AOD-9604 Reviews

EXH.04 / REFERENCES

the full citation index

Every primary source used on this site, sortable and filterable — peer-reviewed peptide research, FDA committee materials, the WADA Prohibited List, and contemporaneous trade reporting.

Back to researchAbout this site

How this index is built

Every quantitative or factual claim on AOD-9604 Reviews maps to a citation in the table below. Numbers in square brackets in the body text — [1], [2], [3] — refer to the entries here. The primary sources are peer-reviewed research papers (Hormone Research, International Journal of Obesity, Endocrinology, Journal of Endocrinology and Metabolism, Annals of Clinical and Laboratory Science, Cartilage, Drug Testing and Analysis), the December 2024 FDA Pharmacy Compounding Advisory Committee materials (committee briefing, nomination dossier, joint-health attachment, and the 'Saving AOD9604' public-testimony submission), the WADA Prohibited List, and one piece of contemporaneous trade reporting from the Calzada-era 2012 pivot announcement. Where a DOI is available it is included; where the canonical link is to PubMed, PMC, or a regulatory docket the URL is the canonical address.

Notes on the evidence base

Two features of the AOD-9604 literature shape how the citations cluster. First, almost all of the positive obesity-efficacy evidence comes from a single Australian research lineage (Ng / Heffernan / Monash, with Metabolic Pharmaceuticals as sponsor); independent replication of the chronic-dosing weight-loss phenotype outside this lineage is sparse. Second, the human safety pool — by contrast — is unusually large for a research peptide, with roughly 900 subjects across six trials, and is documented in a single dedicated safety paper (Stier, Vos, Kenley 2013) plus the 2014 metabolism review (Moré & Kenley). The cartilage-repair evidence base reduces to one in-vivo study (Kwon & Park 2015), supporting in-vitro chondrocyte work referenced in the 2024 Cartilage review (Liao et al.), and the public-testimony dossier submitted to the December 2024 FDA PCAC meeting. The 2024 regulatory record (PCAC vote, FAERS/CAERS dossier, public testimony) is the newest cluster and the one that most distinguishes a 2026 review from a 2015-era review of the same compound.

  1. Ng FM, Sun J, Sharma L, Libinaka R, Jiang WJ, Gianello R. Metabolic studies of a synthetic lipolytic domain (AOD9604) of human growth hormone. Hormone Research. 2000;53(6):274-278. ↗
  2. Heffernan MA, Thorburn AW, Fam B, Summers R, Conway-Campbell B, Waters MJ, Ng FM. Increase of fat oxidation and weight loss in obese mice caused by chronic treatment with human growth hormone or a modified C-terminal fragment. International Journal of Obesity and Related Metabolic Disorders. 2001;25(10):1442-1449. ↗
  3. Heffernan M, Summers RJ, Thorburn A, Ogru E, Gianello R, Jiang WJ, Ng FM. The effects of human GH and its lipolytic fragment (AOD9604) on lipid metabolism following chronic treatment in obese mice and beta(3)-AR knock-out mice. Endocrinology. 2001;142(12):5182-5189. ↗
  4. Stier H, Vos E, Kenley D. Safety and Tolerability of the Hexadecapeptide AOD9604 in Humans (Phase IIa weight-loss signal, METAOD005 1 mg arm: 2.6 kg vs 0.8 kg placebo). Journal of Endocrinology and Metabolism. 2013;3(1-2):7-15. ↗
  5. Stier H, Vos E, Kenley D. Safety and Tolerability of the Hexadecapeptide AOD9604 in Humans (Phase IIb pivotal METAOD006/OPTIONS, n=502, 24 weeks, oral 0.25-1 mg daily — no statistically significant weight loss vs placebo; programme discontinued February 2007). Journal of Endocrinology and Metabolism. 2013;3(1-2):7-15. ↗
  6. Stier H, Vos E, Kenley D. Safety and Tolerability of the Hexadecapeptide AOD9604 in Humans (pooled safety analysis, six trials, ~900 subjects, IV 25-400 μg/kg single dose; oral 0.25-54 mg/day for up to 24 weeks). Journal of Endocrinology and Metabolism. 2013;3(1-2):7-15. ↗
  7. Moré MI, Kenley D. Safety and Metabolism of AOD9604, a Novel Nutraceutical Ingredient for Improved Metabolic Health (chronic toxicology: 6-month rat NOAEL 100 mg/kg/day; 9-month cynomolgus monkey NOAEL 50 mg/kg/day; Ames / CHO / micronucleus genotoxicity negative). Journal of Endocrinology and Metabolism. 2014;4(3):64-77. ↗
  8. Moré MI, Kenley D. Safety and Metabolism of AOD9604, a Novel Nutraceutical Ingredient for Improved Metabolic Health (pharmacokinetics: plasma t½ ≈ 3-4 min IV in pigs; oral bioavailability ≈ 40% in rats; sequential N-terminal proteolysis). Journal of Endocrinology and Metabolism. 2014;4(3):64-77. ↗
  9. Kwon DR, Park GY. Effect of Intra-articular Injection of AOD9604 with or without Hyaluronic Acid in Rabbit Osteoarthritis Model. Annals of Clinical and Laboratory Science. 2015;45(4):426-432. ↗
  10. Liao HJ, Chen HT, Chang CH. Peptides for Targeting Chondrogenic Induction and Cartilage Regeneration in Osteoarthritis. Cartilage. 2024. ↗
  11. Liao HJ, Chen HT, Chang CH. Peptides for Targeting Chondrogenic Induction and Cartilage Regeneration in Osteoarthritis (cell-culture chondrocyte work: increased proteoglycan and type-II collagen production cited as supporting in-vitro evidence for AOD-9604). Cartilage. 2024. ↗
  12. Cox HD, Lopes F, Woldemariam GA, Becker JO, Parkin MC, Thomas A, Butch AW, Cowan DA, Thevis M, Bowers LD, Hoofnagle AN. Detection and in vitro metabolism of AOD9604. Drug Testing and Analysis. 2015;7(1):31-38. ↗
  13. U.S. Food and Drug Administration. Bulk Drug Substance Nomination — AOD-9604 (PCAC briefing materials, December 4, 2024) — FAERS through January 2024 and CAERS from 1 January 2004 through 3 April 2024 returned zero AOD-9604-attributed adverse-event reports. 2024. ↗
  14. U.S. Food and Drug Administration. December 4, 2024 Meeting of the Pharmacy Compounding Advisory Committee — Meeting Materials and Roster (PCAC voted that AOD-9604 free base and acetate should not be added to the 503A Bulks List). 2024. ↗
  15. Moré MI, Kenley D. Safety and Metabolism of AOD9604, a Novel Nutraceutical Ingredient for Improved Metabolic Health (U.S. self-affirmed GRAS designation, approximately 1 mg per serving, oral food / beverage / dietary-supplement matrices; not an FDA drug approval). Journal of Endocrinology and Metabolism. 2014;4(3):64-77. ↗
  16. World Anti-Doping Agency. The Prohibited List — Section S2 (Peptide Hormones, Growth Factors, Related Substances and Mimetics — growth hormone fragments and releasing factors). 2025. ↗
  17. Proactive Investors news desk. Calzada identifies cartilage repair and muscle enhancement benefits in compound (Calzada Ltd. corporate announcement of AOD-9604 pivot from obesity to cartilage-repair / OA indication). Proactive Investors. 2012. ↗
  18. BioSpace news desk. Metabolic Pharmaceuticals's Obesity Trial Update: First 100 Subjects Complete The Phase 2B Trial Of AOD9604 (interim analysis: 1 mg oral arm — ~2.8 kg mean weight loss in first 100 subjects, >3× placebo). BioSpace. 2004. ↗
  19. U.S. Food and Drug Administration — PCAC Public Docket. Joint Health and Cartilage Repair — AOD-9604 Bulk Drug Substance Nomination Attachment (FDA-2024-N-4777-0002 / Attachment 17) — compiles the chondrocyte and rabbit cartilage research literature submitted in support of the 503A nomination. 2024. ↗
  20. Ng FM, Sun J, Sharma L, Libinaka R, Jiang WJ, Gianello R. Metabolic studies of a synthetic lipolytic domain (AOD9604) of human growth hormone (compound design history: Monash University / Prof. Frank Ng; intended separation of hGH lipolytic activity from growth-promoting and IGF-1-elevating effects). Hormone Research. 2000;53(6):274-278. ↗
  21. Moré MI, Kenley D. Safety and Metabolism of AOD9604, a Novel Nutraceutical Ingredient for Improved Metabolic Health (integrated mechanism review: β3-AR → cAMP → PKA → HSL lipolytic cascade in adipocytes; GHR-independent; upstream cell-surface binding partner unresolved). Journal of Endocrinology and Metabolism. 2014;4(3):64-77. ↗
  22. U.S. Food and Drug Administration — PCAC Public Docket. 'Saving AOD9604' (Edwin Lee MD, FACE) — Pharmacy Compounding Advisory Committee Public Testimony, December 4, 2024 — compounding-pharmacy submission summarising observational clinical use and arguments for retaining 503A access; not adopted by the committee. 2024. ↗
  23. AOD-9604 (Metabolic Pharmaceuticals). Current Opinion in Investigational Drugs. 2004;5(4):437-441. ↗
  24. Halford JC. Obesity drugs in clinical development. Current Opinion in Investigational Drugs. 2006;7(4):312-318. ↗
  25. Adan RA. Central and peripheral molecular targets for antiobesity pharmacotherapy. Clinical Pharmacology and Therapeutics. 2010;87(6):748-751. ↗