drug development programs in other regulated industries.”
As the federal movement towards expanded research into psychedelic assisted therapies gains momentum, embrace of this legislation continues to be a rare bipartisan effort.
Three years ago, Texas Rep. Dan Crenshaw filed the The Douglas Mike Day Psychedelic Therapy to Save Lives Act of 2023 which would have “required the Department of Defense (DOD) to award grants to eligible entities to research the treatment of certain members of the Armed Forces through the use of specified psychedelic substances (e.g., MDMA).” Specifically, the research would have been focused on active-duty soldiers who have been diagnosed with either PTSD or some type of traumatic brain injury. Named after one of Crenshaw’s fellow Navy SEALS who tragically took his own life, this bill was geared towards veteran health.
While the proposed legislation was ultimately unsuccessful, HR 3684 had many bipartisan co-sponsors that disagreed with Crenshaw on many other issues, most notably Rep. Alexandra Ocasio Cortez. Those who follow U.S. politics understand the strength of a bipartisan initiative when Reps. Crenshaw and AOC join to co-sponsor a bill.
Since 2023, many more bills and attempted amendments to support research into psychedelic therapies have been filed, some of which would have allotted funding of clinical trials and several more geared towards veterans. Interestingly, some of this proposed legislation was filed by two of Crenshaw’s fellow retired Navy SEALs in the battlefield of the U.S. Congress; Reps. Morgan Luttrell (R-TX) and Derek Van Orden (R-WI).
In 2024, Van Orden authored H.R 7347, which would have required the Secretary of Veterans Affairs to create and provide reports on whether psychedelic drug treatments will be included in the VA formulary after receiving FDA approval. In 2025, Luttrell joined many other veterans who currently serve on both sides of the Congressional aisle and co-sponsored H.R. 2623 which would have designated the VA to construct at least five facilities which would focus on meticulously researching and possibly administering certain psychedelic therapies.
Legislation Propels Ongoing Research
The approval for clinical research into GH001 will further propel ongoing research into the potential therapeutic benefits of 5-MeO-DMT. A combined research initiative by pharmaceutical companies atai Life Sciences and Beckley Psytech, known as ataiBeckley, received a Breakthrough Therapy designation by the FDA on their own intranasal (5-MeO-DMT) benzoate for Treatment-Resistant Depression back in October. With this designation, development and research of BPL-003, an intranasal spray containing 5-MeO-DMT, can be expedited.
This Breakthrough Therapy designation follows a Phase 2b core, blinded study which demonstrated that “a single administration of 8 mg or 12 mg of BPL-003 led to clinically meaningful and statistically significant reductions in depressive symptoms within 24 hours, with effects sustained through the eight-week trial period” according to the findings.
Moreover, the research found that study subjects were ready to be discharged at the 90-minute post-dose assessment period, meaning that BPL-003 could be administered over ideally a 2-hour therapy session.
Cosmo Feilding Mellen, Chief Executive Officer and Co-Founder of Beckley Psytech, said in the ataiBeckley press release that, “Receiving Breakthrough Therapy designation is a significant milestone which highlights the potential of BPL-003 to address the urgent unmet need of patients whose depression is not helped by existing therapies. We believe the Breakthrough Therapy designation supports the strength of our clinical data and, importantly, it will help to ensure the pivotal Phase 3 clinical program will be as expedited and efficient as possible, guided by the FDA.”
FDA approval for critical trials investigating potential new therapies based on 5-MeO-DMT by two different companies is a significant step forward. 2026 could be a monumental year for the investigation of psychedelic assisted therapies and their potential for treatments that surpass current medications.
“The potential for compounds like GH001 to help people with depression is one of the most compelling reasons to support evidence-based psychedelic research,” says Anzarut. “What we’re seeing with this study may show an upcoming broader shift in psychiatric medicine, not just promising signals from small studies, but clinical frameworks that can carry these therapies through regulation and then to patients that need them the most. These treatments could become the next generation of effective care, with the potential to save more lives.”