Jun 1, 2026 Last checked 2026-05-16 UTC Publication Research
Claim boundary.conceptual guideline/protocol-design article only; not clinical outcome evidence, approval, label, reimbursement, access, or proof that systemic involvement improves outcomes. Useful for therapy-model/wiki-source context.
PubMed PMID 42131862 proposes conceptual/systemic guidelines for psychedelic-assisted psychotherapy and research, emphasizing relational dynamics, attachment, family systems, significant relational figures, and a proposed 10-session psilocybin-oriented research protocol.
Source/tracker note
Last checked 2026-05-16 UTC. Claim boundary: conceptual guideline/protocol-design article only; not clinical outcome evidence, approval, label, reimbursement, access, or proof that systemic involvement improves outcomes. Useful for therapy-model/wiki-source context.
May 17, 2026 Last checked 2026-05-17 07:00 UTC Regulation FDA
Claim boundary.regulatory-process/indication list only; not approval, not safety/effectiveness finding, not label/access/reimbursement, and not primary confirmation of the psilocybin/MDD sponsor.
Last checked: 2026-05-17 07:00 UTC. FDA EO/CNPV page still names voucher indications — psilocybin for treatment-resistant depression, psilocybin for major depressive disorder, and methylone for PTSD — but does not name the psilocybin/MDD company. Claim boundary: regulatory-process/indication list only; not approval, not safety/effectiveness finding, not label/access/reimbursement, and not primary confirmation of the psilocybin/MDD sponsor.
Source/tracker note
FDA page excerpt in direct scrape: national priority vouchers to companies studying psilocybin for TRD, psilocybin for MDD, methylone for PTSD; no company named for psilocybin/MDD in checked text.
May 17, 2026 Last checked 2026-05-17 07:00 UTC Regulation Government
Claim boundary.Oregon service-system/rulemaking tracker only, not clinical efficacy, broad safety, or access expansion beyond enacted/final text.
Last checked: 2026-05-17 07:00 UTC. Oregon OPS administrative-rules page still frames 2026 rulemaking as a process informed by OPAB/RAC/public comment, with 2026 rulemaking text/process references; broader final-rule text not verified. Claim boundary: Oregon service-system/rulemaking tracker only, not clinical efficacy, broad safety, or access expansion beyond enacted/final text.
Source/tracker note
Oregon OPS page excerpt: OPS expects to open administrative rules during the fall of each year; 2026 rulemaking section references RAC/public-comment process. Broader 2026 final rule text not verified in this pass.
May 13, 2026 Last checked 2026-05-17 07:00 UTC Publication Research
Claim boundary.uncontrolled open-label small-study signal only; not randomized proof, not suicide-treatment medical advice, not FDA approval/access/label/reimbursement, and not broad safety proof.
Last checked: 2026-05-17 07:00 UTC. PubMed abstract for Journal of Clinical Psychiatry publication (NCT05220410) reports an open-label, single-arm study of 20 adults with chronic suicidal ideation, MDD, and at least two prior antidepressant treatment failures receiving one 25mg psilocybin dose with structured preparation/integration. Primary MSSI change at Week 3: MD 13.95 (95% CI 8.63-19.27; p<.001; d=1.73); by Week 12, 70% had MSSI <=2; no serious AEs in abstract. Claim boundary: uncontrolled open-label small-study signal only; not randomized proof, not suicide-treatment medical advice, not FDA approval/access/label/reimbursement, and not broad safety proof.
Source/tracker note
Abstract: open-label single-arm n=20; chronic suicidal ideation + MDD + >=2 prior antidepressant failures; 25mg psilocybin with support. Week 3 MSSI MD=13.95, 95% CI 8.63-19.27, p<.001; Week 12 70% (n=14) achieved MSSI <=2; no serious adverse events occurred.
May 13, 2026 Last checked 2026-05-15 UTC Publication Research
Claim boundary.descriptive public-dashboard/service-system analysis only; useful for utilization/equity/safety-monitoring tracker; not a clinical efficacy finding and not proof that services are safe for all uses/populations.
Frontiers in Psychiatry article (May 13, 2026; DOI 10.3389/fpsyt.2026.1777387) analyzes 2025 aggregate Oregon Psilocybin Services Public Dashboard data: 5,935 clients, 5,375 sessions, Q2 volume peak, 32.6% out-of-state participants, midlife adult predominance, substantial women/LGBQ+ participation, limited racial diversity, and reported annual behavioral/medical adverse-event rates of 2.42/2.79 per 1,000 sessions.
Source/tracker note
Last checked 2026-05-15 UTC. Claim boundary: descriptive public-dashboard/service-system analysis only; useful for utilization/equity/safety-monitoring tracker; not a clinical efficacy finding and not proof that services are safe for all uses/populations.
May 1, 2026 Last checked 2026-05-17 07:00 UTC Publication Research
Claim boundary.Phase 2 RCT publication, small n, active placebo; not FDA approval, clinical access, label/reimbursement, medical advice, or broad safety proof.
Last checked: 2026-05-17 07:00 UTC. PubMed abstract for JAMA Network Open RCT (NCT04630964) reports 35 adults with moderate-to-severe recurrent MDD randomized 17 psilocybin vs 18 niacin, single 25mg psilocybin or 100mg niacin plus five support sessions. Primary endpoint met: model-estimated between-group MADRS change at Day 8 was -7.27 (95% CI -12.89 to -1.65; p=.01) favoring psilocybin; significant differences also reported at Days 15 and 42, not Day 365. Claim boundary: Phase 2 RCT publication, small n, active placebo; not FDA approval, clinical access, label/reimbursement, medical advice, or broad safety proof.
Source/tracker note
Abstract results: n=35; 17 psilocybin, 18 niacin. Day 8 MADRS between-group difference -7.27; 95% CI -12.89 to -1.65; p=.01. Days 15 and 42 significant; Day 365 no longer significant. No drug-related serious AEs reported; two psilocybin participants reported persistent severe anxiety requiring medical attention.
Apr 24, 2026 Last checked 2026-05-15 UTC Regulation Company
Claim boundary.company/FDA-process milestone only; CNPV and rolling review are not approval, label, reimbursement, clinical access, or an FDA finding that COMP360 is safe or effective. FDA primary page still names indication categories only and does not name the psilocybin/MDD CNPV company; keep psilocybin/MDD company primary-pending.
Compass Pathways primary release says FDA granted an NDA rolling submission/review request and selected COMP360 synthetic psilocybin for the Commissioner's National Priority Voucher program for treatment-resistant depression. The release frames CNPV as enhanced communications and shortened review time after NDA filing while maintaining FDA standards.
Source/tracker note
Last checked 2026-05-15 UTC. Claim boundary: company/FDA-process milestone only; CNPV and rolling review are not approval, label, reimbursement, clinical access, or an FDA finding that COMP360 is safe or effective. FDA primary page still names indication categories only and does not name the psilocybin/MDD CNPV company; keep psilocybin/MDD company primary-pending.
Mar 2, 2026 Last checked 2026-05-16 UTC Publication Research
Claim boundary.pilot single-site RCT/backfill only; not approval, medical advice, access, label, reimbursement, broad smoking-cessation efficacy proof, or proof of generalizability beyond the studied protocol/population. Abstract reports 40.5% prolonged abstinence in psilocybin group vs 10.0% nicotine patch at 6 months and no psilocybin-attributed serious adverse events.
PubMed PMID 41805956 reports a Johns Hopkins pilot randomized clinical trial comparing psilocybin + 13-week CBT with nicotine patch + CBT for smoking cessation; n=82, unblinded, psychiatrically healthy adult smokers, biochemically verified 6-month prolonged abstinence primary endpoint, ClinicalTrials.gov NCT01943994.
Source/tracker note
Last checked 2026-05-16 UTC. Claim boundary: pilot single-site RCT/backfill only; not approval, medical advice, access, label, reimbursement, broad smoking-cessation efficacy proof, or proof of generalizability beyond the studied protocol/population. Abstract reports 40.5% prolonged abstinence in psilocybin group vs 10.0% nicotine patch at 6 months and no psilocybin-attributed serious adverse events.
Feb 17, 2026 Last checked 2026-05-16 16:00 UTC Trial Update Company
Claim boundary.company topline/backfill; not peer-reviewed full dataset, FDA approval, FDA efficacy/safety finding, label, reimbursement, or access claim.
Last checked: 2026-05-16 16:00 UTC. Compass company release reports COMP006, the second Phase 3 COMP360 TRD trial, met its Week 6 MADRS primary endpoint: two 25 mg doses versus 1 mg, mean treatment difference -3.8 points, 95% CI -5.8 to -1.8, p<0.001. Release also restates COMP005 Part A 25 mg vs placebo mean difference -3.6 at Week 6 and says FDA meeting requested to discuss rolling submission/review, with NDA submission expected Q4. Claim boundary: company topline/backfill; not peer-reviewed full dataset, FDA approval, FDA efficacy/safety finding, label, reimbursement, or access claim.
Source/tracker note
Compass: “In COMP006, two doses of COMP360 25 mg versus 1 mg demonstrated a highly statistically significant and clinically meaningful reduction ... mean difference of -3.8 ... (p<0.001).” “Across both Phase 3 trials to date, COMP360 is demonstrating a generally well-tolerated and safe profile with no unexpected safety findings.” “Compass has requested a meeting with the FDA to discuss a rolling submission and review and expects to complete an NDA submission in Q4.”