AOD-9604: What It Is and Its U.S. Regulatory Status

What is AOD-9604?

AOD-9604 (also written AOD 9604) is a synthetic peptide based on a fragment of human growth hormone. It is not FDA-approved for any use, and no FDA-approved medicine contains it. The letters AOD stand for anti-obesity drug, which reflects what it was originally developed for.

Chemically, it is a chain of 16 amino acids: the segment of growth hormone spanning positions 177 to 191, with an extra tyrosine added at the start of the chain. An internal bond between two cysteine building blocks (a disulfide bridge) holds part of the chain in a loop. It is a fragment only and is not the same as growth hormone.

How it was meant to work

Early laboratory and animal work suggested that the tail end of the growth hormone molecule plays a role in fat metabolism. The idea behind AOD-9604 was to keep that activity while avoiding the effects of full-length growth hormone on growth and blood sugar. A company-authored summary of its human trials reported no effect on blood levels of IGF-1, a marker of growth hormone activity.

Research and development history

AOD-9604 was developed in Australia by Metabolic Pharmaceuticals in the late 1990s and tested in the 2000s, mainly as an oral obesity drug.

The largest trial, called OPTIONS, enrolled 536 adults with obesity. Participants took AOD-9604 or a placebo daily alongside a supervised diet and exercise program for 24 weeks. Weight loss with AOD-9604 was not significantly different from placebo at 12 or 24 weeks. On February 21, 2007, the company announced that the results did not support the drug's commercial viability and that development for obesity was terminated. The full trial results were never published in a medical journal.

A 2013 paper summarizing six randomized, placebo-controlled trials in roughly 900 adults reported that side effects were similar to placebo and that no antibodies against the peptide were found in the patients tested. The authors were employees or consultants of the developer. In its 2024 review, the FDA noted that the published reports lack full detail on methods and results, and that it found no human data at all for forms applied to the skin or given under the skin.

U.S. regulatory status

Current status: Not FDA-approved.

Compounding: AOD-9604 was once in Category 2 of the FDA's interim 503A lists, the group of bulk substances that raise significant safety risks. It was removed in September 2024 after the nominators withdrew their nominations. The FDA then reviewed it for the 503A bulks list and concluded there was a lack of evidence that it works for obesity. At the Pharmacy Compounding Advisory Committee meeting on December 4, 2024, members voted 12 to 0 against adding AOD-9604 to the list. As of the FDA's May 14, 2026 update, it is not on the bulks list and is not in Category 1, so it does not meet the conditions for 503A compounding.

Products labeled "for research purposes only" are not approved drugs, and the FDA has not reviewed their contents or quality.

Documented safety information

In its safety summary, the FDA said compounded AOD-9604 may pose a significant risk of immunogenicity (an unwanted immune response) for certain routes of administration and may have complexities with peptide-related impurities. It said it had identified no, or only limited, safety-related information, so it lacks sufficient information to know whether the drug would cause harm in humans. The FDA also pointed out that the disulfide bridge can lead to breakdown of the peptide and clumping (aggregation).

Sport

The World Anti-Doping Agency (WADA) 2026 Prohibited List names AOD-9604 as a growth hormone fragment under class S2. It is prohibited at all times, in and out of competition. According to the FDA's review, Australian regulators have also added AOD-9604 to that country's poisons standard as a performance and image enhancing drug.

Why Peptide Labs does not sell AOD-9604

Peptide Labs does not sell this compound. This page is general information, not medical advice. We are not a pharmacy, we do not supply AOD-9604, and we do not point readers to anyone who does.

For personal medical questions, including questions about weight management, the right person to ask is a licensed healthcare provider. Several FDA-approved medicines for weight management exist, and a clinician can explain whether any of them fit your situation.

Related reading

See the full list of compound profiles in the Peptide Guide. For approved options, see our profile of semaglutide or read what is actually approved among peptides for weight loss.