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AOD-9604

Awaiting Reclassification

The targeted fat-loss fragment

A modified fragment of human growth hormone (residues 176 to 191) studied for fat metabolism.

Educational content. This page describes AOD-9604 for informational purposes only and is not medical advice, diagnosis, or treatment. Consult a licensed provider before starting, stopping, or modifying any therapy.

Primary Use
A modified fragment of human growth hormone (residues 176 to 191) studied for fat metabolism.
Administration
injection
Typical Cycle
12-week cycles
Legal Status
Awaiting Reclassification
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Key Benefits

Targeted Fat Reduction

Stimulates lipolysis and inhibits lipogenesis without the growth-promoting effects of full-length growth hormone.[1][2][5]

No Diabetogenic Effects

Does not impair glucose tolerance or insulin sensitivity, unlike full-length growth hormone therapy.[2][3][4]

No IGF-1 Elevation

Avoids the cell proliferation risk associated with full GH by not stimulating IGF-1 production.[1][3]

Joint & Cartilage Support

Emerging evidence suggests chondroprotective properties, with potential benefits for osteoarthritis cartilage repair.[7]

What is AOD-9604?

AOD-9604 (Advanced Obesity Drug 9604) is a synthetic peptide fragment corresponding to amino acids 176-191 of human growth hormone, with an added tyrosine residue. Developed by Metabolic Pharmaceuticals in Australia, it retains GH's fat-burning properties while eliminating growth-promoting and diabetogenic effects. It received FDA GRAS status in 2007.

While promising in preclinical studies, AOD-9604 did not achieve statistically significant weight loss over placebo in phase 2b/3 human trials, and pharmaceutical development was discontinued. It remains available through compounding pharmacies for body composition optimization.

How Does It Work?

AOD-9604 mimics the lipolytic domain of growth hormone, stimulating beta-3 adrenergic receptors on fat cells to trigger breakdown of stored triglycerides. It simultaneously inhibits lipogenesis — the conversion of excess calories into new fat.

Critically, it does not bind to the GH receptor in the same way as full-length hGH, meaning it does not activate JAK2/STAT5 signaling responsible for anabolic and diabetogenic effects, nor does it stimulate IGF-1 production.

Mechanism of Action

AOD-9604 engages the lipolytic pathway in adipose tissue by mimicking the C-terminal domain of growth hormone, stimulating beta-3 adrenergic receptor-mediated lipolysis and upregulating hormone-sensitive lipase while inhibiting fatty acid synthase, all without activating the GH receptor's JAK2/STAT5 and IGF-1 pathways.

AOD-9604β3-AR StimulationAdrenergic receptorHSL UpregulationHormone-sensitive lipaseFAS InhibitionFatty acid synthaseNo JAK2/STAT5GH receptor bypassLipolysisTriglyceride breakdowninto free fatty acidsFat BreakdownEnhanced fat cellmetabolismAnti-LipogenesisBlocked new fatformationMetabolic SafetyNo IGF-1, no glucoseimpairmentTargeted Fat Metabolism Without GH Side Effects

Clinical Evidence

Key studies supporting the therapeutic use of this peptide.

Chronic Treatment in Obese Mice

Controlled animal studyob/ob mice and beta-3 AR knockout mice

Significantly reduced body fat gain without affecting growth, IGF-1, or insulin sensitivity.

Heffernan M, Summers RJ, Thorburn A, et al.Endocrinology, 142(12):5182-5189 (2001) · PubMed

Phase 2 Clinical Trials

Randomized, placebo-controlledOverweight and obese adults

Well-tolerated with good safety but weight loss did not reach statistical significance over placebo.

Wilding JCurr Opin Investig Drugs, 5(4):436-440 (2004) · PubMed

Osteoarthritis Cartilage Repair

Controlled animal studyRabbits with surgically induced OA

Intra-articular AOD9604 improved cartilage repair markers, especially combined with hyaluronic acid.

Kwon DR, Park GYAnn Clin Lab Sci, 45(4):426-432 (2015) · PubMed

Dosing & Administration

Typical protocols used in clinical practice. Always consult a licensed provider for personalized dosing.

Subcutaneous Injection

Dosage
250–300 mcg
Frequency
Once daily (morning, fasted)
Cycle
12-week cycles

Subcutaneous Injection: Inject into abdominal fat; best on empty stomach

Best taken in the morning fasted to optimize lipolytic activity.

Cycling (12 weeks on, 4 weeks off) is commonly recommended.

Can be combined with CJC-1295/Ipamorelin at provider's discretion.

Side Effects & Safety

Common

  • Injection site redness Mild, transient

Uncommon

  • Headache Mild
  • Mild nausea Usually transient; less common than with GLP-1 agonists

Rare

  • Water retention Mild and temporary

Safety Profile

Favorable safety profile; FDA granted GRAS status in 2007. Does not elevate IGF-1, impair glucose metabolism, or cause fluid retention associated with GH therapy.

However, AOD-9604 failed to demonstrate efficacy over placebo in human trials. Evidence level is substantially lower than FDA-approved therapies.

Patients should source from reputable compounding pharmacies and have realistic expectations.

Contraindications

  • Active malignancy (precaution, though no IGF-1 elevation)
  • Pregnancy or breastfeeding
  • Known hypersensitivity to AOD-9604

Compare with Similar Peptides

See how AOD-9604 compares to peptides with overlapping benefits.

PeptidePrimary UseAdministrationCycle LengthKey Differentiator
AOD-9604Fat ReductionInjection (daily)12-week cyclesGH's fat-burning effects without diabetogenic, anabolic, or IGF-1-elevating properties — though human trial efficacy was not demonstrated
SemaglutideWeight LossInjection (weekly), Oral (daily)OngoingMost clinically validated weight-loss peptide with cardiovascular outcomes data from the SELECT trial
TirzepatideWeight LossInjection (weekly)OngoingOnly dual GIP/GLP-1 agonist, producing up to 22.5% weight loss — the highest of any pharmacotherapy
TesamorelinBody Composition & GHRHSubcutaneous InjectionOngoing dailyThe only FDA-approved GHRH analog with Phase III data in over 800 patients, proven hepatoprotective effects, and physiologic pulsatile GH release
IpamorelinAnti-Aging & Body CompositionInjection (1-3x daily)8–12 weeksMost selective GH secretagogue — clean pulsatile GH release without cortisol, prolactin, or appetite effects

Regulatory Status

Current FDA classification and compounding eligibility.

Under Review (Category 2)

503A Compounding

The FDA placed this substance in Category 2 of the 503A bulk drug substances evaluation, flagging significant safety risks. 503A compounding carries FDA enforcement risk, so most pharmacies decline to prepare it and many physicians hesitate to prescribe it.

Regulatory Detail

hGH fragment 176-191. Nomination withdrawn September 2024, then reviewed by PCAC on December 4, 2024. PCAC voted against inclusion. FDA cited immunogenicity, impurity concerns, and serious adverse events. Remains ineligible for 503A compounding. Not among the 12 peptides HHS withdrew from Category 2 in April 2026.

Next Expected Action

FDA final rulemaking decision post-PCAC rejection. Expected Q2–Q3 2026.

Source

FDA Action History

What do these terms mean?
503A compounding
Licensed pharmacies that prepare custom prescriptions for individual patients based on a physician's order. 503A is the section of the federal law that governs them.
503B outsourcing
FDA-registered facilities that compound in larger batches under stricter federal oversight (closer to a manufacturer than a pharmacy). Used mostly by hospitals and clinics.
Bulk drug substance
The active pharmaceutical ingredient a compounder starts with, before it's made into a finished medication.
Category 1
Interim bucket for bulk substances that have been nominated and don't appear to present significant safety risks. 503A pharmacies may compound them under FDA enforcement discretion while the agency continues its review. Not the same as FDA approval.
Category 2
Bulk substances the FDA has flagged for significant safety risks. 503A compounding carries FDA enforcement risk, so most pharmacies decline to prepare them and many physicians hesitate to prescribe them.
PCAC
Pharmacy Compounding Advisory Committee. The FDA advisory committee that reviews nominated bulk substances and recommends whether they belong in Category 1, Category 2, or on the final 503A Bulks List.

Last verified April 12, 2026. PepHookup tracks public FDA actions. This is not legal or medical advice.

Frequently Asked Questions

Research & References

  1. 1

    Heffernan M, Summers RJ, Thorburn A, et al. The effects of human GH and its lipolytic fragment (AOD9604) on lipid metabolism following chronic treatment in obese mice.” Endocrinology, 142(12):5182-5189 (2001)

  2. 2

    Heffernan MA, Jiang WJ, Thorburn AW, et al. Effects of oral administration of a synthetic fragment of human growth hormone on lipid metabolism.” Am J Physiol Endocrinol Metab, 279(3):E501-E507 (2000)

  3. 3

    Ng FM, Sun J, Sharma L, et al. Metabolic studies of a synthetic lipolytic domain (AOD9604) of human growth hormone.” Horm Res, 53(6):274-278 (2000)

  4. 4

    Ng FM, Jiang WJ, Gianello R, et al. Molecular and cellular actions of a structural domain of human growth hormone on lipid metabolism in Zucker fatty rats.” J Mol Endocrinol, 25(3):287-298 (2000)

  5. 5

    Wu Z, Ng FM Antilipogenic action of synthetic C-terminal sequence 177-191 of human growth hormone.” Biochem Mol Biol Int, 30(1):187-196 (1993)

  6. 6

    Wilding J AOD-9604 Metabolic.” Curr Opin Investig Drugs, 5(4):436-440 (2004)

  7. 7

    Kwon DR, Park GY Effect of Intra-articular Injection of AOD9604 with or without Hyaluronic Acid in Rabbit Osteoarthritis Model.” Ann Clin Lab Sci, 45(4):426-432 (2015)

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