AOD-9604

Also called AOD9604, Tyr-hGH(177–191), a growth hormone fragment1

2D structure of AOD-9604, a chain of 16 amino acids closed into a loop by a disulfide bond
AOD-9604 molecular structureFull structure and downloads
StatusResearch chemical
Evidence3/5Human trials in about 900 people. The largest found no weight loss beyond placebo
Status nowNot FDA-approved, and not approved anywhere. US pharmacies can't legally compound it: FDA's advisers voted 0–12 against, and the 2026 HHS peptide policy leaves it out. Banned in sport at all times.2, 7, 13
LatestOctober 28, 2026: HHS named six peptides pharmacies may compound. AOD-9604 is not one of them.7 April 22, 2026: FDA's list still flags it for a possible "significant risk for immunogenicity."6
NextNo FDA review, rule or trial is scheduled that we could find. Full history

AOD-9604 is a 16-amino-acid piece of human growth hormone, made in the 1990s as an obesity pill. Its developer, Metabolic Pharmaceuticals in Australia, tested it in six human trials. The largest, which randomized 502 adults for 24 weeks, found no significant weight loss beyond placebo, and the company stopped development in February 2007.1 It later called the peptide "generally recognized as safe" for food, but that was its own expert panel's view, not an FDA decision.11 In 2024 FDA's advisers voted 0–12 against letting pharmacies compound it.2 It is still sold online, mostly as injections, a route never tested in a published human trial.1

See every peptide's status in the regulatory tracker

In this guide
  1. Status and summary
  2. At a glance
  3. Where to get it
  4. Molecular structure
  5. What it is
  6. How it works
  7. Evidence map
  8. By goal and route
  9. How it's used
  10. Side effects
  11. Compared with
  12. Stacks
  13. Myths vs evidence
  14. All options and prices
  15. Legal status history
  16. FAQ
  17. References

At a glance

What it isA synthetic 16-amino-acid peptide: the tail end of human growth hormone (amino acids 177 to 191) with a tyrosine added1
FormsFree base and acetate salt. Sold online as injections, tablets and creams1
Best evidenceA 24-week trial in 502 adults with obesity, by mouth: no difference from placebo1
Approved inNowhere1, 14
No good evidence forWeight or fat loss, cartilage repair in people, muscle, anti-aging1, 3
Legal statusNot FDA-approved. No legal compounding path. Not in the HHS peptide policy2, 7
In sportBanned at all times. WADA names it as a growth hormone fragment13
Main risksUnknown long-term safety. FDA flags immune reactions, cancers reported in one trial, and bone and liver findings in animals1, 3
Typical costNo legal US source, so no price we can list

Where to get it

MoveWell sells no peptides. Some links may earn us a commission, which never decides what's listed or the order. All options and prices

No legal sourcePrescription or compounded

No approved product exists, FDA's advisers voted against compounding it, and the HHS policy doesn't cover it.2, 7

Why
Outside the lawResearch vials and sprays

"Research use only" products aren't checked for purity or dose. FDA has said that label doesn't excuse products meant for people.17

Why
Approved insteadWeight-loss medicines

FDA noted several approved drugs treat obesity. See our semaglutide and tirzepatide guides.3

Compare

Molecular structure

A chain of 16 amino acids. A bond between two cysteines closes the middle into a loop. The first amino acid, a tyrosine, was added to the growth hormone piece.

AOD-9604 molecular structure: a chain of 16 amino acids with a disulfide loop, with the added tyrosine and the disulfide bond highlighted

The added tyrosine (residue 1) and the disulfide bond

YTyrLLeuRArgIIleVValQGlnCCysRArgSSerVValEGluGGlySSerCCysGGlyFPhe
Sequence
YLRIVQCRSVEGSCGF
Length
16 amino acids
Loop
Disulfide bond, Cys7 to Cys14
Formula
C78H123N23O23S2
Weight
1,815.1 g/mol
Acetate
C80H127N23O25S2, 1,875.1 g/mol
CAS
221231-10-3
FDA UNII
7UP768IP4M (free base)

Drawn from the sequence, with the disulfide bond, as FDA describes it. Formula, weight, CAS and UNII are FDA's; the formula we computed matches.1

What it is

Growth hormone breaks down stored fat, among many other effects. In the 1990s, Australian researchers looked for the part of the hormone that drives fat loss, and settled on a piece of its last 15 amino acids. Metabolic Pharmaceuticals developed AOD-9604 from that piece, with a tyrosine added at the start.1, 10 FDA describes it as a "synthetic 177-191 fragment (15 amino acids) of hGH" with a tyrosine added.1

The aim was an obesity drug with growth hormone's effect on fat but without its effects on growth or blood sugar. The company tested it by vein and by mouth. When its largest trial failed in 2007, it said the results did "not support the commercial viability of the drug as a treatment for obesity."1

The company then turned to food. In 2012 it announced a "self-affirmed conditional GRAS status" from a panel of US experts it convened, for use in foods, drinks and dietary supplements at up to 1 mg a day per person.11 In 2014 a trade report said it had been designated GRAS for the same uses.12 GRAS covers food ingredients, not injected drugs, and neither report describes an FDA review.11

WADA also names "hGH 176-191," a near-identical growth hormone fragment sold online under names such as Frag 176-191.13 It is a different molecule, and we found no human trial of it.

How it works

What's known comes from animal and lab work. FDA notes its molecular target is unknown.1

  • Fat breakdown in rodents. In obese rats and mice it cut fat-making, raised fat breakdown and burning, and slowed weight gain.1
  • A fat-cell receptor. In obese mice it raised levels of the beta-3 adrenergic receptor, which fat cells use to release fat. In mice lacking that receptor, long-term treatment didn't cause weight loss.10
  • Not growth hormone's receptor. Its developers reported it doesn't bind the growth hormone receptor.1
  • IGF-1. The developer reported no change in IGF-1 in its human trials.8 FDA found no animal data to support the claim that it doesn't raise IGF-1.1

No study has measured how the human body absorbs or clears it. In pigs, it lasted about 3 minutes in the blood after an IV dose.1

Evidence map

Each claimed use is graded separately, because the evidence differs by use.

Weight and fat loss

Placebo-controlled trials in about 900 people. The largest and longest found no benefit

Cartilage and joint repair

One study in 32 rabbits with injected knees. No human study

Muscle, recovery, anti-aging

No studies found. Online claims only

Scale: 5 FDA-approved, 4 strong human, 3 limited human, 2 animal or lab only, 1 anecdotal. Weight loss scores 3 for the amount of human testing, not for results: the results were negative.

Key studies

UseStudyModelFinding
WeightOPTIONS trial, 2007, via FDA1Human RCT n=502, 24 weeksDaily by mouth, plus diet and exercise. No significant difference from placebo on the main weight-loss measure. Development stopped
WeightHerd 2005 abstract, via FDA1Human RCT about 300, 12 weeksDaily by mouth. FDA called the differences small, of unclear meaning, and never fully published
WeightWilding 2004, via FDA1Human n=23, 4 weeksWeekly IV doses in adults with obesity. Weight loss not significant vs placebo
WeightWilding 2004, via FDA1Human n=36 men, 1 weekDoses for one week; FDA's summary doesn't give the route. 1 kg lost on the lowest dose vs 0.6 kg on placebo
SafetyStier 201386 human RCTsDeveloper's summary: side effects "indistinguishable from placebo," no IGF-1 change, no antibodies in those tested
FatHeffernan 200110Mouse 14 daysLower body weight and fat in obese mice. No long-term effect in mice lacking the beta-3 receptor
CartilageKwon 201516Rabbit n=32Knee injections after induced arthritis. Better cartilage scores than saline, best with hyaluronic acid

FDA found no AOD-9604 study on ClinicalTrials.gov.1 The developer sponsored the trials, and its safety and toxicity papers list the company as sponsor and include a company author.8, 9 FDA concluded there is a "lack of evidence to support the effectiveness of AOD-9604" for obesity.1

By goal and route

Pick your goal to see what the evidence supports.

By mouthInjectionCream
Legal statusNo legal sourceNo legal sourceNo legal source
Human evidenceTrials up to 24 weeks: no clear weight lossNo published trial under the skin. IV trials found no significant lossNone
Known risksShort trials only; FDA flags cancers reported in oneFDA cites immune reactions, especially by injectionNo data
CostNo legal sourceNo legal sourceNo legal source

Sources: FDA briefing and slides,1, 3 advisory vote,2 HHS policy.7

How it's used

We don't give a dose. No dose worked in trials, and none has been approved.

The trials gave it by vein or by mouth.1 Clinics and websites sell it mainly as injections under the skin, and also as dissolving tablets.1 FDA found no human exposure by injection under the skin or through the skin.1 We report this as information, not instruction.

Side effects and who should avoid it

  • Short trials only. The longest lasted 24 weeks. FDA said there is "insufficient information to support the long-term use of AOD-9604."3
  • Reported side effects. FDA's summary of the trials lists headache, fatigue, low blood sugar and dizziness in a small IV study, spread similarly between drug and placebo, and chest tightness and diarrhea as serious events.1, 3
  • Cancers. In the 12-week oral trial, five people had serious events, including basal cell and squamous cell skin cancers. Investigators judged none related, but FDA said it has "concerns about the reports of various cancers."1
  • Animal findings. In rats, bone-marker changes that FDA said could suggest harm to bone. In monkeys, liver-cell changes in all high-dose females. DNA-damage tests were equivocal or positive, signals FDA said "cannot be regarded as biologically insignificant."1 The developer's own paper judged these findings not significant.9
  • Immune reactions. FDA "cannot rule out the potential for immunogenicity," especially by injection, because of impurities and clumping in peptide products.1, 6
  • Sterility. In 2021 a US compounder recalled lots of injectable AOD-9604, and of one other injectable peptide, over a lack of sterility assurance.15
  • Who should avoid it. No label exists. It has not been studied in pregnancy, breastfeeding, children, or people with cancer, diabetes or liver disease. Anyone tested in sport should avoid it.13

FDA found no adverse event reports for AOD-9604 in its databases, and said that "does not imply that the substance is safe."1

Compared with

AOD-9604Tesamorelin
What it isA fragment of growth hormoneA copy of the hormone that releases growth hormone (GHRH)
FDA statusNot approved. Advisers voted 0–12 against compoundingApproved, as Egrifta WR, to reduce excess belly fat in adults with HIV
Fat in trialsNo significant weight loss beyond placeboLess deep belly fat in its approved group. The label says it is not for weight loss
IGF-1Developer reports no riseRises; the label asks doctors to monitor it

Sources: FDA briefing,1 advisory vote,2 developer's safety paper,8 Egrifta WR label.18 See our tesamorelin, MK-677 and sermorelin guides for drugs that raise growth hormone itself.

Stacks

Online sellers sometimes pair AOD-9604 with other growth hormone peptides, such as CJC-1295 or ipamorelin. We found no study of any combination. None of these is covered by the HHS policy, which in any case allows one active ingredient per product.5, 7

Myths vs evidence

ClaimAOD-9604 is a proven fat burner
EvidenceIts own developer's largest trial, in 502 adults over 24 weeks, found no more weight loss than placebo. FDA's slides say it "failed to show benefit for weight reduction."1, 3
ClaimFDA approved it as safe (GRAS)
EvidenceThe GRAS status was "self-affirmed" by a panel the company convened, and only for foods, drinks and supplements up to 1 mg a day. It doesn't cover injections, and it isn't FDA approval.11
ClaimIt has growth hormone's fat effect without the side effects
EvidenceThe developer reported a placebo-like safety profile, but it didn't produce the fat loss either. FDA flagged cancers in one trial and found long-term data insufficient.1, 8
ClaimIt regrows cartilage
EvidenceOne study in 32 rabbits whose knees were damaged with an injected enzyme. No human study.16
ClaimIt's legal to buy because it's sold "for research"
EvidenceNo. FDA has told sellers that a research label doesn't excuse products clearly meant for people.17
ClaimIt's allowed in sport because it isn't growth hormone
EvidenceWADA names AOD-9604 on its list as a banned growth hormone fragment, at all times.13

All options and prices

MoveWell sells no peptides. Some links may earn us a commission; that never decides what's listed or the order. Checked November 1, 2026

Licensed compounding, with a prescription

None. FDA's advisers voted 0–12 against adding AOD-9604 to the compounding list, and the HHS policy of October 28, 2026 doesn't include it.2, 7 We found no provider in our checks offering it through a lawful route.

Foods and supplements

The company's GRAS claim was for foods, drinks and dietary supplements.11 We found no US food or supplement containing it that we could confirm is lawfully sold, so we list none.

Research use only products

We don't list sellers. These products are unapproved drugs when they're meant for people. In August 2026 FDA warned five peptide sellers that a "research use only" label is no defense.17

FAQ

Is AOD-9604 legal in the US?

It isn't approved, and pharmacies can't legally compound it. FDA's advisers voted 0–12 against it in 2024, and the 2026 HHS peptide policy doesn't cover it. Products sold "for research" aren't legal for people to use as drugs.

Is it FDA-approved?

No, and it isn't approved anywhere. Its developer stopped work on it as an obesity drug in 2007.

Does it cause weight loss?

Not in its main trials. The largest, in 502 adults over 24 weeks, found no difference from placebo.

Isn't it GRAS?

The company said so, based on a panel it convened, for foods, drinks and supplements up to 1 mg a day. That isn't an FDA approval, and it doesn't apply to injections.

What dose do people use?

We don't give one. No dose worked in trials.

Can athletes use it?

No. WADA bans it at all times as a growth hormone fragment.

Is it the same as Frag 176-191?

Close but not identical. Both are pieces of the end of growth hormone. WADA bans both, and we found no human trial of Frag 176-191.

References

18 sources, with links
  1. FDA. FDA briefing document: AOD-9604-related bulk drug substances, Section 503A bulk drug substances list (Nov 5, 2024). Pharmacy Compounding Advisory Committee, Dec 4, 2024. fda.gov
  2. FDA. Pharmacy Compounding Advisory Committee, Dec 4, 2024: final meeting minutes. fda.gov
  3. FDA. Pharmacy Compounding Advisory Committee, Dec 4, 2024: FDA presentations, morning session (AOD-9604). fda.gov
  4. Federal Register. Pharmacy Compounding Advisory Committee; notice of meeting, Dec 4, 2024. 89 FR (Oct 25, 2024), FR Doc. 2024-24828. govinfo.gov
  5. Reed Smith. FDA removes certain peptide bulk drug substances from Category 2 of interim 503A bulks list and sets dates for PCAC review. Client Alert 2024-208. Link
  6. FDA. Certain bulk drug substances for use in compounding that may present significant safety risks (current as of Apr 22, 2026). fda.gov
  7. BakerHostetler. HHS issues enforcement discretion policy regarding 503A compounding using certain peptide bulk drug substances (Oct 28, 2026). Link
  8. Stier H, Vos E, Kenley D. Safety and tolerability of the hexadecapeptide AOD9604 in humans. J Endocrinol Metab 2013;3(1-2):7–15. DOI 10.4021/jem157w
  9. Moré MI, Kenley D. Safety and metabolism of AOD9604, a novel nutraceutical ingredient for improved metabolic health. J Endocrinol Metab 2014;4(3):64–77. DOI 10.14740/jem213w
  10. Heffernan M et al. The effects of human GH and its lipolytic fragment (AOD9604) on lipid metabolism following chronic treatment in obese mice and β3-AR knock-out mice. Endocrinology 2001;142(12):5182–5189. PMID 11713213
  11. Calzada Limited. ASX announcement: AOD9604 receives GRAS status in the US (Jun 25, 2012). asx.com.au
  12. Lab+Life Scientist. AOD9604 awarded safe status in US (Aug 6, 2014). Link
  13. World Anti-Doping Agency. 2026 Prohibited List, S2.2.3 (copy hosted by SEGAS). PDF
  14. World Anti-Doping Agency. WADA statement on substance AOD-9604 (Apr 2013; copy hosted by the International Weightlifting Federation). Link
  15. FDA. Innoveix Pharmaceuticals, Inc. issues voluntary recall of all sterile compounded drug products due to a lack of sterility assurance (Jul 13, 2021). fda.gov
  16. Kwon DR, Park GY. Effect of intra-articular injection of AOD9604 with or without hyaluronic acid in rabbit osteoarthritis model. Ann Clin Lab Sci 2015;45(4):426–432. PMID 26275694
  17. ArentFox Schiff. RUO-ined: five peptide vendors learn research use only is not a legal strategy (Sep 18, 2026). Link
  18. FDA. EGRIFTA WR (tesamorelin) for injection, prescribing information (revised 3/2025). DailyMed

This page is for education and is not medical advice. AOD-9604 is not FDA-approved. Talk to a clinician before using any peptide.