A fragment of growth hormone that was taken through six human trials by the company that owned it, and did not produce weight loss. Almost everything sold under the name today trades on the trials without mentioning the result.

Summary

  • AOD-9604 is a 16-amino-acid synthetic peptide modelled on residues 177 to 191 of human growth hormone, with an added tyrosine at the N-terminus and a disulfide bridge. It is not growth hormone, and it does not bind the growth hormone receptor.1

  • In obese mice and rats it reduced weight gain and increased fat oxidation without the rise in blood glucose seen with intact growth hormone.13

  • Metabolic Pharmaceuticals ran six human trials in 925 people between 2001 and 2007. By the company's own account they did not show a clinically meaningful weight loss outcome, and the obesity programme was terminated in February 2007.6

  • The efficacy data from those trials have never been published in a peer-reviewed journal. What was published, six years later, is a pooled safety analysis co-authored by the company's chief executive.7

  • Safety in those trials was unremarkable: adverse events were distributed similarly between drug and placebo, and no serious event was judged related to the peptide.7

  • It is not approved as a medicine anywhere. Its "GRAS" status is a self-determination by a company-convened panel for use in foods at up to 1 mg a day; there is no AOD-9604 entry in the FDA's GRAS Notice Inventory.69

  • In December 2024 the FDA's Pharmacy Compounding Advisory Committee voted 0 to 12 against adding it to the list of substances pharmacies may compound, after an FDA review found "a lack of evidence to support the effectiveness of AOD-9604" for obesity by any route.1819

  • Prohibited in sport at all times under WADA section S0, as a substance with no regulatory approval for human therapeutic use.10

  • A targeted PubMed search returns 12 records. None is a human efficacy trial.

The Most Common Error About This Compound

Product pages describe AOD-9604 as "clinically proven" for fat loss and cite the six human trials. The trials were run to test that claim, and they did not support it. The company that funded them said so in writing when it shut the programme down.6 A trial record can be evidence of safety and evidence against efficacy at the same time, and that is the position here.

Identity

What Is AOD-9604?

Human growth hormone is a 191-amino-acid protein. Its C-terminal region, roughly residues 176 to 191, was identified in the 1990s as the part of the molecule responsible for its lipolytic effect on fat cells. AOD-9604 is a synthetic copy of residues 177 to 191 with a tyrosine added at the front, cyclised through a disulfide bond between its two cysteines.5 The name stands for "anti-obesity drug", the number is a compound code, and the compound is also sold as "hGH fragment 176-191" or simply "Frag".

It was developed by Metabolic Pharmaceuticals of Melbourne, later a subsidiary of Calzada Ltd, out of work at Monash University. It is not approved for human use by any regulatory authority.6

Is It Growth Hormone?

No, and the difference is mechanistic rather than cosmetic.

In cells engineered to express the growth hormone receptor, AOD-9604 did not compete with growth hormone for binding and did not stimulate cell proliferation, both of which intact growth hormone does.1 The company's own non-clinical programme reported that it did not raise IGF-1 in any system tested.8

That is the basis for the claim that AOD-9604 separates the fat-burning action of growth hormone from its growth-promoting and glucose-raising actions. It is also why it does not show up on the WADA growth hormone isoform test, which was checked directly and published.11 Neither fact means it works.

Evidence Base

What Did the Animal Studies Show?

The preclinical case was reasonable. In obese ob/ob mice given AOD-9604 or growth hormone by osmotic pump for 14 days, both compounds reduced body weight gain and increased fat oxidation and plasma glycerol, an index of lipolysis. Unlike growth hormone, the fragment did not induce hyperglycaemia or reduce insulin secretion.1

In obese Zucker rats given 500 micrograms per kilogram orally for 19 days, weight gain was reduced by more than half against control, 15.8 grams against 35.6, and euglycaemic clamp studies showed no adverse effect on insulin sensitivity.3

A second mouse study located part of the mechanism. Both growth hormone and AOD-9604 increased expression of the beta-3 adrenergic receptor, the main lipolytic receptor in fat cells, and chronic treatment failed to reduce weight in mice lacking that receptor. The authors concluded the lipolytic effect was not mediated directly through the receptor but was associated with restoring its expression.2

These studies are from a single group with a commercial stake in the outcome, and they are from 2000 and 2001. Nothing since has extended them. They are the reason the human trials were run, not a substitute for the result.

What Happened in the Human Trials?

Six randomised, double-blind, placebo-controlled trials were run between 2001 and 2007, at a contract research unit in Manchester and at sixteen Australian hospitals and medical centres, enrolling 925 people in total. Doses ranged from 25 to 400 micrograms per kilogram intravenously in the early studies and from 0.25 to 54 milligrams daily by mouth in the later ones, with the longest trial running 24 weeks.7

The company's own summary of the outcome is the only primary account that exists: while the trials "proved that AOD9604 was profoundly safe, they did not show a clinically meaningful weight loss outcome across the total trial population. As a result the obesity program was terminated in February 2007."6

The FDA reconstructed the decisive trial from the company's stock exchange filings when it reviewed the compound in 2024. The OPTIONS study enrolled 536 adults with obesity and randomised 502 to oral AOD-9604 at 0.25, 0.5 or 1 mg daily or placebo, alongside a dietitian-supervised diet and exercise programme, for 24 weeks. It was powered to detect a 1.8 kg difference from placebo at 12 weeks. It found none, and on 21 February 2007 the company announced that the results "do not support the commercial viability of the drug as a treatment for obesity."18

The same review located summaries of the earlier, smaller studies. A 12-week study in 300 people reported weight loss rates of 0.13 to 0.22 kg per week on drug against 0.07 on placebo, differences the FDA described as small and of unclear therapeutic meaning, with the largest effect at the lowest dose. A one-week study in 36 men reported 1 kg against 0.6 kg. None of the studies was published with enough methodological detail to evaluate.18

A 2026 review in Frontiers in Endocrinology records the same result in the ordinary language of drug development: AOD-9604 "failed to demonstrate a significant benefit on the primary weight-loss endpoint," and there are no robust data supporting clinically meaningful visceral fat reduction.12

Why Are the Trial Results Not on PubMed?

Because the efficacy results were never submitted to a journal. The trials predate mandatory registration, they do not appear on ClinicalTrials.gov, and the sponsor was a small listed company whose interest in publishing a negative programme ended with the programme.

What was eventually published, in 2013 and 2014 in a journal not indexed by PubMed, is a pooled safety analysis of the six trials and a summary of the animal toxicology.78 Both papers list David Kenley, chief executive of Metabolic Pharmaceuticals, as an author, and the company's April 2013 statement says the publication was a condition of the GRAS panel's opinion.6 That is the context in which to read them: safety papers produced to support a food-ingredient claim, after the drug programme had failed.

What Does the Osteoarthritis Work Amount To?

After the obesity programme closed, the company repositioned the compound toward cartilage and joint repair, and stated in 2013 that work to date had been preclinical only.6

The published animal study is a 2015 rabbit experiment. Thirty-two rabbits with collagenase-induced knee osteoarthritis received weekly intra-articular injections of saline, hyaluronic acid, AOD-9604, or both, for four to seven weeks. Morphological and histological scores were better in every treated group than in saline, and best in the combination group, which also had the shortest period of lameness.4

It is one study, in rabbits, by injection directly into the joint. No human study of AOD-9604 in osteoarthritis has been registered or published, and a 2026 orthopaedic review of therapeutic peptides places the whole class in the position of promising preclinical work without clinical trials.13

Safety

What Is Known?

More than for most compounds in this library, and that is the one respect in which AOD-9604 is unusual.

Across the six trials, adverse events were similar in kind and frequency between AOD-9604 and placebo, the most common being headache and gastrointestinal symptoms. No withdrawal or serious adverse event was judged related to the peptide. Five cancers were recorded among roughly 900 participants and were assessed as unrelated to study medication.7

The animal toxicology reported no genotoxicity in the Ames test, a no-observed-adverse-effect level of 100 mg per kilogram per day in a six-month oral rat study and 50 mg per kilogram per day in a nine-month monkey study, and no stimulation of IGF-1 in any system.8

The FDA read that toxicology more cautiously than its authors. Its 2024 review noted equivocal signals in the Ames assays and an increase in chromosome aberrations in one of two duplicate assays, dismissed by the authors because a higher concentration showed no effect, at which the compound had precipitated out of solution. The agency's conclusion was that "findings of positive genotoxicity signals produced by AOD-9604 in different in-vitro and in-vivo assays cannot be regarded as biologically insignificant." It found no developmental or reproductive toxicity studies at all.18

On the other side of the ledger, the same review searched the FDA's adverse event reporting system and the medical literature through January 2024 and found no reports for AOD-9604 by any route, while noting that the absence of reports for a compounded product does not imply safety.18

What the Safety Record Does Not Cover

Three things, each of which describes how the compound is actually used.

The human trials were oral and intravenous. The gray market sells it as a lyophilised powder for subcutaneous injection, and the FDA's stated concern for injectable routes is immunogenicity from aggregation and peptide-related impurities, on which it has "no, or only limited, safety-related information." The agency also states it has identified serious adverse events that may be associated with AOD-9604, "though causality is not clear."14

The trials used pharmaceutical-grade material of verified identity. The 2026 sports medicine literature is direct about the alternative: rigorous human safety data for unapproved peptides bought direct are scarce, and products are often mislabelled or contaminated.15

And the trials ran 24 weeks at most. Community protocols run the compound in repeated cycles, often stacked with growth hormone secretagogues, which no study has examined.12

Sport and Drug Testing

Is AOD-9604 Prohibited?

Yes, at all times, in and out of competition. It is not named on the WADA Prohibited List; it is caught by section S0, which prohibits any pharmacological substance with no current approval by a governmental regulatory health authority for human therapeutic use, including drugs in pre-clinical or clinical development or discontinued.10 WADA confirmed that classification for AOD-9604 in a statement of 22 April 2013, during the Australian sport supplements inquiry in which the compound featured.6

Can It Be Detected?

Yes. A validated urine method was published in 2015 with a limit of detection of 50 picograms per millilitre, and the same work identified a metabolite, CRSVEGSCG, that is markedly more stable than the parent and extends the detection window.5 The authors noted the peptide was available on several websites and had recently been identified in confiscated vials in the United States.

It does not interfere with the growth hormone isoform immunoassay, so it will not produce a false positive for growth hormone; it is looked for on its own.11

Regulatory Status

Is It Approved Anywhere?

No. The company's 2013 statement is unambiguous: AOD-9604 "has not been granted approval by Australia's Therapeutic Goods Administration or any other government health authority in the world to be marketed as a pharmaceutical product."6

What Does "GRAS" Mean Here?

Less than the label implies.

Generally Recognised As Safe is a status under United States food law, not drug law, and it can be self-determined: a company convenes a panel of qualified experts who conclude that an ingredient is safe for a stated food use. A company may then notify the FDA, which either has "no questions" or raises them. It may also choose not to notify.

The AOD-9604 determination was made by an independent panel convened for the company in June 2012, for use in foods, drinks and dietary supplements at up to 1 mg per day, conditional on publishing the existing safety data.6 A search of the FDA's GRAS Notice Inventory for AOD9604 returns no records.9

So the status is real, narrow and private. It covers oral intake at a dose an order of magnitude below the oral trial doses, it says nothing about injection, and the FDA has not reviewed it. "FDA GRAS-approved" is not a category that exists.

Where Does It Stand on Compounding?

In September 2023 the FDA placed AOD-9604 in Category 2 of its interim policy on bulk substances nominated for compounding, the category for substances that may present significant safety risks. Its stated reasons were the immunogenicity risk of certain routes of administration, complexities of impurity and characterisation, and a lack of safety information sufficient to know whether the drug would cause harm.14

What Happened in December 2024?

AOD-9604 has already had its hearing, and it is the one part of this compound's record that most product pages omit.

On 4 December 2024 the FDA's Pharmacy Compounding Advisory Committee considered AOD-9604 free base and acetate for the 503A bulks list, the register of substances pharmacies may compound. The use evaluated was obesity. The FDA's review concluded there was "a lack of evidence to support the effectiveness of AOD-9604 (free base) and AOD-9604 acetate for the treatment of obesity for any" route of administration, that the compound had failed to beat placebo in most identified studies, that no human exposure by the subcutaneous route had been found, and that multiple approved drugs exist for the same condition. It proposed against inclusion.18

The committee voted 12 to 0 to consider both forms together, and then 0 in favour and 12 against placing them on the list. The minutes record no committee discussion.19 Speakers at the open public hearing in support of the nomination included compounding-sector companies and a lawyer representing them; Eli Lilly also spoke.19

That vote is advisory, but it was unanimous, it followed the agency's own recommendation, and nothing since has reopened it. As of April 2026 the FDA lists AOD-9604 among substances "nominated but withdrawn" by their nominators, alongside its original safety text. It was not among the seven peptides the committee considered in July 2026, and it is not on the 503A bulks list.1416 A pharmacy in the United States has no lawful basis on which to compound it.

The July 2026 votes that made news were on other peptides. A seller citing them as a change in AOD-9604's standing is citing a meeting it was not at, seven months after the meeting it was.

What Is Being Sold

What Did the Owner Say About the Market?

In 2010 Calzada told the Australian Securities Exchange that AOD-9604 was being manufactured in China and elsewhere and sold into various countries in contravention of its patents, primarily to distributors, gymnasiums, weight control centres, private clinics and individuals. Its 2013 statement adds that Metabolic Pharmaceuticals "does not manufacture, distribute or sell AOD9604."6

The only entity that ever made a characterised, trial-grade version of this compound therefore has no connection to anything on sale. Belgian authorities published a case report on exactly this in 2014, characterising seized preparations labelled as AOD-9604 with mass spectrometry.17 The sourcing page covers what that implies.

Related ONPEPS Coverage

What Would Change This Page

Publication of the 2001 to 2007 efficacy data, which exist and have never been released, would settle what was actually observed rather than what was summarised. Any registered human trial for any indication would be the first. A human study of subcutaneous administration, the route people actually use, would address the one safety gap the FDA has named.

References

  1. Heffernan MA, Thorburn AW, Fam B, Summers R, Conway-Campbell B, Waters MJ, et al. Increase of fat oxidation and weight loss in obese mice caused by chronic treatment with human growth hormone or a modified C-terminal fragment. Int J Obes Relat Metab Disord. 2001;25(10):1442-1449. Paywalled. pubmed.ncbi.nlm.nih.gov/11673763

  2. Heffernan M, Summers RJ, Thorburn A, Ogru E, Gianello R, Jiang WJ, et al. 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. Open access. pubmed.ncbi.nlm.nih.gov/11713213

  3. Ng FM, Sun J, Sharma L, Libinaka R, Jiang WJ, Gianello R. Metabolic studies of a synthetic lipolytic domain (AOD9604) of human growth hormone. Horm Res. 2000;53(6):274-278. Paywalled. pubmed.ncbi.nlm.nih.gov/11146367

  4. Kwon DR, Park GY. Effect of intra-articular injection of AOD9604 with or without hyaluronic acid in rabbit osteoarthritis model. Ann Clin Lab Sci. 2015;45(4):426-432. Open access. pubmed.ncbi.nlm.nih.gov/26275694

  5. Cox HD, Smeal SJ, Hughes CM, Cox JE, Eichner D. Detection and in vitro metabolism of AOD9604. Drug Test Anal. 2015;7(1):31-38. Paywalled. pubmed.ncbi.nlm.nih.gov/25208511

  6. Calzada Ltd / Metabolic Pharmaceuticals Pty Ltd. AOD9604 – Important Clarifications. Company statement, 26 April 2013. Primary source for the trial count, the February 2007 termination, the GRAS panel, the 2010 ASX black-market announcements and the WADA statement of 22 April 2013. lateral-pharma.com

  7. Stier H, Vos E, Kenley D. Safety and tolerability of the hexadecapeptide AOD9604 in humans. J Endocrinol Metab. 2013;3(1-2):7-15. Open access; not indexed in PubMed; co-authored by the sponsor's chief executive. doi.org/10.4021/jem157w

  8. Moré MI, Kenley D. Safety and metabolism of AOD9604, a novel nutraceutical ingredient for improved metabolic health. J Endocrinol Metab. 2014;4(3):64-77. Open access; not indexed in PubMed; co-authored by the sponsor's chief executive. doi.org/10.14740/jem213w

  9. US Food and Drug Administration. GRAS Notice Inventory, search for "AOD9604". Returns no records. Searched 16 September 2026. hfpappexternal.fda.gov

  10. World Anti-Doping Agency. The Prohibited List, section S0, Non-approved substances. Current edition. wada-ama.org

  11. Orlovius AK, Thomas A, Schänzer W, Thevis M. AOD-9604 does not influence the WADA hGH isoform immunoassay. Drug Test Anal. 2013;5(11-12):850-852. Paywalled. pubmed.ncbi.nlm.nih.gov/24124033

  12. Dominikowski A, Rękoś Z, Olejarz M, Szczepanek-Parulska E, Domin R, Ruchała M. The emerging landscape of performance-enhancing peptides modulating GH-IGF1 axis: bridging the gap between clinical evidence and patient self-administration. Front Endocrinol (Lausanne). 2026;17:1822475. Open access. pubmed.ncbi.nlm.nih.gov/42395176

  13. Rahman OF, Lee SJ, Seeds WA. Therapeutic peptides in orthopaedics: applications, challenges, and future directions. J Am Acad Orthop Surg Glob Res Rev. 2026;10(1):e25.00236. Open access. pubmed.ncbi.nlm.nih.gov/41490200

  14. US Food and Drug Administration. Category 2 of the Bulk Substances Nominated Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act. Entry for AOD-9604 under "Bulk drug substances nominated but withdrawn". Content current as of 22 April 2026. fda.gov

  15. Mendias CL, Awan TM. Safety and efficacy of approved and unapproved peptide therapies for musculoskeletal injuries and athletic performance. Sports Med. 2026;56(8):1921-1935. Paywalled. pubmed.ncbi.nlm.nih.gov/41966639

  16. US Food and Drug Administration. July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee. Agenda listing the seven substances considered; AOD-9604 is not among them. Docket FDA-2025-N-6895. fda.gov

  17. Vanhee C, Moens G, Deconinck E, De Beer JO. Identification and characterization of peptide drugs in unknown pharmaceutical preparations seized by the Belgian authorities: case report on AOD9604. Drug Test Anal. 2014;6(9):964-968. Paywalled. pubmed.ncbi.nlm.nih.gov/24976118

  18. US Food and Drug Administration. AOD-9604-related bulk drug substances (AOD-9604 (free base) and AOD-9604 acetate): FDA review for the December 4, 2024 meeting of the Pharmacy Compounding Advisory Committee. Docket FDA-2024-N-4777. Primary source for the OPTIONS trial design, the 21 February 2007 announcement, the genotoxicity assessment and the FAERS search. fda.gov

  19. US Food and Drug Administration. Final Summary Minutes of the Pharmacy Compounding Advisory Committee Meeting, December 4, 2024. Approved 21 February 2025. Records the 0 to 12 vote against inclusion. fda.gov

Not Medical Advice

AOD-9604 is not approved for human use in any jurisdiction and is prohibited in sport under WADA section S0. Its human trial record is a safety record from oral and intravenous dosing, not evidence that injecting it does anything. Consult a qualified healthcare provider before acting on anything here.

Evidence counts on the library index retrieved 23 July 2026. Literature and regulatory sources verified 16 September 2026. Re-verify before relying on any regulatory statement here.