AOD-9604: What Lakeland Readers Should Know

AOD-9604 is a lab-made piece of human growth hormone that was developed in Australia as a weight-loss drug. Its biggest trial did not show weight loss, and FDA has said there is no good evidence it works for obesity. This page explains what was studied and what to ask. It is general information, not advice for your situation.

What it is and how it works

AOD-9604 is a chain of 16 amino acids (the building blocks of proteins). It copies the tail end of human growth hormone, with one extra amino acid added. It was developed and patented in the late 1990s by an Australian company, Metabolic Pharmaceuticals.¹

In rats and mice, it reduced weight gain and fat tissue and increased fat breakdown. Unlike full growth hormone, it did not raise blood sugar or affect insulin in those animals, and it does not appear to bind the growth hormone receptor. In its November 2024 review, FDA said the molecule’s true target and how it works “remain unknown.”¹

In the developer’s human trials, levels of IGF-1 did not change in a meaningful way.¹ IGF-1 is a hormone the liver makes in response to growth hormone, so it is often used as a sign of growth hormone activity. This suggests AOD-9604 does not act like growth hormone in people, although that has not been studied directly.

What the research shows (and where evidence is weak)

Six human trials were run, all paid for by the developer, and all used pills or IV infusions. They were summarized in a paper written by people who worked for or consulted for the company.¹

• Small early studies. Three studies of 16 to 36 people, lasting 1 to 4 weeks, found no weight loss that was statistically different from placebo.¹ (A placebo is a dummy treatment used for comparison.)
• A 12-week study of 300 adults. It was reported only as a short conference abstract. It claimed small differences in weekly weight loss that did not rise steadily with dose. FDA said these differences had “unclear meaningful therapeutic effects” and found no full publication.¹
• The largest trial. The OPTIONS trial randomized 502 adults with obesity for 24 weeks, along with diet and exercise. It did not meet its main goal of weight loss at 12 weeks. On February 21, 2007, the company said the results did not support the drug and ended its development for obesity.¹ The trial was never published in a medical journal.

FDA found no human data for the forms sold today: injections under the skin and creams. It found no studies of how the body absorbs or clears AOD-9604, and no AOD-9604 studies listed on ClinicalTrials.gov.¹ FDA concluded there is “a lack of evidence to support the effectiveness” of AOD-9604 for obesity by any route, and noted that clinical guidelines do not mention it.¹

Claims that it repairs joints or cartilage rest on a rabbit model of knee arthritis. FDA did not evaluate those uses.¹

In short, AOD-9604 is not an untested idea. It was tested for weight loss, and the most rigorous trial failed.

FDA and regulatory status

As of FDA documents dated November 2024 to April 2026, AOD-9604 is not FDA-approved for any use. It has no official drug-quality standard (USP monograph) and is not part of any approved drug.¹

• Compounding. FDA recommended that AOD-9604 not be added to the 503A Bulks List, the list of unapproved ingredients that state-licensed pharmacies may use to make custom drugs. At a December 4, 2024 meeting, FDA’s compounding advisory committee voted 0 to 12 against adding it.²
• Safety list. On FDA’s safety-risk page, current as of April 22, 2026, the compounding nominations for AOD-9604 were withdrawn, but FDA still lists its concerns. These include a risk of immune reactions and “serious adverse events that may be associated with AOD-9604, though causality is not clear.”³
• 2026 developments. A law-firm analysis reported that compounding pharmacies sued FDA in 2026 over four peptides, including AOD-9604.⁴ We did not confirm the outcome of that lawsuit. AOD-9604 is not among the six peptides that law-firm summaries list in the draft HHS compounding policy published October 30, 2026.⁵⁶
• “GRAS” claims. In 2014 the developer’s parent company announced that AOD-9604 had been designated “Generally Recognised As Safe” (GRAS) as a food ingredient.⁷ No AOD-9604 notice appears in FDA’s GRAS Notice Inventory.⁸ A food-ingredient status would not, on its own, cover an injected drug.
• Sport. The World Anti-Doping Agency (WADA) 2026 list names AOD-9604 as a prohibited growth hormone fragment, banned at all times.⁹

Our guide to compounded vs. FDA-approved peptides explains these categories.

Common side effects and safety

• Reported in the company trials: headache, diarrhea and gas with pills; headache, tiredness and dizziness with IV dosing. One case of severe chest tightness and one of euphoria were judged possibly related.¹
• Cancers in one trial: In a 12-week trial, five people had serious events, including several cancers. The investigators judged them unrelated, but FDA said there was too little information to judge.¹
• Animal studies: FDA noted a shift in a bone-turnover marker in rats, minimal liver changes in monkeys, and unclear results on genetic-damage tests. It called the animal data “too limited in scope” to judge safety for the forms sold today.¹
• No reports is not proof of safety: FDA’s adverse-event databases held no AOD-9604 reports. FDA stressed that this does not show the substance is safe, in part because compounding pharmacies generally do not report side effects.¹
• Injected peptides: FDA warns that peptides of this size may trigger immune reactions, and that compounded products may contain impurities.¹

Products sold online as “research chemicals” are not made or tested for human use. See our guide to research-chemical peptide risks.

Typical cost range

There is no reliable price data. AOD-9604 is not an approved product, so it has no official list price. What a clinic charges would depend on where the product comes from, the form, how long it is used, and any visit or membership fees. Given FDA’s position against compounding it, ask any clinic exactly how and where it gets the product. Prices vary between clinics and pharmacies. Ask any provider for a written price breakdown before you start.

Our cost guide lists questions to ask about pricing.

Questions to ask a provider

• What human evidence supports using AOD-9604 for my goal, given that its main weight-loss trial failed?
• Which form are you offering, and has that form ever been tested in people?
• Where does the product come from? Is it made by a state-licensed pharmacy, and how is it able to compound a substance FDA advised against?
• What side effects should I watch for, and how do I reach you if I have one?
• Are there FDA-approved options for my goal that have stronger evidence?
• What is the total cost, and what does it include?

If you are comparing clinics, our guide on how to vet a peptide clinic can help you spot red flags.