Mazdutide is a once-weekly GLP-1/glucagon dual receptor agonist (an oxyntomodulin analogue) developed by Innovent Biologics, in-licensed from Eli Lilly. It was approved in China by the NMPA in 2025 for chronic weight management and for type 2 diabetes. It is not approved by the FDA, EMA, or Australia's TGA, where it remains investigational.

Is Mazdutide approved for medical use?

Mazdutide is approved for one or more medical uses in at least one major jurisdiction. United States (FDA): Investigational in the United States; not approved. Developed and studied predominantly in China (Innovent Biologics, in-licensed from Eli Lilly). European Union (EMA): Not authorized; investigational, no marketing authorization. Australia (TGA): Not entered on the Australian Register of Therapeutic Goods (ARTG); investigational only and not approved for supply.

Is Mazdutide legal in Australia?

Mazdutide in Australia (TGA): Not entered on the Australian Register of Therapeutic Goods (ARTG); investigational only and not approved for supply.

Is Mazdutide banned in sport?

Mazdutide under the World Anti-Doping Agency (WADA) code: Not listed on the WADA Prohibited List. As an incretin-class agent (a GLP-1/glucagon dual agonist) it is not a banned substance.

Dual agonist of the glucagon-like peptide-1 (GLP-1) and glucagon receptors; a synthetic oxyntomodulin analogue

Mazdutide

Approvedaka IBI362, LY3305677

Mazdutide is a dual agonist of the GLP-1 and glucagon receptors based on the gut hormone oxyntomodulin, developed mainly for the Chinese market by Innovent Biologics (in-licensed from Eli Lilly). Clinical trials, conducted largely in China, report dose-dependent reductions in body weight and blood glucose. China's National Medical Products Administration (NMPA) approved mazdutide in 2025, first for chronic weight management and subsequently for glycemic control in adults with type 2 diabetes. It is not approved by the FDA, EMA, or Australia's TGA, and in those jurisdictions it remains investigational.

Mechanism

In plain terms, mazdutide mimics two hormones at once to reduce appetite and improve how the body uses sugar and fat. Technically, it is a synthetic analogue of oxyntomodulin that agonizes both the glucagon-like peptide-1 (GLP-1) receptor and the glucagon receptor. GLP-1 activity promotes satiety and glucose-dependent insulin secretion, while glucagon-receptor agonism is thought to increase energy expenditure and lipid metabolism, a combination intended to enhance weight loss.

Regulatory Status by Region

China (NMPA)Approved. China's National Medical Products Administration approved mazdutide in 2025, first for chronic weight management in adults with overweight or obesity and subsequently for glycemic control in adults with type 2 diabetes (Innovent Biologics).
United States (FDA)Investigational in the United States; not approved. Developed and studied predominantly in China (Innovent Biologics, in-licensed from Eli Lilly).
Australia (TGA)Not entered on the Australian Register of Therapeutic Goods (ARTG); investigational only and not approved for supply.
European Union (EMA)Not authorized; investigational, no marketing authorization.
WADANot listed on the WADA Prohibited List. As an incretin-class agent (a GLP-1/glucagon dual agonist) it is not a banned substance.

See the full regulatory status matrix

Key Studies

A phase 2 randomised controlled trial of mazdutide in Chinese overweight adults or adults with obesity (Ji et al.) (opens in a new tab) (Nat Commun 2023;14:8289; DOI 10.1038/s41467-023-44067-4; PMID 38092790)
Treatment With 9-mg Mazdutide for Weight Reduction in Chinese Adults With Obesity: The GLORY-2 Randomized Clinical Trial (Gao et al.) (opens in a new tab) (JAMA 2026 (published online June 7, 2026); DOI 10.1001/jama.2026.8142; PMID 42251595)

Related Clinical Trials

Latest research

Efficacy and safety of mazdutide in adults with obesity or overweight: a US-based, multicentre, phase 2, randomised, placebo-controlled clinical trial. (opens in a new tab)
The lancet. Diabetes & endocrinology · Aug 21, 2026
Renoprotective effects of tubular glucagon receptor activation mediated by V-ATPase. (opens in a new tab)
Science advances · Aug 7, 2026

See all recent Mazdutide research

Common Questions

What is Mazdutide?: Mazdutide is a once-weekly GLP-1/glucagon dual receptor agonist (an oxyntomodulin analogue) developed by Innovent Biologics, in-licensed from Eli Lilly. It was approved in China by the NMPA in 2025 for chronic weight management and for type 2 diabetes. It is not approved by the FDA, EMA, or Australia's TGA, where it remains investigational.
Is Mazdutide approved for medical use?: Mazdutide is approved for one or more medical uses in at least one major jurisdiction. United States (FDA): Investigational in the United States; not approved. Developed and studied predominantly in China (Innovent Biologics, in-licensed from Eli Lilly). European Union (EMA): Not authorized; investigational, no marketing authorization. Australia (TGA): Not entered on the Australian Register of Therapeutic Goods (ARTG); investigational only and not approved for supply.
How does Mazdutide work?: In plain terms, mazdutide mimics two hormones at once to reduce appetite and improve how the body uses sugar and fat. Technically, it is a synthetic analogue of oxyntomodulin that agonizes both the glucagon-like peptide-1 (GLP-1) receptor and the glucagon receptor.
Is Mazdutide legal in Australia?: Mazdutide in Australia (TGA): Not entered on the Australian Register of Therapeutic Goods (ARTG); investigational only and not approved for supply.
Is Mazdutide banned in sport?: Mazdutide under the World Anti-Doping Agency (WADA) code: Not listed on the WADA Prohibited List. As an incretin-class agent (a GLP-1/glucagon dual agonist) it is not a banned substance.