Mazdutide: What It Is and Its U.S. Regulatory Status

What is mazdutide?

Mazdutide is a synthetic peptide that activates two hormone receptors, the GLP-1 receptor and the glucagon receptor. It was approved in China in 2025 for weight management and type 2 diabetes, but it is not FDA-approved and remains investigational in the United States.

Mazdutide was discovered by Eli Lilly (code LY3305677) and has been developed in China by Innovent Biologics (code IBI362) under a 2018 partnership. Lilly keeps the rights outside China.

How it works

GLP-1 is a gut hormone released after eating. Medicines that act on its receptor, such as semaglutide, slow stomach emptying, reduce appetite and help control blood sugar. Glucagon is a pancreatic hormone that raises blood sugar but also affects energy use and fat processing in the liver. Combining the two actions in one molecule is intended to add glucagon's effects on energy use to the appetite effects of GLP-1.

Clinical trials

• GLORY-1 (phase 3, published in The New England Journal of Medicine in 2025): 610 Chinese adults with overweight or obesity, followed for 48 weeks. Innovent reported average weight loss of 12.0% and 14.8% with the two tested strengths, versus 0.5% with placebo.
• GLORY-2 (phase 3, published in JAMA in June 2026): 461 Chinese adults with moderate to severe obesity. Average weight loss was about 16.7% with mazdutide versus 1.5% with placebo after 60 weeks.
• DREAMS-1 (phase 3): 320 Chinese adults with type 2 diabetes, followed for 24 weeks. Both tested strengths lowered HbA1c, a measure of long-term blood sugar, more than placebo.

Nearly all of this evidence comes from trials in China. Lilly says mazdutide is being studied for obesity and alcohol use disorder, and it is running a phase 2 study that includes many U.S. sites.

Approval in China

China's National Medical Products Administration approved mazdutide for chronic weight management in adults with overweight or obesity on June 27, 2025, and for blood sugar control in adults with type 2 diabetes on September 19, 2025. According to Innovent, it was the first dual GLP-1 and glucagon receptor agonist approved anywhere.

U.S. regulatory status

Current status: Investigational – not FDA-approved.

Approval in China does not carry over to the United States. A drug must be approved by the FDA before it can be marketed to U.S. patients, and as of September 2026 the FDA had not approved mazdutide. It does not appear in any category of the FDA's 503A nomination lists (as updated May 14, 2026) and is not on the 503A bulks list, so it does not meet the conditions for 503A compounding.

Mazdutide offered online is not an approved medicine. Products labeled "for research purposes only" or "not for human consumption" are not approved medicines, and the FDA has not reviewed their contents, purity or quality. Several GLP-1-based medicines, including semaglutide and tirzepatide, are FDA-approved for weight management.

Documented safety information

In GLORY-2, vomiting, nausea and diarrhea were the most common adverse events and were reported far more often with mazdutide than with placebo. Stomach and bowel side effects are also the most common with other GLP-1-based medicines. U.S. regulators have not reviewed mazdutide's safety data or approved any labeling for it.

Why Peptide Labs does not sell mazdutide

Peptide Labs does not sell this compound. This page is general information, not medical advice. We are not a pharmacy, we do not supply mazdutide, and we do not point readers to anyone who does.

If you have questions about weight management or diabetes, talk to a licensed healthcare provider, who can discuss FDA-approved options.

Related reading

See the full list of compound profiles in the Peptide Guide. Related profiles: survodutide, another GLP-1 and glucagon dual agonist, retatrutide and semaglutide. You can also read semaglutide vs. tirzepatide or our guide to peptides for weight loss.