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Is AOD-9604 Legal in Kentucky? How to Access It Legally

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17 linked public sourcesEditorial, sourcing, and corrections policy

HealthRX.com

AOD-9604 has no FDA-recognized compounding route in Kentucky

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Key numbers

  • 24-weekHuman study: 24-week oral obesity trial (502 randomized) showed no significant weight-loss benefitSource: pubmed.ncbi.nlm.nih.gov, as cited Nov 7, 2026
  • 14 daysMice: 14 days of injected AOD9604 cut body weight and fat (animal data, not human)Source: pubmed.ncbi.nlm.nih.gov, as cited Nov 7, 2026
  • 15.8 gRats: oral AOD9604 for 19 days held weight gain to 15.8 g vs 35.6 g in controlsSource: pubmed.ncbi.nlm.nih.gov, as cited Nov 7, 2026

From the public record

FDA product listings naming AOD-9604

The FDA NDC Directory holds 5 listings naming AOD-9604 from 5 firms: 5 bulk ingredient listings and 0 finished product listings, 0 under an FDA-approved application. A listing is a registration by a firm, not an FDA approval.

FDA product listings naming AOD-9604: the figures
MeasureValueNote
Listings naming AOD-96045
Bulk ingredient listings5raw material registrations, not finished medicines
Of those, bulk ingredient for human prescription compounding1
Finished product listings0
Listings under an FDA-approved application0
Firms with a listing5

Source: FDA, National Drug Code Directory via openFDA, data as of Nov 11, 2026

How this was calculated

Searched ingredient and product names in the NDC Directory download for the exact name variants, then counted listings by FDA marketing category and by listing firm.

Scope: Current NDC Directory listings whose ingredient or product name contains AOD-9604 or AOD 9604 or AOD9604

Firms submit listings themselves. A listing does not mean FDA has reviewed the substance for safety or effectiveness, or that it may lawfully be compounded.

Download the data (CSV)

At a glance

  • FDA approval / None, for any indication [5][6]
  • Compounding lists / In no category on FDA's list for state-licensed pharmacies and physicians or its list for outsourcing facilities [2][3][4]
  • FDA safety view / In FDA's nominated-but-withdrawn table, with stated immunogenicity and safety concerns [1]
  • HHS peptide policy / Not one of the six peptides in HHS's draft enforcement-discretion policy [7][8]
  • Human efficacy / 24-week oral obesity study (502 randomized) showed no significant benefit on its primary weight-loss endpoint; sponsor-reported [6]
  • Sport / Prohibited at all times by WADA as a growth hormone fragment [9][10]
  • Supply / Found in confiscated vials in the US and Belgium [11][12]

Is AOD-9604 FDA-approved?

No. AOD-9604 is a 16-amino-acid fragment of human growth hormone: hGH amino acids 177 to 191 with an extra tyrosine at the N-terminus, which is why it is also called hGH fragment 176-191 [11]. An Australian company, Metabolic Pharmaceuticals, developed it as an anti-obesity candidate; phase IIa trials were underway by February 2002 and it never reached approval [5][6]. FDA's GRAS Notice Inventory contains no AOD-9604 notice, so there is no FDA no-questions letter for it [13].

What FDA says about compounding it

AOD-9604 sits in FDA's table of bulk substances nominated but withdrawn, which holds substances previously in category 2 whose nominators withdrew them [1]. FDA's stated concerns are immunogenicity risk for certain routes of administration, no or only limited safety information, and serious adverse events that may be associated with AOD-9604, though causality is not clear [1]. Removal from category 2 was not a finding that it is safe [1].

It appears in no category on FDA's list for state-licensed pharmacies and physicians, or on FDA's list for outsourcing facilities, so the category 1 policy does not extend to it [2][3][4]. It is not one of the six peptides in HHS's draft enforcement-discretion policy filed October 28, 2026, and was not on the agenda of FDA's July 2026 advisory committee meeting [7][8][14]. Compounded drugs are not FDA-approved: FDA does not review their safety, effectiveness or quality before they reach patients [15].

Does Kentucky change this?

The federal status above applies in Kentucky. It leaves no FDA-recognized compounding route for AOD-9604 in the state.

What the animal and human data show

Animal studies have reported weight and fat changes, but these findings do not establish benefit in people. Oral AOD9604 at 500 micrograms per kilogram per day for 19 days cut body-weight gain in obese Zucker rats to 15.8 g versus 35.6 g in controls, without worsening insulin sensitivity [16]. In obese mice, 14 days of injected AOD9604 reduced body weight and body fat; in mice lacking the beta-3 adrenergic receptor the long-term effects were not seen [17].

In people, a 2026 review describes a 24-week study (534 enrolled, 502 randomized) of AOD9604 as an oral anti-obesity candidate that did not show a significant benefit on its primary weight-loss endpoint. The review notes that this rests on sponsor-reported results rather than a peer-reviewed randomized trial [6]. AOD-9604 has no approved dose, and that human study tested an oral candidate, not the injected products sold online [6].

Where the peptide comes from

AOD-9604 has been found in confiscated vials in the United States and Belgium, and a study reported that it was available on internet websites [11][12]. WADA's Prohibited List names AOD-9604 and hGH 176-191 in section S2.2.3 as growth hormone fragments, prohibited at all times, and it is on both the 2026 and 2027 Lists [9][10].

Check what you know

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1. According to the article, what is AOD-9604 a fragment of?

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Frequently asked questions

Is AOD-9604 approved for weight loss?
No. A 24-week study with 534 enrolled and 502 randomized participants testing oral AOD9604 as an anti-obesity drug did not show a significant benefit on its primary weight-loss endpoint, and the sponsor's obesity program was dropped [6].
Can a Kentucky pharmacy compound AOD-9604?
FDA's category 1 policy of generally not acting against qualifying compounders does not extend to AOD-9604, which is in no category on the list for state-licensed pharmacies and physicians or the list for outsourcing facilities [2][3][4]. FDA has also listed immunogenicity risk and limited safety information among its concerns [1].
Is AOD-9604 banned in sport?
Yes. WADA names AOD-9604 and hGH 176-191 in section S2.2.3 as growth hormone fragments, prohibited at all times, and it is on both the 2026 and 2027 Prohibited Lists [9][10].
Does AOD-9604 have GRAS status?
No. FDA's GRAS Notice Inventory contains no AOD-9604 entry, so there is no FDA no-questions letter [13]. GRAS is a food-ingredient standard and would not make an injectable lawful as a drug [13].

Reader questions

What people actually ask

Short answers drawn from the sources this article cites.

Where can I get AOD-9604 peptide online?

No legal source for buying AOD-9604 is established. It has been found in confiscated vials in the United States and Belgium, and a study reported it was available on internet websites. It is not FDA-approved, and FDA does not review compounded drugs for safety, effectiveness or quality before they reach patients.

Can you take AOD-9604 orally?

Oral use is not established as lawful or effective. An oral form was tested in a 24-week human study of an anti-obesity candidate, which did not show a significant benefit on its primary weight-loss endpoint. Oral dosing in obese rats cut weight gain, but those animal results do not establish benefit in people.

What is the AOD-9604 protocol?

AOD-9604 has no approved dose. Animal studies used doses such as 500 micrograms per kilogram per day for 19 days in obese Zucker rats, and the human study tested an oral candidate, not the injected products sold online.

References

Show all 17 referencesHide references
  1. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks | FDA.
  2. U.S. Food and Drug Administration.
  3. U.S. Food and Drug Administration.
  4. Bulk Drug Substances Used in Compounding of the FD&C Act | FDA.
  5. Wilding J. AOD-9604 Metabolic. Curr Opin Investig Drugs. 2004;5(4):436-40.
  6. 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.
  7. Official web page.
  8. Official web page.
  9. World Anti-Doping Agency.
  10. World Anti-Doping Agency.
  11. Cox HD, Smeal SJ, Hughes CM, Cox JE, Eichner D. Detection and in vitro metabolism of AOD9604. Drug Test Anal. 2015;7(1):31-8.
  12. 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):964-8.
  13. GRAS Notices.
  14. U.S. Food and Drug Administration.
  15. Human Drug Compounding Laws | FDA.
  16. 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):274-8.
  17. 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):5182-9.
Evidence overview for Is AOD-9604 Legal in Kentucky? How to Access It Legally