Compounds / AOD-9604

AOD-9604

Also known as: AOD9604; Tyr-hGH fragment 177-191; Anti-Obesity Drug 9604; CAS 221231-10-3

NOT FDA APPROVED Tier 2 – Clinical Growth HormoneWeight Management

Primary research focus: Metabolic research (lipolysis and fat metabolism; investigated for obesity)

Last updated July 2026 · Reviewed against FDA labeling and published research.

What is AOD-9604?

AOD-9604 is a synthetic 16-amino acid peptide based on the C-terminal fat-metabolizing fragment of human growth hormone (residues 176-191), with a tyrosine added at the N-terminus and a disulfide bridge for stability. It was developed by Metabolic Pharmaceuticals (Australia) to isolate growth hormone's lipolytic activity without its growth-promoting or blood-sugar effects. It reached Phase 2 obesity trials but did not show sufficient efficacy, and it is not FDA-approved as a drug.

How it works

AOD-9604 is proposed to promote lipolysis (fat breakdown) and inhibit lipogenesis (fat storage), mimicking the fat-metabolizing action of the growth hormone C-terminus without stimulating IGF-1 or affecting glucose and insulin. Preclinical work has linked its activity to beta-3-adrenergic signaling and increased beta-3-adrenoreceptor expression in obese animal models. It does not act as a high-affinity antagonist at the growth hormone receptor, and its precise mechanism in humans is not fully established.

How it’s supplied

Not an FDA-approved or commercially manufactured medicine. In clinical trials it was given as oral tablets (and intravenously in early studies). It is sold as a research-grade lyophilized peptide for reconstitution and, separately, appears as a GRAS-status food/supplement ingredient. Research material is not FDA-reviewed for potency or sterility.

Dosage Chart

RouteSubcutaneous
For reference only, compiled from FDA labeling, clinical trials, and established protocols. Not medical advice or a dosing recommendation. Confirm against current prescribing information and consult a qualified healthcare professional.
Vial size
BAC water

Units shown are for a U-100 insulin syringe (100 units = 1 mL), calculated from the vial size and BAC water you select. Always confirm against your prescription and your syringe markings.

PhaseDoseFrequencyNotes
Weeks 1-4 250mcg 1x Daily
Weeks 5-12 500mcg 1x Daily
Special considerations
  • Rotate injection sites to reduce irritation and lipohypertrophy
  • Not for use during pregnancy or breastfeeding
  • Do not exceed the recommended dose to try to speed results
  • Administer in the morning on an empty stomach

Potential Benefits and Side Effects

Effects reported in published research. Not a promise of results, and not medical advice.

Reported benefits
  • Reported in preclinical and clinical research; note that pivotal weight-loss efficacy was not demonstrated.
  • Lipolytic (fat-breakdown) and anti-lipogenic effects in preclinical models.
  • Modest, statistically significant fat loss versus placebo in an earlier Phase 2 study, not replicated in the pivotal Phase 2b trial.
  • Clean safety and tolerability profile across trials, without IGF-1 or glucose disruption.
  • Preclinical signals for cartilage and joint tissue support (investigational).
Reported side effects
  • Clinical trials reported no serious adverse events attributed to the compound.
  • Mild, transient injection-site reactions were noted in some settings.
  • No significant changes in glucose, insulin, HbA1c, IGF-1, cortisol, or thyroid hormones were detected at tested doses.

Warnings and contraindications

Important safety information. This is not exhaustive — read the full prescribing information and consult your prescriber or pharmacist.

Warnings
  • No FDA-approved drug labeling exists; the following reflect trial observations and the compound's status, not established label warnings.
  • Clinical trials reported a clean safety profile, with no serious adverse events attributed to the compound and no significant changes in glucose, insulin, HbA1c, IGF-1, cortisol, or thyroid hormones.
  • Efficacy for weight loss was not sufficient for drug approval; benefit should not be overstated.
  • AOD-9604 is on the WADA Prohibited List and is banned in sport.
  • Research-grade material varies in identity and purity.
  • Safety in pregnancy and breastfeeding has not been established for therapeutic use.
Contraindications
  • Not established as a drug; no FDA-approved labeling. Precautionary considerations include known hypersensitivity to the peptide and use by competitive athletes subject to anti-doping rules.

Reconstitution Steps

How to prepare the lyophilized vial. Confirm specifics with your pharmacist or prescriber.

  1. Confirm the amount of peptide in the vial and the volume of diluent you intend to use before starting.
  2. Wash your hands and gather supplies: the lyophilized peptide vial, the diluent (typically bacteriostatic water), an alcohol swab, and a sterile syringe.
  3. Let the peptide vial and diluent reach room temperature if they were refrigerated or frozen.
  4. Wipe the rubber stopper of both the peptide vial and the diluent vial with a fresh alcohol swab and let them air dry.
  5. Draw the intended diluent volume into the syringe.
  6. Insert the needle into the peptide vial and slowly release the diluent down the inside wall of the vial rather than directly onto the powder, to avoid foaming.
  7. Do not shake. Gently swirl or roll the vial until the powder is fully dissolved.
  8. Inspect the solution: it should be clear and colorless with no visible particles. Do not use if cloudy or containing particles.
  9. Note the resulting concentration (peptide amount divided by the diluent volume) so it matches the reconstitution calculator on this page.
  10. Label the vial with the reconstitution date and store as directed under reconstituted storage.

US regulatory status

Classifications are public record but can change. For reference only, not legal advice.

DEA scheduleNot a controlled substance
Development stageDiscontinued / withdrawn
503A compoundingUnder review
503B compoundingNot eligible

Development: AOD-9604 originated from work at Monash University and was developed by Metabolic Pharmaceuticals (Australia). It went through six human clinical trials (the METAOD program) enrolling roughly 900 participants. An earlier Phase 2 study showed modest, statistically significant fat loss versus placebo, but the pivotal Phase 2b trial failed to replicate significant weight loss, and formal obesity drug development was halted around 2007. The FDA later granted GRAS (generally recognized as safe) status for use as a food ingredient (a safety designation, not drug approval, and not an efficacy finding). The Australian TGA rejected an obesity indication.

Notes: AOD-9604 is not FDA-approved as a drug. It holds GRAS status for food-ingredient use, which addresses safety at supplement-level use and is separate from drug approval. It was placed on the FDA Category 2 list of bulk drug substances (restricting compounding). In a February 2026 US Department of Health and Human Services announcement, AOD-9604 was among peptides slated to move back to Category 1 (interim compounding permitted while the FDA continues review), reportedly effective in April 2026; this area is evolving and should be verified against the current FDA list. AOD-9604 is on the WADA Prohibited List. It is not a controlled substance. (Status current as of mid-2026.)

International status

UKNot approved (MHRA)
EUNot approved (EMA)
AustraliaNot approved (TGA); obesity indication was rejected
CanadaNot approved (Health Canada)

Pharmacokinetics

Molecular weightApproximately 1,815 Da. A 16-amino acid modified fragment (tyrosine plus human growth hormone residues 177-191) containing a disulfide bridge. CAS 221231-10-3.
Half-lifeShort; reported on the order of tens of minutes in circulation. Oral bioavailability is low, which shaped the tablet formulations used in trials.
Time to peakNot well characterized in humans across formulations; rapid after intravenous dosing in early studies.
ClearanceCleared by peptidase degradation; detailed human clearance parameters are not well characterized.
Sequence16-amino acid modified C-terminal human growth hormone fragment: Tyr-(hGH 177-191), i.e., Tyr-Leu-Arg-Ile-Val-Gln-Cys-Arg-Ser-Val-Glu-Gly-Ser-Cys-Gly-Phe, with a disulfide bond between the two cysteine residues. Distinct from the unmodified HGH Fragment 176-191.

Storage and handling

TemperatureResearch-grade lyophilized powder is typically stored frozen at -20 degrees C for long-term storage and refrigerated at 2 to 8 degrees C short term. Not a clinically stored, FDA-approved product.
Light sensitiveProtect from light and moisture; keep the vial sealed.
Shelf lifeLyophilized powder is generally stable for months when frozen; follow the supplier certificate of analysis. There is no FDA-established drug shelf life.
Reconstituted storageAfter reconstitution, solutions are generally refrigerated at 2 to 8 degrees C and used within the period indicated by the supplier, with freeze-thaw cycles minimized. No FDA-established in-use dating for drug use.

Important Notes

Practical considerations for consistency and safety.

  • AOD-9604 is a modified analog of HGH Fragment 176-191, not the identical raw fragment.
  • It underwent real clinical trials but did not demonstrate weight loss sufficient for drug approval; its GRAS status is a food-safety designation, not proof of efficacy.
  • Its compounding status is in flux (Category 2 versus Category 1); verify the current FDA classification.
  • It is banned in sport under the WADA Prohibited List.
  • Research-grade material varies in identity and purity.

Lifestyle Factors

  • Studied as an adjunct in the context of weight management; it does not suppress appetite the way GLP-1 medicines do.
  • Human lifestyle interactions beyond trial conditions are not well characterized.

Related compounds

Important disclaimer

This page is an educational reference, not medical advice, a diagnosis, or a treatment recommendation, and not a substitute for your prescriber or pharmacist. Approval and regulatory status varies by compound and can change. Always confirm against current prescribing information and consult a qualified healthcare professional before making any decision about a medication.