# AOD-9604: FDA Status, Research and Uses

> AOD-9604 facts: FDA compounding status, the 2024 advisory committee vote, WADA ban, obesity trials, doses used in studies and side effects.

- Canonical URL: https://livingpluspeptides.com/peptides/aod-9604/
- Last updated: October 25, 2026
- Publisher: Living+

AOD-9604 is a 16-amino-acid fragment of human growth hormone, first developed in the late 1990s as a possible obesity drug. It is not FDA approved. In 2024, FDA advisers voted 12 to 0 against adding it to the 503A compounding list. FDA found that in most obesity trials it did not lead to more weight loss than placebo [2, 3].

## Regulatory status

- FDA approved: No
- 503A compounding: [Nomination withdrawn or removed](https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks). Nominations withdrawn; FDA reviewed it on its own and its advisory committee voted 12 to 0 against adding it to the 503A bulks list on Dec 4, 2024. FDA's safety risk page (updated Apr 22, 2026) lists it under nominated but withdrawn.
- 503B bulks list: [Not nominated](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/UCM467374.pdf). Not on FDA's 503B categories list (updated March 21, 2025).
- WADA prohibited: [Yes](https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf) (S2.2.3 Growth hormone fragments (named: AOD-9604))
- FDA drug shortage: [Not on the shortage list](https://api.fda.gov/drug/shortages.json?search=generic_name:%22AOD-9604%22)
- DEA schedule: [Not scheduled](https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf)
- Last verified: November 2, 2026

Checked against: [FDA: Certain bulk drug substances for use in compounding that may present significant safety risks](https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks), [FDA briefing document: AOD-9604, PCAC December 4, 2024](https://www.fda.gov/media/183584/download), [FDA: Final summary minutes, PCAC December 4, 2024](https://www.fda.gov/media/185642/download), [FDA: 503B categories list (updated March 21, 2025)](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/UCM467374.pdf), [WADA: 2026 Prohibited List (PDF)](https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf), [openFDA Drugs@FDA query: AOD-9604 (no matches)](https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22AOD-9604%22), [openFDA drug shortages query: AOD-9604](https://api.fda.gov/drug/shortages.json?search=generic_name:%22AOD-9604%22), [DEA Diversion: Controlled Substances - Alphabetical Order](https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf)

## Key facts

- Class: Modified fragment of human growth hormone (Tyr-hGH 177-191) [2, 5]
- Amino-acid length: 16 amino acids [2]
- Half-life: About 3 minutes after an IV dose in pigs; not established in humans [2]
- Route used in studies: IV and oral in human trials; other routes only in animal studies [2, 9]
- First studied: Late 1990s (developed by Metabolic Pharmaceuticals, Australia) [2]

## How it works

AOD-9604 is a lab-made peptide based on the tail end of human growth hormone. FDA describes it as a 15-amino-acid piece of growth hormone (positions 177 to 191) with one extra tyrosine added, for 16 amino acids in total [2]. Researchers built it to keep the fat-burning activity of growth hormone without its other effects [5].

In obese mice, AOD-9604 reduced weight gain and raised fat burning, much like full growth hormone. Unlike growth hormone, it did not raise blood sugar, and it did not compete for the growth hormone receptor or make cells multiply [7]. In obese rats, an oral dose for 19 days cut weight gain by more than half without harming insulin sensitivity [8].

The trials in people tell a different story. A summary of six company-funded trials reported no effect on IGF-1 and no harm to blood sugar control [5]. FDA's 2024 review found that in most studies AOD-9604 did not lead to more weight loss than placebo. The largest trial, with 536 people enrolled, missed its main weight loss goal, and the company stopped developing it for obesity [2].

It has also been studied in a rabbit model of knee osteoarthritis [9]. FDA did not find human data for under-the-skin (SC) or topical use [2].

## What the research shows

| Study | Year | Participants | Design | Result | Link |
| --- | --- | --- | --- | --- | --- |
| Human trial: Stier et al. 2013 (safety summary of six trials) | 2013 | Adults in six trials; the largest had 502 adults with obesity | Summary of six randomized, double-blind, placebo-controlled trials, IV and oral [2, 5] | Authors reported a safety profile similar to placebo, no IGF-1 change and no antibodies in those tested. Funded by the developer [2, 5]. | [Source](https://doi.org/10.4021/jem157w) |
| Human trial: Wilding 2004 (early obesity trials) | 2004 | Three small trials: 23 adults, 16 men and 36 men with obesity | Review of three early dose-escalation trials (one IV, one oral, one route not stated) [2] | FDA notes these trials showed no statistically significant weight loss compared with placebo [2]. | [Source](https://pubmed.ncbi.nlm.nih.gov/15134286/) |
| Animal study: Kwon et al. 2015 (rabbit knee osteoarthritis) | 2015 | 32 rabbits | Randomized animal study, weekly knee joint injections with or without hyaluronic acid [9] | AOD-9604 was studied for cartilage repair; groups given it had lower cartilage damage scores than saline [9]. | [Source](https://pubmed.ncbi.nlm.nih.gov/26275694/) |
| Animal study: Heffernan et al. 2001 (obese mice) | 2001 | Obese and lean mice | 14 days of hGH, AOD-9604 or saline by mini-pump, plus cell tests [7] | AOD-9604 reduced weight gain and raised fat burning in obese mice without raising blood sugar. It did not compete for the growth hormone receptor [7]. | [Source](https://pubmed.ncbi.nlm.nih.gov/11673763/) |
| Animal study: Ng et al. 2000 (obese Zucker rats) | 2000 | Obese Zucker rats | Daily oral dosing for 19 days compared with controls [8] | Weight gain fell by more than 50% compared with controls, with no harm to insulin sensitivity [8]. | [Source](https://pubmed.ncbi.nlm.nih.gov/11146367/) |

## Doses used in studies

Human trials of AOD-9604 used IV or oral doses. IV trials gave single doses of 25 to 400 mcg/kg of body weight. Oral trials used single doses of 9, 27 and 54 mg, daily doses of 1 to 30 mg for 12 weeks, and daily doses of 0.25, 0.5 or 1 mg for 24 weeks [2].

In animal studies, obese rats received an oral dose of 500 mcg/kg each day for 19 days [8], and rabbits received 0.25 mg into the knee joint once a week [9].

**Dosing is set by a licensed provider.**

## Side effects and safety

AOD-9604 is not FDA approved, so there is no FDA label or boxed warning. FDA says compounded AOD-9604 may carry a significant risk of immune reactions and has impurity and quality concerns. FDA has also identified serious adverse events that may be linked to it, though causality is not clear [1].

In the IV trials, the most common side effects were headache, fatigue, low blood sugar and dizziness. One person had severe chest tightness and five reported euphoria, both judged possibly related [2]. In the oral trials, headache, diarrhea and gas were most common. In one 12-week trial, five people had serious events, including several cancers, which investigators judged unrelated [2].

The trial authors reported no antibodies against AOD-9604 in the people tested [5]. FDA notes the IV studies were small and short, and the developer funded the six trials [2].

- [FDA: Certain bulk drug substances for use in compounding that may present significant safety risks](https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks) (2026-04-22)

## Legal and regulatory status

- 2026-04-22: FDA's safety risk page, updated this date, lists AOD-9604 among substances whose nominations were withdrawn, with immune reaction and serious adverse event concerns [1]. [Source](https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks)
- 2026-01-01: The WADA 2026 Prohibited List took effect. It names AOD-9604 as a growth hormone fragment under S2.2.3, banned at all times [4, 11]. [Source](https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf)
- 2024-12-04: FDA's Pharmacy Compounding Advisory Committee voted 12 to 0 against placing AOD-9604 (free base) and AOD-9604 acetate on the 503A bulks list. The nominations had been withdrawn, but FDA reviewed it on its own [3, 12]. [Source](https://www.fda.gov/media/185642/download)
- 2007-02-21: The developer announced that its phase 2B results did not support the commercial viability of AOD-9604 as an obesity treatment and ended development, as reported by FDA [2]. [Source](https://www.fda.gov/media/183584/download)

See every peptide's status side by side in the [Peptide Status Tracker](https://livingpluspeptides.com/regulation/tracker/#row-aod-9604).

## Frequently asked questions

### Is AOD-9604 FDA approved?

No. FDA's 2024 review lists no approved drug containing it, and FDA advisers voted against adding it to the 503A compounding list [2, 3].

### Can pharmacies legally compound AOD-9604?

It is not on the 503A bulks list. FDA advisers voted 12 to 0 against adding it in December 2024, and FDA lists safety concerns for compounded AOD-9604 [1, 3].

### Is AOD-9604 GRAS?

FDA's 2024 review lists FDA's GRAS Notice Inventory among the databases it searched, and the review does not describe any GRAS notice for AOD-9604 [2]. GRAS is a food term, and AOD-9604 is not an approved drug [2].

### Did AOD-9604 cause weight loss in trials?

FDA found that in most trials it did not beat placebo. The largest trial, with 536 people enrolled, did not show a significant difference in weight loss at 12 weeks [2].

### Is AOD-9604 banned by WADA?

Yes. The WADA Prohibited List names AOD-9604 as a growth hormone fragment under S2.2.3, banned at all times [4].

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

AOD-9604 is Tyr-hGH 177-191, growth hormone positions 177 to 191 with an added tyrosine [2, 5]. WADA lists AOD-9604 and hGH 176-191 as separate examples of growth hormone fragments [4].

### Does AOD-9604 raise IGF-1?

In the six company trials, the authors reported no effect on serum IGF-1 levels [5].

### What side effects were reported with AOD-9604?

Trials reported headache, fatigue, low blood sugar, dizziness, diarrhea and gas. FDA also notes serious adverse events that may be linked to it, with causality unclear [1, 2].

## Sources

1. [FDA: Certain bulk drug substances for use in compounding that may present significant safety risks](https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks)
2. [FDA briefing document: evaluation of AOD-9604-related bulk drug substances, PCAC December 4, 2024](https://www.fda.gov/media/183584/download)
3. [FDA: Final summary minutes, PCAC meeting December 4, 2024](https://www.fda.gov/media/185642/download)
4. [WADA: 2026 Prohibited List (PDF)](https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf)
5. [Stier et al. 2013, J Endocrinol Metab (DOI)](https://doi.org/10.4021/jem157w)
6. [Wilding 2004, Curr Opin Investig Drugs (PubMed)](https://pubmed.ncbi.nlm.nih.gov/15134286/)
7. [Heffernan et al. 2001, Int J Obes Relat Metab Disord (PubMed)](https://pubmed.ncbi.nlm.nih.gov/11673763/)
8. [Ng et al. 2000, Horm Res (PubMed)](https://pubmed.ncbi.nlm.nih.gov/11146367/)
9. [Kwon et al. 2015, Ann Clin Lab Sci (PubMed)](https://pubmed.ncbi.nlm.nih.gov/26275694/)
10. [FDA: Bulk drug substances nominated for use in compounding under section 503A (updated May 14, 2026)](https://www.fda.gov/media/94155/download)
11. [WADA: Prohibited List resource page (2026 List in force)](https://www.wada-ama.org/en/resources/world-anti-doping-code-and-international-standards/prohibited-list)
12. [FDA: Transcript, PCAC meeting December 4, 2024](https://www.fda.gov/media/185641/download)

Educational information, not medical advice. This site sells nothing.