Mazdutide in Australia: a factual overview

Quick answer

Mazdutide is an investigational peptide that acts as a dual agonist at the GLP-1 receptor and the glucagon receptor. It was developed by Innovent Biologics under a licence from Eli Lilly and carries the research codes IBI362 and LY3305677.

In China, mazdutide received its first regulatory approval from the National Medical Products Administration (NMPA) in 2025 for chronic weight management, under the brand name Xinermei. It is not approved by the Therapeutic Goods Administration (TGA) in Australia and does not appear on the Australian Register of Therapeutic Goods (ARTG). In Australia it is an unapproved substance supplied for laboratory research use only.

What is mazdutide?

Mazdutide is a once-weekly synthetic peptide that is structurally based on oxyntomodulin, a naturally occurring hormone. In published descriptions it is engineered with a fatty-acyl modification intended to extend its circulating half-life, a design feature common to several long-acting peptide analogues.

It is most often referred to in the scientific literature by its development codes, IBI362 and LY3305677, which reflect its origin as a collaboration between Innovent Biologics and Eli Lilly. The name mazdutide is the international non-proprietary name assigned to the molecule.

How it is commonly identified

• Generic name: mazdutide
• Development codes: IBI362, LY3305677
• Developer: Innovent Biologics, licensed from Eli Lilly
• Molecule type: synthetic oxyntomodulin analogue, a peptide
• China brand name: Xinermei

How the mechanism is described

Mazdutide is classified as a dual agonist. According to the published literature it binds and activates two receptors at once: the glucagon-like peptide-1 receptor (GLP-1R) and the glucagon receptor (GCGR). This is different from a single-target GLP-1 receptor agonist, which engages only one of these pathways.

In mechanistic reviews, the GLP-1 receptor component is associated with glucose-dependent effects on insulin signalling and with pathways involved in appetite and gastric emptying. The glucagon receptor component is described in the research context as acting on hepatic energy pathways, including lipid oxidation and thermogenesis. These are statements about receptor biology drawn from the literature and are not claims about outcomes in any person.

Dual agonist versus single-target designs

The peptide research field distinguishes between single, dual, and triple receptor agonists. Semaglutide is a single-target GLP-1 receptor agonist. Tirzepatide is a dual GIP and GLP-1 receptor agonist. Mazdutide sits in a different dual category, combining GLP-1 and glucagon receptor activity, while compounds such as retatrutide are described as triple agonists.

Mazdutide is frequently noted as the first dual glucagon and GLP-1 receptor agonist to reach regulatory approval anywhere in the world, which is why it is often referenced as a distinct class of investigational metabolic peptide.

Receptor targets at a glance

• Single agonist, example semaglutide: GLP-1 receptor only
• Dual GIP and GLP-1, example tirzepatide: two incretin receptors
• Dual GLP-1 and glucagon, mazdutide: one incretin plus glucagon receptor
• Triple agonist, example retatrutide: GIP, GLP-1 and glucagon receptors

Regulatory status in China

In 2025, mazdutide became the first dual glucagon and GLP-1 receptor agonist to be approved by China's National Medical Products Administration. The approval was for long-term body weight management in adults meeting defined body mass index thresholds, and the product is marketed in China under the brand name Xinermei.

Later in 2025, Chinese regulators also recognised an additional indication relating to glycaemic control in adults with type 2 diabetes. These approvals were based on data from the GLORY programme of Phase 3 studies conducted primarily in Chinese adults.

Where it sits globally

Outside China, mazdutide remains investigational. At the time of writing it has not been approved by the United States Food and Drug Administration or by the European Medicines Agency, and its approved status is limited to China. The GLORY series of Phase 3 trials and additional studies continue to generate data that regulators and researchers assess.

Because approval in one country does not transfer to another, the status of mazdutide differs sharply between jurisdictions. A compound can be a marketed medicine in one market and an unapproved research substance in another at the same point in time.

Mazdutide and Australian regulation

In Australia, therapeutic goods are generally required to be entered on the Australian Register of Therapeutic Goods before they can be lawfully supplied for therapeutic use. Mazdutide is not approved by the TGA and does not appear on the ARTG.

For that reason mazdutide is treated in Australia as an unapproved substance. On this store it is made available for laboratory and research use only. It is not a registered medicine, and no therapeutic use is represented or implied.

An approved medicine has been assessed by the regulator for quality, safety, and performance for a specified use, carries approved product information, and is tied to a sponsor on the register. An unapproved research compound has not completed that pathway in Australia, so it carries none of those regulatory assurances and is restricted to research contexts. This distinction is the core reason the two cannot be treated interchangeably.

Why the framing matters

Terms such as approved, listed, registered, and unapproved have specific meanings under Australian law. Using them loosely can misrepresent the regulatory status of a substance. This guide therefore keeps to what can be verified: mazdutide's receptor mechanism as described in the literature, its 2025 NMPA approval in China, its ongoing investigational status elsewhere, and its absence from the ARTG.

Where a specific fact cannot be confirmed, it is better to state the position neutrally than to assume it. If you require a definitive legal position for a particular activity, obtain independent professional advice rather than relying on a general explainer.

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