Jun 1, 2026 Publication Research
PubMed PMID 42136434 is a World Psychiatry letter titled “Prevalence and predictors of sexual and physical violence during psychedelic use in a US population-based study.” PubMed has no abstract in the fetched record.
Source/tracker note
Last checked 2026-05-16 UTC. Claim boundary: safety/public-health source to retrieve and read before quoting rates or predictors; PubMed title/journal metadata alone should not be upgraded into prevalence figures, causal claims, clinical risk estimates, approval/access claims, or broad safety conclusions.
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 CNPV pilot page still states selected pre-market applications remain subject to the same statutory/regulatory approval requirements and that approval decisions remain with the relevant FDA product Center. Claim boundary: CNPV/rolling review is regulatory-process context only, not approval or an FDA safety/effectiveness finding.
Source/tracker note
FDA CNPV pilot page excerpt: applications selected for CNPV are subject to the same statutory and regulatory approval requirements; review teams develop independent recommendations; approval decision remains with the relevant product Center.
May 17, 2026 Trial Update Company
Last checked: 2026-05-17 07:00 UTC. Reunion May 11 release still verifies RE104/luvesilocin RECONNECT presentation schedule only: APA poster May 18 and ASCP oral May 26. Actual APA/ASCP artifacts/data materials were not verified in this pass. Claim boundary: company schedule/pipeline watch only; no approval/access/final efficacy/safety upgrade.
Source/tracker note
Reunion release excerpt: ASCP Pharmaceutical Pipeline Session May 26, 2026 2:00-2:10 PM ET; APA poster titled RE104: A Novel Psychedelic Agent for Postpartum Depression. Actual meeting materials pending.
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 Trial Update Company
Last checked: 2026-05-17 07:00 UTC. Targeted ClinicalTrials.gov searches for Ascend DT120, Definium Ascend, lysergide tartrate MDD Ascend, and DT120 MDD still did not find an Ascend NCT; DT120 MDD search returned older/non-Ascend NCT05407064. Claim boundary: Definium Ascend remains company-release tracked until registry/results artifacts appear; no approval/access/efficacy/safety upgrade.
Source/tracker note
Targeted ClinicalTrials.gov output: Ascend DT120 / Definium Ascend / lysergide tartrate major depressive disorder Ascend = no results; DT120 major depressive disorder returned NCT05407064, not Ascend.
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 16, 2026 Publication Research
PubMed PMID 42134338 is a Lancet editorial titled “Psychedelics: after the renaissance.” PubMed has no abstract in the fetched record.
Source/tracker note
Last checked 2026-05-16 UTC. Claim boundary: high-level field-commentary tracker only until full text is reviewed; not clinical evidence, approval/access evidence, safety/efficacy proof, or source for specific factual claims beyond title/journal/date metadata.
May 15, 2026 Publication Research
Last checked: 2026-05-16 20:00 UTC. PubMed abstract describes a Journal of Affective Disorders retrospective cohort of 233 TRD patients receiving esketamine plus dexmedetomidine patient-controlled sleep (PCSL), with follow-up at 1, 3, and 6 months. Abstract reports HAMD/PSQI decreases and response rates of 62.00%, 59.73%, and 58.49%, with no serious adverse events observed during follow-up. Claim boundary: retrospective uncontrolled multimodal clinic-regimen signal only; not randomized proof, not classic psychedelic efficacy evidence, not approval/label/access/reimbursement, not medical advice, and not generalizable safety proof.
Source/tracker note
PubMed PMID 41621446 / DOI 10.1016/j.jad.2026.121311. Abstract: retrospective inclusion of 233 TRD patients; HAMD and PSQI assessed at 1, 3, and 6 months after first esketamine infusion; PCSL and additional esketamine recorded; HAMD/PSQI scores decreased significantly; response rates 62.00%, 59.73%, 58.49%; no serious adverse events observed during follow-up.
May 15, 2026 Publication Research
PubMed PMID 41616859 is a systematic review/meta-analysis of nine observational real-world studies of intranasal esketamine for treatment-resistant depression; abstract reports symptom reduction/remission patterns and pooled adverse-event/dissociation estimates.
Source/tracker note
Last checked 2026-05-16 UTC. Claim boundary: observational real-world evidence synthesis only; not new approval, label expansion, reimbursement/access finding, proof of comparative efficacy, or broad safety guarantee. Abstract itself cautions that observational evidence and absence of control groups mean effect sizes should be interpreted with caution.
May 15, 2026 Publication Research
PubMed PMID 42131860 is a narrative review of psychedelic respiratory-health evidence; it describes preclinical/mechanistic signals around serotonergic pathways, airway smooth muscle, and inflammation, but states human studies have not confirmed bronchodilatory effects and respiratory-centered evidence remains limited.
Source/tracker note
Last checked 2026-05-15 UTC. Claim boundary: narrative review/knowledge-map item only; it should not be used as proof of human respiratory benefit, broad safety, clinical efficacy, approval, label, reimbursement, or access.
May 15, 2026 Publication Research
PubMed PMID 42131859 reports an analysis of 2015-2019 NSDUH data among U.S. adults who first used LSD at least five years earlier; estimated 4.2% used LSD in the past year, with past-year use declining as time since initiation increased and correlates including perceived lower risk/higher availability and other substance-use variables.
Source/tracker note
Last checked 2026-05-15 UTC. Claim boundary: nonmedical-use epidemiology and public-health context only; self-report survey correlates are not clinical efficacy evidence, therapeutic safety evidence, approval/access evidence, or a basis for causal claims about LSD.
May 15, 2026 Publication Research
PubMed PMID 42100741 / iScience evaluates whether machine-learning models on dried-leaf images can recover folk classifications of Banisteriopsis caapi, the ayahuasca vine; reported SVM overall accuracy reached about 70%, with higher accuracy for some folk types and lower accuracy where morphology overlaps.
Source/tracker note
Last checked 2026-05-15 UTC. Claim boundary: ethnobotany/classification and wiki/source-map item only; not clinical evidence about ayahuasca effects, safety, efficacy, legal access, or medical use.
May 15, 2026 Publication Research
PubMed PMID 41633448 / Journal of Affective Disorders reports a framework-guided qualitative analysis of 21 interviews with Australian clinicians, researchers, and patients after Australia rescheduled MDMA to permit authorized prescribing for PTSD outside clinical trials; intended to inform guideline development.
Source/tracker note
Last checked 2026-05-15 UTC. Claim boundary: qualitative implementation/guideline-context evidence only; not an efficacy trial, not a broad safety finding, and not evidence of approval/access outside the Australian authorized-prescribing context described by the article.
May 15, 2026 Publication Research
PubMed PMID 41672133 / Neuropharmacology tested endogenous and exogenous DMT handling in rat brain after monoamine-oxidase, acidic-metabolite-transport, serotonin-uptake, and vesicular-monoamine-transporter manipulations. The authors report no evidence that DMT is formed or stored in serotonin terminals and emphasize rapid metabolism of exogenous DMT.
Source/tracker note
Last checked 2026-05-15 UTC. Claim boundary: preclinical/basic-neurochemistry rat-brain study only; useful for tightening endogenous-DMT claim boundaries, not for adjudicating human psychedelic experience, clinical efficacy/safety, approval, label, reimbursement, or access.
May 14, 2026 Publication Research
Last checked: 2026-05-16 16:00 UTC. Journal of Affective Disorders abstract reports a MGH Ketamine Clinic observational/network-analysis study of 447 TRD patients receiving acute-phase IV ketamine or intranasal esketamine. Abstract says pre-treatment symptom-network density was higher in non-responders than responders and frames baseline network density as a potential correlate of ketamine outcomes. Claim boundary: observational clinic/precision-medicine correlate; not psychedelic efficacy evidence, not randomized proof, not approval/access/medical advice.
Source/tracker note
Abstract: “447 patients receiving acute-phase intravenous ketamine or intranasal esketamine at the MGH Ketamine Clinic were included.” “Pre-treatment network density was significantly higher in non-responders ... compared to responders ...” “Pre-treatment network density serves as a potential correlate of treatment outcomes of ketamine for TRD.”
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
PubMed PMID 42129626 reports that single-dose ibogaine in adult mice restored juvenile-like experience-dependent plasticity in visual cortex after monocular deprivation and was accompanied by changes in perineuronal nets, parvalbumin staining, and inhibitory synaptic markers.
Source/tracker note
Last checked 2026-05-15 UTC. Claim boundary: preclinical mouse neuroplasticity study only; not human addiction, depression, PTSD, Parkinson's, clinical efficacy, broad safety, approval, label, reimbursement, or access evidence.
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 12, 2026 Trial Update Company
AtaiBeckley company release says BPL-003 Phase 3 ReConnection remains on track for Q2 2026, with ReConnection-1 ~350 and ReConnection-2 ~230, MADRS Week 4 primary, and 52-week OLE; VLS-01 Phase 2 Elumina topline is anticipated Q4 2026; EMP-01 oral R-MDMA Phase 2a in SAD showed company-described convergent improvements; cash/securities were $209.9M with runway into 2029.
Source/tracker note
Last checked 2026-05-16 UTC. Claim boundary: company-reported pipeline/capitalization and Phase 3-design tracker only; not approval, label, reimbursement, access, independent efficacy/safety confirmation, or proof that planned Phase 3 studies will start/succeed. Keep BPL-003, VLS-01, and EMP-01 separate from unrelated CNPV/company-primary-pending items.
May 11, 2026 Publication Research
PubMed PMID 42114863 / BMJ Open article describes development of the MDMA-Assisted Psychotherapy Side Effects Tool (M-SET) via Delphi process. Track as safety/tolerability measurement infrastructure, not efficacy evidence or regulatory approval.
Source/tracker note
PubMed page checked 2026-05-14; DOI 10.1136/bmjopen-2025-105630. Guardrail: tool-development/publication item only; does not establish MDMA-assisted therapy safety, efficacy, approval, or access.
May 8, 2026 Publication Research
PubMed PMID 42104189 / Clinical Pharmacology & Therapeutics scoping review identifies 26 eligible registered interventional trials of DMT, ayahuasca, and DMT plus harmine on ClinicalTrials.gov. Review says the registry landscape expanded after 2020–2021 and remains dominated by early-stage safety/physiological and subjective-effect characterization, with disorder-specific symptom endpoints less often primary.
Source/tracker note
Last checked 2026-05-15 UTC. Claim boundary: review/registry-map item only; supports wiki/trial-landscape context, not clinical efficacy/safety conclusion, approval, label, reimbursement, or access.
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.
May 1, 2026 Publication Research
Last checked: 2026-05-16 16:00 UTC. British Journal of General Practice narrative review/public-health article describes rising UK ketamine misuse among young people; PubMed lists May 2026. Abstract says deaths increased six-fold over the past decade, ketamine is now the fifth most commonly used drug among young people, and urinary/abdominal presentations can mask dependence or ketamine-related harm. Claim boundary: narrative/public-health signal, not clinical efficacy evidence, not US prevalence, not medical advice, and distinct from regulated ketamine/esketamine treatment contexts.
Source/tracker note
Abstract: “Ketamine ... has become one of the fastest growing substances of misuse in the UK, with deaths increasing six-fold over the past decade.” “It is now the fifth most commonly used drug among young people...” “presentations frequently occur under the guise of urinary or abdominal symptoms.”
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.
Apr 22, 2026 Regulation White House + AP + press roundup
Today's psychedelics coverage is still centered on the Trump / White House executive-order wave, especially ibogaine, Right-to-Try access, FDA and rescheduling implications, Texas follow-through, and psychedelic-biotech read-throughs. Side threads included new psilocybin-use prevalence data, ketamine FDA-review chatter, and retreat-safety coverage.
Source/tracker note
Source roundup anchored in the Apr. 18 White House fact sheet and AP, then broadened across Time, CNN, Reuters, CNBC, Rolling Stone, BioPharma Dive, BioSpace, Psychedelic Alpha, Texas Standard, and MedPage Today. Main practical read: the order is the real news, not loose ibogaine chatter alone.
Mar 31, 2026 Funding Company
Source/tracker note
Atai announced completion of Series C funding round at $3.2B valuation. New capital allocated to accelerate clinical programs across psilocybin, MDMA, and novel compounds.
Mar 31, 2026 Publication Research
Source/tracker note
Multi-site study (n=150) shows ketamine-induced glutamatergic changes correlate with rapid symptom improvement in treatment-resistant depression.
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 31, 2026 Trial Update MAPS Official
Source/tracker note
Additional safety monitoring completed on 200+ subjects in expanded Phase 3 cohorts. No serious adverse events reported. Efficacy trends continue to match primary trial data.
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 Regulation FDA
Source/tracker note
New FDA guidance clarifies regulatory pathway for psychedelic-assisted therapies, streamlining trial design requirements.
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 30, 2026 Trial Update MAPS Official
Source/tracker note
Latest enrollment numbers and safety data from Phase 3 MDMA-assisted psychotherapy trials show positive outcomes.
Mar 25, 2026 Publication Company
GH Research now has its randomized Phase 2b GH001 TRD data in a peer-reviewed journal, which is a stronger source layer than a topline press release alone. The cleaner claim is the Day 8 placebo-controlled antidepressant effect; the severity-independent remission analysis is post hoc and should be treated more cautiously.
Source/tracker note
GH001 vs Placebo in Patients with Treatment-Resistant Depression was published in JAMA Psychiatry. GH Research reiterates a -15.5 point placebo-adjusted MADRS reduction from baseline on Day 8 and says day-8 remission ranged from 53.9% to 63.6% across patients with 2 to at least 5 prior treatment failures.
Mar 5, 2026 Trial Update Company
Helus/Cybin company release reports topline Phase 2 signal-detection results for HLP004 in GAD: 36 patients randomized 2:1 active-to-control, two intramuscular doses three weeks apart, company-reported HAM-A change and six-month response/remission summaries; registry cross-check is NCT06051721.
Source/tracker note
Last checked 2026-05-16 UTC. Claim boundary: company-reported topline/backfill only; not peer-reviewed publication, approval, label, reimbursement, access, independent efficacy confirmation, broad safety, or Phase 3 success. Company reports no drug-related SAEs/suicidality-related signals and acute effects ~90 min, but these remain company topline claims from a small signal-detection study.
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.
Jan 5, 2026 Regulation Company
FDA lifted the GH001 IND clinical hold, allowing U.S. enrollment and giving GH Research a path to align a global Phase 3 program in TRD. The milestone matters, but the efficacy support still comes from earlier Phase 2b company-reported data rather than pivotal evidence.
Source/tracker note
GH001 cleared by FDA for U.S. clinical investigation, enabling U.S. subject enrollment. Company says global Phase 3 initiation is targeted for 2026 and cites prior Phase 2b data of a -15.5 placebo-adjusted MADRS reduction on Day 8 and 57.5% remission on Day 8.
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.
No updates match the current filters.