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Lead program: Phase I
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Scottsdale Research Institute

Also known as: SRI

Data updated

1 Drug Candidate

Scottsdale Research Institute (SRI) is an Arizona-based research organization conducting the world's first controlled clinical trial of whole psilocybin mushrooms. Their FDA-approved Phase 1 study tests naturally-grown whole mushrooms (30mg psilocybin dose) for PTSD in first responders and military veterans, funded by $5M from the Arizona Legislature. The study explores the entourage effect hypothesis compared to isolated synthetic psilocybin. Led by Dr. Sue Sisley.

Pipeline Intelligence

Developer Momentum

Programme tracker
Active candidates
1

All tracked candidates active

Active programmes
1

All tracked programmes active

Lead stage
Phase I

Current furthest stage

Forecast coverage
1 of 1

1 active programme with forecast fields

Latest sourced update

First Responders with PTSD Are Turning to Arizona Psilocybin Trial

Apr 24, 2026 - news - InvestigateTV - Whole Psilocybin Mushroom (Psilocybe cubensis)

Next known catalyst

Phase I topline

Timing not specified - Whole Psilocybin Mushroom (Psilocybe cubensis) / Whole Mushroom Psilocybin Phase 1/2 PTSD (NCT07275970) — FDA Authorized - Confidence: 45%

5 sources0 pipeline-linked trials0 pipeline-linked papers

Development Programmes

1

Whole Psilocybin Mushroom (Psilocybe cubensis)

Psilocybin
Phase I

PTSD in first responders and veterans — 4.32g whole mushroom in chocolate capsule (~30mg psilocybin). First-ever FDA-authorized whole mushroom psilocybin trial.

Programme Tracker

PTSD

Primary: US (FDA)
Phase IActive

Forecast

Phase I topline

Recruiting Phase 1 trial NCT07275970 is listed with a February 2026 start for whole psilocybin-containing mushrooms in adults with PTSD. Recent reporting says Arizona funding and first-responder interest are supporting the study.

Milestones

Phase I started

Completed

Actual: Dec 1, 2025

First patient enrolled — Army veteran Nick Jones became the first participant in the whole mushroom trial

Why it matters: First dosing confirms the trial is operational. The group therapy format with whole mushroom in chocolate form is unique among clinical psychedelic trials. 24-participant design across police, firefighter, and veteran populations will test generalizability across first-responder groups.

Watch next: Enrollment of all 24 participants and initial safety data

Regulatory review accepted

Completed

Actual: Jan 1, 2025

FDA authorized Phase 1/2 trial using whole psilocybin mushroom — first-ever FDA authorization for a whole mushroom product in a clinical trial

Why it matters: FDA authorization for a whole botanical mushroom product (not synthetic or extracted psilocybin) is a regulatory landmark. All prior FDA-authorized psilocybin trials used synthetic (COMPASS/GH Research) or extracted (Filament) forms. The "entourage effect" hypothesis — that other mushroom compounds enhance or modulate the therapeutic response — can now be tested clinically. Dr. Sue Sisley holds the only DEA Schedule I license for farming psilocybin mushrooms for human research.

Watch next: Enrollment completion and Phase 1/2 safety/efficacy data

Funding milestone

Completed

Actual: May 1, 2023

Arizona legislature approved $5M for psilocybin research; SRI ultimately awarded ~$2.7M

Why it matters: State government funding for a psilocybin trial is unprecedented in the US. Arizona's bipartisan support signals growing political acceptance of psychedelic research. The $2.7M funds the first-ever FDA-authorized whole mushroom clinical trial.

Recorded Events

Dec 1, 2025: Phase I started

Jan 1, 2025: Regulatory review accepted

May 1, 2023: Funding milestone

Evidence Links

ClinicalTrials.gov NCT07275970 - Whole Psilocybin Mushrooms for PTSD

clinical-trial-registry - ClinicalTrials.gov - Mar 9, 2026 - Verified

Recruiting Phase 1 study of organic whole psilocybin-containing mushrooms in adults with PTSD.

First Responders with PTSD Are Turning to Arizona Psilocybin Trial

news - InvestigateTV - Apr 24, 2026 - Verified

Recent reporting describes Arizona funding and first-responder interest in the SRI whole-mushroom PTSD trial.

Alira Health Partners with Scottsdale Research Institute for Psilocybin Clinical Trials

partner-announcement - Alira Health - Jan 1, 2024 - Verified

Partner announcement supports SRI/Alira regulatory collaboration on psilocybin clinical trial work.

Similar Developers

Reference points selected from shared pipeline stage, indications, compounds, regulatory pathways, and evidence footprint.

View landscape
Lobe Sciences
Phase I1 active candidate1 trial
shared compound: PsilocybinPhase I peersame regulator: US FDAsimilar active pipeline size
Mydecine Innovations
Phase II2 active candidates
shared compound: Psilocybinsame indication: PTSDsame regulator: US FDAsimilar active pipeline size
Otsuka Pharmaceutical
Phase III2 active candidates
shared compound: Psilocybinsame indication: PTSDsame regulator: US FDAsimilar active pipeline size
Arcadia Medicine
Phase I3 active candidates
same indication: PTSDPhase I peersame regulator: US FDAboth have forecast coverage

Quick Facts

Type
Non-Profit
Lead Stage
Phase I
Website
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