Reviewed & approved by Dr. Nova Reyes · Last checked 2026-10-15. ← Back to Evidence Library

AOD-9604: what the evidence says

Legend: HUMAN data · ANIMAL / LAB data · UNKNOWN · UNVERIFIED: not yet confirmed against a primary source

What "No human data" means here: for injected use and for "other uses," we found nothing at all in people. For joints, the only evidence is animal studies.

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What is it?

AOD-9604 ("Anti-Obesity Drug 9604") is Tyr-hGH 177-191, the tail end of growth hormone plus one tyrosine. Researchers at Monash University (Frank Ng's group) found that this piece seemed to keep growth hormone's fat-burning effect in obese mice, without raising blood sugar. In their studies, it did not attach to the growth hormone receptor and did not make cells grow the way growth hormone does. ^{R1, R8, R10}

How it works is still unknown. FDA's 2024 review says its molecular target "remain[s] unknown." ^R6

About the evidence

• Who did the studies: every human trial was run and paid for by the developer, Metabolic Pharmaceuticals. The only peer-reviewed summary of them (Stier 2013) was written by people tied to the company. One author held a 6.9% stake in its parent company, Calzada, and another was a consultant and former medical director. The obesity animal studies come from Frank Ng's Monash University group. Ng also reviewed drafts of the company's 2013 safety paper. UNVERIFIED Formal funding ties between that group and the company (not stated in the abstracts). ^{R3, R8, R10, R11}
• What kind: six randomized, double-blind, placebo-controlled trials (by mouth or IV) between 2001 and 2006, with 893 participants in total. ^R3 These include small phase 1-type studies (a small first study in people, focused mainly on safety and how the body handles the drug) and phase 2 trials (mid-size studies testing doses and early effects). The company described its last trial as phase 2B but "with phase 3 conditions." No phase 3 trial (large studies confirming benefit and safety before approval) was ever run. ^{R2, R3}
• Mostly unpublished: the weight-loss results appear only in company announcements, a review that cites company press releases, and a conference abstract. FDA could not find a full publication. ^{R2, R4, R6} Stier 2013 reports safety only.
• No human data on how the body handles it: FDA found no human study of how long it lasts in the body or how much is absorbed, by any route. ^R6
• ClinicalTrials.gov: no AOD-9604 trials listed (search Oct 15, 2026).

Does it help weight loss?

Human By mouth: no benefit shown in the largest trial. - OPTIONS trial (METAOD006), 2006–2007: 502 adults with obesity were randomized to one of three daily pill doses or placebo for 24 weeks, along with a diet and exercise program. Weight loss compared with placebo (a dummy pill) "was too low to reach statistical significance" at 12 or 24 weeks, meaning the difference may have been due to chance. After allowing for diet and exercise, it was under 1 kg in every dose group. The trial was designed to detect a 1.8 kg difference. On Feb 21, 2007, the company ended development for obesity. ^R2 - Earlier trial (METAOD005): 300 adults with obesity, five doses or placebo for 12 weeks, with no diet program. The company said every dose group lost more than placebo, but the best dose "fell short of significance" (p = 0.1) overall and reached it only in women. These results exist only as a conference abstract and company statements. ^{R2, R6} - Small early studies: in IV and pill studies of 16 to 36 men, weight changes were not significantly different from placebo. ^{R4, R6}

A change in fat-related blood markers isn't a health benefit. Several small studies reported a rise in blood fatty acids, but that didn't lead to meaningful weight loss. ^{R4, R6}

Unknown Injected under the skin: never studied in people. ^R6

Does it help osteoarthritis or joints?

Unknown Unknown in people. No human study. - Animal Rabbits (Kwon 2015): 32 rabbits with chemically damaged knees got weekly knee injections of saline, hyaluronic acid (a standard joint lubricant), AOD-9604, or both. Both AOD-9604 groups had less cartilage damage than saline, and the combination did best. Limping lasted less long in the combination group. ^R9 - The company announced plans to study it for osteoporosis in 2007. We found no published human results. ^R2 UNVERIFIED Vendor and clinic claims of cartilage repair in people.

A lab or animal change isn't a health benefit.

Is it safe?

• Human Trials by mouth and IV (company data): the authors say adverse events (problems reported after use, which may or may not have been caused by the drug) looked similar to placebo, and that no withdrawals or serious adverse events were caused by the drug. They found no change in IGF-1 or blood sugar handling, and no antibodies against it in the people tested. ^R3
• Human What FDA flagged in those same summaries: in the 12-week trial, five people on AOD-9604 had serious adverse events, all cancers or growths (basal cell carcinoma, squamous cell carcinoma, a lipoma, breast cancer, melanoma). The investigators judged none related to the drug. FDA said the information is too thin to know. Other events included severe chest tightness on IV AOD-9604 (possibly related), euphoria on IV AOD-9604 (5 people vs 0 on placebo), and more headache, diarrhea and gas at the highest pill dose. ^R6
• Human Dropouts vs placebo (OPTIONS): by week 24, 26% of the placebo group had stopped attending, vs 28–32% across the AOD-9604 groups. The company called this no significant difference. These numbers cover dropouts for any reason, not just side effects. ^R2
• Unknown Injections: no human safety data. FDA says injected peptides like this may trigger an unwanted immune reaction (immunogenicity) because of clumping and impurities. ^{R6, R7}
• Animal Lab tests for DNA damage: FDA called the results "equivocal" (unclear) and the animal toxicity data too limited to judge safety. ^R6
• Unknown FDA adverse event databases: no reports found as of early 2024. FDA notes that this doesn't mean it's safe. ^R6
• Unknown Long-term use: no data beyond 24 weeks by mouth.

What we don't know

• Unknown Whether injected AOD-9604 does anything in people, or is safe
• Unknown How it works and how long it lasts in the body
• Unknown Whether the cancers in the 12-week trial were chance
• Unknown Any effect on joints, cartilage or bone in people
• Unknown Full results of the trials that were never published

Is it legal?

• US drug: not FDA-approved. Sold online as "research use only," which is not a legal medicine for people.
• Compounding: FDA reviewed AOD-9604 for its 503A bulks list, which lets pharmacies compound a substance. At the Dec 4, 2024 meeting, its advisory committee voted 12 to 0 against adding it. ^{R13, R6} It also appears on FDA's "significant safety risks" page under substances nominated but withdrawn, with the note that "FDA has also identified serious adverse events that may be associated with AOD-9604, though causality is not clear." (FDA page current as of Apr 22, 2026.) ^R7 No final FDA decision found. AOD-9604 is not on the 503A bulks list (21 CFR 216.23, checked Oct 15, 2026) or the 503B bulks list. FDA's latest annual report on the committee says "the Agency is reviewing recommendations made at the meeting," and we found no proposed or final rule on AOD-9604 in the Federal Register. FDA's pending rule on the 503A list dates from a 2019 proposal that predates this review. ^R17 Without a list entry, pharmacies have no approved basis to compound it.
• GRAS / food ingredient: in 2012, Calzada (Metabolic's parent) announced a "self-affirmed conditional GRAS" finding ("generally recognized as safe": a company-hired expert panel's view that it is safe as a food ingredient, GRAS Associates), for use in foods. The condition was publishing its safety data (Stier 2013 followed). ^{R5, R3} Self-affirmed GRAS means the company decided this without FDA review. FDA's GRAS rules allow this, but FDA has not evaluated it. ^R12 UNVERIFIED We did not search FDA's GRAS Notice Inventory ourselves. FDA lists that inventory among the databases it checked in 2024. ^R6 GRAS status would not cover injections, drugs or medical claims.
• Elsewhere: we found no approval by any regulator. Caution We did not check non-US drug registries one by one.
• Athletes: WADA's 2026 list names AOD-9604 under S2.2.3 ("growth hormone fragments, e.g. AOD-9604 and hGH 176-191"), banned at all times, in and out of competition. ^R14

As of Oct 15, 2026.

What's in the vial?

Unknown For "research use" or fake (counterfeit) products, the contents are unknown. Scientists at Belgium's national public health institute identified AOD-9604 in medicines seized by Belgian authorities, and US anti-doping scientists noted it in confiscated vials. ^{R15, R16} FDA says suppliers' certificates of analysis lacked testing for impurities, clumping and contamination. ^R6 We test retail products blind under the Open Peptide Standard. See results at /tests/. A passing test covers one batch, tested on one date. It does not mean the compound itself is safe.

What do users report?

Self-report, not evidence.

Unknown TBD. We'll only list this once we can cite a public source.

Study details

^{R2–R4, R6} Human Human studies: full table

Study arms are what researchers used, not recommendations. All six trials were funded by Metabolic Pharmaceuticals. ^R3

Study	People	Design	Study arm	Reported	Limitations	Citation
METAOD001	15 men, BMI 24–30	Dose escalation, placebo-controlled, crossover	IV single doses 25–400 µg/kg	No serious AEs; AEs similar to placebo	Tiny; single doses	Stier 2013 R3; FDA 2024 R6
METAOD002	23 men with obesity	Placebo-controlled, 4 single doses, 7-day washouts	IV 25, 50, 100 µg/kg	Weight −0.58 kg over 3 weeks, not different from placebo; 1 severe chest tightness (possibly related); euphoria 5 vs 0	Tiny; short	Wilding 2004 R4; FDA 2024 R6
METAOD003	16–17 men with obesity	Dose escalation, placebo-controlled	Oral 9, 27, 54 mg, weekly	No significant weight loss; 2 SAEs at 54 mg (diarrhea possibly related; pneumonia unrelated)	Tiny; counts differ between sources (16 vs 17)	R4, R6
METAOD004	36 men with obesity	Randomized, double-blind, placebo-controlled, 7 days	Oral 9, 27, 54 mg daily (9 per group)	Wilding: 1 kg vs 0.6 kg at the lowest dose; more headache, diarrhea, gas at 54 mg	One week; dose in Wilding listed as 10/30/60 mg	R4, R6
METAOD005	300 adults with obesity	Double-blind, placebo-controlled, 12 weeks, no diet program	Oral 1, 5, 10, 20, 30 mg daily (50 per group)	Best dose (1 mg) p = 0.1 overall; significant in women only; 5 SAEs, all cancers/growths, judged unrelated	Conference abstract only; FDA found no full publication	R2, R6
METAOD006 (OPTIONS)	534–536 enrolled, 502 randomized; BMI 30–45	Randomized, double-blind, placebo-controlled, 24 weeks + diet and exercise	Oral 0.25, 0.5, 1 mg daily	Primary endpoint not met; < 1 kg vs placebo all groups; still attending at week 24: 92/125 placebo, 90/127, 90/125, 85/125	Unpublished except company release; enrollment differs (534 Stier vs 536 company)	R2, R3

^R8–R11 Animal Animal studies

Study	Animals	Study arm	Reported	Funding / ties	Citation
Ng 2000	Obese Zucker rats	Oral 500 µg/kg daily, 19 days	Weight gain cut by over half (15.8 vs 35.6 g); no effect on insulin sensitivity	Monash (Ng) group Caution funding not in abstract	PMID 11146367 R10
Heffernan 2001a	Obese (ob/ob) and lean mice; cells	14-day infusion	Less weight gain, more fat burning; no high blood sugar; did not bind hGH receptor or drive cell growth	Monash (Ng) group Caution funding not in abstract	PMID 11673763 R8
Heffernan 2001b	Obese mice; β3-receptor knockout mice	14 days, injected into belly cavity	Weight and fat loss; effect lost in knockout mice	Monash (Ng) group Caution funding not in abstract	PMID 11713213 R11
Kwon 2015	32 rabbits, chemically damaged knees	Knee injection 0.25 mg weekly, ± hyaluronic acid	Less cartilage damage than saline; combination best	Caution Not in abstract (Catholic University of Daegu)	PMID 26275694 R9

Sources (as of Oct 15, 2026)

• ^R1 Cox HD, et al. Detection and in vitro metabolism of AOD9604. Drug Test Anal. 2015;7(1):31-8. doi:10.1002/dta.1715. PMID 25208511 (structure; WADA status; confiscated vials in the USA)
• ^R2 Metabolic Pharmaceuticals, ASX announcement, "Phase 2B clinical trial results," Feb 21, 2007 (with trial design and results appendices). https://data-api.marketindex.com.au/api/v1/announcements/XASX:PNV:XX270709/pdf
• ^R3 Stier H, Vos E, Kenley D. Safety and Tolerability of the Hexadecapeptide AOD9604 in Humans. J Endocrinol Metab. 2013;3(1-2):7-15. doi:10.4021/jem157w (not in PubMed). Declared interests: Kenley 6.9% stake in Calzada; Vos consultant and former medical director of Metabolic; Stier's employer consults for Metabolic. Metabolic funded all six trials. https://www.jofem.org/index.php/jofem/article/view/157
• ^R4 Wilding J. AOD-9604 Metabolic. Curr Opin Investig Drugs. 2004;5(4):436-40. PMID 15134286. Caution Abstract only on PubMed; trial details taken from FDA's summary of this paper ^R6.
• ^R5 Calzada Ltd, ASX announcement, "AOD9604 Receives GRAS Status," Jun 25, 2012. https://announcements.asx.com.au/asxpdf/20120625/pdf/4270mj9x71tv3k.pdf
• ^R6 FDA, Briefing Document for AOD-9604 Related Bulk Drug Substances, Pharmacy Compounding Advisory Committee, Dec 4, 2024. https://www.fda.gov/media/183584/download
• ^R7 FDA, Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (content current as of 04/22/2026): AOD-9604 under "nominated but withdrawn." https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
• ^R8 Heffernan MA, et al. Int J Obes Relat Metab Disord. 2001;25(10):1442-9. doi:10.1038/sj.ijo.0801740. PMID 11673763
• ^R9 Kwon DR, Park GY. Ann Clin Lab Sci. 2015;45(4):426-32. PMID 26275694
• ^R10 Ng FM, et al. Horm Res. 2000;53(6):274-8. doi:10.1159/000053183. PMID 11146367
• ^R11 Heffernan M, et al. Endocrinology. 2001;142(12):5182-9. doi:10.1210/endo.142.12.8522. PMID 11713213
• ^R12 FDA, Generally Recognized as Safe (GRAS). https://www.fda.gov/food/food-ingredients-packaging/generally-recognized-safe-gras
• ^R13 FDA, Final Summary Minutes, Pharmacy Compounding Advisory Committee, Dec 4, 2024 (AOD-9604 vote: 0 yes, 12 no, 0 abstain). https://www.fda.gov/media/185642/download
• ^R14 WADA 2026 Prohibited List, S2.2.3: "growth hormone fragments, e.g. AOD-9604 and hGH 176-191"; prohibited at all times. Checked in the official PDF text (mirror copy; wada-ama.org blocks automated download). https://www.wada-ama.org/en/resources/world-anti-doping-code-and-international-standards/prohibited-list
• ^R15 Vanhee C, et al. Drug Test Anal. 2014;6(9):964-8. doi:10.1002/dta.1687. PMID 24976118 (Belgian seizure case report; Caution no abstract, title only checked)
• ^R16 = ^R1 Cox 2015 (confiscated vials in the USA)
• ^R17 FACA database, Pharmacy Compounding Advisory Committee, 2026 current fiscal year report ("The Agency is reviewing recommendations made at the meeting"): https://www.facadatabase.gov/FACA/apex/FACACommitteeLevelReportAsPDF?id=a10t0000001gzugAAA ; 503A rulemaking RIN 0910-AH81 (2019 proposal, final rule projected May 2026): https://www.reginfo.gov/public/do/eAgendaViewRule?RIN=0910-AH81&pubId=202504 ; 503B list: https://www.fda.gov/drugs/human-drug-compounding/503b-bulk-drug-substances-list . Caution The FACA report and rule agenda were read via search summary; absence of a final decision is based on searches, not proof.

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Disclaimer

This page is for education and harm reduction. It is not medical advice and not a recommendation to use AOD-9604. Its safety in humans is not established, especially as an injection. Please talk to a clinician you trust, especially if you have or have had cancer, are pregnant, or are a tested athlete. Seek care right away for a serious reaction, and report it to FDA MedWatch (https://www.fda.gov/safety/medwatch).