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AOD-9604 Compounding Pharmacy FDA and State Board Enforcement History

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11 linked public sourcesEditorial, sourcing, and corrections policy

At a glance

  • FDA approval / Not FDA-approved [1][2]
  • FDA compounding listing / Nominated-but-withdrawn safety-risk table [6]
  • FDA list for state-licensed pharmacies and physicians / In no category; the category 1 no-action policy does not cover it [3][5]
  • FDA list for outsourcing facilities / In no category [4]
  • HHS peptide draft / Not among the six peptides in the October 2026 draft [7][8]
  • July 2026 advisory committee / AOD-9604 not on the agenda [9]

Is AOD-9604 approved or on FDA's compounding lists?

AOD-9604 was developed by an Australian company, Metabolic Pharmaceuticals, as an anti-obesity drug candidate, and phase IIa trials were underway by February 2002 [1]. It never reached approval, and the obesity program was later dropped [1][2].

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substances that may present significant safety risks (content dated 04/22/2026) lists AOD-9604 in the nominated-but-withdrawn table.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 states that compounded drugs containing AOD-9604 may pose significant immunogenicity risk for certain routes of administration (peptide impurities and characterization problems); that it has identified no, or only limited, safety information; and that it has identified 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 [6].

On FDA's list for state-licensed pharmacies and physicians, AOD-9604 appears in none of the three categories of FDA's interim policy. Category 1, whose no-action approach applies only if conditions are met, therefore does not reach it. It is likewise in no category on FDA's list for outsourcing facilities [3][4][5]. FDA says a bulk substance used by a state-licensed pharmacy must comply with an applicable USP or NF monograph, be a component of an FDA-approved drug product when no applicable monograph exists, or appear on FDA's bulks list [5]. AOD-9604 was never FDA-approved [1][2].

Belgian authorities and US investigators have identified AOD-9604 in seized or confiscated vials, and a review describes unregulated supply chains with uncertainty about product composition and dose [10][11][2]. The main human weight-loss study described in a 2026 review was a 24-week trial of an oral drug candidate, with 534 enrolled and 502 randomized. The review reports that it failed to show a significant benefit on the primary weight-loss endpoint, and notes that this rests on sponsor-reported results rather than a peer-reviewed trial [2].

Did the 2026 peptide actions cover AOD-9604?

No. HHS's draft enforcement-discretion policy for compounded peptides, filed October 28, 2026 as Federal Register document 2026-22192 with publication scheduled for October 30, 2026, covers six peptides: BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500. AOD-9604 is not among them [7][8].

The Pharmacy Compounding Advisory Committee's July 23-24, 2026 meeting took up BPC-157, KPV, TB-500, MOTS-c, emideltide, Semax and epitalon. AOD-9604 was not on that agenda [9].

What do the federal pages say about state boards?

These FDA records do not show whether a state pharmacy board has taken enforcement action involving AOD-9604 [6][3][4][5].

Frequently asked questions

Has FDA approved AOD-9604?
No. It never reached approval, and the obesity program was dropped [1][2].
Is AOD-9604 on FDA's compounding lists?
No. It appears in none of the three categories on the list for state-licensed pharmacies and physicians, and in no category on the list for outsourcing facilities, so the category 1 no-action policy does not cover it [3][4][5].
Did the HHS peptide policy cover AOD-9604?
No. The draft filed October 28, 2026 covers six peptides: BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500. AOD-9604 is not one of them [7][8].
Why is AOD-9604 in FDA's withdrawn table?
The table lists substances previously in category 2 whose nominators withdrew them. FDA states that removal from category 2 was not a finding that it is safe [6].

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. U.S. Food and Drug Administration. U.S. Food and Drug Administration
  5. 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
  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. Official web page. Official web page
  8. Official web page. Official web page
  9. U.S. Food and Drug Administration. U.S. Food and Drug Administration
  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. Identification and characterization of peptide drugs in unknown pharmaceutical preparations seized by the Belgian authorities: case report on AOD9604
  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. Detection and in vitro metabolism of AOD9604
Evidence overview for AOD-9604 Compounding Pharmacy FDA and State Board Enforcement History