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Is AOD-9604 Legal in Illinois? What Federal Rules Say

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Published Updated Last reviewed
16 linked public sourcesEditorial, sourcing, and corrections policy

HealthRX.com

No FDA-approved route to AOD-9604 exists federally

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Key numbers

  • 24-weekLength of the main oral AOD9604 human study, which missed its primary weight-loss endpointSource: pubmed.ncbi.nlm.nih.gov, as cited Nov 8, 2026
  • 534 peoplePeople enrolled in the main oral AOD9604 human study (502 randomized)Source: pubmed.ncbi.nlm.nih.gov, as cited Nov 8, 2026
  • 15.8 gWeight gain in obese rats given oral AOD9604 for 19 days, versus 35.6 g in controlsSource: pubmed.ncbi.nlm.nih.gov, as cited Nov 8, 2026

See the public record for AOD-9604

At a glance

  • FDA approval / none [6]
  • FDA list for state-licensed pharmacies / no category [3]
  • FDA list for outsourcing facilities / not listed [4]
  • HHS draft peptide policy, October 2026 / does not include AOD-9604 [7]
  • Main human study / 24 weeks, 534 enrolled, 502 randomized, oral, missed primary endpoint [6]
  • Sport / prohibited at all times by WADA [8]

What is AOD-9604?

AOD-9604 is a 16-amino-acid fragment of human growth hormone: hGH residues 177 to 191 with an extra tyrosine at the N-terminus, which is why it is also called hGH fragment 176-191 [9]. It is not full-length growth hormone [6][9]. An Australian company, Metabolic Pharmaceuticals, developed it as an anti-obesity drug candidate; phase IIa trials were under way by February 2002 [1]. It never reached approval [6].

Where AOD-9604 sits on FDA's lists

FDA's page on bulk substances that may present significant safety risks lists AOD-9604 in the nominated-but-withdrawn table [2]. FDA's stated concerns: compounded drugs containing AOD-9604 may pose a significant immunogenicity risk for certain routes because of 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 [2]. Removal from category 2 was not a finding that it is safe [2].

AOD-9604 appears in none of the three categories on FDA's list for state-licensed pharmacies and physicians, updated May 14, 2026 [3], and it does not appear on FDA's list for outsourcing facilities, updated March 21, 2025 [4]. FDA's category 1 policy does not cover it [5]. Compounded drugs are not FDA-approved, and FDA does not review their safety, effectiveness or quality before they reach patients [10].

The October 2026 HHS draft that would exercise enforcement discretion for certain compounded peptides names six (BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500), and AOD-9604 is not among them [7][11]. FDA's GRAS Notice Inventory contains no AOD-9604 notice, so there is no FDA no-questions letter for it [12].

What the human and animal data show

A 2026 review describes a 24-week oral AOD9604 study with 534 people enrolled and 502 randomized; it did not show a significant benefit on its primary weight-loss endpoint [6]. The review notes the conclusion rests on sponsor-reported phase 2 results rather than peer-reviewed randomized trials, and that there are no robust human data for visceral-fat reduction or other metabolic benefit [6]. There is no approved dose [6].

In obese Zucker rats, oral AOD9604 at 500 microgram/kg daily for 19 days cut weight gain to 15.8 g versus 35.6 g in controls [13]. In obese mice, 14 days of intraperitoneal AOD9604 reduced body weight and fat, and the long-term effect did not appear in mice lacking the beta-3 adrenergic receptor [14].

What about Illinois?

FDA's compounding lists and the HHS draft policy are federal documents, and none of them addresses Illinois law. Federally, AOD-9604 has no approval and no place on FDA's compounding lists. It has been identified in confiscated vials in the US and in preparations seized by Belgian authorities, which shows it circulates on the gray market [9][15].

Questions worth asking

Choose the questions you want to keep

Is AOD-9604 banned in sport?

Yes. WADA's Prohibited List names AOD-9604 and hGH 176-191 in section S2.2.3 on growth hormone fragments, prohibited at all times in and out of competition, and it stays on the 2027 List [8][16].

Frequently asked questions

Is AOD-9604 FDA-approved?
No. It is not an FDA-approved drug and appears in none of the identified categories on FDA's compounding lists for state-licensed pharmacies or outsourcing facilities [6][3][4].
Can a state-licensed pharmacy compound AOD-9604 under FDA's list?
FDA says state-licensed pharmacies may compound only with bulk substances that comply with a USP or NF monograph, are components of FDA-approved drugs, or appear on FDA's bulks list; AOD-9604 is in no category of that list [3][5].
Did AOD-9604 work for weight loss in people?
A 2026 review describes a 24-week oral AOD9604 study with 534 people enrolled and 502 randomized; it did not show a significant benefit on its primary weight-loss endpoint, and the result rests on sponsor-reported phase 2 data [6].
Is AOD-9604 banned in sport?
Yes. WADA names AOD-9604 and hGH 176-191 in section S2.2.3 of its Prohibited List, prohibited at all times in and out of competition, and it stays on the 2027 List [8][16].

Reader questions

What people actually ask

Short answers drawn from the sources this article cites.

Are peptides legal in Illinois?

None of the FDA or HHS documents addresses Illinois law specifically. Federally, AOD-9604 has no FDA approval and no place on FDA's compounding lists.

Can I get in trouble for ordering peptides online?

No legal consequences for individuals who order peptides online are described. AOD-9604 has been identified in confiscated vials in the US and in preparations seized by Belgian authorities, which shows it circulates on the gray market.

What peptides are being legalized?

The October 2026 HHS draft policy would exercise enforcement discretion for certain compounded peptides. It names six: BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500. AOD-9604 is not among them.

References

Show all 16 referencesHide references
  1. Wilding J. AOD-9604 Metabolic. Curr Opin Investig Drugs. 2004;5(4):436-40.
  2. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks | FDA.
  3. U.S. Food and Drug Administration.
  4. U.S. Food and Drug Administration.
  5. Bulk Drug Substances Used in Compounding of the FD&C Act | FDA.
  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. 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.
  10. Human Drug Compounding Laws | FDA.
  11. Official web page.
  12. GRAS Notices.
  13. 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.
  14. 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.
  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.
  16. World Anti-Doping Agency.
Evidence overview for Is AOD-9604 Legal in Illinois? What Federal Rules Say