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Regulatory Explainer

Is AOD-9604 Legal in Australia? (2026)

A plain-language look at how AOD-9604 sits within Australian medicines regulation, including the Poisons Standard, the ARTG and anti-doping rules. General information only, not legal or medical advice.

Poisons Standard scheduleSchedule 4 (Prescription Only Medicine), effective 1 June 2015
ARTG statusNot registered on the ARTG
TGA approvalNot approved for any human therapeutic use
WADA statusProhibited in sport (growth hormone fragment, S2 class, at all times)
MechanismSynthetic peptide fragment of the C-terminus of human growth hormone (around residues 177 to 191)
Research historyInvestigated by Metabolic Pharmaceuticals; obesity development discontinued in 2007
Supply framingResearch use only, not intended for human consumption

The short answer

AOD-9604 is a regulated substance in Australia. It is named in the Poisons Standard (the SUSMP) as a Schedule 4 substance, which is the Prescription Only Medicine category. It is not registered on the Australian Register of Therapeutic Goods (ARTG) and has not been approved by the Therapeutic Goods Administration (TGA) for any human therapeutic use.

Because it sits in Schedule 4, AOD-9604 is not a substance that can be legally sold over the counter or marketed to the public as a therapeutic product. Materials sold under this name in Australia are generally supplied on a research-use-only basis, meaning they are not intended for human consumption. AOD-9604 is also prohibited in sport under the World Anti-Doping Agency (WADA) framework.

This article is general information only and is not legal or medical advice. Regulatory status can change over time. Always check the current Poisons Standard, the ARTG and official TGA and Sport Integrity Australia guidance, and seek qualified professional advice for your situation.

What is AOD-9604?

AOD-9604 is a synthetic peptide. Its name is an abbreviation of Advanced Obesity Drug. The molecule is based on a short fragment from the C-terminus (the tail region) of human growth hormone, corresponding to the residues around positions 177 to 191, with a modification intended to stabilise the fragment. In other words, it is a laboratory-made copy of a small portion of a naturally occurring hormone sequence rather than the full hormone.

It was originally developed in Australia by Metabolic Pharmaceuticals. The scientific interest in the fragment related to how the C-terminal region of growth hormone interacts with fat metabolism in preclinical and laboratory models. This article describes that research history for context only and makes no claim about any effect in humans.

At a glance

  • A synthetic peptide fragment, not the full growth hormone molecule
  • Derived from the C-terminal region of human growth hormone (around residues 177 to 191)
  • Originally developed as an investigational candidate, not an approved medicine
  • Studied in preclinical fat-metabolism research, with no approved human use

How the Poisons Standard treats AOD-9604

The Poisons Standard, formally the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP), is the national document that classifies medicines and chemicals into schedules. Each schedule carries different controls on how a substance can be supplied and accessed. Schedule 4 is the Prescription Only Medicine category, which means lawful access runs through a prescription from an authorised health practitioner.

AOD-9604 was added to Schedule 4 of the Poisons Standard, with this entry taking effect from 1 June 2015. This decision came through the scheduling committee process that also addressed a number of other growth-hormone-related peptides. The committee noted that the long-term safety of these substances was not established and that there were concerns about their supply, including sale over the internet.

Schedule 4How AOD-9604 is classified in the Australian Poisons Standard (Prescription Only Medicine)

Being in Schedule 4 is the key legal fact for most readers. It places AOD-9604 outside the category of products that can be freely bought and sold to consumers, and it means any legitimate therapeutic access would have to go through a regulated prescribing pathway. That pathway does not currently exist for an approved AOD-9604 product, because the substance is not on the ARTG.

ARTG and TGA approval status

The ARTG is the central database of therapeutic goods that may lawfully be supplied in Australia. If a medicine is approved for sale, it is listed or registered on the ARTG. AOD-9604 is not on the ARTG as an approved therapeutic good, and the TGA has not approved it for any human therapeutic indication.

This matters because an unapproved substance cannot be lawfully advertised or sold to the public as a medicine, and it has not been assessed by the TGA for quality, safety or efficacy in the way an approved product would be. The absence from the ARTG is consistent with the Schedule 4 listing: the substance is recognised and controlled in the Poisons Standard, but it has no approved consumer product behind it.

Not on the Australian Register of Therapeutic Goods. Not TGA-approved for human therapeutic use. Any product sold under this name is supplied for laboratory research use only and is not intended for human consumption.

What research-use-only means

When AOD-9604 is offered in Australia, it is typically described as a research chemical supplied for laboratory and research purposes only. This framing exists precisely because the substance is not an approved medicine and is not registered on the ARTG. Research-use-only means the material is not intended for human or veterinary use, not for diagnosis, and not for therapeutic application.

Research-use-only labelling is a statement about intended use, not a loophole that converts an unapproved substance into a consumer product. It does not authorise human dosing, self-administration or any clinical use. The scheduling and ARTG position described above continues to apply regardless of how a product is marketed.

Research-use-only in practice

  • Supplied for laboratory and research contexts, not for people
  • Not a medicine, supplement or food
  • No dosing, protocol or administration guidance is appropriate or provided
  • The Schedule 4 listing and the lack of ARTG registration still apply

Anti-doping and WADA status

In the context of sport, AOD-9604 is a prohibited substance. It falls within the WADA framework for peptide hormones, growth factors and related substances. As a growth hormone fragment, it is captured by the S2 class of the WADA Prohibited List and is treated as prohibited at all times, meaning both in-competition and out-of-competition.

In Australia, anti-doping rules are administered by Sport Integrity Australia, which applies the WADA Prohibited List. Athletes who are subject to anti-doping rules should treat AOD-9604 as banned and should check the current Prohibited List and official Sport Integrity Australia resources before using any substance. The AOD-9604 name featured publicly in an Australian sport supplements investigation, which reinforced its prohibited status in competitive sport.

AOD-9604 is prohibited in sport under the WADA framework (growth hormone fragment, S2 class, prohibited at all times). Athletes should always confirm against the current Prohibited List and Sport Integrity Australia guidance.

Clinical and research history

AOD-9604 has an unusual history for a substance now sold in the research-chemical market: it was investigated in formal clinical trials. Metabolic Pharmaceuticals ran clinical studies, including a Phase 2b obesity trial, to examine the candidate in humans. The reported outcome of that programme did not support approval for an obesity indication, and development for that use was discontinued in 2007.

This history is relevant to the legal picture because it helps explain why AOD-9604 is a scheduled but unapproved substance. It was taken through investigational development, that development did not result in an approved medicine, and it was later named in the Poisons Standard. The research history is presented here as factual context and is not a statement about whether the substance is effective or safe for any use.

A substance can be well known and even clinically studied while still being unapproved and tightly controlled. Scheduling and ARTG status are separate from a substance's research profile.

Bottom line for Australia

To summarise the regulatory position as it stands in 2026: AOD-9604 is named in the Poisons Standard as a Schedule 4 (Prescription Only) substance, it is not on the ARTG and not TGA-approved for human therapeutic use, and it is prohibited in sport under the WADA framework. Products sold under this name in Australia are supplied on a research-use-only basis and are not intended for human consumption.

Regulatory classifications are reviewed and updated over time, so the current Poisons Standard, the ARTG and official TGA and Sport Integrity Australia sources are always the authoritative references. This page is a general explainer and should not be relied on as legal or medical advice.

Frequently asked questions

Is AOD-9604 legal to buy in Australia?+

AOD-9604 is a Schedule 4 (Prescription Only) substance in the Poisons Standard and is not on the ARTG, so there is no approved consumer product. Material sold under this name is supplied for laboratory research use only and is not intended for human consumption. This is general information, not legal advice.

What schedule is AOD-9604 in the Poisons Standard?+

AOD-9604 is listed in Schedule 4 of the Poisons Standard, which is the Prescription Only Medicine category. The entry took effect from 1 June 2015. Always confirm the current listing in the official Poisons Standard, as scheduling can change.

Is AOD-9604 approved by the TGA?+

No. AOD-9604 is not registered on the Australian Register of Therapeutic Goods and has not been approved by the TGA for any human therapeutic use. It is recognised in the Poisons Standard as a scheduled substance, but it has no approved product behind it.

Is AOD-9604 banned in sport?+

Yes. As a growth hormone fragment, AOD-9604 is captured by the S2 class of the WADA Prohibited List and is treated as prohibited at all times. Athletes should check the current Prohibited List and Sport Integrity Australia guidance before using any substance.

What is AOD-9604 made from?+

It is a synthetic peptide based on a fragment of the C-terminal region of human growth hormone, corresponding to the residues around positions 177 to 191, with a stabilising modification. It is a laboratory-made copy of part of a hormone sequence, not the full hormone.

Why was AOD-9604 added to the Poisons Standard?+

It was included in Schedule 4 through the national scheduling committee process, which addressed several growth-hormone-related peptides. Reasons noted included that the long-term safety of these substances was not established and that there were concerns about their supply.

Does research-use-only mean AOD-9604 is safe to use?+

No. Research-use-only is a statement that a material is intended for laboratory research and not for human or veterinary use. It does not authorise human dosing and makes no claim about safety or effect. The scheduling and ARTG position still applies.

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