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

At a glance

  • FDA approval / None; the obesity program was dropped [1][2]
  • FDA compounding lists / In none of the three interim categories [3][4]
  • Outsourcing facilities / Not on FDA's list for outsourcing facilities [5]
  • FDA safety view / Immunogenicity risk; serious adverse events of unclear causality [6]
  • Approved dose / None [2]
  • Human evidence / 24-week oral study of 502 randomized people failed its weight-loss endpoint [2]
  • Sport / WADA prohibits it at all times [7][8]

Is AOD-9604 an FDA-approved drug?

No. It is a 16-amino-acid fragment of human growth hormone, hGH amino acids 177 to 191 plus an N-terminal tyrosine, which is why it is also called hGH fragment 176-191 [2][9]. Metabolic Pharmaceuticals developed it for obesity; phase IIa trials were underway by February 2002, it never reached approval, and the obesity program was dropped [1][2]. A 24-week study of an oral version, with 534 enrolled and 502 randomized people, showed no significant benefit on the primary weight-loss endpoint. A 2026 review notes that this conclusion rests on sponsor-reported phase 2 results rather than peer-reviewed randomized trials [2]. No approved dose exists [2].

Can a Louisiana pharmacy compound it on a prescription?

Compounding rules limit which bulk substances may be used. AOD-9604 appears in none of the three categories on FDA's list for state-licensed pharmacies and physicians, and it is not on FDA's list for outsourcing facilities [3][5][4]. FDA's category 1 no-action policy does not cover it [3][4]. HHS's draft enforcement-discretion policy for compounded peptides, filed in October 2026, names six other peptides (BPC-157, epitalon, KPV, MOTS-c, Semax, TB-500) and not AOD-9604 [10][11]. So no FDA compounding policy in these lists gives a clear legal route to routine compounded access.

What does FDA say about its safety?

FDA's page on bulk substances that may present significant safety risks (content dated 04/22/2026) lists AOD-9604 in the 'nominated but withdrawn' table. That table holds substances previously in category 2 whose nominators withdrew them. FDA's stated concerns are these: compounded drugs containing it may pose significant immunogenicity risk for certain routes of administration, tied to peptide impurities and characterization problems; FDA has identified no, or only limited, safety information; and FDA has identified serious adverse events that may be associated with AOD-9604, though causality is not clear [6]. Removal from category 2 was not a finding that it is safe [6].

What is the evidence for the fat-loss and joint-repair claims?

Animal studies reported changes in weight and fat, but the 24-week human oral study did not show a significant benefit on its primary weight-loss endpoint [2][12][13]. In obese Zucker rats, oral AOD9604 500 microgram/kg/day for 19 days cut body-weight gain to 15.8 g versus 35.6 g in controls [12]. In obese mice, 14 days of injected AOD9604 reduced body weight and fat [13]. Joint-repair claims rest on a rabbit knee osteoarthritis study, with no convincing human trial [14][2].

Can you buy AOD-9604 online?

AOD-9604 circulates on the gray market. It has been identified in confiscated vials in the USA and in preparations seized by Belgian authorities [9][15]. Claims that it is 'GRAS' do not trace to FDA: FDA's GRAS Notice Inventory contains no AOD-9604 notice [16]. GRAS is a food-ingredient concept and would not make an injectable lawful as a drug.

Frequently asked questions

Is AOD-9604 legal in Louisiana?
There is no clear legal route to routine access. AOD-9604 is not FDA-approved [1][2], and FDA's category 1 compounding policy does not cover it [3][4].
Can a Louisiana pharmacy fill a compounded AOD-9604 prescription?
AOD-9604 is absent from FDA's compounding categories for state-licensed pharmacies and physicians and from the outsourcing-facility list [3][5][4]. FDA also lists it in its 'nominated but withdrawn' table with stated safety concerns [6].
Is AOD-9604 approved for weight loss?
No. The 24-week oral study (502 randomized) failed its primary weight-loss endpoint, the results are sponsor-reported, and no approved dose exists [2].
Does WADA ban AOD-9604?
Yes. WADA names AOD-9604 and hGH 176-191 in S2.2.3 as growth hormone fragments, prohibited at all times in and out of competition, on both the 2026 and 2027 Lists [7][8].

References

  1. Wilding J. AOD-9604 Metabolic. Curr Opin Investig Drugs. 2004;5(4):436-40. AOD-9604 Metabolic
  2. 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. The emerging landscape of performance-enhancing peptides modulating GH-IGF1 axis: bridging the gap between clinical evidence and patient self-administration
  3. U.S. Food and Drug Administration. U.S. Food and Drug Administration
  4. Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act | FDA. Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act | FDA
  5. U.S. Food and Drug Administration. U.S. Food and Drug Administration
  6. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks | FDA. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks | FDA
  7. World Anti-Doping Agency. World Anti-Doping Agency
  8. World Anti-Doping Agency. World Anti-Doping Agency
  9. 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. Detection and in vitro metabolism of AOD9604
  10. Official web page. Official web page
  11. Official web page. Official web page
  12. 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. Metabolic studies of a synthetic lipolytic domain (AOD9604) of human growth hormone
  13. 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. 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
  14. 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):426-32. Effect of Intra-articular Injection of AOD9604 with or without Hyaluronic Acid in Rabbit Osteoarthritis Model
  15. 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. Identification and characterization of peptide drugs in unknown pharmaceutical preparations seized by the Belgian authorities: case report on AOD9604
  16. GRAS Notices. GRAS Notices
Evidence overview for Is AOD-9604 Legal in Louisiana? How to Access It Legally