9 of 12 veterans reach remission from PTSD in new trial

THE DISPATCH

A new pilot trial out of Ohio State University just reported something this newsletter told you plainly didn't exist three weeks ago: real outcomes data for psilocybin as a dedicated treatment for severe, treatment-resistant PTSD in veterans. Thirteen veterans enrolled, twelve completed two psilocybin sessions each, and nine reached full remission one month later, an early signal in the exact population this newsletter's clinician and patient readers ask about most. It is one pilot, not a body of evidence: establishing that this treatment works will still take years and hundreds more patients.¹ The veterans in this trial are the leading edge of a treatment model that does not yet have a name. It will take much more data to get there.

In this issue:

→ What the new Ohio State pilot trial found, and what its small size still leaves open

→ An independently run veteran retreat program reporting a similar signal at a larger scale

→ MDMA's second attempt at FDA approval for PTSD, and where Compass Pathways' own regulatory filing stands

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THE SCIENCE

On July 30, 2026, researchers at The Ohio State University's Center for Psychedelic Drug Research and Education (CPDRE) published an open-label pilot trial reporting real clinical outcomes, not just safety, for psilocybin-assisted therapy in veterans with severe, treatment-resistant PTSD.¹ Thirteen veterans enrolled; one withdrew before the first dosing session, leaving 12 who completed two psilocybin sessions two to three weeks apart, 15 milligrams followed by 25 milligrams, alongside roughly 16 hours of preparation and integration therapy.¹ Nine of the 12 (75 percent) met criteria for full remission on the clinician-administered CAPS-5 scale one month after their second session, and 10 of the 12 (83 percent) showed a clinically meaningful symptom reduction.¹ The average CAPS-5 score dropped by 27.5 points from a baseline of 39.7, a Cohen's d of 2.30, an effect size treatment-resistant conditions rarely produce in any modality.¹ Self-reported symptoms on the PCL-5 fell even further, with meaningful improvement already visible one week after the second session.¹ No serious adverse events were reported, and the most common side effects, headache, anxiety, and dizziness, were mild and resolved within a week.¹ A sample this size is not statistically powered to detect rare or delayed adverse events, a limitation the study's own authors note.

Three weeks ago, this newsletter covered the first Phase 2 trial built specifically to test psilocybin's safety in PTSD as a primary diagnosis, and noted plainly that full efficacy data for a dedicated PTSD treatment did not yet exist. This is that data, earlier and smaller than a Phase 2 readout, but real. The trial is open-label and unblinded, and it enrolled just 13 people who volunteered and passed a rigorous screening process, which means the results describe what happened in a specific, self-selected group rather than what would happen across a broader, randomized population. The researchers are careful about this themselves: the paper's own limitations section names the small sample, the absence of a control group, and the short one-month follow-up window as real constraints on what can be concluded. What the trial does establish credibly is that a structured, two-dose psilocybin protocol delivered inside a real therapy framework produced a large, measurable symptom reduction with no serious safety signal, in a population that had already tried and failed standard treatments for years. That is precisely the evidence a larger, controlled trial gets built around next, and it arrives just as the FDA's own updated guidance on how to design that next trial, covered in this issue's Radar, starts reshaping how sponsors build them.

The honest reading: PTSD-specific psilocybin therapy now has a safety trial and an outcomes trial, run independently of each other, both pointing the same direction, and neither large enough to stand alone. A dedicated, randomized, controlled Phase 2 efficacy trial is the next real threshold. Until then, this pilot is the strongest outcomes signal available for a population this newsletter tracks closely and cannot afford to overstate results for.

A separate, independently run veteran program outside the clinical trial system reported a similar pattern this year, at a larger scale.

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THE STORY

Since 2023, the program has hosted eight veteran-focused retreats through a partnership with the SEAL Future Foundation, serving 80 veterans through a structured six-day protocol built around two supervised psilocybin sessions and medical oversight.² Ninety percent of participants reported significant relief and lasting benefit, a self-reported figure from a program operating entirely outside a clinical trial, with none of the controls or standardized outcome measures the Ohio State pilot used.² It carries none of the rigor of a clinical trial, but real-world programs like this carry a different kind of value: high ecological validity, real veterans in real circumstances, outside the controlled conditions a trial protocol requires. At a larger scale than any trial run so far, it points in the same direction: veterans with treatment-resistant conditions reporting outcomes that standard care had not delivered.

Rose Hill Life Sciences is a psychedelic research organization – specializing in the production and research of Psilocybe cubensis operating at the intersection of science and therapeutic integration.

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ON OUR RADAR

① MDMA's Second Attempt at FDA Approval On August 10, 2026, Resilient Pharmaceuticals resubmitted its FDA application for MDMA-assisted therapy in PTSD, two years after the agency's 2024 rejection of the same therapy under Lykos Therapeutics.³ No new Phase 3 trial was run. Instead, the resubmission draws on third-party data, including a small VA study with long-term follow-up, and a new Phase 1 safety study in 32 healthy volunteers, addressing the concerns that drove the original rejection.³ Whether the agency accepts it will say as much about the psilocybin trials now being built under the FDA's evolving standards as it does about MDMA.

② Compass Pathways' Rolling NDA Moves Forward Compass Pathways confirmed on August 5, 2026 that its rolling FDA application for synthetic psilocybin (COMP360) in treatment-resistant depression is underway, backed by two completed Phase 3 trials showing improvement sustained through six months.⁴ A National Priority Voucher awarded earlier this year could shorten the review window substantially. The company reported $433.3 million in cash as of June 30, 2026, funding it says covers a targeted first-half 2027 launch and beyond.⁴

③ HHS and VA Sign a Five-Year Psychedelics Pact On July 13, 2026, HHS and the VA signed a five-year agreement to expand veteran participation in psychedelic trials, train clinicians for future FDA-approved rapid-acting therapies, and share real-world safety data with regulators.⁵ The partnership covers four compounds under study, MDMA, ketamine, ibogaine, and psilocybin, with ibogaine for opioid use disorder as the near-term focus.⁵ It is a structural commitment, not a new trial, the kind of groundwork that determines how fast an approved therapy actually reaches veterans.

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YOU ASKED

Q: "A patient with treatment-resistant PTSD asked me about the new Ohio State psilocybin data. What do I actually tell them?"

Tell them what the trial shows and what it doesn't. Twelve people completed treatment, of 13 who enrolled, all volunteers who passed a rigorous screening process, and saw a large, statistically significant reduction in PTSD symptoms with no serious safety signal, a real and encouraging result. It is not proof the treatment works broadly: there was no control group and no comparison to a placebo or an active treatment, so some of what participants experienced could reflect expectation, the intensive therapy component, or simply time passing. The most accurate thing you can tell a patient is that this is a promising early signal in exactly their diagnosis, not yet an established treatment, and that the trial designed to answer the harder question, a randomized, controlled Phase 2 study, is the one worth watching for next.

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This week's takeaway: supervised, legal psilocybin access already exists in Oregon and Colorado, and it hasn't yet translated into anything a VA provider can prescribe, refer to, or bill for. The VA's own trial, evaluating the same compound at nine of its facilities, enrolled its first veteran this year, the start of the pathway that could close that gap.

This week's takeaway: a small but rigorously run pilot trial just reported that 9 of 12 veterans with severe, treatment-resistant PTSD reached full remission after psilocybin-assisted therapy, the first outcomes data of its kind in this population. It is preliminary, not proof, and the next trial to add a control group will tell us whether the signal holds.

A question worth sitting with: how much weight should a result this size, this early, carry with a patient who has already run out of standard options?

Read the study directly: Communications Medicine: Safety, feasibility, and preliminary clinical outcomes of psilocybin-assisted therapy for veterans with severe, treatment-resistant PTSD

Know a veteran still cycling through treatments that aren't working? Forward them this, not as a recommendation, as information they deserve to have.

— Rotem Petranker

PhD, Clinician and Psychedelic Researcher

Advancing the development of novel psychedelic-based therapeutics

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FOOTNOTES

¹ Armstrong, S.B., Levin, A.W., Sepeda, N.D., Shaub, H., Hunter, T., Douglas, A., Lancelotta, R., Davis, A.K. "Safety, feasibility, and preliminary clinical outcomes of psilocybin-assisted therapy for veterans with severe, treatment-resistant PTSD: an open-label pilot clinical trial." Communications Medicine, July 30, 2026. https://www.nature.com/articles/s43856-026-01767-4

² GlobeNewswire / ONE Retreats. "ONE Retreats' Transformative Psilocybin Wellness Initiative Addresses Mental Health Conditions for Veterans." February 26, 2025. https://www.globenewswire.com/news-release/2025/02/26/3032979/0/en/ONE-Retreats-Transformative-Psilocybin-Wellness-Initiative-Addresses-Mental-Health-Conditions-for-Veterans.html

³ MAPS (Multidisciplinary Association for Psychedelic Studies). "MAPS Responds to Report of Progress for MDMA-Assisted Therapy for PTSD with FDA." GlobeNewswire, August 10, 2026. https://www.globenewswire.com/news-release/2026/08/10/3342145/0/en/maps-responds-to-report-of-progress-for-mdma-assisted-therapy-for-ptsd-with-fda.html; Psychedelic Alpha. "Two Years After Rejection, Resilient Quietly Refiles MDMA for PTSD Application." August 2026. https://psychedelicalpha.com/news/two-years-after-rejection-resilient-quietly-refiles-mdma-for-ptsd-application/

⁴ Compass Pathways. "Compass Pathways Announces Second Quarter and First Half 2026 Financial Results and Business Highlights." August 5, 2026. https://ir.compasspathways.com/News--Events-/news/news-details/2026/Compass-Pathways-Announces-Second-Quarter-and-First-Half-2026-Financial-Results-and-Business-Highlights/default.aspx

⁵ U.S. Department of Health and Human Services. "HHS & VA Announce Bold, Comprehensive Partnership to Advance Rapid-Acting Mental Health Treatments for Veterans." July 13, 2026. https://www.hhs.gov/press-room/hhs-va-partner-advance-psychedelic-therapies-veterans.html; Psychable. "What the New VA and HHS Partnership Means for Psychedelic Therapy for Veterans." 2026. https://psychable.com/law/what-the-new-va-and-hhs-partnership-means-for-psychedelic-therapy-for-veterans

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