Could psilocybin be the first FDA-approved psychedelic? Australia to fund psychedelic-assisted therapy for veterans; No differences between microdosing and placebo for mood and cognition
Plus: AtaiBeckley merger completed, and Psychedelic use in the real world
Happy Friday and welcome back to The Microdose, an independent journalism newsletter brought to you by the U.C. Berkeley Center for the Science of Psychedelics.
Could psilocybin be the first FDA-approved psychedelic?
On Tuesday, British psychedelics company Compass Pathways announced that they’ve accelerated the timeline for the commercial launch of using their formulation of synthetic psilocybin, COMP360, by 9 to 12 months.
The company released preliminary results in June indicating that COMP360 decreased depression symptoms. In a press release summarizing the company’s most recent earnings call, the company said they’d had “positive” meetings with the U.S. Food and Drug Administration in September, and that they plan to release data from COMP005, a Phase 3 trial, early next year, as well as some data from COMP006, another Phase 3 trial.
After that, Compass “may begin a rolling submission in alignment with the FDA,” the company’s CEO Kabir Nath told The Microdose. “We now expect the 26-week readout from COMP006 in early Q3 2026, and we anticipate that dataset will be the final component to complete our NDA package for COMP360 in treatment-resistant depression. We are very encouraged by FDAs support of our TRD program and excited to advance our mission to transform the mental health landscape.” Given that the FDA takes 6 to 10 months to review new drug applications, this new timeline could mean COMP360 approval sometime in 2027.
After Lykos’s new drug application for MDMA was not approved by the Food and Drug Administration last summer, industry insiders have been looking to Compass as the psychedelics company most likely to seek a new drug approval. Atai’s former CEO Florian Brand posted on X that the news is “a clear sign that the FDA remains pragmatic, flexible and forward-leaning on evidence-based innovation in mental health.” Christian Angermayer, atai’s other co-founder and an early Compass founder, called the news “one of the clearest signs that we are truly entering the age of psychedelic medicine.”
Australia to fund psychedelic-assisted therapy for veterans
Last Friday, Australia’s Department of Veterans’ Affairs announced that it would provide funding for veterans to receive MDMA-assisted therapy to treat PTSD, and psilocybin-assisted therapy for treatment-resistant depression. The country surprised psychedelic insiders in 2023 when it announced that it would begin allowing authorized psychiatrists to deliver psychedelic-assisted therapy.
According to 2021 census data, there are around 600,000 veterans in Australia. In the Department of Veterans’ Affairs announcement about their decision, the agency said that not all veterans diagnosed with PTSD or treatment-resistant depression would be eligible; rather, they will need to be assessed by providers for approval. Moreover, individuals cannot self-fund treatment, and their provider must request funds from the department for treatment.
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No differences in mood and cognition between microdosing and placebo
While many people say microdosing improves their mood, well-being, or productivity, results from two double-blind trials suggest that a placebo produces similar improvements. In a paper published recently in Neuropharmacology, participants received either microdoses of psilocybin mushrooms, or a placebo pill that contained inert cellulose or non-psychedelic mushrooms. Before beginning the study, researchers measured participants’ performance on cognitive tests and found that there were no differences between the placebo group and the microdose group after participants received their doses. There was also no significant difference in participants’ ratings of pleasure or arousal.
However, the researchers say that most participants reported feeling some kind of subjective effect, and that 48% of participants who reported symptoms were in the placebo condition. That included two participants in the placebo condition reporting “strong adverse reactions, including flashbacks, extreme insomnia, and intense emotional experiences.” Microdoses are meant to be sub-perceptual,meaning they don’t cause common psychedelic effects like hallucinations. In this study, when researchers asked participants to guess whether they received a microdose or placebo, their guesses were no better than chance.
The results suggest that expectation makes substantial contributions to the effects of microdosing, and, in the authors’ words, “contribute to the growing number of placebo-controlled studies [of microdosing] that report inconsistent findings regarding cognitive and emotional benefits.”
AtaiBeckley merger completed
On Wednesday, atai Life Sciences and Beckley Psytech announced that their merger was complete: the company is now AtaiBeckley.
The two companies first announced their merger plans in June, pending results from a Phase 2B study using BPL-003, a synthetic nasal form of 5-MeO-DMT, for treatment-resistant depression. Preliminary results from that study were released in July, and 12mg and 8mg doses of BPL-003 reduced participants’ depression scores significantly more than a 0.3mg (placebo) dose. Three weeks ago, BPL-003 received Breakthrough Therapy designation from the U.S. Food and Drug Administration.
According to the company, AtaiBeckley expects to meet with the FDA to discuss its Phase 3 trials for BPL-003 soon, and that those trials could begin in mid-2026.
Psychedelic use in the real world
Psilocybin use in the United States has “sharply increased,” according to a new review published in JAMA Psychiatry, and alongside it, psychedelics-related poison control center calls have surged as well. According to poison control center reports, people have taken a psychedelic together with another substance in approximately 30% of cases; those substances are typically either cannabis or alcohol, and 85% of those cases resulted in hospitalization.
The authors, researchers at the University of Colorado Anschutz Medical Campus, argue that more research is necessary to better understand how psychedelics interact with other drugs. Such research could also improve public health approaches to keeping people safer. The researchers also recommend potency testing to better inform consumers. Cannabis, they say, is a good comparative case study: while the potency of cannabis flower in 1995 was about 4% THC, it’s now more than 20%. Similarly, the potency of psilocybin containing mushrooms can vary widely; the researchers cite data from Oakland Hyphae, whose analyses found that some samples had more than 20-fold more psilocybin content than others.
The researchers also identify an understudied aspect of psychedelics: the effects of naturally occurring, whole psilocybin mushrooms, rather than the synthetic compounds currently being developed and studied by psychedelic pharmaceutical companies. (Last week, Phoenix NPR affiliate KJZZ reported that a study using whole psilocybin mushrooms will soon be underway in Arizona.)
“The purpose of this review is not to advocate for stricter laws or greater enforcement of psilocybin or psychedelic use outside the clinic,” the authors conclude, “but rather to underscore the urgent need for new research programs to address the public health implications of a social environment that is already promoting greater use of psilocybin and other psychedelics.”
The FDA’s rejection of Lykos’s new drug application for MDMA is an opportunity, writes consultant Jama Pitman in an op-ed for STAT. “This moment is less a dead end than an opportunity to learn from the Lykos experience and move the field forward,” she says, suggesting that future studies employ better trial design, full safety disclosures, and long-term observation.
Last week, the non-profit National Security Archive, based on the George Washington University campus, published newly declassified transcripts from closed-door 1975 hearings in which Sidney Gottlieb, who worked on the government’s MK-ULTRA mind control experiments, testified about the government’s disturbing LSD research projects.
This week, the Psychedelic Access and Research European Alliance (PAREA) sent a letter to Ursula von der Leyen, President of the European Commission, calling on the commission to launch a “mental health moonshot” that would support research into novel therapies like psychedelics.
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