AOD-9604: Trial Results, Safety, Legal Status and Risks (2026)

Quick answers

What is it?: A lab-made chain of 16 amino acids: the tail end of human growth hormone plus one extra amino acid¹. An Australian company developed it as a weight-loss pill in the late 1990s and 2000s¹². It is not an approved medicine¹³.
Does it work?: No. In the largest trial, 502 adults with obesity took a daily pill or placebo; weight loss was not clearly better on the pill¹². The company then dropped it as an obesity drug¹. FDA found no human studies of shots under the skin¹.
Is it safe?: Not well tested. Company trials in nearly 900 people found side effects similar to placebo². But four people taking it in one 12-week trial were diagnosed with cancer; FDA cannot rule out a link¹². Shots under the skin have no human safety data¹.
Is it legal?: It is not an approved drug, and US pharmacies may not make it¹⁴. In 2024, FDA’s advisers voted 12-0 against letting pharmacies use it⁵. In Australia it is illegal to have without a prescription⁶. It is banned in sport at all times⁷⁸.
What is in the vials?: Unknown. Finnrick, a testing service, had published no AOD-9604 results as of 5 October 2026⁹. Two of three supplier certificates sent to FDA lacked tests for impurities, germs and bacterial toxins¹. In 2020 and 2021, two US firms recalled AOD-9604 vials over sterility doubts¹⁰.

What it is

AOD-9604 is a lab-made peptide of 16 amino acids. It copies the last 15 amino acids of human growth hormone (positions 177 to 191) and adds one tyrosine at the front; its two cysteines are joined by a sulfur-sulfur (disulfide) bridge that closes part of the chain into a loop¹². A 2026 review expands the name as ‘anti-obesity drug 9604’¹¹, and some clinic websites call it ‘advanced obesity drug’¹. It was designed to keep growth hormone’s fat-reducing action without its effects on growth and blood sugar²³. In cell tests it did not bind the growth hormone receptor or make receptor-bearing cells multiply¹². In obese rats and mice it slowed weight gain and increased fat breakdown and fat burning without raising blood sugar or reducing insulin sensitivity¹²¹³. In mice lacking the beta-3 adrenergic receptor, a fat-cell receptor that triggers fat breakdown, long-term treatment no longer changed body weight¹⁴. FDA reads this as the effect depending at least partly on that receptor, and concluded in 2024 that the molecular target and mechanism remain unknown¹. In the company’s human trials it did not change blood levels of IGF-1 (insulin-like growth factor 1), a hormone that growth hormone raises². A 2026 orthopedic review nonetheless grouped it with growth hormone boosters said to ‘activate IGF-1 signaling’¹⁵; the trial data do not support that².

Researchers reported in 1993 that a synthetic copy of growth hormone’s positions 177 to 191 blocked fat building in rat fat tissue, and in 1994 that it cut weight gain and fat mass in obese mice¹⁶¹⁷. Metabolic Pharmaceuticals, an Australian company, developed and patented AOD-9604 in the late 1990s¹, and by February 2002 it was in early (phase IIa) trials for obesity¹⁸. From 2001 to 2006 the company ran six trials in 893 adults, most with obesity², and a 2006 review still listed it among obesity drugs in clinical development¹⁹. On 21 February 2007 the company announced that its largest trial did ‘not support the commercial viability of the drug as a treatment for obesity’ and ended development for that use¹. In 2012 Metabolic, a wholly owned subsidiary of Calzada, named bone, cartilage and muscle disease as other possible uses, said AOD-9604 was a key ingredient of another company’s cosmetic anti-cellulite cream, and announced a ‘self-affirmed conditional GRAS status’ for use in foods at up to 1 mg per person per day²⁰. GRAS means ‘generally recognized as safe’. Self-affirmed means FDA did not review it: the company hired a consulting firm for an independent safety review, and a panel of US experts made the determination²²⁰. The condition was publication of the safety studies in a peer-reviewed journal²⁰²¹, which company-linked authors did in 2013 and 2014²²¹. FDA’s inventory of GRAS notices showed no AOD-9604 notice when we searched it on 5 October 2026²².

Benefits: what the research shows

Every human trial FDA found in its 2024 review was run by the developer: six trials from 2001 to 2006 in 893 adults, most with obesity¹². Only their safety results were published in a journal, by authors tied to the company². Efficacy results are known from company announcements, a 2005 meeting abstract and a 2004 summary, as reviewed by FDA in 2024¹. The largest trial, OPTIONS (which FDA matches to trial METAOD006), randomized 502 adults with obesity to 0.25, 0.5 or 1 mg a day by mouth or placebo for 24 weeks, alongside a supervised diet and exercise program¹². It was designed to detect a 1.8 kg difference from placebo at 12 weeks, but weight loss versus placebo at 12 and 24 weeks was too small to reach statistical significance, and the company ended development for obesity in 2007¹. An earlier 12-week trial in 300 adults (1 to 30 mg a day) reported weight loss of 0.22 kg a week on 1 mg versus 0.07 kg on placebo, with the 1 mg effect called ‘significant’ for women, smaller waists at all doses and no steady dose-response¹. FDA said the differences were small and of unclear clinical meaning, and that the abstract gave too little detail to judge¹. Three small early trials found no significant weight loss versus placebo¹. A 2026 review notes that the negative verdict rests on sponsor-reported results rather than peer-reviewed efficacy papers³. FDA concluded there is ‘a lack of evidence to support the effectiveness’ of AOD-9604 for obesity by any route¹. In trials, people have only taken it as pills or as single IV infusions². FDA found no human data on injection under the skin, a main form sold today, or on creams¹. ClinicalTrials.gov listed no AOD-9604 studies when searched on 5 October 2026²⁵. Fat-loss effects are shown mainly in obese rats and mice¹²¹³¹⁴. Claims for joints and cartilage rest on one rabbit study, in which weekly knee injections improved cartilage scores after arthritis was induced with an enzyme, most when combined with hyaluronic acid²⁶; a 2026 review found no convincing human evidence for these uses³.

Key human studies

Study	Design	People	Dose and route	Result
Metabolic Pharmaceuticals, OPTIONS trial (matched by FDA to METAOD006): results announced 21 February 2007, not published in a journal; as summarized by FDA in 2024. Safety data in Stier H, Vos E, Kenley D. Safety and Tolerability of the Hexadecapeptide AOD9604 in Humans. J Endocrinol Metab 2013;3(1-2):7-15¹Source	Randomized, double-blind, placebo-controlled trial at 16 Australian hospitals and medical centers in adults aged 18 to 65 with a BMI of 30 to 45; 4-week placebo run-in, then 24 weeks of treatment alongside a dietitian-supervised diet and exercise program; 4-week follow-up	502	0.25, 0.5 or 1 mg by mouth (tablets) once daily, or placebo	Weight loss versus placebo at 12 weeks (the primary endpoint) and at 24 weeks was too small to reach statistical significance; the trial was powered to detect a 1.8 kg difference, and the company ended development for obesity¹. During treatment 78.7% had at least one adverse event. Serious adverse events: 8 of 125 on placebo, 3 of 127 on 0.25 mg, 1 of 125 on 0.5 mg and 6 of 125 on 1 mg (18 of 502, 3.6%). IGF-1 did not differ from placebo, and no antibodies against the drug were found in the people tested².
Herd et al. 2005, scientific meeting abstract (matched by FDA to METAOD005), as summarized by FDA in 2024. Safety data in Stier H, Vos E, Kenley D. Safety and Tolerability of the Hexadecapeptide AOD9604 in Humans. J Endocrinol Metab 2013;3(1-2):7-15¹Source	Randomized, double-blind, placebo-controlled trial at 5 Australian hospitals in men and women aged 30 to 65 with a BMI of 35 or more; 2-week placebo run-in, then 12 weeks of treatment	300	1, 5, 10, 20 or 30 mg by mouth (capsules) once daily, or placebo (50 per group)	The abstract reported weight loss of 0.22 kg a week on 1 mg, 0.13 kg on 20 mg and 0.15 kg on 30 mg versus 0.07 kg on placebo, with the 1 mg effect called ‘significant’ for women. FDA called the differences small and found no full publication¹. During treatment 88.9% had at least one adverse event, similar across groups. Five people had serious adverse events: basal cell carcinoma, lipoma and squamous cell carcinoma (20 mg), breast cancer (5 mg) and malignant melanoma (10 mg). The investigator judged none related²; FDA said the information is insufficient to tell¹.
Stier H, Vos E, Kenley D. Safety and Tolerability of the Hexadecapeptide AOD9604 in Humans. J Endocrinol Metab 2013;3(1-2):7-15 (trial METAOD004)²DOI	Randomized, double-blind, placebo-controlled, dose-escalation trial in men aged 18 to 54 with a BMI of 30 or more; 7 days of dosing and 7 days of follow-up	36	9, 27 or 54 mg by mouth (capsules) daily for 7 days, or placebo (9 per group)	207 adverse events, all but one mild or moderate, and no serious ones; headache, diarrhea and flatulence were more common at 54 mg. IGF-1, glucose and insulin did not change². A 2004 summary reported 1 kg of weight loss over the week at the lowest dose versus 0.6 kg on placebo, and no statistically significant weight loss in the early trials¹.
Stier H, Vos E, Kenley D. Safety and Tolerability of the Hexadecapeptide AOD9604 in Humans. J Endocrinol Metab 2013;3(1-2):7-15 (trial METAOD003)²DOI	Double-blind, placebo-controlled, 4-period crossover (Latin square) trial in men aged 35 to 54 with a BMI of 35 or more; single doses 2 weeks apart	17	Single doses of 9, 27 and 54 mg by mouth (capsules) and placebo	15 of 17 completed; 97 adverse events. Two serious events at 54 mg: diarrhea, judged possibly related, and bronchial pneumonia, judged unrelated². No significant weight loss versus placebo¹.
Stier H, Vos E, Kenley D. Safety and Tolerability of the Hexadecapeptide AOD9604 in Humans. J Endocrinol Metab 2013;3(1-2):7-15 (trial METAOD002)²DOI	Double-blind, placebo-controlled, 4-period crossover (Latin square) trial in men aged 19 to 50 with a BMI of 35 or more; single 20-minute IV infusions 7 days apart	23	25, 50 and 100 µg/kg IV and placebo, one dose per period	118 adverse events and no serious ones; headache in 16 of 23. One severe chest tightness at 50 µg/kg was judged possibly related, and 5 of 23 reported mild or moderate euphoria during drug periods but none on placebo. Glucose and IGF-1 did not change significantly². Weight change did not differ significantly from placebo¹.
Stier H, Vos E, Kenley D. Safety and Tolerability of the Hexadecapeptide AOD9604 in Humans. J Endocrinol Metab 2013;3(1-2):7-15 (trial METAOD001)²DOI	Double-blind, placebo-controlled, dose-escalation safety trial in healthy men with a BMI of 24 to 30; three doses and placebo per person, 7 days apart, with growth hormone given as a comparison	15	Single 20-minute IV infusions of 25 to 400 µg/kg	14 of 15 completed. 29 adverse events in 12 men, none serious or severe; the safety profile was comparable with growth hormone and placebo².

Doses studied

Doses below are what studies used or what a label says. They are not advice, and gray-market products may not contain what their label says.

In human studies

Single 20-minute IV infusions of 25 to 400 µg/kg in healthy men, and 25, 50 and 100 µg/kg in men with obesity². By mouth: single doses of 9, 27 and 54 mg; 9, 27 or 54 mg daily for 7 days; 1, 5, 10, 20 or 30 mg daily for 12 weeks; and 0.25, 0.5 or 1 mg daily for 24 weeks². The company’s 2012 food-ingredient determination covered up to 1 mg per person per day²⁰. No dose has been studied in humans for injection under the skin, a main form sold, or for skin creams¹.

In animal studies

Obese Zucker rats: 500 µg/kg a day by mouth for 19 days¹³. Obese mice: 250 µg/kg a day for 14 days, by pump under the skin or by injection into the abdomen¹. Rabbits with enzyme-induced knee arthritis: 0.25 mg injected into the knee once a week in weeks 4 to 7²⁶. Toxicity studies: 0.1, 1 or 10 mg/kg a day IV for 4 weeks in rats; 0.5, 20 or 100 mg/kg a day by mouth for 26 weeks in rats; and 0.5, 10 or 50 mg/kg a day by mouth for 9 months in monkeys¹²¹. Pig absorption study: 400 µg/kg IV and 2 mg/kg by mouth¹²¹. These are animal research doses, not human doses.

What users report Anecdotal · not validated · not a recommendation

One community reference page lists 250 to 500 µg (micrograms) once a day⁴⁰. A 2026 medical review describes bodybuilding-forum reports of 250 to 500 µg a day, split into 2 or 3 doses³.

Half-life: About 3 minutes in pigs after an IV dose; unknown in humans²¹Animal and lab data only. In pigs given 400 µg/kg into a vein, blood levels peaked at 2 minutes and fell with a half-life of about 3 minutes¹²¹. In rat plasma (the liquid part of blood) kept at room temperature in a test tube, the half-life was about 4 minutes; the peptide was trimmed from its front end and gone by 56 minutes²¹. In lab tests in serum, one breakdown product (CRSVEGSCG) was more stable than the parent peptide and its other breakdown products³⁷. Oral doses in pigs gave blood levels that implied an impossible 170% absorption, so FDA called oral absorption unclear even in animals¹. FDA found no human data on absorption or clearance by any route¹.
Routes: By mouth (capsules, tablets): human trials up to 24 weeks
Into a vein (IV infusion): single doses in two small human trials
Injection under the skin: a main form sold by clinics and online; no human data found
Troches and dissolving tablets: marketed by clinics; no study of these forms found
Skin cream (transdermal): proposed for compounding and used in a cosmetic anti-cellulite cream; no human data found
Injection into a muscle: on the label of a recalled compounded product; no human data found
Injection into the knee joint: one rabbit study
Pump under the skin or injection into the abdominal cavity: mouse studies only

Every dose studied for AOD-9604, with sources →

Legal status

United States: Not approved by FDA for any use, and not a component of any FDA-approved drug; there is no USP or NF monograph¹. FDA found it marketed by wellness clinics, medical spas and concierge services as injections, capsules, tablets, troches and dissolving tablets, sometimes mixed with other drugs¹. In July 2021 a Texas compounder recalled 1,316 vials of compounded AOD-9604 for injection, distributed nationwide, over a lack of sterility assurance, and an Indiana firm had recalled 3 vials for the same reason in November 2020¹⁰. FDA’s 2022 warning letter to the Texas firm cited insanitary conditions, including household dish detergent used to clean glassware for sterile injections²⁸. The developer’s 2012 ‘self-affirmed conditional GRAS’ claim covered use as a food ingredient, not as a drug²⁰, and FDA’s GRAS notice inventory showed no AOD-9604 notice on 5 October 2026²². As of 25 September 2026, AOD-9604 was not listed as a federally controlled substance²⁹.
US pharmacies: Section 503A of federal drug law covers compounding by pharmacies for individual patients. FDA placed AOD-9604 in Category 2 of its interim 503A categories list, substances that raise significant safety risks, on 29 September 2023³⁰. Both nominators withdrew their nominations in September 2024³¹³². FDA staff then reviewed the free base and the acetate salt on the agency’s own initiative and on 5 November 2024 proposed not adding either to the 503A bulks list, the list of substances pharmacies may use, citing poor chemical characterization, missing bacterial endotoxin testing for injections, no evidence of effectiveness and limited safety data¹. On 4 December 2024 the Pharmacy Compounding Advisory Committee (PCAC) voted 0 to 12 on adding them, with no abstentions⁵. FDA’s safety-risk page (current as of 22 April 2026) lists AOD-9604 among substances ‘nominated but withdrawn’ that were previously in Category 2²⁷. It says compounded AOD-9604 ‘may pose significant risk for immunogenicity’ (unwanted immune reactions) for some routes and that FDA ‘lacks sufficient information to know whether the drug would cause harm’²⁷. AOD-9604 is in no category of the interim list as updated on 14 May 2026⁴, so US pharmacies cannot lawfully compound it under section 503A. No 503B outsourcing facility (a larger compounder registered with FDA) reported AOD-9604 products from 2017 to 2023¹.
Other countries: Australia: the Poisons Standard in force from 1 October 2026 lists AOD-9604 as a Schedule 4 (prescription only) poison and in Appendix D clause 5, which makes possession without authority illegal⁶. FDA’s 2024 review notes that Australia’s medicines scheduling committee had earlier added it to the Poisons Standard as a performance and image enhancing drug¹. Canada: Health Canada says peptides are generally regulated as prescription drugs and, on 9 April 2026, said ‘research use only’ labels do not make such products legal³³. In an August 2025 notice it listed AOD9604 among unauthorized injectable peptides seized from an online seller, noting that selling unauthorized drugs is illegal in Canada³⁴, and a December 2025 notice listed an AOD-9604 product among items seized from a Vancouver fitness business³⁵. UK: the MHRA has said it disregards ‘research purposes’ claims used to get around medicines rules (reported 4 April 2026)³⁶; AOD-9604’s specific UK status was not verified. Elsewhere: a 2026 medical review says no major regulatory agency has approved it for any use³, and FDA found no monograph for it in the European, Chinese, Indian or Japanese pharmacopoeias¹. EU and New Zealand legal status: not verified.
Sport: Prohibited at all times, in and out of competition. The 2026 WADA Prohibited List names AOD-9604 as an example of a growth hormone fragment in class S2.2.3, next to hGH 176-191⁷. Like everything in class S2, it is a non-Specified substance: it is not among the substances WADA considers more likely to be taken for reasons other than sport performance⁷. The 2027 List (published 21 September 2026, in force 1 January 2027) keeps the same wording⁸. FDA’s 2024 review recounts that an Australian Crime Commission report listed it among peptides supplied to athletes, that football players admitted using it, and that unlabeled vials containing it were obtained from German and Belgian elite athletes¹. A urine test with a detection limit of 50 pg/mL was published in 2015; the same paper notes AOD-9604 was found in vials confiscated in the US³⁷. Belgian authorities identified it in seized unknown preparations³⁸, and a 2013 study found it does not interfere with WADA’s growth hormone isoform test³⁹.

AOD-9604 in the legal tracker →

Quality and the gray market

What testing finds

No independent purity tests were found. Finnrick, a service that publishes lab results for peptide samples, listed AOD-9604 on 5 October 2026 but showed ‘No published AOD-9604 tests yet’⁹. FDA concluded in 2024 that AOD-9604 is not well characterized¹. Supplier certificates of analysis sent with the nominations lacked key tests: two had no results for impurities, aggregates (clumped peptide), microbes or bacterial endotoxins, and a third had none for aggregates or microbes¹. One nomination named the free base but attached a certificate for the acetate salt that gave the free base’s CAS number, formula and weight, and some suppliers’ websites show a structure that does not match the sequence¹. The disulfide bridge can break, or link molecules into pairs and clumps; FDA says it cannot rule out immune reactions to such impurities¹. Two US recalls of AOD-9604 vials cited a lack of sterility assurance: 3 vials from an Indiana firm in November 2020 and 1,316 compounded vials from a Texas firm, distributed nationwide, in July 2021¹⁰. Belgian authorities identified AOD-9604 in seized unknown preparations³⁸.

How it is sold

US wellness clinics, medical spas and concierge services sell it as injections, capsules, tablets, troches and dissolving tablets¹. FDA found clinic products such as a 600 µg/mL 10 mL vial, a 1 mg capsule and a 250 µg dissolving tablet, a compounding pharmacy offering a 1,000 µg/mL injectable vial, and blends: with aminophylline, glycyrrhizic acid and N-acetyl BPC-157 for injection, and with topiramate, naltrexone and MIC (methionine, inositol and choline) by mouth¹. Clinics often promote it with BPC-157 for cartilage and bone repair, and in 2024 one clinic website said the peptide was ‘no longer available due to it being placed on the FDA’s list’¹. Online shops sell it in vials labeled for research only: on 5 October 2026 a 5 mg vial was fourth of 104 products on one US research-peptide shop’s popularity-sorted list, at $41, and the shop says its products are ‘not for human consumption’⁴¹. Health Canada’s 2025 notices list AOD-9604 products among those seized from online sellers³⁴³⁵. A 2026 medical review covers it among unregulated peptides marketed as ‘research compounds’ and used without medical supervision³.

Side effects and risks

No proven benefit: in the largest trial, weight loss did not differ significantly from placebo¹.
Untested route: FDA found no human data for injection under the skin, a main form sold, or for creams¹.
Possible cancer signal: basal cell and squamous cell skin cancers, a melanoma and a breast cancer were reported in four people taking it in one 12-week trial². The investigator judged them unrelated², but FDA says the information is insufficient to decide¹.
Immune reactions: FDA says the peptide, its impurities or clumps could provoke immune responses, especially when injected under the skin, and that it lacks the data to rule this out¹²⁷. Pill trials found no antibodies against it in the people tested².
Animal warning signs: FDA reads a dose-related shift in a bone-turnover marker in rats, liver-cell changes in monkeys and equivocal gene-damage tests as possible safety signals¹. The company-funded authors who reported these studies saw no evidence of gene damage and did not attribute the liver findings to the drug²¹.
Side effects in trials: headache was the most common; diarrhea and flatulence were more frequent at high oral doses; one IV trial reported euphoria in 5 of 23 men and one severe chest tightness judged possibly related².
Contamination and sterility: two US recalls of AOD-9604 vials cited a lack of sterility assurance, and FDA found supplier certificates without tests for microbes or bacterial endotoxins¹¹⁰. Health Canada warns that unauthorized injectable peptides can cause infections and allergic reactions and may contain contaminants³⁴.
No long-term data: the longest human use studied was 24 weeks of pills, and FDA says there is not enough information to support long-term safety¹².
Legal risk: possession without a prescription is illegal in Australia, and selling unauthorized drugs is illegal in Canada⁶³⁴.
Anti-doping: banned at all times for tested athletes, and a urine test exists⁷³⁷.

Documented harms

Apr 2013Published company data on a 12-week trial of daily pills (METAOD005): five people had serious adverse events, namely basal cell carcinoma, lipoma and squamous cell carcinoma at 20 mg, breast cancer at 5 mg and malignant melanoma at 10 mg². The investigator judged none related²; FDA said in 2024 that the information is insufficient to tell¹.
Apr 2013In a single-dose pill trial (METAOD003), one man had serious diarrhea at 54 mg, judged possibly related, and another had bronchial pneumonia, judged unrelated². In a single-dose IV trial (METAOD002), one man had severe chest tightness at 50 µg/kg, judged possibly related, and 5 of 23 reported euphoria during drug periods².
30 Nov 2020An Indiana firm began a voluntary Class II recall of 3 vials of AOD-9604 (1,200 µg/mL, 5 mL), shipped to 7 states, because its production processes could not assure sterility¹⁰.
9 Jul 2021A Texas compounder began a voluntary Class II recall of 1,316 vials of compounded AOD-9604, 3 mg, for injection under the skin or into a muscle, distributed nationwide, for lack of sterility assurance¹⁰. FDA’s 2022 warning letter cited insanitary conditions at the firm²⁸.
5 Nov 2024FDA’s review found no adverse event reports for AOD-9604 in FAERS, its drug adverse event database, through 7 January 2024, none in CAERS (foods, supplements and cosmetics) from 1 January 2004 to 3 April 2024, and no published case reports; FDA said the lack of reports ‘does not imply that the substance is safe’¹.
1 Aug 2025Health Canada warned that unauthorized injectable peptides seized from an online seller, including AOD9604, may cause infection, allergic reactions and other poor outcomes, and may contain contaminants³⁴.
24 Dec 2025Health Canada warned about unauthorized products seized from a Vancouver fitness business and sold online, including an AOD-9604 product³⁵.
30 Jul 2026An openFDA search of FAERS (data as of the 30 July 2026 update) found no reports listing a drug name that begins with ‘AOD’⁴².

Questions people ask

Is AOD-9604 FDA approved?

No. FDA has not approved it for any use, and it is not part of any approved drug¹. US pharmacies may not compound it either⁴.

Does AOD-9604 work for weight loss?

The human evidence says no. In its developer’s largest trial, of 502 adults, weight loss did not differ significantly from placebo at 12 or 24 weeks, and development for obesity stopped in 2007¹. Fat-loss effects have been shown mainly in obese rats and mice¹²¹³.

Is AOD-9604 safe?

Company trials in nearly 900 people, mostly with pills, reported side effects similar to placebo². FDA still found too little information to judge its safety, including cancers reported in one trial, and no human data at all for shots under the skin¹.

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

Nearly. AOD-9604 is growth hormone’s positions 177 to 191 with a tyrosine added at the front, while hGH 176-191 has phenylalanine in that spot²²⁴. AOD-9604 is sometimes labeled ‘hGH 176-191’ or just ‘GH fragment’³, and the WADA Prohibited List names both as banned growth hormone fragments⁷.

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

No. It is a fragment, not a growth hormone booster: in lab tests it did not bind the growth hormone receptor¹², and the company’s trials found no change in IGF-1 levels².

Is AOD-9604 banned in sports?

Yes. The WADA Prohibited List names it as a growth hormone fragment, banned at all times, in both 2026 and 2027⁷⁸. A urine test for it was published in 2015³⁷.

What is still unknown

FDA found no journal report of the full results of the 24-week OPTIONS trial (METAOD006) or the 12-week METAOD005 trial; the efficacy figures it summarized come from company announcements and a meeting abstract.
FDA found no human data on AOD-9604 given by injection under the skin or in skin creams; absorption and blood levels by those routes are unknown.
Whether the cancers reported in METAOD005 were related to the drug cannot be judged from the published data.
The 2012 GRAS panel report is not public and no AOD-9604 notice appears in FDA’s GRAS inventory; whether AOD-9604 was ever sold in US foods or supplements was not verified.
Whether the cosmetic anti-cellulite cream that contained AOD-9604 is still sold was not verified.
Australian trial registrations (ANZCTR) and the 2016 Australian scheduling decision pages could not be opened; Australian status here comes from the October 2026 Poisons Standard.
UK, EU and New Zealand legal status was not verified.
No independent lab tests of gray-market AOD-9604 purity or identity were found.
Joint and cartilage claims rest on one rabbit study; FDA found no clinical study of AOD-9604 in people with osteoarthritis.
Sources disagree on trial details: OPTIONS enrollment (536 per FDA, 534 per the company paper, 502 randomized in both), total trial participants (893 or 925), and the size and doses of two early oral trials.

Sources

1FDA Briefing Document, Pharmacy Compounding Advisory Committee meeting of December 4, 2024: FDA Evaluation of AOD-9604-Related Bulk Drug Substances (AOD-9604 (free base) and AOD-9604 acetate) U.S. Food and Drug Administration, 5 Nov 2024. fda.gov
2Safety and Tolerability of the Hexadecapeptide AOD9604 in Humans Journal of Endocrinology and Metabolism, Apr 2013. jofem.org
3The emerging landscape of performance-enhancing peptides modulating GH-IGF1 axis: bridging the gap between clinical evidence and patient self-administration Frontiers in Endocrinology, 2026. pubmed.ncbi.nlm.nih.gov
4Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act (categories list) U.S. Food and Drug Administration, 14 May 2026. fda.gov
5Final Summary Minutes of the Pharmacy Compounding Advisory Committee Meeting, December 4, 2024 U.S. Food and Drug Administration, 21 Feb 2025. fda.gov
6Therapeutic Goods (Poisons Standard—October 2026) Instrument 2026 (F2026L01327) Federal Register of Legislation, Australian Government, 28 Sep 2026. legislation.gov.au
7World Anti-Doping Code International Standard: Prohibited List 2026 World Anti-Doping Agency, 24 Sep 2025. wada-ama.org
8World Anti-Doping Code International Standard: Prohibited List 2027 World Anti-Doping Agency, 21 Sep 2026. wada-ama.org
9AOD-9604 Safety Testing Results & Vendor Ratings Finnrick, accessed 5 Oct 2026. finnrick.com
10Drug recall (enforcement) reports for products described as AOD-9604, openFDA drug/enforcement API (2 records: D-0131-2021 and D-0693-2021) U.S. Food and Drug Administration (openFDA), 23 Sep 2026. api.fda.gov · data query
11Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance Sports Medicine, Aug 2026. pubmed.ncbi.nlm.nih.gov
12Increase of fat oxidation and weight loss in obese mice caused by chronic treatment with human growth hormone or a modified C-terminal fragment International Journal of Obesity and Related Metabolic Disorders, Oct 2001. pubmed.ncbi.nlm.nih.gov
13Metabolic studies of a synthetic lipolytic domain (AOD9604) of human growth hormone Hormone Research, 2000. pubmed.ncbi.nlm.nih.gov
14The 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, Dec 2001. pubmed.ncbi.nlm.nih.gov
15Therapeutic Peptides in Orthopaedics: Applications, Challenges, and Future Directions Journal of the American Academy of Orthopaedic Surgeons Global Research & Reviews, 1 Jan 2026. pubmed.ncbi.nlm.nih.gov
16Antilipogenic action of synthetic C-terminal sequence 177-191 of human growth hormone Biochemistry and Molecular Biology International, May 1993. pubmed.ncbi.nlm.nih.gov
17Reduction of cumulative body weight gain and adipose tissue mass in obese mice: response to chronic treatment with synthetic hGH 177-191 peptide Biochemistry and Molecular Biology International, Aug 1994. pubmed.ncbi.nlm.nih.gov
18AOD-9604 Metabolic Current Opinion in Investigational Drugs, Apr 2004. pubmed.ncbi.nlm.nih.gov
19Obesity drugs in clinical development Current Opinion in Investigational Drugs, Apr 2006. pubmed.ncbi.nlm.nih.gov
20AOD9604 Receives GRAS Status (ASX announcement) Calzada Limited, 25 Jun 2012. aspecthuntley.com.au
21Safety and Metabolism of AOD9604, a Novel Nutraceutical Ingredient for Improved Metabolic Health Journal of Endocrinology and Metabolism, Jun 2014. jofem.org
22GRAS Notice Inventory: search for ‘9604’ (Records Found: 0) U.S. Food and Drug Administration, accessed 5 Oct 2026. hfpappexternal.fda.gov
23Aod-9604 (PubChem CID 71300630) PubChem, National Center for Biotechnology Information, accessed 5 Oct 2026. pubchem.ncbi.nlm.nih.gov
24P01241 SOMA_HUMAN: Somatotropin (human growth hormone, GH1) UniProt, accessed 5 Oct 2026. uniprot.org
25ClinicalTrials.gov search: AOD9604 OR AOD-9604 OR “AOD 9604” (0 studies) ClinicalTrials.gov, accessed 5 Oct 2026. clinicaltrials.gov
26Effect of Intra-articular Injection of AOD9604 with or without Hyaluronic Acid in Rabbit Osteoarthritis Model Annals of Clinical and Laboratory Science, 2015. pubmed.ncbi.nlm.nih.gov
27Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks U.S. Food and Drug Administration, 22 Apr 2026. fda.gov
28Warning letter to Innoveix Pharmaceuticals, Inc. (MARCS-CMS 624782) U.S. Food and Drug Administration, 26 Jan 2022. fda.gov
2921 CFR Part 1308, Schedules of Controlled Substances (eCFR, as of 25 September 2026) Electronic Code of Federal Regulations (eCFR), 25 Sep 2026. ecfr.gov
30Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act (categories list updated 29 September 2023) U.S. Food and Drug Administration (copy hosted by the Alliance for Pharmacy Compounding), 29 Sep 2023. join.a4pc.org
31Withdrawal from Wells Pharmacy Network (FDA-2015-N-3534-0471) Regulations.gov (U.S. Food and Drug Administration docket FDA-2015-N-3534), 19 Sep 2024. regulations.gov
32Withdrawal from LDT Health Solutions, Inc (FDA-2015-N-3534-0472) Regulations.gov (U.S. Food and Drug Administration docket FDA-2015-N-3534), 20 Sep 2024. regulations.gov
33Think twice before injecting peptides bought online: unauthorized products can seriously harm you (RA-81874) Health Canada, 9 Apr 2026. recalls-rappels.canada.ca
34Unauthorized injectable peptide drugs seized and sold by Canada Peptide may pose serious health risks (RA-77807) Health Canada, 1 Aug 2025. recalls-rappels.canada.ca
35Unauthorized health products sold online and seized at Rize Fitness may pose serious health risks (RA-81403) Health Canada, 24 Dec 2025. recalls-rappels.canada.ca
36Medicines watchdog to investigate UK peptide clinics over health claims The Guardian, 4 Apr 2026. theguardian.com
37Detection and in vitro metabolism of AOD9604 Drug Testing and Analysis, Jan 2015. pubmed.ncbi.nlm.nih.gov
38Identification and characterization of peptide drugs in unknown pharmaceutical preparations seized by the Belgian authorities: case report on AOD9604 Drug Testing and Analysis, Sep 2014. pubmed.ncbi.nlm.nih.gov
39AOD-9604 does not influence the WADA hGH isoform immunoassay Drug Testing and Analysis, 2013. pubmed.ncbi.nlm.nih.gov
40AOD-9604 Dosage, Safety & Stacks Peptide Initiative, 10 Aug 2026. peptideinitiative.com
41Core Peptides shop page sorted by popularity Core Peptides (vendor), accessed 5 Oct 2026. corepeptides.com (seller page, deliberately not linked)
42FDA Adverse Event Reporting System (FAERS) reports naming AOD-9604, openFDA drug/event API (no matches) U.S. Food and Drug Administration (openFDA), 30 Jul 2026. api.fda.gov · data query

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