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

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13 linked public sourcesEditorial, sourcing, and corrections policy

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 use [1][2]
  • FDA compounding lists / In no category on FDA's lists [4][5][6]
  • FDA safety page / 'Nominated but withdrawn' table [3]
  • Sport / WADA S2.2.3, prohibited at all times [7][8]
  • Human data / 24-week oral trial, 502 randomized, failed endpoint [2]

What AOD-9604 is

AOD-9604 is a 16-amino-acid fragment of human growth hormone (residues 177 to 191 plus an N-terminal tyrosine), also called hGH fragment 176-191; it is not full-length growth hormone [9]. Metabolic Pharmaceuticals developed it as an anti-obesity candidate, with phase IIa trials under way by February 2002; it never reached approval [1][2].

What federal compounding rules say

FDA's page on bulk substances that may present significant safety risks when compounded lists AOD-9604 in the 'nominated but withdrawn' table, which holds substances previously in category 2 whose nominators withdrew them. FDA cites immunogenicity risk for certain routes of administration from peptide impurities and characterization problems, limited safety information, and serious adverse events that may be associated with AOD-9604, though causality is not clear. Removal from category 2 was not a finding that it is safe [3].

AOD-9604 appears in none of the three categories on FDA's list for state-licensed pharmacies and physicians (updated May 14, 2026) or on FDA's list for outsourcing facilities (updated March 21, 2025) [4][5][6].

FDA says state-licensed pharmacists and physicians may compound only with bulk substances that meet a USP or NF monograph, are components of an FDA-approved drug, or appear on FDA's list of bulk drug substances that can be used in compounding [6]. A state pharmacy license does not change that.

Gray-market vials and sport rules

AOD-9604 has been found in confiscated vials in the USA and in seized preparations in Belgium [9][10]. Compounded drugs are not FDA-approved, and FDA does not review their safety, effectiveness, or quality before marketing [11][12]. WADA names AOD-9604 and hGH 176-191 in S2.2.3, prohibited at all times, on the 2026 and 2027 Lists [7][8].

How strong is the human evidence?

The main human obesity trial described in a 2026 review was a 24-week oral study, with 534 enrolled and 502 randomized. It failed to show a significant benefit on the primary weight-loss endpoint, and the review notes that this rests on sponsor-reported phase 2 results rather than peer-reviewed randomized trials [2]. There is no approved dose, and injected gray-market products have no efficacy trials [2].

Frequently asked questions

Is AOD-9604 FDA-approved?
No. It was developed as an anti-obesity candidate, with phase IIa trials under way by February 2002, and never reached approval [1][2].
Is AOD-9604 GRAS?
No AOD-9604 notice appears in FDA's GRAS Notice Inventory [13]. GRAS is a food-ingredient concept and would not make an injectable lawful as a drug [13].
What does FDA say about compounded AOD-9604?
FDA lists it in the 'nominated but withdrawn' table with stated safety concerns [3].
Did the human weight-loss trial succeed?
No. The 24-week oral study (534 enrolled, 502 randomized) failed its primary weight-loss endpoint; the result is sponsor-reported phase 2 data [2].

References

Show all 13 referencesHide references
  1. Wilding J. AOD-9604 Metabolic. Curr Opin Investig Drugs. 2004;5(4):436-40.
  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.
  3. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks | FDA.
  4. U.S. Food and Drug Administration.
  5. U.S. Food and Drug Administration.
  6. Bulk Drug Substances Used in Compounding Under the FD&C Act | FDA.
  7. World Anti-Doping Agency.
  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. 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.
  11. Official web page.
  12. Official web page.
  13. GRAS Notices.
Evidence overview for Is AOD-9604 Legal in Oregon? How to Access It Legally