AOD-9604

A 16-amino-acid piece of human growth hormone: the stretch from position 177 to 191, with an extra tyrosine added at the front to make it more stable, closed into a loop by a link between its two cysteines. Because it is only the tail of the hormone, it cannot switch the growth hormone receptor on. It was developed from the late 1990s by the Australian company Metabolic Pharmaceuticals as a tablet for obesity; that programme was terminated in February 2007. It is sold today as a powder for injection under the skin and as a cream — neither of which has ever been given to a person in a published study.

Sold as

Studied only as oral capsules and tablets, and as an infusion into a vein. Sold as a powder for injection under the skin and as a cream applied to the skin — neither route has been given to a person in any published study.

Legal status in the EU

Not approved as a medicine in the EU, the United States, Australia or anywhere else — a point the owner's own 2013 statement to the Australian Securities Exchange makes explicitly. On 4 December 2024 the FDA's Pharmacy Compounding Advisory Committee voted 12 to 0 against adding AOD-9604 (free base) and AOD-9604 acetate to the list of substances US pharmacies may compound from; the FDA review behind that vote found no evidence of effectiveness for obesity by any route, inadequate chemical characterisation, and an unresolved immunogenicity risk for the injected form. The frequently repeated claim that it holds US "GRAS" status is what the company's own chief executive called “self-affirmed conditional GRAS status”, announced in June 2012 by a panel of US experts, covering up to 1 mg/day in food and never submitted to the FDA; FDA's public GRAS Notice Inventory contains no entry for AOD-9604. Named on the WADA 2026 Prohibited List under S2.2.3, growth hormone fragments.

Growth hormone's fat-releasing activity sits in the tail end of the molecule, and AOD-9604 is that piece on its own. In obese rats and mice it increases fat breakdown and fat burning and cuts weight gain without pushing blood sugar up, which full-length growth hormone does. In laboratory tests it neither attaches to the growth hormone receptor nor makes receptor-carrying cells multiply, and in people it left IGF-1 unchanged. In mice engineered without the beta-3 adrenergic receptor — the main fat-release switch on a fat cell — long-term treatment failed to change body weight or fat breakdown, but the authors of that study concluded the effect is not directly mediated through that receptor, and in a single-dose experiment it still raised fat burning in those same mice. The US regulator stated in December 2024 that the molecular target and the mechanism of action remain unknown.

Part of the bodyWhat happensHow it is knownKind of evidence

Body weight

This is what it was made for, and it is the thing that was measured most carefully. In the largest trial, adults with obesity took a tablet every day for 24 weeks while following a diet and exercise programme run by a dietitian. Everybody lost weight — about 3 to 4 kilograms — including the people whose tablets contained nothing. On the company's own chart of that trial, which the US regulator reproduced in 2024, the four lines run together for the whole 24 weeks and end less than a kilogram apart. The trial had been built to pick up a difference of 1.8 kilograms against dummy tablets. It found nothing close to that at 12 weeks, which was the question it was designed to answer, or at 24 weeks.

Measured in 502 randomised adults with obesity aged 18 to 65, over 24 weeks, against a dummy tablet, with neither the participants nor the staff knowing who had which. The number enrolled is given as 536 in the company's own filing and 534 in the sponsor's safety paper. The company announced the failure to the Australian stock exchange on 21 February 2007 and ended the obesity programme.

Measured in people

Source [01]Source [07]Source [16]

The growth signal in the blood (IGF-1)

Nothing moved, and that is the point of the compound. Growth hormone itself works largely by making the liver pour out IGF-1, the signal that reaches muscle, bone and every other tissue, and that is also where growth hormone's problems come from. AOD-9604 is only the tail of the molecule and cannot switch the growth hormone receptor on, so IGF-1 should stay flat. It did. Across 12 and 24 weeks of daily tablets there was no statistically significant difference in IGF-1 between any dose group and the dummy tablets.

Measured before and during treatment in the two long trials: 300 adults over 12 weeks and 502 adults over 24 weeks, both against dummy tablets. In laboratory work the fragment also failed to displace growth hormone from its receptor and did not make receptor-carrying cells multiply.

Measured in people

Source [01]Source [03]Source [12]

Blood sugar and insulin

Also nothing, and again that was the goal. Growth hormone given for months pushes blood sugar up and makes the body respond worse to insulin, which is the main reason it was never usable as a weight-loss drug. AOD-9604 did not do that. Participants swallowed a measured sugar drink and had their blood sugar and insulin checked before treatment and again after 12 and 24 weeks. The differences between the dose groups and the dummy tablets were tiny and none reached statistical significance.

Measured with a sugar-drink test in the two long trials, 300 adults over 12 weeks and 502 adults over 24 weeks, both against dummy tablets. The same absence of any effect on blood sugar was seen earlier in obese rats and in obese mice, where growth hormone itself raised blood sugar and the fragment did not.

Measured in people

Source [03]Source [12]Source [13]

Fat cells

The idea is that the fragment makes fat cells release their stored fat into the blood, where it can be burned. In the early studies in obese men, the amount of loose fat circulating in the blood did go up a few hours after a dose, by injection into a vein and by mouth. That is the closest thing to a working signal anyone has recorded in a person. It never turned into weight coming off: in the same studies the weight change was not different from dummy treatment.

Reported in obese men in the company's early studies — 23 people given single doses into a vein, and 16 given single doses by mouth. These findings survive only in a 2004 review article, whose own sources were company press releases that the US regulator notes are no longer available anywhere.

One small study

Source [01]

Waistline

One claim of a real effect exists, and it is thin. In the 12-week study in 300 adults, the authors reported that waist measurements shrank faster on every dose of AOD-9604 than on dummy tablets, and that the difference was statistically significant at all doses. No measurements were ever printed. That result appears only in a short conference abstract; the study's methods and results were never published, and the regulator that went looking in 2024 could not find them either.

Reported for 300 adults with obesity aged 30 to 65 over 12 weeks, in a conference abstract only. The bigger trial that followed, in 502 people over 24 weeks, listed waistline reduction among its secondary questions, but no waistline result from it has ever been published either.

One small study

Source [01]Source [07]

Body fat, in animals

In animals the compound does what it was designed to do. Obese rats given it by mouth every day for about three weeks put on about half as much weight as rats given salt water, and the fat tissue itself was more active at releasing fat. Obese mice treated for two weeks gained 5 to 10 per cent less weight than untreated mice, burned more fat, had more of the breakdown product of fat in their blood, and ended with less white fat and less brown fat. They were not eating less. None of this was ever reproduced in a person.

Seen in obese Zucker rats over 19 days and in obese ob/ob mice over 14 days, each against animals given the carrier liquid alone, and in some experiments against growth hormone itself.

Only seen in animals

Source [12]Source [13]Source [17]

Knee cartilage, in rabbits

The joint and cartilage claims that clinics now sell rest on one animal study. Thirty-two rabbits had knee osteoarthritis induced with an enzyme, then had weekly injections into the joint of salt water, hyaluronic acid, AOD-9604, or AOD-9604 together with hyaluronic acid. The joints given the combination looked better under the microscope than either treatment alone, and those rabbits limped for a shorter time. Nothing similar has been tried in a person.

Seen in 32 rabbits with chemically induced knee osteoarthritis, over 8 weeks, against salt water and against hyaluronic acid alone. The US regulator declined in 2024 to even assess joint uses, because nobody submitted and it could not find any human study of them.

Only seen in animals

Source [01]Source [14]

Under the skin, which is how it is sold

Nothing is known. Every one of the six trials gave AOD-9604 either as a capsule or tablet swallowed, or as a drip into a vein. What is sold today is a powder to mix and inject under the skin, or a cream to rub on. No published study has ever given a person either of those, at any dose, for any length of time. The US regulator looked for such data in 2024 for exactly this reason and found none.

Not measured. Six published trials, all oral or intravenous. The regulator searched the published literature and the two nominations it received and identified no human exposure by injection under the skin or through the skin.

Claimed, never tested

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The decisive trial in people failed. METAOD006, the OPTIONS study, randomised 502 adults with obesity (534 enrolled according to the sponsor's own safety paper, 536 according to the company's stock-exchange filing; BMI 30–45) to 0.25, 0.5 or 1 mg of oral AOD-9604 daily or placebo for 24 weeks, on top of a dietitian-supervised diet and exercise programme; weight loss did not differ significantly from placebo at the 12-week primary endpoint or at 24 weeks, and the sponsor announced termination of the obesity programme on 21 February 2007. The trial was powered for an 80% chance of significance if the drug beat placebo by 1.8 kg. Six randomised, double-blind, placebo-controlled trials were run between 2001 and 2006 in roughly 900 adults, but only the safety data were ever published (Stier et al., J Endocrinol Metab 2013, written by the sponsor's staff and consultants). The efficacy results survive only as a stock-exchange announcement, a conference abstract and a review article whose own references were company press releases the FDA notes are no longer available. The widely repeated "2.6 kg in 12 weeks" comes from that abstract (300 participants; 0.22 kg/week on 1 mg against 0.07 kg/week on placebo) and was not confirmed by the larger, longer trial. No AOD-9604 study is registered on ClinicalTrials.gov. What the programme did establish is a negative: IGF-1 and glucose tolerance were unchanged throughout, and no anti-AOD-9604 antibodies were found in anyone tested.

Markers of fat being released into the blood rose within two to four hours of a dose in the early studies. Body weight never followed: at 12 weeks and at 24 weeks the people taking it had lost no more than the people taking dummy tablets. IGF-1, the growth signal, had not moved at 12 or 24 weeks either, and neither had the way the body handled sugar. In pigs the peptide is absorbed from the gut and then broken down quickly, and no half-life has ever been reported for a person. The longest anyone has been followed in a published study is 24 weeks of daily tablets plus four weeks afterwards.

What was measuredWhat happenedIn whomHow it is known

Body weight, in the trial built to settle the question

No significant difference from dummy tablets, either at 12 weeks — the question the trial was designed around — or at 24 weeks. In the company's own chart, reproduced by the US regulator, all four groups including the dummy-tablet group fall to roughly 3 to 4 kilograms below their starting weight, ending less than a kilogram apart. The trial was powered to have an 80 per cent chance of proving a difference if AOD-9604 beat the dummy tablets by 1.8 kilograms. It did not.

502 randomised adults with obesity, aged 18 to 65, body mass index 30 to 45; the enrolment figure is 536 in the company's filing and 534 in the sponsor's safety paper. Doses of 0.25, 0.5 or 1 milligram daily by mouth, or dummy tablets, for 24 weeks, after a 4-week run-in on dummy tablets. Everyone also followed a dietitian-supervised diet and exercise programme.

Measured in people

Source [01]Source [07]

IGF-1, the growth signal that growth hormone works through

No statistically significant difference between any dose group and dummy tablets, at any time point, in any of the six studies. In the 24-week trial the average change across everyone was small and the comparison between groups came out at p = 0.51 after 12 weeks and p = 0.76 after 24 weeks — meaning the differences seen were the kind you would expect from chance alone.

Measured in both long trials: 300 adults over 12 weeks and 502 adults over 24 weeks, each against dummy tablets, and checked in the shorter studies as well.

Measured in people

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How the body handles sugar

No significant difference from dummy tablets after 12 or 24 weeks of daily tablets. The authors also noted, without being able to prove it, that people who already handled sugar poorly seemed less likely to develop diabetes during the 12-week study if they were on AOD-9604 than on dummy tablets. They wrote that this would need its own trial. That trial has never been run.

Sugar-drink tests in the two long trials, 300 adults over 12 weeks and 502 adults over 24 weeks, both against dummy tablets.

Measured in people

Source [01]Source [03]

Whether the immune system starts attacking it

No antibodies against AOD-9604 were found in anyone tested, at any point, in either long trial. That is a real result, and a narrow one: the tests were done on people swallowing it, over 12 and 24 weeks, and in the 24-week trial only on a selected subset. The US regulator's specific worry in 2024 was about injecting it under the skin, which raises the risk of an immune reaction and which nobody has ever studied.

Blood samples from participants in the 12-week trial at the start and after 4, 8 and 12 weeks, and from a subset of participants in the 24-week trial.

Measured in people

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Body weight, in the earlier 12-week study — the source of the figures that still circulate

Weight came off faster on every dose than on dummy tablets, most on the smallest dose. The reported rates were 0.22 kilograms a week on 1 milligram, 0.13 on 20 milligrams and 0.15 on 30 milligrams, against 0.07 a week on dummy tablets. Over 12 weeks that is roughly 2.6 kilograms against 0.8 kilograms, which is where the numbers repeated by sellers come from. The authors called the effect "significant" for women only. The 5 and 10 milligram groups were never reported. This exists as a conference abstract and nothing else: no methods, no tables, no publication.

300 adults with obesity aged 30 to 65, body mass index 35 or above, 54 per cent men. Doses of 1, 5, 10, 20 or 30 milligrams daily by mouth or dummy tablets, 50 people per group, for 12 weeks after a 2-week run-in.

One small study

Source [01]Source [03]

Body weight, in the three earliest studies

Nothing beyond dummy treatment in any of them. In 23 obese adults given single doses into a vein once a week, weight fell 0.58 kilograms on average over three weeks, which was not different from dummy treatment. In 16 obese men given weekly doses by mouth for four weeks there was no significant weight loss against dummy treatment either. In 36 obese men treated for one week, the 10 milligram dose gave 1 kilogram against 0.6 kilograms on dummy treatment, and the larger doses did less.

23, 16 and 36 adults with obesity, over 3 weeks, 4 weeks and 1 week respectively, each against dummy treatment. These are the same early studies summarised in the sponsor's 2013 safety paper.

One small study

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Body weight gain in obese animals

Obese rats given it by mouth every day gained about half as much weight as rats given salt water, roughly 16 grams against 36. Obese mice treated for 14 days gained 5 to 10 per cent less weight than untreated mice, burned more fat and had more fat-breakdown product in the blood, without eating less. Growth hormone did the same things in these animals but also pushed their blood sugar up; the fragment did not.

Adult obese Zucker rats — treated for 19 days according to the original paper and 21 according to the US regulator's summary of it — and obese ob/ob mice over 14 days, each against animals given the carrier liquid, and in parallel against growth hormone itself.

Only seen in animals

Source [12]Source [13]

Damaged knee cartilage in rabbits

Rabbits injected in the joint with AOD-9604 together with hyaluronic acid had less cartilage damage under the microscope than rabbits given either one alone, and limped for a shorter time than any other group. Rabbits given salt water did worst.

32 rabbits with knee osteoarthritis induced by an enzyme, in four groups, given weekly injections into the joint and assessed at 8 weeks.

Only seen in animals

Source [14]

In the trials the side-effect profile was indistinguishable from placebo: headache, diarrhoea and flatulence, dose-related at the highest oral doses (54 mg). Five of the 300 participants in the 12-week study developed cancers or growths — two skin cancers, a lipoma, a breast cancer and a melanoma — all in AOD-9604 groups and none on placebo; the investigator judged them unrelated, and the FDA stated in December 2024 that the available information is insufficient to establish that. Genotoxicity assays came back inconsistent, turning positive once and negative on repeat, and the FDA concluded the positive signals cannot be dismissed. No carcinogenicity study and no reproductive or developmental toxicity study has ever been performed in any species. Rats dosed orally for 26 weeks showed dose-dependent changes in a bone-turnover marker; cynomolgus monkeys dosed for 9 months showed minimal-to-slight periportal vacuolation in liver cells. The FDA's central concern is immunogenicity from subcutaneous injection — the route that has never been studied — combined with unknown impurities and aggregates in unregulated material.

EffectWhat it feels likeHow often

Cancers found during the 12-week studySerious

The doctor running the study judged none of them related to the treatment, on three grounds: nothing appeared in the highest dose group of all, so there was no dose pattern; three were skin cancers and the study ran in Australia, which has the world's highest rate of them; and the participants were people with a body mass index of 35 or more who had gone a long time without medical care, a group in which several cancers are more common anyway. In December 2024 the US regulator said plainly that it had concerns about these reports and that the information available is not enough to establish that the cancers were unrelated. IGF-1, the growth signal usually blamed for cancer risk with growth hormone, did not rise in any of these people.

Five people out of 300, all of them in groups taking AOD-9604 and none in the dummy-tablet group: a basal cell skin cancer, a squamous cell skin cancer and a lipoma in the 20 milligram group, a breast cancer in the 5 milligram group and a melanoma in the 10 milligram group.

Source [01]Source [03]

Headache

Mild or moderate. The pattern that matters is that it happened about as often on dummy tablets as on the real thing in the long studies, which is why the sponsor describes the side-effect profile as indistinguishable from placebo.

The commonest complaint in every study. About 7 in 10 people in the 23-person intravenous study. About 4 in 10 during treatment in the 12-week study — against 3 in 10 during the run-in period when everybody was on dummy tablets. About 1 in 4 in the 24-week study, spread evenly across the dose groups and the dummy-tablet group.

Source [01]Source [03]

Loose stools, wind and stomach upset

One case of diarrhoea at that 54 milligram dose was recorded as a serious adverse event and judged possibly related to the treatment — the only event in the whole programme that a study doctor tied to AOD-9604 at that level of seriousness. The doses now sold are far smaller than 54 milligrams, but they are also injected rather than swallowed, and nobody has studied that.

The second commonest group of complaints, and the only one that clearly tracked the dose. In the 12-week study about 1 in 10 people had diarrhoea. In the seven-day study the group on the largest oral dose, 54 milligrams, had more headaches, diarrhoea and wind than the smaller-dose groups or the dummy tablets.

Source [01]Source [03]

A feeling of tightness in the chest

A single event in a study of 23 men is exactly the kind of signal that a study this small cannot separate from chance. It is written down here because a chest symptom in a safety file should not be left out on the grounds that it was probably nothing.

One person out of 23, in the study that gave it as a drip into a vein. It was recorded as severe and judged possibly related to the treatment. Two other severe events in the same study happened in people receiving dummy infusions.

Source [01]Source [03]

Feeling unusually good

Each man in that study received the real thing and the dummy at different times, so the comparison is with himself. It was judged possibly related to the treatment. Nobody has looked into it since, and no effect on mood was reported in any of the longer studies.

5 people out of 23 in the intravenous study reported mild or moderate euphoria during the periods when they were given AOD-9604. Nobody reported it during the periods when they were given a dummy infusion.

Source [01]Source [03]

Signals in animals that were never chased down in people

Rats given it by mouth for 26 weeks showed dose-related changes in a blood marker of bone turnover — down at 13 weeks, up at 26 weeks in females — which the regulator said could suggest an effect on bone. Monkeys given it by mouth for nine months showed small bubble-like holes in the liver cells nearest the blood vessels, which the regulator said could indicate liver damage; what was inside them was never described. And the tests for damage to DNA came back inconsistent: two of them turned positive once and negative on repeat, and the regulator concluded the positive signals cannot be dismissed. No cancer study in animals and no study of effects on pregnancy or fertility has ever been done, at all.

Three, from the one published animal safety paper, which the US regulator read closely in 2024 and did not accept at face value.

Source [01]Source [04]

Anything from injecting it under the skin

This matters more here than it sounds. The US regulator's central safety objection in December 2024 was that injecting a peptide under the skin is the route most likely to provoke an immune reaction, and that nobody knows what impurities or clumped-together peptide is in the material being sold, because there is no published test for either. The same review concluded that the substance is not physically and chemically well characterised.

Not measured. Not once, in any published study. All six trials used capsules, tablets or a drip into a vein.

Source [01]Source [02]

Anything that takes longer than six months to show up

There is also almost nothing on the record from people using it outside trials. The US regulator searched its own side-effect database for reports involving AOD-9604 up to January 2024 and found none at all, and searched its separate food and supplement database from 2004 to 2024 and found none there either. It said in the same breath that this does not mean the substance is safe: nobody files a form about something they bought online.

Not measured. The longest anyone has been given AOD-9604 in a published study is 24 weeks, followed for four weeks afterwards.

Source [01]Source [03]

These are the amounts the studies below gave their participants, and they are here as facts about those studies. They are not a recommendation, not a starting point and not a range to pick from. What a person should take, if anything, is a question for a doctor who knows them.

METAOD001 — the first study in people, in 15 healthy men, testing whether a dose into a vein is tolerated, against dummy infusions and against a single dose of real growth hormone

Single doses into a vein, given over 20 minutes, ranging from 25 to 400 micrograms per kilogram of body weight. Each man received three different doses and a dummy infusion, one week apart.

Single doses, separated by seven-day washout periods.

Source [01]Source [03]

METAOD002 — the same question in 23 men with obesity aged 19 to 50, each receiving every dose and a dummy infusion in turn

Single doses into a vein over 20 minutes: 25, 50 and 100 micrograms per kilogram of body weight, plus a dummy infusion.

Four single doses, each separated by a seven-day washout period.

Source [01]Source [03]

METAOD003 — the first attempt at swallowing it, in 17 men with obesity aged 35 to 54

Single doses in capsules: 9, 27 and 54 milligrams, plus dummy capsules. Each man received all of them in turn.

Single doses, separated by two-week washout periods.

Source [01]Source [03]

METAOD004 — the first study of taking it every day, in 36 men with obesity aged 18 to 54, nine per group

Capsules of 9, 27 or 54 milligrams once daily, or dummy capsules.

Seven days of treatment with a further seven days of follow-up.

Source [01]Source [03]

METAOD005 — the 12-week study in 300 adults with obesity at five Australian hospitals, and the source of the weight-loss figures still quoted by sellers

Capsules of 1, 5, 10, 20 or 30 milligrams once daily, or dummy capsules, 50 people per group.

12 weeks of treatment after a two-week run-in during which everybody took dummy capsules.

Source [01]Source [03]

METAOD006, the OPTIONS study — the trial that decided it, in 502 randomised adults with obesity at 16 Australian hospitals and medical centres, run under conditions the company described as phase 3

Tablets of 0.25, 0.5 or 1 milligram once daily, or dummy tablets, alongside a dietitian-supervised diet and exercise programme for everyone.

24 weeks of treatment after a four-week run-in on dummy tablets, with four weeks of follow-up afterwards.

Source [01]Source [03]Source [07]

What people report

• Whether it does anything at all when injected under the skin, which is how almost everyone now takes it: no published study has ever given it to a person that way.
• Whether the cream form does anything: no published study has ever put it on a person's skin either.
• What dose would be right for an injection, since the only doses ever studied were swallowed or dripped into a vein.
• How long it lasts in a person's blood: no half-life has ever been reported for a human, by any route.
• Whether it reduces body fat as opposed to body weight — fat was never measured directly in the large trials, only weight and waist.
• Whether it builds or preserves any muscle: never measured, in any study, in any species.
• Whether it helps any injury heal in a person: the healing evidence is 32 rabbits' knees.
• Whether it helps osteoarthritis or thinning bones in a person: the US regulator declined to assess either use in 2024 because no human study exists.
• Whether the waistline result from the 12-week study was real: it appears only in a conference abstract with no numbers, methods or publication behind it.
• Whether the hint that it protected people with borderline blood sugar from developing diabetes means anything: the authors said it needed its own trial, and that trial was never run.
• Whether the five cancers in the 12-week study had anything to do with it: the study doctor said no, and the US regulator said in 2024 that there is not enough information to be sure.
• Whether it causes cancer over years: no long-term animal cancer study has ever been done.
• Whether it is safe in pregnancy or affects fertility: no reproductive or developmental study has ever been done, in any species.
• What it does in children: no safety information exists at any dose.
• Whether it damages DNA: the laboratory tests came back positive once and negative on repeat, and the regulator concluded the positive signals cannot be dismissed.
• What the bone-turnover changes in six-month rats and the liver-cell changes in nine-month monkeys would mean for a person: nobody followed them up.
• Whether the immune system reacts to it when it is injected, which is the regulator's central safety concern and the one route never tested.
• What happens after six months, which is as long as any published study has run.
• What is in the vials sold online: the published chemical analyses are of material seized by police and customs, not of anything bought as a customer.
• Why the two head-counts for the whole trial programme disagree: the sponsor's own safety paper says 893 people in six trials to 2006, the parent company's 2013 statement says 925 to 2007.
• What the 24-week trial actually found in numbers: the efficacy results were never published in a scientific journal, and only a chart survives.

Does AOD-9604 work for weight loss?

Not in the trial designed to answer that question. 502 adults with obesity took it or dummy tablets daily for 24 weeks while following a supervised diet and exercise programme, and the two groups lost the same amount of weight — roughly 3 to 4 kilograms, most of which the dummy-tablet group lost too. The company that owned it announced the failure in February 2007 and shut the obesity programme down the same day.

Source [01]Source [07]

Is AOD-9604 FDA approved?

No, and the claim that it is comes from a misunderstanding worth spelling out. In June 2012 the company that owned AOD-9604 announced that it had obtained what it called a self-affirmed conditional GRAS status — Generally Recognised As Safe — for up to 1 milligram a day in food and drink. That determination was made by a panel of experts the company itself assembled. It was never submitted to the US regulator and never reviewed by it: a search of the regulator's public inventory of GRAS notices returns no entry for AOD-9604. GRAS is about a food ingredient's safety in any case, not about whether something works, and it says nothing about injecting anything.

Source [01]Source [08]Source [09]

Is AOD-9604 legal?

It is not an approved medicine in the EU, the United States, Australia or anywhere else, so it cannot legally be sold or advertised to the public as one. In the United States a pharmacy may only mix a medicine from a raw substance that appears in an official pharmacopeia, is part of an approved medicine, or sits on a list the regulator keeps — and on 4 December 2024 the regulator's advisory committee voted 12 to nothing against adding either form of AOD-9604 to that list. What is sold online is usually labelled for research use only.

Source [01]Source [02]Source [07]

What are the side effects of AOD-9604?

In the trials the commonest were headache, loose stools and wind, and they happened about as often in the people taking dummy tablets, which is why the sponsor describes the safety profile as indistinguishable from placebo. Five people in the 12-week study developed cancers or growths while taking it; the study doctor judged them unrelated and the US regulator said in 2024 that there is not enough information to be sure of that. The honest headline is that nothing is known about the form people actually buy: no published study has ever injected it under the skin or put it on the skin.

Source [01]Source [03]

AOD-9604 vs semaglutide — how do they compare?

They are not comparable, and that is the whole answer. Semaglutide is an approved weight-management medicine with published trials behind it and an official product information sheet listing what it does and what it costs you. AOD-9604 was tested against dummy tablets for 24 weeks in 502 adults with obesity and produced no measurable advantage, and its maker abandoned it in 2007. When the US regulator assessed AOD-9604 in 2024 it listed semaglutide among the approved medicines already available for the same condition.

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Is AOD-9604 the same as HGH fragment 176-191?

Effectively yes — they are two names for the same thing, and the numbers differ only because of where you start counting. AOD-9604 is the stretch of human growth hormone from position 177 to 191, with an extra tyrosine stuck on the front to make it more stable. Counting that added tyrosine as though it were position 176 gives you the name "fragment 176-191". Both names are printed on the WADA prohibited list side by side.

Source [03]Source [05]Source [10]

Is AOD-9604 banned in sport?

Yes, and at all times, in and out of competition. The 2026 prohibited list names it explicitly under growth hormone fragments, alongside the name hGH 176-191. Before it was named, it was already banned as a substance with no approval from any health authority anywhere, which the World Anti-Doping Agency stated publicly on 22 April 2013. A laboratory method for finding it in urine was published in 2015, so it is testable as well as banned.

Source [05]Source [06]Source [15]

Does AOD-9604 raise IGF-1 or cause the problems growth hormone causes?

It does not raise IGF-1, and that is its one solidly demonstrated property. Across 12 and 24 weeks of daily tablets there was no significant difference in IGF-1 between anyone taking it and anyone taking dummy tablets, and there was no worsening of blood sugar either. In the laboratory it does not attach to the growth hormone receptor and does not make cells multiply. The catch is that the same evidence is why it does not build anything: it is not a growth hormone booster, and it did not change body weight either.

Source [01]Source [03]Source [12]

Does AOD-9604 help joints, cartilage or injuries?

There is one study, and it is in rabbits. Thirty-two rabbits with chemically induced knee arthritis were injected in the joint weekly; the ones given AOD-9604 together with hyaluronic acid had less visible cartilage damage and limped for less time than the ones given either alone. No person has ever been given it for a joint problem in a published study. When the US regulator was asked in 2024 to approve it for arthritis and thinning bones, it declined to assess those uses because there was nothing to assess.

Source [01]Source [14]

Can you buy AOD-9604, and what is actually in the vial?

It is widely sold online as a powder labelled for research use only, and by wellness clinics and medical spas as an injection or a cream. Nobody has published an analysis of what a customer receives. The published chemical analyses of AOD-9604 preparations are of material seized by the Belgian authorities and confiscated in the United States, not of anything bought as a customer, and the US regulator stated in 2024 that no test for impurities, clumping, microbial contamination or bacterial toxins exists in the public domain for this substance.

Source [01]Source [15]Source [18]

Why do people inject it if the studies used tablets?

Because that is how it is sold, not because anybody showed it works better that way. All six trials used capsules, tablets or a drip into a vein, and pig studies showed the peptide is absorbed from the gut perfectly well. The injected and skin-cream forms exist because those were among the forms a compounding pharmacy and a peptide society asked the US regulator to allow pharmacies to make — and the regulator pointed out that not a single person in the published literature has ever received either.

Source [01]Source [04]

Each letter represents one amino acid.

1. [01]FDA briefing document, AOD-9604-related bulk drug substances (AOD-9604 free base and AOD-9604 acetate), Pharmacy Compounding Advisory Committee, 4 December 2024 (2024)
2. [02]Final summary minutes, Pharmacy Compounding Advisory Committee meeting of 4 December 2024 — AOD-9604 vote: 0 yes, 12 no (2024)
3. [03]Stier H, Vos E, Kenley D. Safety and Tolerability of the Hexadecapeptide AOD9604 in Humans. J Endocrinol Metab 2013;3(1-2):7-15 — the six trials, and the sequence YLRIVQCRSVEGSCGF (Tyr-hGH 177-191) (2013)
4. [04]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 — the animal toxicology and genotoxicity package (2014)
5. [05]WADA World Anti-Doping Code International Standard – Prohibited List 2026, section S2.2.3 (growth hormone fragments, "AOD-9604 and hGH 176-191") (2026)
6. [06]WADA statement on substance AOD-9604, 22 April 2013 (prohibited at all times under S0, non-approved substances) (2013)
7. [07]Calzada Limited announcement to the Australian Securities Exchange, AOD9604 — Important Clarifications, 26 April 2013 (obesity programme terminated February 2007; not approved by any health authority) (2013)
8. [08]Calzada Limited announcement to the Australian Securities Exchange, AOD9604 Receives GRAS Status, 25 June 2012 — "self-affirmed conditional GRAS status" from a company-convened expert panel (2012)
9. [09]FDA GRAS Notice Inventory — searchable public file of GRAS notices submitted since 1998; a search returns no entry for AOD9604
10. [10]UniProt P01241, human somatotropin — mature residues 177–191 are LRIVQCRSVEGSCGF, the chain AOD-9604 is cut from
11. [11]PubChem CID 71300630, AOD9604 — C78H123N23O23S2, 1815.1 g/mol, cyclised by a disulfide bond between the two cysteines
12. [12]Heffernan 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 2001;25:1442-9 (2001)
13. [13]Ng FM et al. Metabolic studies of a synthetic lipolytic domain (AOD9604) of human growth hormone. Horm Res 2000;53:274-8 (2000)
14. [14]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;45:426-32 — the only joint-repair evidence, in 32 rabbits (2015)
15. [15]Cox HD et al. Detection and in vitro metabolism of AOD9604. Drug Test Anal 2015;7:31-8 — urine detection method, limit 50 pg/mL (2015)
16. [16]Dominikowski et al., performance-enhancing peptides modulating the GH-IGF1 axis (Front Endocrinol 2026, free full text) — 24-week trial in 534 enrolled/502 randomised failed the primary weight-loss endpoint (2026)
17. [17]Heffernan MA et al. The effects of human GH and its lipolytic fragment (AOD9604) on lipid metabolism following chronic treatment in obese mice and beta(3)-AR knock-out mice. Endocrinology 2001;142(12):5182-9 — concludes the lipolytic actions are NOT mediated directly through the beta(3)-adrenergic receptor (2001)
18. [18]Vanhee and colleagues, identification and characterization of peptide drugs in unknown pharmaceutical preparations seized by the Belgian authorities: case report on AOD9604 (Drug Test Anal) (2014)