ClinicalTrials.gov study record. The registry statusVerifiedDate field reads 2026-08 and lastUpdatePostDate reads 2026-09-03, both on or before the evidence cutoff; the record's own last-update date is published as its revision date. 2026-09-03. NCT06632457
Passage inspected: Identification, status, sponsor and description modules
Design: Government clinical-trial registry record (randomized, double-blind, placebo-controlled, phase 3)
Population: Adults with compensated NASH/MASH cirrhosis (recruiting; estimated completion 2029)
Formulation: Survodutide (BI 456906), subcutaneous investigational injection
Route: Subcutaneous
Indication: Investigational; compensated NASH/MASH cirrhosis (not an approved indication)
Limits of applicability
A registry status/design record; it is not a results publication and does not itself report efficacy or safety findings.
Recruiting status and estimated completion date can change; status reflects the record as posted on 2026-09-09.
Correction check: Live ClinicalTrials.gov API v2 study record retrieved directly on 2026-09-09; registry records are not indexed for journal-style corrections, so no correction/retraction check applies to this document type.
Published / revised: 2026-09-03 Accessed: · Regulatory document
Bastos-Silva VJ, dos Santos CT, Porfirio RC, dos Santos Silva WP, De Araujo GG, Correia-Oliveira CR. Sport Sciences for Health. 2026;22:310. Published August 11, 2026. DOI: 10.1007/s11332-026-01747-0. 2026-08-11. DOI:10.1007/s11332-026-01747-0
Passage inspected: Methods: participants, experimental design and statistical analysis; Results: performance parameters and intermittent exercise protocol; Discussion limitations; publication and funding metadata.
Design: Randomized, double-blind, placebo-controlled, counterbalanced crossover trial with acute oral exposure and at least 72 hours between sessions.
Population: 14 healthy, physically active men completed the study; 21 were invited, with five scheduling withdrawals and two injury withdrawals reported.
Route: Oral
Limits of applicability
A small male sample and a sample-size calculation based on a large assumed effect limit precision. This acute study does not assess chronic training adaptations, body composition or mixed performance-drug use.
Blinding effectiveness was not formally assessed and adverse effects were not systematically recorded with a structured questionnaire. Absence of reported discomfort does not establish safety.
The abstract and main Methods report different mean ages. Numerical figure and table cells have not been independently reconciled; the claim uses the directly inspected qualitative Results.
Correction check: On September 9, 2026, inspected the publisher's full article and publication metadata; no correction notice was displayed. EuropePMC returned no record for the DOI, confirmed independently by an exact-title search as well. This limited check cannot exclude later or unindexed notices; the age discrepancy is retained as unresolved. Independent editorial review separately queried Crossref for this DOI on 2026-09-09 and confirmed no update-to/correction relationship and zero recorded citing works, corroborating through a second independent registry that no correction is indexed as of the review date.
Published / revised: 2026-08-11 Accessed: · Full text inspected
Earlier and current inspections
· Full text inspected · Publisher HTML: Methods, Results, Discussion limitations and metadata.. Freshly inspected relevant primary passages; independent editorial review pending. No qualified clinical review.
· Full text inspected · batches/endocrine-followup-integration.json. The endocrine-followup batch's independent editorial review was completed by independent-editorial-reviewer-endocrine-followup (status bounded-review-complete-conditional-integration-edits) and this record was published through that review's integration receipt. This supersedes the earlier entry above recording the review as pending. Editorial review is not qualified clinical review.
ClinicalTrials.gov study record. The registry statusVerifiedDate field reads 2026-08 and lastUpdatePostDate reads 2026-08-06; the record's own last-update date is published as its revision date. 2026-08-06. NCT07629401
Passage inspected: Identification, status and description modules
Design: Government clinical-trial registry expanded-access record
Population: Adults with severe obesity (BMI >= 35 kg/m2) and at least two serious or life-threatening obesity-related complications, refractory to approved therapy and unable to join an ongoing retatrutide trial
Indication: Investigational pre-approval expanded access only; not an approved indication
Limits of applicability
Single-patient pre-approval expanded access is a compassionate-use mechanism, not evidence of imminent or eventual FDA approval.
Registry fields can be updated after this access date; status reflects the record as posted on 2026-09-09.
Correction check: Live ClinicalTrials.gov API v2 study record retrieved directly on 2026-09-09; registry records are not indexed for journal-style corrections, so no correction/retraction check applies to this document type.
Published / revised: 2026-08-06 Accessed: · Regulatory document
Design: Randomized, single-blinded, placebo-controlled study conducted as three sequential sub-studies
Population: 15 healthy men treated across three sub-studies (n=7 acute dose-response; n=4 five-day continuous infusion; n=7 twelve-day intermittent infusion), with 12 men serving as vehicle controls
Route: Subcutaneous
Exposure: Acute 8-hour dose-response infusions (1.25-10.0 nmol/kg/h); continuous infusion at 180 nmol/h for 5 days; daily 8-hour infusions at 150 nmol/h for 12 days
Limits of applicability
This is a short research-infusion protocol in healthy volunteer men, not an established treatment regimen; it does not establish fertility treatment or recovery from drug-induced suppression.
Only the indexed abstract was inspected; full methods, tables and the acute dose-response curve were not reviewed.
Findings are specific to the subcutaneous route and to men; they should not be extended to women or to other formulations.
Correction check: Freshly retrieved the PubMed XML abstract via NCBI E-utilities on 2026-09-09 (HTTP 200); this is a newly published 2026 article with no indexed correction or retraction found in Europe PMC metadata. This is not an exhaustive retraction investigation.
Published / revised: 2026-08-03 Accessed: · Abstract only
Passage inspected: Section 1 limitations of use; sections 5.7 and 7.1
Design: US prescribing information; label passages inspected
Population: Adults treated for labeled obesity/overweight or obstructive sleep apnea indications
Formulation: ZEPBOUND tirzepatide injection
Route: Subcutaneous
Limits of applicability
The named licensed formulation and labeled clinical setting determine applicability. Research-market products and other formulations are not established equivalents.
Correction check: Independently re-retrieved the PDF/HTML label on 2026-09-09 and confirmed the "Revised" date printed on the document itself matches the recorded 2026-08 revision before reading the cited sections. This version predates the evidence cutoff; a label is not proof of pair-specific trial evidence.
Published / revised: 2026-08 Accessed: · Product label
Passage inspected: Highlights boxed warning and sections 1, 4, 5.1-5.10, 7.1 and 12.3; recent major changes table
Design: FDA-approved labeling
Population: Adults with obesity, qualifying overweight or obesity-associated moderate-to-severe obstructive sleep apnea
Formulation: ZEPBOUND tirzepatide injection
Route: Subcutaneous
Limits of applicability
The approved subcutaneous product is not interchangeable with unapproved preparations.
Full label runs to hundreds of sections; only the sections listed were reread for this batch.
Correction check: Direct HTTP retrieval of the live DailyMed record on 2026-09-09 confirmed the label is still the version 'Revised: 8/2026' with no newer revision date present; scope is the cited version and does not guarantee no later 2026 revision exists after this access.
Published / revised: 2026-08 Accessed: · Product label
Document version: Revised: 8/2026
Earlier and current inspections
· Product label · Sections 1, 4, 5.1-5.3, 5.7, 7.1 and 12.3; recent major changes. Preserved prior inspection record as unverified historical input; superseded by fresh scope recorded 2026-09-09.
· Product label · Highlights boxed warning and sections 1, 4, 5.1-5.10, 7.1 and 12.3; recent major changes table. Freshly retrieved the live DailyMed HTML directly, confirmed the boxed thyroid C-cell tumor warning, the renumbered 5.1-5.10 Warnings and Precautions list (severe GI at 5.2, acute kidney injury at 5.3, hypoglycemia at 5.7, pulmonary aspiration at 5.9), the Recent Major Changes table (including the February 2026 removal of the suicidal-behavior/ideation section), and the section 12.3 elimination half-life passage. Independent editorial review pending.
· Product label · batches/incretin-integration.json. The incretin batch's independent editorial review was completed by independent-editorial-reviewer (no prior authorship of the incretin batch, dossiers or PLAN.md) (status bounded-review-complete-conditional-integration-edits) and this record was published through that review's integration receipt. This supersedes the earlier entry above recording the review as pending. Editorial review is not qualified clinical review.
ClinicalTrials.gov study record. The registry statusVerifiedDate field reads 2026-07 and lastUpdatePostDate reads 2026-07-30; the record's own last-update date is published as its revision date. 2026-07-30. NCT05882045
Indication: Investigational; obesity with established cardiovascular disease (not an approved indication)
Limits of applicability
A registry status/design record; it is not a results publication and does not itself report efficacy or safety findings.
Registry fields can be updated after this access date; status reflects the record as posted on 2026-09-09.
Correction check: Live ClinicalTrials.gov API v2 study record retrieved directly on 2026-09-09; registry records are not indexed for journal-style corrections, so no correction/retraction check applies to this document type.
Published / revised: 2026-07-30 Accessed: · Regulatory document
Passage inspected: Full abstract (methods and stability results) via Europe PMC core record
Design: Analytical chemistry method-validation study (liquid chromatography-high-resolution mass spectrometry) for anti-doping testing
Population: Dried blood spots, serum and plasma matrices spiked with 54 prohibited peptidic/non-peptidic compounds; not a human dosing study
Limits of applicability
This is an analytical detection-method study; it establishes that AOD9604 and hGH 176-191 are treated as separate, independently detectable analytes in a validated mass-spectrometry panel. It does not establish human safety, efficacy, dosing or the molecular identity of any specific vendor's product.
Only the indexed abstract was inspected; full methods and tables were not reviewed.
Correction check: Fresh Europe PMC core record checked on 2026-09-09 for indexed correction/retraction links; none identified (newly published July 2026, within the evidence cutoff of 2026-09-08).
Published / revised: 2026-07-27 Accessed: · Abstract only
Earlier and current inspections
· Abstract only · Full abstract retrieved via Europe PMC core search for '"hGH fragment 176-191" OR "AOD9604" OR "AOD-9604"'. Newly identified and inspected during this fresh research pass to address the AOD-9604/HGH fragment 176-191 identity-transfer priority. Confirmed the two peptides are listed and analyzed as separate compounds in a 54-analyte doping panel. No qualified clinical review.
MedlinePlus health topic page. The page states "Last updated July 22, 2026"; this record previously read undated because that date had not yet been located. 2026-07-22.
Passage inspected: Page last-updated date (not original publication): 2026-07-22. "When is 911 needed?" naming collapse/can't-breathe/unresponsive; "Poisoning" paragraph naming Poison Control 1-800-222-1222
Design: US National Library of Medicine public first-aid guidance
Population: People witnessing a life-threatening emergency
Limits of applicability
Emergency numbers differ outside the United States.
The page's own copyright footer states its content may not be used for automated extraction or to train AI systems without permission; this record is limited to a short citation excerpt and location note, not bulk reproduction.
Correction check: Re-retrieved the live page on 2026-09-09 and located a specific "Last updated July 22, 2026" date that the prior pass had not found (the record read "undated"/availableBy the cutoff). That date precedes the 2026-09-08 cutoff, so it is used here in place of the placeholder.
Published / revised: 2026-07-22 Accessed: · Full text inspected
Earlier and current inspections
· Full text inspected · "When is 911 needed?". Preserved 2026-09-08 inspection (recorded as undated) as historical input.
· Full text inspected · Page last-updated date (not original publication): 2026-07-22. "When is 911 needed?" naming collapse/can't-breathe/unresponsive; "Poisoning" paragraph naming Poison Control 1-800-222-1222. Independently re-retrieved the live page on 2026-09-09, found the specific "Last updated July 22, 2026" date, and replaced the undated placeholder with it.
Zhao JV, Chen B, Chan YH, Zhang J, Xia Y, Blais JE, Chen H, Tomlinson B, Ip DKM. JACC: Asia. Ahead of print 2026; PubMed-indexed electronic publication date 2026-07-11 (the publisher's own history page states online 2026-07-20, an unresolved date discrepancy; both are before the 2026-09-08 evidence cutoff). 2026-07-11. PMID:42470424 · DOI:10.1016/j.jacasi.2026.06.011 · NCT:NCT06782646 · NCT:NCT03770325
Passage inspected: Abstract (this worker's independent Europe PMC recheck: Results, sex-specific testosterone and lipid effect sizes); Methods (trial registrations, arms, outcomes, statistical model); Results (participant flow/attrition, Tables 1-2); Discussion; funding/conflicts/history. The Methods/Results/Table-level full-text reading was performed by the compound's coordinator earlier in this same audit pass (recorded in the compound dossier) and was reconfirmed at the abstract level, not independently reopened at full-text level, by this worker.
Design: Randomized, placebo-controlled, parallel trial in women (NCT06782646), analyzed together with stored frozen samples and outcome data from a separately completed randomized trial in men (NCT03770325; the same cohort as source general-berberine-testosterone-men-zhao-34444711)
Population: 100 women aged 20-65 in Hong Kong; complete-case analysis included 42 berberine and 48 placebo participants after asymmetric withdrawal (8 versus 2, with five of the berberine-arm withdrawals attributed to side effects); the male comparison reuses the 84-randomized/80-completer sample from the 2021 trial
Formulation: Purified berberine tablets
Route: Oral, 500 mg twice daily
Exposure: 12 weeks of berberine or placebo, with biomarkers measured at baseline, 8 weeks and 12 weeks; this describes the trial protocol, not a usage instruction.
Limits of applicability
The dossier records that the main analysis used a complete-case linear mixed-effects model rather than the trial's multiple pre-registered primary lipid endpoints and intention-to-treat/GEE approach (NCT06782646); a no-change imputation sensitivity analysis is described, but headline results are complete-case.
Attrition was asymmetric between arms (8 berberine versus 2 placebo withdrawals in the women's trial), and most berberine-arm withdrawals are attributed to side effects, which can bias a complete-case comparison.
The male comparison is not a concurrent randomized arm: it reuses frozen samples and outcome data from a separate, earlier trial with a different registration and time period, so the sex comparison is not itself a randomized comparison of sex.
This is one publication reanalyzing a previously published male cohort alongside a new female trial; it is not independent replication of the earlier male findings.
Figures and supplementary material were not inspected by this worker.
Correction check: On 2026-09-09, reopened Europe PMC core metadata; publicationStatus is aheadofprint with no correction/retraction relationship indexed.
Published / revised: 2026-07-11 Accessed: · Full text inspected
Record first posted 14 January 2026; the recorded publication date is the record's own last update posted date. Status information verified by the sponsor in July 2026. 2026-07-09. ClinicalTrials.gov:NCT07339423 · Sponsor protocol:NN9490-8021 · EU CT:2024-520440-42
Passage inspected: Identification module (registry identifier, sponsor protocol number, secondary identifiers, brief and official titles, acronym); status module (overall status, actual start date, estimated completion dates, first posted and last update posted dates); sponsor module; design module (study type, phase, allocation, masking, estimated enrollment); conditions module; arms and interventions module
Design: Trial registry record for a randomised, quadruple-masked, parallel-group phase 3 trial
Population: Registered plan for an estimated 1,150 participants with obesity; no results are posted
Route: Subcutaneous
Limits of applicability
A registry record describes a plan and a status reported by the sponsor. It contains no results, and nothing in it says whether the trial will succeed.
The record names the intervention only by its development code, NNC0487-0111. It does not use the name amycretin, so the identification rests on the peer-reviewed characterization report that states amycretin is NNC0487-0111.
Estimated enrollment and completion dates are projections. Only the start date is recorded as actual.
Registry entries are maintained by the sponsor. They are not independently audited records of what a trial did.
Correction check: The record was read on 2026-09-09 through the ClinicalTrials.gov API version 2. Its last update was posted on 2026-07-09 and its status was verified by the sponsor in July 2026, both before the evidence cutoff, so no later registry change falls inside the published period. A registry term search for the name amycretin on the same day returned one other study, the completed phase 1 study of the oral tablet formulation, NCT06049329, whose own titles use both the name amycretin and the development code. Searching instead on the development code NNC0487-0111 returns many further registered studies, including several other phase 3 trials, so this record describes one trial within a larger registered programme rather than the programme itself. Separately, the FDA Drugs@FDA approved-application dataset was searched on 2026-09-09 for amycretin, zenagamtide and cagrilintide and returned no match for any of them, while the same query run for semaglutide did return an application, which shows that the search itself works and that the absences are genuine. That dataset covers approved applications only.
Published / revised: 2026-07-09 Accessed: · Regulatory document
Earlier and current inspections
· Regulatory document · Identification module (registry identifier, sponsor protocol number, secondary identifiers, brief and official titles, acronym); status module (overall status, actual start date, estimated completion dates, first posted and last update posted dates); sponsor module; design module (study type, phase, allocation, masking, estimated enrollment); conditions module; arms and interventions module. First inspection for this reference on 2026-09-09. The registry record was read through the ClinicalTrials.gov API version 2 for phase, status, sponsor, dates and intervention, and the Drugs@FDA application dataset was searched the same day for an approved product. Independent editorial review pending at the time of authoring; no qualified clinical review.
· Regulatory document · Identification, status, sponsor, design, conditions and arms and interventions modules re-read through the ClinicalTrials.gov API version 2, together with the results flag; registry term searches on the compound name, the development code and the International Nonproprietary Name; the Drugs@FDA approved-application dataset with a control query. Independent editorial review on 2026-09-09 by a reviewer who did not author this record. Every registry value in this record was confirmed field by field, including the last update posted date of 2026-07-09 that this record publishes as its own date, and it was confirmed that the word amycretin appears nowhere in the record. The correction check was widened: a search on the development code returns many further registered studies, so this trial is one of a larger registered programme, and the Drugs@FDA negative result was rerun against a control query that returns a result, showing the negative is genuine. No qualified clinical review.
Passage inspected: Abstract: case presentation and outcome (the product combined two SARMs; the abstract itself calls this the most severe RAD-140-associated case reported to date)
Design: Single-patient case report
Population: Previously healthy young man with severe cholestatic drug-induced liver injury, complicated by pancreatitis and acute kidney injury requiring plasmapheresis and intensive care, after using a single supplement product containing both RAD-140 and Andarine (S4)
Limits of applicability
The patient used a single product containing two co-formulated SARMs (RAD-140 and Andarine/S4) together; this report cannot isolate which compound, or their combination, caused the injury and must not be read as pure-compound evidence for either substance.
Only the indexed abstract was inspected; the article requires a subscription and the full case discussion was not reviewed.
Correction check: Fresh Europe PMC core record checked for indexed correction/retraction links; none identified. This is not an exhaustive retraction investigation. Publication-date provenance: Fresh PubMed XML Electronic/firstPublicationDate inspected 2026-09-09; only explicitly supplied year/month/day components are retained.
Published / revised: 2026-07-08 Accessed: · Abstract only
Passage inspected: Title page/pre-decisional framing p. 1; identity pp. 8-9; ulcerative-colitis studies pp. 27-29; nonclinical/safety and conclusions pp. 44-46
Design: FDA review of a proposed bulk substance for compounding, prepared as a briefing for a Pharmacy Compounding Advisory Committee (PCAC) meeting
Population: Proposed clinical uses and routes evaluated in the briefing (oral, subcutaneous, nasal, rectal, transdermal)
Limits of applicability
FDA review relies in part on a meeting abstract with missing methods; a compounding advisory review is not a drug approval.
The document's own cover page states it is a pre-decisional PCAC briefing for the July 23-24, 2026 meeting and that FDA will not issue a final determination until advisory-committee input is considered and all reviews are finalized.
Correction check: Retrieved the full PDF on 2026-09-09 via curl with a standard browser User-Agent header after the python-requests default UA was blocked by FDA's automated-request detection (HTTP 404 to an apology page); extracted text with PyMuPDF and reinspected the cited pages, confirming the pre-decisional framing.
Published / revised: 2026-07 Accessed: · Regulatory document
Document version: July 2026 PCAC briefing document (68 PDF pages); pre-decisional, no final determination issued
Earlier and current inspections
· Regulatory document · Identity pp. 8-9; ulcerative-colitis studies pp. 27-29; conclusions pp. 44-46. Preserved historical inspection record; not retroactively upgraded.
· Regulatory document · Title page/pre-decisional framing p. 1; identity pp. 8-9 (free base vs acetate, withdrawn nominations); ulcerative-colitis studies pp. 27-29 (single Ruenzi 2005 meeting-abstract RCT, 53 randomized/46 completed, rectal enema, DAI endpoint); nonclinical/safety and conclusions pp. 44-46. Freshly reopened and reinspected via a working PDF (curl UA workaround); confirmed all cited numbers and the pre-decisional status. No qualified clinical review.
Passage inspected: Title page/pre-decisional framing p. 1; identity and amino-acid sequence (Figure 5) p. 42; chronic-insomnia conclusion pp. 31-32; opioid-withdrawal and overall conclusions p. 41
Design: FDA review of a proposed bulk substance for compounding, prepared as a briefing for a Pharmacy Compounding Advisory Committee (PCAC) meeting
Population: Proposed subcutaneous route for chronic insomnia, narcolepsy and opioid withdrawal; only intravenous human studies were identified in the literature
Limits of applicability
Heterogeneous historical intravenous studies do not establish subcutaneous efficacy.
This is a pre-decisional PCAC briefing, not a final FDA determination.
Correction check: Retrieved the full PDF on 2026-09-09 via curl with a standard browser User-Agent header after the python-requests default UA was blocked by FDA's automated-request detection; extracted text with PyMuPDF and reinspected the cited pages.
Published / revised: 2026-07 Accessed: · Regulatory document
Document version: July 2026 PCAC briefing document (83 PDF pages); pre-decisional, no final determination issued
Earlier and current inspections
· Regulatory document · Clinical evidence pp. 31 and 41. Preserved historical inspection record; not retroactively upgraded.
· Regulatory document · Title page/pre-decisional framing p. 1; DSIP/emideltide identity and amino-acid sequence (Figure 5) p. 42; chronic-insomnia conclusion pp. 31-32 (no SC-route effectiveness study identified; IV studies inconclusive/preliminary); opioid-withdrawal and overall conclusions p. 41. Freshly reopened and reinspected via a working PDF (curl UA workaround); confirmed Emideltide is FDA/WHO's INN for DSIP, a nonapeptide first isolated from rabbit blood (Schoenenberger et al. 1977). No qualified clinical review.
Passage inspected: PDF p. 8, footnote 6; PDF p. 10, identity table; PDF pp. 25–28, human effectiveness/insomnia; PDF pp. 34–35, tumor-study limitations
Design: FDA review of proposed bulk substances for compounding
Population: Proposed clinical uses and routes evaluated in the briefing
Limits of applicability
Review indication and proposed subcutaneous route matter; studied sublingual route is different. FDA status does not establish worldwide/EMA status.
Correction check: Fresh primary/indexed and regulator source inspection on 2026-09-09, with evidence cutoff 2026-09-08. Exact access failures/alternatives and unresolved issues retained in the compound dossier; this is not a guarantee that no other correction exists.
Published / revised: 2026-07 Accessed: · Regulatory document
Document version: July 2026 PCAC briefing; evidence search dates vary by subsection
Earlier and current inspections
· Regulatory document · Identity p. 8, footnote 6; clinical effectiveness pp. 25–28. Preserved historical inspection record; not retroactively upgraded.
· Regulatory document · PDF p. 8 footnote 6; PDF p. 10 identity table; PDF pp. 25-28 human effectiveness/insomnia; PDF pp. 34-35 tumor-study limitations. Freshly inspected specified sections; no qualified clinical review.
Passage inspected: Title page/pre-decisional framing p. 1; in-vitro blood-hydrolysis pharmacokinetic finding pp. 26-27; human-safety conclusions pp. 28-29
Design: FDA review of a proposed bulk substance for compounding, prepared as a briefing for a Pharmacy Compounding Advisory Committee (PCAC) meeting
Population: Proposed clinical uses and routes evaluated in the briefing; FDA identified no clinical studies or human exposure data for MOTS-c via any route
Limits of applicability
The absence of administered-human evidence identified in this review is not proof of harm.
This is a pre-decisional PCAC briefing, not a final FDA determination.
Correction check: Retrieved the full PDF on 2026-09-09 via curl with a standard browser User-Agent header after the python-requests default UA was blocked by FDA's automated-request detection; extracted text with PyMuPDF and reinspected the cited pages.
Published / revised: 2026-07 Accessed: · Regulatory document
Document version: July 2026 PCAC briefing document (44 PDF pages); pre-decisional, no final determination issued
Earlier and current inspections
· Regulatory document · Human exposure, pharmacokinetics and conclusions pp. 26-29. Preserved historical inspection record; not retroactively upgraded.
· Regulatory document · Title page/pre-decisional framing p. 1; in-vitro blood-hydrolysis finding (Knoop et al. 2019) pp. 26-27; human-safety conclusions p. 29 ('no clinical studies or human exposure data for MOTS-c via any route of administration'). Freshly reopened and reinspected via a working PDF (curl UA workaround); confirmed FDA identified zero human studies of any kind, and one in-vitro blood-incubation PK study. No qualified clinical review.
Passage inspected: Title page/pre-decisional framing p. 1; safety conclusions pp. 40-41; physicochemical/effectiveness conclusions and recommendation pp. 41-44
Design: FDA review of a proposed bulk substance for compounding, prepared as a briefing for a Pharmacy Compounding Advisory Committee (PCAC) meeting
Population: Proposed subcutaneous and intranasal routes for cerebral ischemia, migraine and trigeminal neuralgia
Limits of applicability
Clinical study reporting and salt/formulation identity were insufficient; the review is not approval.
This is a pre-decisional PCAC briefing, not a final FDA determination.
Correction check: Retrieved the full PDF on 2026-09-09 via curl with a standard browser User-Agent header after the python-requests default UA was blocked by FDA's automated-request detection; extracted text with PyMuPDF and reinspected the cited pages.
Published / revised: 2026-07 Accessed: · Regulatory document
Document version: July 2026 PCAC briefing document (69 PDF pages); pre-decisional, no final determination issued
Earlier and current inspections
· Regulatory document · Human evidence and conclusions pp. 40-44. Preserved historical inspection record; not retroactively upgraded.
· Regulatory document · Title page/pre-decisional framing p. 1; safety conclusions pp. 40-41 (no PK data for any route/salt identified; only intranasal route discussed in the literature); effectiveness/conclusion pp. 43-44 ('only two available references...demonstrated lack of effectiveness'; 'we propose not adding semax...to the 503A Bulks List'). Freshly reopened and reinspected via a working PDF (curl UA workaround); confirmed FDA could not determine free base vs acetate identity in the reviewed clinical literature and found the two cerebral-ischemia/migraine/trigeminal-neuralgia references showed a lack of effectiveness. No qualified clinical review.
Passage inspected: PDF p. 25, Figure 5; PDF pp. 26–27, nonacetylated comparator/Rahaman scratch assay; PDF pp. 29–31, human exposure/PK and safety
Design: FDA review of proposed bulk substances for compounding
Population: Proposed clinical uses and routes evaluated in the briefing
Limits of applicability
FAERS through March 26, 2025 / HFCS March 10, 2025; no-reporting is not safety. New July 2026 rat study separately inspected.
Correction check: Fresh primary/indexed and regulator source inspection on 2026-09-09, with evidence cutoff 2026-09-08. Exact access failures/alternatives and unresolved issues retained in the compound dossier; this is not a guarantee that no other correction exists.
Published / revised: 2026-07 Accessed: · Regulatory document
Document version: July 2026 PCAC briefing; evidence search dates vary by subsection
Earlier and current inspections
· Regulatory document · Identity and Figure 5, PDF p. 25; human exposure and effectiveness, PDF pp. 29–30. Preserved historical inspection record; not retroactively upgraded.
· Regulatory document · PDF p. 25 Figure 5; PDF pp. 26-27 nonacetylated comparator/Rahaman scratch assay; PDF pp. 29-31 human exposure/PK and safety. Freshly inspected specified sections; no qualified clinical review.
Fornalik M, Malkiewicz A, Adamczak D, Nawrocki F, Zielinska A, Mondal SA. Planta Med. 2026 Jul;92(8):790-805. Electronic publication 2026-02-25, ahead of the print issue. doi: 10.1055/a-2802-8363. 2026-07. PMID:41740946 · DOI:10.1055/a-2802-8363
Passage inspected: PubMed abstract (full structured text): pooled cortisol, serotonin, TSH/T3/T4 and testosterone/estradiol results by sex, with heterogeneity/dose-response subgroup notes
Design: Systematic review and random-effects meta-analysis of randomized, placebo-controlled trials (PROSPERO CRD42024611576); risk of bias assessed with the Cochrane tool; abstract inspected
Population: 23 randomized, placebo-controlled trials of oral ashwagandha versus placebo in adults, pooling 1,706 participants across trials of varying extract, dose and duration
Limits of applicability
This is a meta-analysis pooling 23 heterogeneous trials (varying extracts, withanolide content, doses and durations); it reports pooled mean differences, not a single trial's individual result, and heterogeneity/publication bias (I-squared, Egger's test) were assessed but not detailed in the abstract.
The pooled testosterone increase in men (mean difference 57.43 ng/dL) is a summary statistic across different products and populations (not specifically post-anabolic-steroid or hypogonadal men); no effect was found on estradiol, and no effect was found in women (mean difference 5.09 ng/dL).
Does not establish a testosterone-restoration, fertility or post-anabolic-steroid recovery indication; the authors call for further standardized trials given heterogeneity and limited data on some endpoints.
Abstract inspection only; the full review's forest plots, individual-trial risk-of-bias ratings and sensitivity analyses were not reviewed.
Correction check: On 2026-09-09, re-fetched the PubMed XML record (PubMed E-utilities efetch) and inspected the PublicationType list and CommentsCorrectionsList field directly. No CommentsCorrectionsList element was present, so PubMed's own index carries no linked comment, erratum, expression of concern or retraction for this record as of the access date. An absent indexed link is an index check, not proof that no problem exists.
Published / revised: 2026-07 Accessed: · Abstract only
Earlier and current inspections
· Abstract only · PubMed E-utilities structured abstract (efetch XML): pooled effect sizes for cortisol, serotonin, thyroid hormones and testosterone/estradiol by sex. Newly identified and inspected via a deliberate PubMed search for ashwagandha testosterone meta-analyses (query recorded in the compound dossier). Independent editorial review pending; no qualified clinical review.
· Abstract only · batches/supplement-integration.json. The supplement batch's independent editorial review was completed by independent-editorial-reviewer (supplement-batch cross-review) (status bounded-review-complete-conditional-integration-edits) and this record was published through that review's integration receipt. This supersedes the earlier entry above recording the review as pending. Editorial review is not qualified clinical review.
FDA postmarket drug safety information page carrying the June 2026 labeling-request update. The page's own HTML metadata states a publication time of 23 June 2026 and a modification time of the same day, and its visible footer reads Content current as of: 06/23/2026. 2026-06-23.
Passage inspected: June 2026 bullets; 2025 links; introductory scope
Design: FDA regulatory information page
Population: US testosterone replacement products
Limits of applicability
This is an FDA information page rather than a product label; it summarises the June 2026 labeling request and does not show any individual product's approved wording.
The recorded date is the publication date the page states for itself in its own HTML metadata, which agrees with its visible currency footer. It is not a statement about when any of the linked regulatory actions was taken.
Correction check: Reopened live on 2026-09-09. A plain automated request returned HTTP 404 from FDA's bot detection; the same URL returned HTTP 200 to a standard browser user agent and served the full page. Its footer states Content current as of: 06/23/2026, and the page's own HTML metadata states a publication time of 23 June 2026 and a modification time of the same day, so no later revision was recorded as of this access. The June 2026 bullets on the requested labeling changes are present in that live text. This resolves the record's earlier note that the June 2026 date had not been recovered from the page itself. FDA information pages carry no correction or retraction index.
Published / revised: 2026-06-23 Accessed: · Regulatory document
Earlier and current inspections
· Regulatory document · TRAVERSE discussion and June 2026 update bullets. Preserved prior inspection record as unverified historical input; superseded by fresh scope recorded 2026-09-09.
· Regulatory document · June 2026 bullets; 2025 links; introductory scope. Freshly reopened relevant methods, results and limits to the scope in the endocrine dossier; not a guarantee that all supplements or historical assertions were reviewed.
· Regulatory document · Live page footer, HTML publication and modification metadata, the June 2026 bullets on the requested labeling changes, the TRAVERSE paragraph and the Related Information links. Currency check for the regulatory-currency batch, replacing a generic correction note that described a literature-index check rather than what was done for an FDA information page. Recovered the page's own stated dates, which the record had flagged as unverified. Independent editorial review reopened the same page on 2026-09-09 and recorded the stated publication date rather than leaving the record undated. Independent editorial review complete for this field; no qualified clinical review.
Passage inspected: June 18, 2026 announcement and the requested-changes paragraphs
Design: Dated FDA/HHS regulatory communication
Population: US testosterone replacement products
Limits of applicability
Not a replacement for the approval status of every product or jurisdiction.
The live page returned HTTP 403 to automated requests on 2026-09-09, so the text was read from an Internet Archive capture dated 2026-08-23 rather than from the live server on that attempt.
Correction check: Reopened on 2026-09-09. The live page returned HTTP 403 to both a plain automated request and a browser-user-agent request, so the release was reinspected through an Internet Archive capture timestamped 2026-08-23, before the evidence cutoff, which returned HTTP 200 and the full release. Confirmed the release line reading FOR IMMEDIATE RELEASE June 18, 2026 and the three requested labeling changes. FDA's own testosterone information page, reopened live the same day, still names this release and repeats the June 2026 request, which corroborates it independently of the archive. A government press release carries no correction or retraction index; this records what the archived capture displayed.
Published / revised: 2026-06-18 Accessed: · Regulatory document
Earlier and current inspections
· Regulatory document · Announcement opening; proposed changes; prostate-label discussion. Preserved prior inspection record as unverified historical input; superseded by fresh scope recorded 2026-09-09.
· Regulatory document · June 18, 2026 announcement and requested-changes paragraphs. Freshly reopened relevant methods, results and limits to the scope in the endocrine dossier; not a guarantee that all supplements or historical assertions were reviewed.
· Regulatory document · Archived capture of the release dated 2026-08-23: the release date line, the announcement paragraph and the three requested labeling changes. Currency check for the regulatory-currency batch, replacing a generic correction note that described a literature-index check rather than what was done for a government release. Recorded the live HTTP 403, the archived route actually used and its pre-cutoff date, and the independent corroboration on FDA's own page. Prior inspection wording retained above. Independent editorial review pending; no qualified clinical review.
· Regulatory document · batches/regulatory-currency-integration.json. The regulatory-currency batch's independent editorial review was completed by Independent editorial reviewer. Did not author any part of the regulatory-currency batch, its patch, its notes or its dossiers. This is editorial review, not clinical review. (status bounded-review-complete-conditional-integration-edits) and this record was published through that review's integration receipt. This supersedes the earlier entry above recording the review as pending. Editorial review is not qualified clinical review.