AOD-9604: what the trials show, status and safety

Summary

AOD-9604 is a lab-made piece of human growth hormone, designed to burn fat without acting like the hormone. Nine trials tested it in people. The largest, in 502 adults with obesity, missed its weight target, and the company ended the project in 2007. Three later pain trials failed too. No country has approved it, and the anti-doping list names it.

Key findings at a glance

• The biggest trial missed its target. In 502 randomised adults with obesity, over 24 weeks, AOD-9604 did not beat a dummy tablet on weight. The sponsor told the Australian stock exchange in 2007 that the results did not support the project, and closed it ^[1].
• Those weight figures have never been published. No journal has ever carried them. A 2026 review points out that the whole conclusion rests on what the sponsor announced, not on a peer-reviewed trial report ^[2].
• Three pain trials, three failures. Nerve pain missed by a wide margin (p = 0.67). Migraine came closest at two hours (p = 0.1488), and back and leg pain missed at all twelve time points (best p = 0.3983) ^[3], ^[4], ^[5].
• "GRAS" is not an approval. A consultancy hired by the company issued a conditional determination in 2012, for use as a food ingredient at up to 1 milligram a day by mouth. The FDA's own inventory of such notices holds no record of AOD-9604 ^[6], ^[7].
• Nobody has measured how long it lasts. In the only published human pharmacokinetics, neither the half-life nor the total exposure could be calculated, because too few blood samples stayed measurable ^[5].
• Named on the anti-doping list. Section S2.2.3 of the 2026 Prohibited List names AOD-9604, and German anti-doping law names it in its annex ^[8], ^[9].
• No trial ever injected it under the skin. All nine controlled studies in people used the mouth or a vein. That is not the route the grey market uses ^[2], ^[3], ^[10].

What it is

AOD-9604 is a synthetic peptide of sixteen building blocks, cut from the tail end of human growth hormone and closed by a small ring between its two cysteines ^[11]. It is not growth hormone, it does not release growth hormone, and the body does not make it. Metabolic Pharmaceuticals in Melbourne developed it with Monash University ^[6].

The grey-market name "fragment 176-191" is slightly wrong. The molecule is the stretch 177 to 191 plus one extra tyrosine at the front, which the makers added for stability and which formally occupies position 176 ^[10]. After the obesity project collapsed, the peptide was picked up again under the code LAT-8881 by Lateral Pharma, this time for pain ^[3].

Quick facts

How it works

The idea behind AOD-9604 was to keep the part of growth hormone that breaks down fat and throw away everything else. Whether that idea works in people has never been shown.

• It may act directly on fat cells. The proposal is that it speeds up the breakdown of stored fat and slows its build-up. The evidence for this comes from obese mice and rats, not from people ^[16], ^[17].
• It does not switch on the growth hormone receptor. That receptor only fires when two copies of it are pulled together by two separate contact points on the hormone. AOD-9604 overlaps part of the first contact point and lacks the second entirely. In laboratory tests it neither competed with growth hormone for the receptor nor made cells divide ^[16].
• The beta-3 receptor was tested and ruled out as the direct route. In obese mice, both growth hormone and AOD-9604 restored this receptor to normal levels. But in mice bred without it, the long-term weight and fat-breakdown effects vanished, so the authors concluded it is not the direct messenger ^[18].
• An enzyme of fat synthesis may be blocked. Inhibition of acetyl-CoA carboxylase has been proposed for this region of growth hormone. It has never been examined in people ^[10].
• Why it might relieve pain is unexplained. No mechanism was ever named for the pain work, and all three trials built on the idea came back negative ^[3], ^[4], ^[5].

This puts AOD-9604 in a different family from the peptides it is usually filed with. Tesamorelin, sermorelin, CJC-1295 and ipamorelin all prompt the pituitary gland to release the body's own growth hormone. AOD-9604 is a piece of that hormone, and it releases nothing ^[2].

What the trials found

Nine controlled trials in people are on record. Six were run by Metabolic Pharmaceuticals between 2001 and 2006, with 893 participants between them. Three were run by Lateral Pharma between 2019 and 2023 ^[3], ^[4], ^[5], ^[10]. Not one of them showed a benefit.

Weight in obesity

Phase 2b RCT The decisive trial enrolled 534 adults with obesity and randomised 502 of them, at sixteen Australian hospitals and centres. After a four-week run-in on dummy tablets, they took 0.25, 0.5 or 1 milligram of AOD-9604 or placebo daily for 24 weeks ^[10].

It missed its weight target. In 2007 the sponsor announced that the results did not support the commercial viability of the obesity project, and terminated the programme ^[1].

Phase 2b RCT The exact weight figures have never appeared anywhere. The safety paper published in 2013 deliberately reports none of them, and no journal has carried them since ^[10]. A 2026 review notes that the negative verdict therefore rests on what the sponsor said about its own trial, rather than on a peer-reviewed efficacy report ^[2].

Nerve pain

Phase 2a RCT Fifty-three adults with shingles nerve pain or diabetic nerve damage took 30 milligrams twice a day for four weeks ^[3]. Everyone received both the peptide and a dummy, in turn.

Pain scores fell by 0.87 points on the peptide (standard deviation 1.53) and by 0.74 on the dummy (standard deviation 2.09), on an eleven-point scale. The difference of 0.14 points was far too small to rule out chance (95 percent confidence interval -0.76 to 0.49; p = 0.67). Twenty people responded on the peptide, nineteen on the dummy.

Migraine

Phase 2 RCT Twenty-one adults treated a single migraine attack with two 30-milligram capsules, 60 milligrams in all, taken within the first hour of onset ^[4]. The design was again a cross-over. Headache scores were compared at seven points across 24 hours, and none showed a difference that could be separated from chance.

The closest was two hours in, at 0.89 points (confidence interval -2.11 to 0.32; p = 0.1488). After 24 hours, eleven participants were pain-free on the peptide and twelve on the dummy.

Back and leg pain

Phase 2 RCT Twenty-six people took part in a two-part study ^[5]. Its second half infused a single dose into a vein and followed pain for six hours.

All twelve time points came back negative. The best of them was a difference of 0.32 points (confidence interval -1.09 to 0.44; p = 0.3983). At the six-hour mark it was 0.15 points (p = 0.6892).

Growth hormone effects that never appeared

Phase 2b RCT The growth factor IGF-1, which rises when growth hormone acts, did not move. In the 24-week trial the average change was 1.76 nanomoles per litre at twelve weeks and 1.24 at 24 weeks. There was no difference between the groups (p = 0.50844 and p = 0.75754) ^[10].

Blood sugar held steady as well. Fasting glucose changed by -0.02 units at twelve weeks (p = 0.73488) and by 0.04 units at 24 weeks (p = 0.62787).

Phase 2b RCT No antibodies against AOD-9604 were found at any point. The 12-week trial tested everyone at the start and after four, eight and twelve weeks. The 24-week trial tested a subgroup, with the same result ^[10].

That matters only for swallowed doses. It says nothing about repeated injections, which is exactly the gap the FDA points to ^[19].

How long it stays in the body

Phase 1 In the first half of the back-pain study, healthy volunteers received single infusions of 0.8, 1.2 and 1.8 milligrams per kilogram into a vein ^[5]. Peak blood levels averaged 12.6, 10.2 and 13.8 nanograms per millilitre.

Higher doses did not produce higher peaks, and the spread between individuals was enormous. Some participants had no measurable level at all and were dropped from the analysis.

Neither the total exposure nor the terminal half-life could be worked out, because fewer than three measurable samples remained during the elimination phase ^[5]. Peak levels were reached after 0.08 hours, roughly five minutes.

Animal results

Animal data In animals the picture is the opposite, and consistently so. Obese Zucker rats given 500 micrograms per kilogram by mouth daily for nineteen days gained 15.8 grams (plus or minus 0.6), against 35.6 grams (plus or minus 0.8) in the controls. That is a reduction of more than half, with no loss of insulin sensitivity ^[17].

In obese mice, both growth hormone and AOD-9604 slowed weight gain, raised fat burning and increased the fat-breakdown marker glycerol. Only growth hormone pushed blood sugar up ^[16].

Animal data A separate line of work concerns joints. Thirty-two rabbits were given knee arthritis with two doses of 2 milligrams of collagenase per joint ^[20].

They were split into four groups, each injected weekly straight into the joint for four to seven weeks. The groups received 0.6 millilitres of saline, 6 milligrams of hyaluronic acid, 0.25 milligrams of AOD-9604, or the last two together.

At eight weeks both had improved the cartilage scores against saline, and the combination beat either alone. This is the entire basis of every joint claim made for the peptide, and there is no human counterpart.

What is still unknown

• Whether it does anything under the skin. Not one controlled trial has used that route, and it is the one the grey market uses ^[2], ^[10].
• Whether repeated injections provoke antibodies. The reassuring antibody data come from swallowed doses only ^[10], ^[19].
• How long it lasts. Neither half-life nor total exposure could be measured, even after infusion into a vein ^[5].
• What it actually did to weight. The efficacy figures from all six early trials remain unpublished ^[2], ^[10].
• Anything about joints in people. No trial has ever examined joints, cartilage, wound healing or connective tissue ^[20].
• What happens beyond 24 weeks. Nobody has taken it for longer, and no data exist for adolescents, pregnancy or breastfeeding ^[10].

Side effects and safety

Across 893 participants the peptide was hard to tell apart from a dummy tablet, which is the one genuinely reassuring finding here ^[10]. It applies to swallowed and infused doses for up to 24 weeks, and to material made under pharmaceutical conditions.

• Headache was the most common event nearly everywhere. After infusion into a vein it affected 16 of 23 volunteers, or 69.6 percent. Over 12 weeks of tablets it reached 42.6 percent, and over 24 weeks 25.9 percent, with no pattern by group ^[10].
• Stomach and bowel complaints affected 22.9 percent in the 24-week trial, diarrhoea 7.8 percent. Diarrhoea, wind and extra headaches clustered at the highest swallowed dose of 54 milligrams ^[10].
• Euphoria was reported by 5 of 23 volunteers after infusion, mild to moderate, and only while they were on the peptide. Nobody reported it on the dummy ^[10].
• Infections such as colds affected 46.8 percent over 24 weeks, which the authors attribute to the length of the observation period ^[10].
• Low blood sugar was noted three times among the 15 volunteers in the first infusion study ^[10].

Two findings need stating plainly rather than in a list.

Five cancers in the twelve-week trial. Three occurred in the 20-milligram group: a basal cell carcinoma, a lipoma and a squamous cell carcinoma. One occurred in the 5-milligram group (breast cancer) and one in the 10-milligram group (a melanoma) ^[10]. The investigator classed none as treatment-related.

The sponsor's reasoning was that the highest dose group had no cases at all. It also noted that three of the five were skin cancers in Australia, and that obesity itself raises cancer risk. That reasoning has never been checked independently.

The FDA's position. The agency lists AOD-9604 among bulk substances "nominated but withdrawn" for compounding, on its page of substances that may present significant safety risks ^[19].

Compounded preparations containing it "may pose significant risk for immunogenicity for certain routes of administration", it writes. It "has also identified serious adverse events that may be associated with AOD-9604, though causality is not clear". It names neither the events nor their number.

In 2022 the agency wrote to a compounding pharmacy over AOD-9604 prepared for injection under the skin or into muscle. The complaint was that nothing assured it was sterile ^[21].

There are no contraindications, no interaction warnings and no restrictions on file, because no authority has ever reviewed a product label for it ^[7]. Women able to bear children were excluded from the first four trials altogether ^[10].

Doses used in studies

The doses below are simply what the cited studies gave, listed so that the results can be understood. They are not advice on how to use anything.

Every dose ever given to a person was swallowed or infused into a vein, in a trial, under supervision. No controlled study has injected AOD-9604 under the skin. That is the route grey-market regimens describe: 250 to 500 micrograms a day, split across two or three injections, in blocks of eight to twelve weeks ^[2].

Animal doses in milligrams per kilogram cannot be scaled up to people. The 2012 food determination covers up to 1 milligram a day by mouth ^[6].

Development and approval status

• 2000 to 2001 — the fat-burning effect is described in obese mice and rats ^[16], ^[17].
• 2002 — a contemporary review records that mid-stage trials in obesity are running ^[23].
• 2007 — the 24-week trial misses its weight target and the obesity programme is terminated ^[1].
• 2012 — a consultancy hired by the company issues a conditional food-ingredient determination ^[6].
• 2019 to 2023 — three pain trials under the code LAT-8881 all miss their targets ^[3], ^[4], ^[5].
• 2022 — the FDA writes to a compounding pharmacy over injectable preparations ^[21].
• 2026 — the substance stands named on the anti-doping list, in German anti-doping law and in the Australian Poisons Standard ^[8], ^[9], ^[15].

Every register query behind this table was run on 10 September 2026.

Australia is the strictest case on record. The Poisons Standard of June 2026 lists AOD-9604 as prescription-only. It then lists it a second time in an appendix headed with the rule that possessing these substances without authority is illegal ^[15].

It appears there as item 3, directly after the anabolic steroids. The oddity is that no AOD-9604 product has ever been licensed in Australia, so a prescription for it cannot realistically be written.

The 2012 food determination deserves the same precision. The company hired the consultancy GRAS Associates, whose expert panel reviewed the company's own safety data. The panel called the peptide generally recognised as safe for food use, conditionally, at up to 1 milligram per person per day ^[6].

The FDA neither reviewed nor confirmed this, and its inventory of such notices returns no record ^[7]. In the European Union the category does not exist at all, and novel food ingredients require an authorisation there.

Switzerland has acted against this family of products. On 22 June 2026 customs, the medicines agency and the anti-doping agency jointly checked 46 consignments and held 23 back, 21 of them classed as doping material ^[25].

Anti-doping

AOD-9604 is banned in sport at all times, in and out of competition. It counts as a non-specified substance, the stricter of the two categories. Section S2.2.3 of the 2026 Prohibited List names "growth hormone fragments, e.g. AOD-9604 and hGH 176-191" ^[8].

Both labels appear in the same line, so a product sold under either name is caught. German anti-doping law lists the same two names in its annex, which brings criminal and administrative penalties into play ^[9].

Detection is routine. A validated method finds AOD-9604 in urine down to 50 picograms per millilitre. One of its breakdown products proved considerably more stable than the peptide itself, which widens the window in which a sample still shows it ^[26].

It also appears in a screen for small peptides run by direct injection of urine ^[27]. A 2026 workflow covers it among 54 banned substances in dried blood, serum and plasma ^[28]. One point is easy to get wrong: the standard growth hormone test does not pick AOD-9604 up, so laboratories run a separate method for it ^[29].

The wider picture for this family is at peptides banned in sport.

Compared with related peptides

Three things stand out. AOD-9604 sits one section higher on the banned list than the releasing peptides, because it is a piece of the hormone rather than something that triggers it ^[8].

It is also the only entry here that has been through a full mid-stage programme in people and come out with nothing to show. That is a stronger statement than the untested status of ipamorelin or CJC-1295 ^[1], ^[10].

And the row that matters most is the last one. Semaglutide belongs to a different hormone family, has an approval and is not banned in sport ^[8], ^[30]. Whatever AOD-9604 was meant to be, it is not a version of that.

Common misconceptions

• "It works like growth hormone on fat." It is less than a twelfth of the hormone, and the receptor needs two contact points it does not have. In the laboratory it did not bind, and in people the growth factor IGF-1 never rose over 24 weeks (p = 0.75754) ^[10], ^[16].
• "It has GRAS status, so the FDA cleared it." The determination came from a panel the company hired, was explicitly conditional, and covered food at up to 1 milligram a day by mouth. The FDA's inventory holds no record, and the agency has objected to the injectable form ^[6], ^[7], ^[21].
• "Fragment 176-191 and AOD-9604 are the same molecule." Not quite. AOD-9604 carries an extra tyrosine that the plain fragment lacks, which is why two different registry numbers circulate. In grey-market goods it is anyone's guess which of the two is inside ^[10], ^[15].
• "If it counts as a food ingredient, it cannot be doping." Food law and sport law are separate systems. The 2026 Prohibited List names it, German law names it, and Australia bans possession without a permit ^[8], ^[9], ^[15].
• "It is a growth hormone secretagogue like ipamorelin." It is not, and even the specialist literature gets this wrong. A 2026 orthopaedic review files it among secretagogues said to switch on IGF-1 signalling, when 24 weeks of dosing moved IGF-1 not at all ^[10], ^[31].
• "It has hardly been studied, so the question is open." The opposite. Nine controlled trials, one of them with 502 randomised participants, and three modern ones with results filed publicly. The question was asked properly and the answer came back negative every time ^[3], ^[4], ^[5], ^[10].
• "The half-life is known, so the injection timing follows from it." No half-life exists. It could not be calculated even after infusion into a vein, and peak levels did not rise with the dose ^[5].
• "What is sold under this name is the trial substance." Belgian authorities seized preparations that had to be identified in a laboratory before anyone knew what they held ^[32]. Vials confiscated in the United States contained the peptide, which is also advertised on numerous websites ^[26]. Reviews describe mislabelled and contaminated goods across this whole supply chain ^[33], ^[34].

Frequently asked questions

Is AOD-9604 approved anywhere?

No. No country has licensed it as a medicine, for any condition. Register searches in the United States, the European Union, the United Kingdom, Canada, Australia and Switzerland were run on 10 September 2026 and came back empty. Australia goes further than the others and makes possessing it without a permit an offence.

What is AOD-9604?

It is a lab-made peptide of sixteen building blocks, copied from the tail end of human growth hormone. An extra tyrosine at the front makes it more stable. Metabolic Pharmaceuticals in Melbourne developed it with Monash University, and the body does not make it.

Did AOD-9604 work in the trials?

No, not once. The largest trial randomised 502 adults with obesity and ran for 24 weeks, and it missed its weight target. Three later trials in nerve pain, migraine and back pain missed theirs as well, the closest being a p value of 0.1488 two hours into a migraine attack.

Does AOD-9604 have GRAS status from the FDA?

No. In 2012 the company paid a private consultancy. Its expert panel called AOD-9604 generally recognised as safe, conditionally, for use as a food ingredient at up to 1 milligram a day by mouth. The FDA was not involved, and its inventory of such notices returns no record for AOD-9604.

What are the known side effects of AOD-9604?

Headache was the most common in almost every trial, in 16 of 23 volunteers after infusion into a vein. Diarrhoea, wind and nausea followed at the highest doses swallowed. Five participants in the 12-week trial developed cancers, which the sponsor judged unrelated. The FDA states that it has identified serious adverse events whose cause is unclear.

How long does AOD-9604 stay in the body?

Nobody knows. In the only published human pharmacokinetic study, the half-life could not be calculated at all, because too few measurable blood samples remained once levels started to fall. Peak levels did not rise with the dose either. Any figure quoted online for a half-life is invented.

Is AOD-9604 banned in sport?

Yes, at all times, in and out of competition. Section S2.2.3 of the 2026 Prohibited List names it, and it names the alternative label hGH 176-191 in the same line. German anti-doping law lists it by name too. Laboratories detect it down to 50 picograms per millilitre of urine.

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

Almost, but not quite. AOD-9604 is the stretch 177 to 191 of growth hormone plus one added tyrosine, which formally sits in position 176 and gave the shorter label its name. Two different registry numbers circulate as a result. For anti-doping purposes the distinction makes no difference, since both names are listed.

Does AOD-9604 help joints or cartilage?

There is no evidence in people. The claim rests on a single study in 32 rabbits with artificially induced knee arthritis, injected weekly straight into the joint under ultrasound guidance. No human trial has ever looked at joints, cartilage or wound healing.

Why does this page list AOD-9604 doses?

Because they are facts from the published trials and registry records, and the results cannot be read without them. The point worth noticing is the route: every dose ever given to a person was swallowed or infused into a vein. No controlled trial has injected AOD-9604 under the skin.

Cite this page

The facts on this page were checked on 10 September 2026, and every register search behind the status table was run on that date. Nobody is developing AOD-9604 any more, so the regulatory and anti-doping entries are the parts most likely to change.

myPeptides Research & Editing. (2026). AOD-9604: what the trials show, status and safety. Version 1.0, 10 September 2026. myPeptides Peptide Register. Retrieved from https://mypep.app/peptides/aod-9604

How pages in this register are compiled and graded is described under methodology; the full register is at peptides.

Last verified: 10 September 2026. Next review: on any publication of the unreleased efficacy data, on any change in the FDA compounding lists, or on any change in the anti-doping or Poisons Standard classification.