Identity & applicability

Regulatory recordSupporting passage inspected

FDA describes AOD-9604 as a modified growth-hormone fragment with an added tyrosine. A product labeled only “HGH fragment 176–191” cannot be assumed to match the chemically characterized AOD-9604 preparation or inherit its clinical evidence.[1]

  • This is an applicability limitation: shorthand product names alone cannot establish molecular equivalence.
  • The source document itself is not fully internally consistent about the tyrosine's location: pp. 7 and 11 both state 'N-terminal end' while a pharmacology section on p. 28 states 'C-terminal'. This claim follows the twice-repeated pp. 7/11 wording; the discrepancy is preserved here rather than silently resolved. See peptide-hgh-fragment-176-191-identity-1 for independent analytical confirmation that AOD-9604 and hGH fragment 176-191 are treated as distinct, separately detectable molecules.
Inspection history

Clinical review: not reviewed by a qualified clinician.

· Independently inspected the listed passages; replaced or qualified inherited assertions. No qualified clinical review has occurred.

· Independent fresh reinspection for the deep-evidence pass: reopened every cited source at its passages via NCBI E-utilities / DailyMed / accessdata.fda.gov / govinfo.gov / Wayback Machine mirror, checked Europe PMC correction/retraction metadata where applicable, and confirmed the claim's wording against the primary text. Disposition: supported within the stated scope. No qualified clinical review.

Analytical chemistryAbstract inspected

A 2026 anti-doping mass-spectrometry method validated AOD9604 and hGH fragment 176-191 as separate, independently detectable analytes within a 54-compound panel in blood matrices. This analytical work treats them as distinct molecules for detection purposes; it does not test human safety, efficacy or dosing of either, and it does not establish the identity or purity of any specific vendor's research product sold under either name.[2]

  • This is a doping-control detection-method study in spiked blood matrices, not a clinical or pharmacological study; it cannot establish effects or safety of either compound in humans.
  • It confirms only that the two names correspond to analytically distinguishable substances in this method, not the composition of any particular commercial product labeled with either name.
  • Only the indexed abstract was inspected; full methods and tables were not reviewed.
Inspection history

Clinical review: not reviewed by a qualified clinician.

· Newly authored during the fresh deep-evidence pass from a directly inspected regulator/analytical passage not previously reflected in a claim for this compound. No qualified clinical review.

What remains unresolved

Editorial assessment

These notes describe the scope of this review. Linked PMIDs are audit identifiers; an identifier alone does not verify a claim.

Used FDA’s chemical description to require matching identity before transferring AOD-9604 evidence.

  • Exact composition of research-market fragment products and direct human clinical evidence remain unresolved.
  • Other inherited assertions not supported by the published claim set remain unverified; no qualified clinician review has occurred.

This reference does not supply a dosing plan, monitoring timetable or recovery regimen. Discuss personal symptoms, medicines and laboratory results with a qualified clinician.

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References

  1. FDA December 2024 compounding briefing: AOD-9604

    Bini Mathew, Chioma Amaechi, US Food and Drug Administration, Office of Pharmaceutical Quality. FDA Briefing Document, Pharmacy Compounding Advisory Committee (PCAC) Meeting, December 4, 2024; internal memorandum dated November 5, 2024. 2024-12-04. Regulatory document.

    Inspected location: PDF p.1 (memo date/pre-decisional notice); pp.7 and 11 (identity); p.28 (pharmacology section identity restatement); pp.25-27 (OPTIONS trial and effectiveness conclusion); pp.41-42 (safety conclusion and 503A Bulks List recommendation)

    Study context and inspection record
  2. Rapid and harmonized analytical workflow for the determination of peptidic and non-peptidic doping agents in dried and liquid blood matrices.

    Mazzarino M, Colpaert T, Deventer K, Van Eenoo P. Analyst. 2026 Jul 27;151(15):4398-4413. 2026-07-27. PMID:42328738 · DOI:10.1039/d6an00455e Abstract only.

    Inspected location: Full abstract (methods and stability results) via Europe PMC core record

    Study context and inspection record

Source inspection and clinical review are separate. An abstract check is not a full-text review. The records above identify what was actually inspected and do not certify the complete literature.

Recorded verification attempts
  • peptide-fda-aod-2024: Identity pp. 7 and 11; OPTIONS trial and effectiveness pp. 25–27

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Related records in this class

Grouped under Peptides for navigation only. Shared class membership does not make findings, formulations or evidence interchangeable between records.

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