AOD-9604: the obesity peptide that failed, and its FDA status

AOD-9604 is not FDA-approved, and as of Oct 27, 2026 a licensed pharmacy may not compound it. It was developed in Australia as an obesity drug, its maker stopped that work in 2007 after its largest trial missed its main goal, and in December 2024 FDA advisers voted 12 to 0 against letting pharmacies compound it. This guide covers what AOD-9604 is, what its trials measured, and what the FDA has and hasn’t decided. It covers status only, not dosing.

What AOD-9604 is

AOD-9604 is a lab-made peptide of 16 amino acids. The FDA describes it as “a synthetic fragment of human growth hormone (hGH) (15 amino acids: 177-191) with an additional tyrosine at the N-terminal end” (FDA briefing). The Australian company Metabolic Pharmaceuticals developed and patented it in the late 1990s as a treatment for obesity, built from the end of the growth hormone molecule that early lab work linked to fat breakdown.

Today it is sold far beyond that use. The FDA found medical spas and wellness clinics marketing AOD-9604 for weight loss, osteoarthritis, osteoporosis, cartilage, diabetes, depression, anti-aging, skin care and muscle-building, often in injections and sometimes paired with BPC-157. Outsourcing facilities reported compounding no AOD-9604 products from 2017 to 2023.

From obesity drug to clinic peptide

What the trials measured

The research on AOD-9604 comes almost entirely from its developer, and most of it was never fully published. The FDA’s 2024 review is the most complete public account.

• In mice. A 2001 study gave obese mice, and mice lacking a fat-cell receptor called beta-3, daily injections of growth hormone or AOD-9604 for 14 days and measured body weight, body fat and receptor levels (Heffernan 2001).
• Small human studies. Three studies of 16 to 36 adults with obesity, lasting 1 to 4 weeks and giving AOD-9604 by vein, by mouth or by a route the paper didn’t state, measured a blood marker of fat breakdown and body weight. According to the FDA, the published description reported no statistically significant weight loss compared with placebo and gave limited detail.
• A 12-week oral study. About 300 adults with obesity took one of five oral doses or placebo for 12 weeks. It exists only as a 2005 meeting abstract; the FDA said the reported differences were small, with “unclear meaningful therapeutic effects”, and it found no full publication.
• The OPTIONS trial. This randomized, double-blind trial enrolled 536 adults aged 18 to 65 with a BMI of 30 to 45 (502 randomized). They took oral AOD-9604 or placebo once a day, with a dietitian-supervised diet and exercise program, for 24 weeks. The main goal was a statistically significant weight loss at 12 weeks versus placebo. According to the FDA’s account of the company’s stock exchange filings, the trial found no significant difference, and on Feb 21, 2007 the company said “Development of the drug for this condition is terminated.”

The FDA’s conclusion: “there is a lack of evidence to support the effectiveness of AOD-9604 (free base) and AOD-9604 acetate for the treatment of obesity for any ROA” (route of administration). It also noted that no AOD-9604 study is listed on ClinicalTrials.gov, and that it found no human data at all for injection under the skin or for creams, two of the three forms nominated for compounding (the third was an oral capsule).

What the FDA has decided

It isn’t approved, and it can’t be compounded

Under section 503A, a pharmacy may compound from a bulk ingredient only if it has a USP or National Formulary monograph, is a component of an FDA-approved drug, or is on the 503A bulks list. While that list is built, the FDA allows compounding with substances in its Category 1 that were nominated before Jan 7, 2025 (FDA interim policy). AOD-9604 has no monograph, is not part of any approved drug, and is not on the bulks list or in Category 1 (FDA categories list).

The 2024 review and vote

A compounding pharmacy and a peptide society had nominated AOD-9604 for weight loss, osteoporosis and osteoarthritis, and both withdrew their nominations. The FDA evaluated it anyway, for obesity, “due to FDA’s significant safety concerns related to the use of certain peptides in compounded drug products” (FDA briefing). It concluded the criteria weigh against adding AOD-9604 to the bulks list and proposed that it not be added.

The Pharmacy Compounding Advisory Committee met on Dec 4, 2024 (Federal Register) and voted 12 to 0 against adding AOD-9604 or its acetate salt to the list (FDA minutes).

The FDA’s safety note

AOD-9604 was previously in Category 2, the FDA’s list of substances that may present significant safety risks. The FDA’s safety page now lists it under “nominated but withdrawn”, with this note: the agency “has identified no, or only limited, safety-related information. Therefore, the agency lacks sufficient information to know whether the drug would cause harm when administered to humans. FDA has also identified serious adverse events that may be associated with AOD-9604, though causality is not clear” (FDA).

The company-funded safety summary that nominators cited was written by employees or consultants of Metabolic Pharmaceuticals, and the FDA said it could not draw definitive conclusions about safety from it.

What hasn’t happened

The FDA has not published a final rule on AOD-9604, and it doesn’t need one to keep it out of pharmacies. With no approval and no compounding route, there is no lawful prescription source as of Oct 27, 2026.

Sport and other countries

WADA’s 2026 Prohibited List names AOD-9604 in class S2.2.3, growth hormone fragments, banned at all times (WADA). The FDA’s review notes that an Australian Crime Commission report listed it among peptides supplied to athletes, and that Australia added it to its Poisons Standard as a performance and image enhancing drug, which makes possession without a lawful prescription illegal there.

AOD-9604 is not on the DEA’s list of controlled substances, dated Oct 21, 2026 (DEA).

What about vials and creams sold online?

AOD-9604 is widely sold online in vials labeled for laboratory research, and in oral forms such as dissolving tablets. Buying these to use is unsafe and unregulated. No prescriber decides whether it suits you, no licensed pharmacy answers for what is in the product, and the FDA found no human data for the injected or skin forms at all. Our guide on whether peptides are safe covers how to check a provider.

If weight loss is the goal

The FDA’s own review points out that several drugs are approved for weight management in adults with obesity, including semaglutide (Wegovy), tirzepatide (Zepbound), liraglutide (Saxenda), naltrexone with bupropion (Contrave), orlistat and phentermine with topiramate (Qsymia). These have FDA-reviewed trial results and labels that list their risks. Our guides to peptides vs GLP-1 medications and Ozempic alternatives compare them, and the weight loss hub explains how prescriptions work online.

The bottom line

AOD-9604 was built to treat obesity, and its developer abandoned it in 2007 after its largest trial found no significant difference from placebo. The FDA has never approved it, reviewed it in 2024 and proposed keeping it off the compounding list, and its advisers agreed 12 to 0. As of Oct 27, 2026 there is no lawful prescription source, and WADA bans it. For where every other peptide stands, see are peptides legal in 2026, peptides for muscle growth or the peptides hub.