Jun 1, 2026 Publication Research
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 Regulation FDA
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 Regulation Government
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 14, 2026 Trial Update Company
Company release says Filament PEX010 shipments are supporting Bruyère PSYCHED-PAL palliative-care work, a University of Calgary subjective-experience/risperidone healthy-adult mechanism trial, and a UBC bipolar-II TRD psilocybin RCT. Cross-check registry IDs: NCT07063862, NCT06768944, NCT06943573. Treat as supply/research-infrastructure and trial-watch only.
Source/tracker note
Newsfile/Red Light Holland Corp. release, May 14, 2026. Guardrail: company shipment announcement plus registry cross-checks; not approval, not access, and not new efficacy/safety finding for the named studies.
May 14, 2026 Publication Research
Review article only: useful background on adolescent anorexia-nervosa considerations for psilocybin-assisted therapy, but not clinical trial results. Track as research context around developmental, consent, and treatment-model adaptations.
Source/tracker note
PubMed PMID 42128951 / Current Psychiatry Reports, May 14, 2026. Flatiron scan posture: PAT-for-AN work has focused mainly on adults; adolescent-specific issues are developmental/consent/model adaptations. Guardrail: review article, not efficacy/safety results.
May 13, 2026 Publication Research
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 Publication Research
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 Publication Research
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 Regulation Company
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 31, 2026 Approval Company
Source/tracker note
FDA completed Type B meeting on COMP360. Agency confirmed acceptability of proposed pivotal trial design for TRD indication. No major deficiencies identified.
Mar 30, 2026 Publication Research
Source/tracker note
New peer-reviewed study confirms psilocybin's neuroplasticity effects in treating major depressive disorder.
Mar 30, 2026 Approval Company
Source/tracker note
COMPASS reports continued progress on COMP360 for treatment-resistant depression with 70% response rate in latest cohort.
Mar 2, 2026 Publication Research
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 Trial Update Company
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.”
Jan 7, 2026 Regulation Company
Compass says FDA accepted the IND for COMP360 in PTSD, moving the program into a controlled late-stage trial with a clear Week 8 CAPS-5 endpoint and an open-label extension. This is a real regulatory advance, but the underlying human dataset is still small, so the key editorial question is how much of the early signal survives a blinded design.
Source/tracker note
FDA accepted the IND application for COMP360 in PTSD, enabling initiation of a Phase 2b/3 trial. Part A compares two 25 mg COMP360 sessions against two 1 mg sessions, with CAPS-5 total severity score at Week 8 as the primary endpoint.
Sep 2, 2025 Publication Company
Compass published its 22-patient open-label PTSD study, giving a more citable source base for the COMP360/PTSD story. The symptom changes are large and durable enough to matter editorially, but because the trial was open-label and uncontrolled, this remains supportive evidence rather than decisive proof.
Source/tracker note
In the open-label Phase 2 PTSD study, a single 25 mg COMP360 dose was reported as well tolerated in 22 patients with no serious adverse events. Mean CAPS-5 score fell 29.9 points at Week 4 and 29.5 points at Week 12 from a 47.5 baseline; remission was 63.6% at Week 4 and 54.5% at Week 12.