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Also: LY3305677 · 玛仕度肽
Four separate measurements, never averaged. Independent evidence counts only studies with no sponsor attached. Methodology version v2.0-2026-10 · how we grade evidence
Approved in mainland China only. China’s National Medical Products Administration approved it for chronic weight management on 27 June 2025 and for glycaemic control in type 2 diabetes on 19 September 2025. It is not approved in the United States, the European Union, the United Kingdom or anywhere else, and no FDA or EMA submission has been announced, so outside China it cannot be legally obtained as a medicine. A supplementary application for a higher-dose presentation was accepted for NMPA review on 25 November 2025 and no approval of it was found as of October 2026.
Innovent also reports large liver-fat and waist-circumference reductions. The generalisability limit is the thing to hold onto: essentially the entire phase 3 database is in Chinese adults, and there is no completed phase 3 evidence in any other population, so safety and efficacy elsewhere are not established. There is no cardiovascular outcomes trial result, maximum controlled exposure is 60 weeks, and Western post-marketing surveillance does not exist because the drug is not marketed there.
Every pivotal trial was designed, funded and analysed by Innovent, which reported GLORY-2 and the DREAMS diabetes trials by press release rather than in a peer-reviewed journal. Innovent reports no new safety signals and a profile consistent with the GLP-1 class.
Compounded or "research-grade" versions sold outside China’s regulated supply chain are not the approved product, and the data below do not describe them.
At a glance
An analogue of oxyntomodulin, a naturally occurring peptide that activates both the GLP-1 and glucagon receptors. GLP-1 agonism suppresses appetite and enhances glucose-dependent insulin secretion; glucagon-receptor agonism is intended to raise energy expenditure and mobilise hepatic fat. This is the same receptor pair as survodutide on a different molecular scaffold — an oxyntomodulin analogue rather than a glucagon analogue. The liver-fat findings in GLORY-1, reductions of 65.85% and 80.24% against 5.27% on placebo among participants starting with liver fat of 10% or more, are consistent with the glucagon-receptor component acting in humans. The individual receptor contributions have not been dissected in a human study.
Dated determinations, each flagged for whether it is final and whether it covers safety only. A safety review is not an efficacy finding, and most reporting in this category conflates the two.
Mazdutide is approved in mainland China only. It is not approved in the United States, the European Union, the United Kingdom or anywhere else, and no FDA or EMA submission has been announced. Outside China it remains fully investigational and cannot be legally obtained as a medicine. The practical limit on any future application is that essentially the whole phase 3 database is in Chinese adults. Date recorded as the date the regulatory record was checked, since this is a continuing absence rather than an event.
A supplementary application for a higher-dose presentation for adults with moderate-to-severe obesity, based on phase 3 GLORY-2, was accepted for review by the NMPA Center for Drug Evaluation on 25 November 2025. No evidence was found that it has been approved as of 13 October 2026, so it is recorded as still under review.
Announced 19 September 2025: approved as monotherapy, or in combination with metformin and/or a sulfonylurea, or with metformin and/or an SGLT2 inhibitor. This is the second full NMPA dossier review of the drug.
Announced 27 June 2025: approved as an adjunct to a reduced-calorie diet and increased physical activity in adults with obesity (BMI 28 or above) or overweight (BMI 24 or above) with at least one weight-related comorbidity. Note that the BMI thresholds are lower than those used in United States and European labels for this drug class.
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