AOD-9604: Fat-Loss Peptide Explained - Evidence, Dosage, Oral vs Injection

Key takeaways

• AOD-9604 is a synthetic copy of the tail end of human growth hormone (amino acids 177 to 191, plus one added tyrosine), designed in the 1990s at Monash University to keep growth hormone's fat-burning effect without its effects on blood sugar and growth. It does not raise growth hormone or IGF-1.
• In obese mice and rats it cut weight gain and increased fat breakdown. In people, six trials by its developer found it safe, but the 24-week phase 2b trial of about 530 obese adults showed no significant weight loss and the program was abandoned in 2007. No positive human trial has ever been published.
• Every human efficacy study used oral tablets at 0.25 to 30 mg a day. The injections, drops and troches sold online were never tested for fat loss, so the doses circulating for them are invented.
• FDA placed AOD-9604 in Category 2 of its compounding evaluation in September 2023, its advisory committee reviewed it in December 2024 and FDA proposed not to permit it. As of October 2026 no licensed US pharmacy may compound it. The 'GRAS' status sellers cite is a 2014 company self-determination that FDA never reviewed.
• If fat loss is the goal, the tools a clinician can actually prescribe, GLP-1 therapy first, have the trials this peptide never passed.

AOD-9604 at a glance

Also called

AOD9604, hGH fragment 176-191 (modified), Tyr-hGH 177-191, AOD-9401 (earlier analog), lipolytic fragment of growth hormone

Class

Synthetic 16-amino-acid peptide copying the C-terminal tail of human growth hormone (residues 177 to 191 with an added tyrosine); a lipolytic fragment, not a growth hormone secretagogue

Route

Oral tablets in the clinical trials; sold today as subcutaneous injections, sublingual drops, troches and capsules

FDA status

Never FDA-approved. Development as an obesity drug ended in 2007 after the phase 2b trial showed no significant weight loss. Placed in FDA's Category 2 (significant safety risk for compounding) on September 29, 2023; FDA proposed not to add it to the 503A bulks list after the December 4, 2024 advisory committee review. Not among the twelve peptides removed from Category 2 in April 2026; FDA now lists it as nominated but withdrawn, and it still cannot be compounded.

FDA Category 2 (compounding restricted)

No

Available by prescription (US)

Not compoundable: it is not on the 503A bulks list; it was in Category 2 from 2023 and is now listed as nominated but withdrawn

Best-studied use

Obesity: six human trials from 2001 to 2006 with about 900 participants, none showing durable weight loss; lipolysis and reduced weight gain in obese mice and rats

Typical monthly cost (telehealth, 2026)

No legal prescription product exists; research-vendor listings are not a comparable product and are not priced here

What AOD-9604 is and how it was supposed to work

Human growth hormone is a 191-amino-acid protein with two broad jobs: it drives growth and anabolism through IGF-1, and it breaks down fat. In the early 1990s Frank Ng's group at Monash University in Melbourne reported that a small piece of the hormone's C-terminal tail, residues 177 to 191, reduced weight gain and fat mass in obese mice on its own, without the rest of the molecule (Natera 1994). The idea was that the lipolytic activity could be separated from the growth and insulin-resistance effects that make intact growth hormone unsuitable as an obesity drug.

AOD-9604 ("anti-obesity drug 9604") is the refined version of that fragment: the 16 amino acids 177 to 191 with a tyrosine added at the front, following an earlier analog called AOD-9401. Metabolic Pharmaceuticals, a Melbourne company spun out of the Monash work, developed it as an oral obesity drug through the early 2000s.

Two features matter for everything that follows. First, AOD-9604 is a fragment of growth hormone, not a releaser of it: it does not bind the growth hormone receptor, did not make cells proliferate in receptor assays, and did not change IGF-1 in any human trial (Heffernan 2001). That rules out the "growth hormone benefits" sellers attach to it, and it is why a list of growth-hormone-like effects (muscle, recovery, skin, sleep) has no mechanism here. Second, it was designed and tested as an oral drug. The injectable vials sold today are a different route that the clinical program never studied.

What the evidence actually shows

AOD-9604 claims, graded by the evidence behind them

Claim	Grade	What the evidence shows	Sources
Stimulates fat breakdown and reduces weight gain in obese animals	D	Oral AOD9604 at 500 micrograms per kilogram a day for 19 days halved weight gain in obese Zucker rats and raised fat-tissue lipolysis without hurting insulin sensitivity. Fourteen-day infusions cut weight gain and increased fat oxidation in ob/ob mice without the hyperglycemia seen with intact growth hormone, and its predecessor AOD-9401 did the same by mouth. Consistent animal data, 1994 to 2001, all from the developer's group.	Natera 1994; Ng 2000; Heffernan 2000; Heffernan 2001
Causes weight loss in obese adults	C	Weak and negative. A 12-week oral study of 300 obese adults reported about 2.6 to 2.8 kg lost at 1 mg a day versus 0.8 kg on placebo, with higher doses doing worse; the 24-week phase 2b trial of about 530 adults on 0.25 to 1 mg tablets showed no significant weight loss and development ended in 2007. Neither result was published in a peer-reviewed journal.	News-Medical 2004; Valentino 2010; Stier 2013
Safe and well tolerated in humans	B	Six placebo-controlled company trials from 2001 to 2006, 893 participants: single intravenous doses up to 400 micrograms per kilogram, oral doses up to 54 mg, and 1 mg a day for up to 24 weeks. Adverse events were similar to placebo, no anti-AOD9604 antibodies were detected and IGF-1 did not change; the 54 mg oral dose caused more gastrointestinal complaints. Published by company-linked authors in a minor journal; no data beyond 24 weeks.	Stier 2013
Raises growth hormone or IGF-1, or works like HGH	D	No. AOD9604 does not compete for the growth hormone receptor and did not induce cell proliferation in vitro, and IGF-1 was unchanged in every human study. Its selling point was precisely that it is not growth hormone.	Heffernan 2001; Stier 2013
Works when taken by mouth	C	Oral tablets are the only form with human data, and those data were negative for weight loss. In animals the peptide is cleared from blood within minutes (intravenous half-life about 3 minutes in pigs) and was estimated to be about 40% absorbed orally in rats. Sublingual drops, troches and capsules have no absorption or efficacy data at all.	Moré 2014; Stier 2013
Injections work better than oral	D	No injection has ever been tested for fat loss in people; the only parenteral human data are single intravenous doses in phase 1 safety studies. The 250 to 500 microgram daily subcutaneous doses circulated online were never studied.	Stier 2013
Repairs cartilage or treats osteoarthritis	D	One rabbit study: weekly intra-articular injections for four weeks improved cartilage scores, more so combined with hyaluronic acid. Nothing in humans, and nothing by injection under the skin.	Kwon 2015
Recognized as safe by FDA (GRAS)	C	The developer announced in 2014 that an expert panel it convened had concluded AOD9604 was generally recognized as safe for foods and supplements at up to 1 mg a day, conditional on publishing its safety data. That is a company self-determination. FDA's GRAS Notice Inventory contains no notice for AOD9604, so FDA has never evaluated or agreed with the claim, and GRAS says nothing about efficacy.	Lab Online 2014; Moré 2014; FDA GRAS inventory 2026
Improves cholesterol or glucose tolerance	C	Company reports of the 12-week study described slightly better cholesterol profiles and fewer cases of impaired glucose tolerance; the pooled safety analysis found a non-significant trend toward better glucose tolerance and said it would need its own trial. Not confirmed anywhere.	News-Medical 2004; Stier 2013

The story in that table is a drug-development arc, and it is worth reading as one.

The animal data were good. Between 1994 and 2001 the Monash group published a run of studies in which the fragment did what growth hormone does to fat without doing what growth hormone does to glucose: in obese Zucker rats, 19 days of oral dosing reduced weight gain by more than half and left insulin sensitivity intact on clamp testing (Ng 2000); in ob/ob mice, 30 days of oral dosing with the predecessor fragment AOD-9401 lowered weight gain from day 16 onward without reducing food intake, and the peptide was lipolytic in human fat tissue in a dish (Heffernan 2000). This is the evidence sellers quote, and it is real. It is also where the evidence stops.

The human efficacy data were not. The 12-week study reported in December 2004 enrolled 300 obese adults at five Australian sites and tested oral doses of 1, 5, 10, 20 and 30 mg; the company said the 1 mg group lost 2.8 kg against 0.8 kg on placebo, and that higher doses did less (News-Medical 2004). A dose-response that runs backwards is a warning sign, and the confirmatory trial confirmed it: about 530 obese adults took 0.25, 0.5 or 1 mg tablets or placebo for 24 weeks, and the drug "failed to induce significant weight loss"; development was terminated in 2007 (Valentino 2010). The developer's own 2014 review attributes the failure partly to the intensive diet and exercise program added to that trial, with the weight-loss manuscript "in preparation" (Moré 2014); twelve years later it has not appeared.

The safety data are the best part of the record, with caveats. The 2013 pooled analysis of all six trials, 893 participants, is reassuring on its own terms: adverse events indistinguishable from placebo, no antibodies, no IGF-1 change (Stier 2013). The caveats are that the authors were affiliated with the company, the journal is minor, the exposure was oral tablets of pharmaceutical quality for at most 24 weeks, and nothing in it applies to injecting a vial of unknown content.

What you are promised versus what is documented

Sales pages for AOD-9604 promise fat loss "without diet changes", targeted belly-fat reduction, cartilage repair, "the fat-burning power of HGH without the side effects", better metabolism and GRAS-certified safety. Sorted by the evidence:

• Documented in humans: short-term tolerability of oral tablets at up to 1 mg a day for 24 weeks; no change in IGF-1 or glucose.
• Documented in animals only: reduced weight gain, increased lipolysis and fat oxidation in obese rodents; cartilage scores in rabbits.
• Tested and failed: weight loss in obese adults, in the one adequately sized trial.
• Never tested: any injection for fat loss; drops, troches or capsules by any measure; "targeted" belly-fat loss; effects on muscle, recovery, sleep or skin; use for longer than 24 weeks.

Note how the marketing inverts the record. The one route with human data (oral) is sold as the "less effective" option, and the route with no data (injection) is sold as the real thing. Neither has evidence for the thing you would be buying it for.

AOD-9604 vs tesamorelin, 5-amino-1MQ and GLP-1 drugs

Read the tesamorelin profile for the one GH-axis peptide with real fat data, the 5-amino-1MQ profile for the other "fat-loss" product sold alongside AOD-9604, and the best peptides for weight loss ranking for the honest ordering.

Dosage: what was studied versus what sellers circulate

Two observations. The injection doses sold online are a tenth to a quarter of the lowest oral dose that produced even a company-reported signal, on the theory that injection avoids first-pass losses; that theory has never been tested, and the oral route was chosen by the developer because the peptide was in fact absorbed. And the trial doses were measured in milligrams of pharmaceutical-grade tablets; a research vial labeled "5 mg" tells you nothing about what is inside.

How to read a vendor's reconstitution chart

The arithmetic on those charts is ordinary and it hides the problem. A vial labeled 5 mg reconstituted with 2 mL of bacteriostatic water would contain 2.5 mg/mL, so a 300 microgram dose would be 0.12 mL, or 12 units on a U-100 insulin syringe. The reconstitution calculator will give you that number for any vial. What it cannot tell you is whether the vial holds 5 mg, 2 mg, a different peptide, or endotoxin, because nobody with a license tested it. That is the difference between a compounded prescription and a research chemical, and for AOD-9604 only the second exists.

Side effects and who should not use it

What the trials showed. Across 893 participants and up to 24 weeks of oral dosing, adverse events were similar in frequency and type to placebo; serious adverse events occurred (18 patients in the 24-week trial) but none was judged definitely related; no antibodies to the peptide were found; IGF-1, glucose tolerance and insulin did not change (Stier 2013). The highest oral doses (54 mg) were associated with more gastrointestinal upset. Animal toxicology reported no-adverse-effect levels of 100 mg/kg a day in rats and 50 mg/kg a day in monkeys (Moré 2014).

What the trials cannot tell you. Everything above applies to swallowed tablets of known content. The products sold now are injected, unlabeled and untested, and the risks that matter are the ones FDA raises for every research peptide: injection-site reactions, bacterial contamination of a non-sterile vial, wrong or inconsistent concentration, and immune reactions to synthesis impurities and aggregates. FDA's reviews for the 2024 advisory committee raised immunogenicity, impurity and characterization concerns for the peptides it reviewed, AOD-9604 among them (FDA PCAC 2024).

Theoretical concerns. AOD-9604 does not raise IGF-1, so the growth-signaling worry that applies to growth hormone and its secretagogues does not apply here on current evidence. How it acts on fat cells was never fully settled; the developer's own papers describe a mechanism separate from the growth hormone receptor without identifying the receptor it does use.

Who should not use it. Nobody can be advised to use an unapproved, untested product, so the list is short and categorical: anyone pregnant or breastfeeding; anyone with a cancer history, on precautionary grounds for any growth-hormone-derived peptide; anyone subject to drug testing in sport. Athletes should note that WADA treats AOD-9604 as prohibited at all times under section S0, which covers any pharmacological substance not approved for human use by any health authority, and that anti-doping laboratories have published methods to detect it and its metabolites in urine (Cox 2015).

Legal status in the United States

AOD-9604's legal position is clear and unfavorable, and the sequence is documented.

• Never approved. No regulator anywhere has approved AOD-9604 for any use. Its drug development ended in 2007.
• Category 2 from September 29, 2023. FDA added "AOD 9604" to Category 2 of its interim 503A bulk-substances evaluation, alongside BPC-157, CJC-1295, ipamorelin, kisspeptin-10, thymosin alpha-1 and others, because it had identified significant safety risks with compounding them (FDA 503A categories, September 2023). Category 2 substances are not covered by FDA's enforcement discretion, and pharmacies do not compound them. FDA's May 14, 2026 update no longer lists AOD-9604 in Category 2; it now appears among nominated-but-withdrawn substances, which ends the safety flag but gives no basis for compounding (FDA categories 2026).
• Reviewed December 4, 2024. FDA's Pharmacy Compounding Advisory Committee took up AOD-9604 (both the free base and the acetate) at its December 2024 meeting, together with CJC-1295 and thymosin alpha-1; FDA's reviewers recommended against adding it to the 503A bulks list, the committee agreed unanimously (0 yes, 12 no, per FDA's final summary minutes), and FDA proposed not to include it (Alliance for Pharmacy Compounding 2024); (FDA PCAC 2024). Final rulemaking is pending.
• Not part of the 2026 thaw. The twelve peptides FDA removed from Category 2 on April 15, 2026 did not include AOD-9604, and it was not on the July 2026 advisory agenda. It remains non-compoundable. The peptide legal tracker carries the full list and will record any change.
• No other route. It has no USP monograph and is not a component of any approved drug, so even apart from Category 2 it fails all three tests for 503A compounding. It is not on the 503B list either.
• GRAS is not a drug status. Generally-recognized-as-safe status concerns food ingredients, not drugs, and in AOD-9604's case it was a self-determination by a company-convened panel announced in August 2014 (Lab Online 2014). FDA's GRAS Notice Inventory lists no notice for AOD9604, which means FDA was never asked to review the conclusion and never did (FDA GRAS inventory 2026). Even if it were accepted, GRAS would cover putting up to 1 mg a day in a food, not injecting a drug.

Cost and what a clinician can actually prescribe

There is no legal price for AOD-9604 because there is no legal product. Research-vendor listings exist, and we do not quote or link to them; the number on such a listing buys an unlabeled vial, not a medication, and the two are not comparable.

If the goal behind the search is fat loss, the options a licensed clinician can prescribe in October 2026 are, in order of evidence: GLP-1 therapy (semaglutide, tirzepatide), which produces 15% to 20% weight loss in large trials and costs about $299 to $449 a month as a brand pen or $150 to $350 compounded under the conditions in our legal tracker; tesamorelin, for the narrower problem of visceral fat without excess weight, available only as the brand Egrifta at about $2,400 to $2,800 a month; and, with far weaker evidence, sermorelin. Our compounded semaglutide versus tirzepatide guide and cost guide have the details.

A provider who lists AOD-9604 next to those options is telling you something about how they source and how they read evidence. Ask which pharmacy fills it; for AOD-9604 there is no honest answer.

Bottom line

AOD-9604 is the rare research peptide whose human story is complete: designed on a sound idea, backed by clean animal data, taken through six human trials by a company that wanted it to work, and dropped in 2007 when the only large trial showed no weight loss. The product sold today is a different route at a different dose with no trial behind it, no basis for compounding since FDA's 2023 Category 2 flag, and a GRAS claim FDA never reviewed. It is probably not dangerous at the doses in the trials; it is also, on the only evidence that exists, not effective.

If you want to lose fat, the evidence points somewhere else, and so does the law.

Frequently asked questions

+−What is AOD-9604 and what does it do?

AOD-9604 is a synthetic copy of the last 16 amino acids of human growth hormone, the region the Monash University team that designed it believed carried the hormone's fat-burning activity. In obese mice and rats it reduced weight gain, increased fat breakdown and raised fat oxidation without the blood-sugar problems of intact growth hormone. In humans, six trials run by its Australian developer found it safe but, in the only large trial, no better than placebo for weight loss. It does not raise growth hormone or IGF-1.

+−Does AOD-9604 work for weight loss?

The best available answer is no. A 12-week study of 300 obese adults reported about 2 kg more weight loss than placebo at the 1 mg oral dose, but higher doses did worse, and the 24-week phase 2b trial of about 530 adults taking 0.25 to 1 mg tablets showed no significant weight loss, after which the developer ended the program in 2007. Neither trial was published in a peer-reviewed journal. There are no trials of the injectable, drop or troche forms sold today.

+−What AOD-9604 dosage was actually studied?

In people, oral tablets of 1 to 30 mg a day for 12 weeks and 0.25 to 1 mg a day for 24 weeks, plus single intravenous doses up to 400 micrograms per kilogram in phase 1. The 1 mg oral dose was the one the developer pursued. The 250 to 500 microgram daily injections and the drops and troches sold online were never tested for fat loss in any trial, so there is no studied dose for them.

+−AOD-9604 oral drops, troches or capsules versus injection: which works?

Neither has shown fat loss in people. The only human efficacy data come from oral tablets, and those were negative in the pivotal trial. Animal data show the peptide is broken down within minutes in blood and about 40% absorbed orally in rats, which is better than most peptides but was not enough to produce an effect in humans. Injections avoid the gut but have never been tested for fat loss at any dose.

+−Is AOD-9604 FDA approved or legal?

It has never been approved anywhere. In September 2023 FDA placed it in Category 2 of its compounding evaluation, meaning it may present significant safety risks and no licensed pharmacy should compound it; FDA's advisory committee reviewed it in December 2024 and FDA proposed not to add it to the permitted list. It was not among the twelve peptides removed from Category 2 in April 2026, but FDA now lists it as nominated but withdrawn rather than in Category 2; it still cannot be compounded. Vials and drops sold as research chemicals are unapproved drugs when marketed for human use; possessing them is not a crime, but no clinician can lawfully have them made for you.

+−Does AOD-9604 raise growth hormone or IGF-1?

No. It is a fragment of growth hormone, not a releaser of it, and it does not bind the growth hormone receptor. IGF-1 did not change in any of the human trials, which is why the developer could argue it lacked the diabetes and growth-signaling risks of growth hormone. It also means the muscle and recovery benefits claimed for it have no mechanism and no data.

+−What are the side effects of AOD-9604?

In the six company trials, covering 893 participants and up to 24 weeks of oral dosing, adverse events were similar to placebo, no antibodies to the peptide were found and IGF-1 and glucose did not change; the highest oral doses caused more stomach upset. That record applies to pharmaceutical-grade tablets taken by mouth. For the unregulated injections sold today, the realistic risks are injection-site reactions, contamination, wrong concentration and immune reactions to impurities, none of which has been studied.

+−AOD-9604 vs tesamorelin: which is better for belly fat?

They are not comparable. Tesamorelin is an FDA-approved GHRH analog, prescribable as the brand Egrifta, with an 806-patient trial program showing a 15% reduction in visceral fat. AOD-9604 is a failed obesity drug with no positive controlled trial and no legal supply. If visceral fat is the specific target, tesamorelin has the evidence; if weight loss is the goal, GLP-1 therapy has far more than either.

+−Is AOD-9604 banned in sports?

Yes. WADA treats it as a non-approved substance under section S0 of the Prohibited List, which bans at all times any pharmacological substance not approved for human therapeutic use by any health authority. It became known to the public through the 2013 Essendon Football Club supplements case, and anti-doping laboratories have published detection methods for it.

Sources

1. StudyNatera SH et al. Reduction of cumulative body weight gain and adipose tissue mass in obese mice: response to chronic treatment with synthetic hGH 177-191 peptide. Biochem Mol Biol Int 1994;33:1011-21. (1994)
2. StudyNg FM et al. Metabolic studies of a synthetic lipolytic domain (AOD9604) of human growth hormone. Horm Res 2000;53:274-8. (2000)
3. StudyHeffernan MA, Jiang WJ, Thorburn AW, Ng FM. Effects of oral administration of a synthetic fragment of human growth hormone on lipid metabolism. Am J Physiol Endocrinol Metab 2000;279:E501-7. (2000)
4. StudyHeffernan MA et al. Increase of fat oxidation and weight loss in obese mice caused by chronic treatment with human growth hormone or a modified C-terminal fragment. Int J Obes Relat Metab Disord 2001;25:1442-9. (2001)
5. StudyKwon DR, Park GY. Effect of intra-articular injection of AOD9604 with or without hyaluronic acid in rabbit osteoarthritis model. Ann Clin Lab Sci 2015;45:426-32. (2015)
6. StudyCox HD, Smeal SJ, Hughes CM, Cox JE, Eichner D. Detection and in vitro metabolism of AOD9604. Drug Test Anal 2015;7:31-8. (2015)
7. ReviewValentino MA, Lin JE, Waldman SA. Central and peripheral molecular targets for antiobesity pharmacotherapy. Clin Pharmacol Ther 2010;87:652-62. (2010)
8. StudyStier H, Vos E, Kenley D. Safety and tolerability of the hexadecapeptide AOD9604 in humans. J Endocrinol Metab 2013;3:7-15. (Pooled analysis of six company-sponsored trials, 893 participants.) (2013)
9. ReviewMoré MI, Kenley D. Safety and metabolism of AOD9604, a novel nutraceutical ingredient for improved metabolic health. J Endocrinol Metab 2014;4:64-77. (Company-sponsored review.) (2014)
10. NewsNews-Medical. Obesity drug codenamed AOD9604 highly successful in trials (company-sourced report of the 12-week, 300-patient oral study). December 16, 2004. (2004)
11. NewsLab Online (Life Scientist). AOD9604 awarded safe status in US (company announcement of a self-determined GRAS conclusion, up to 1 mg per person per day). August 6, 2014. (2014)
12. RegulatoryFDA. GRAS Notice Inventory (searched for AOD9604 on October 9, 2026: no records found). (2026)
13. RegulatoryFDA. Bulk drug substances nominated for use in compounding under section 503A: notice of updates to the 503A categories, updated September 29, 2023 (adds AOD 9604, BPC-157, CJC-1295, ipamorelin acetate and others to Category 2). Copy hosted by the Alliance for Pharmacy Compounding. (2023)
14. NewsAlliance for Pharmacy Compounding. PCAC to discuss 503A bulks list substances (ipamorelin and kisspeptin-10 on October 29, 2024; AOD-9604, CJC-1295 and thymosin alpha-1 on December 4, 2024). September 2024. (2024)
15. RegulatoryFDA. 2024 meeting materials, Pharmacy Compounding Advisory Committee (including FDA's reviews and the summary minutes of the December 4, 2024 meeting). (2024)
16. RegulatoryFDA. Bulk drug substances nominated for use in compounding under section 503A: Category 1, 2 and 3 lists and updates (updated May 14, 2026). (2026)