Mazdutide: First Approval

Drugs. 2025 Dec;85(12):1621-1627. doi: 10.1007/s40265-025-02249-y. Epub 2025 Sep 30.

Abstract

Mazdutide (Xinermei®) is a dual glucagon receptor (GcgR) and glucagon-like peptide-1 receptor (GLP-1R) agonist being developed by Eli Lilly and Company along with Innovent Biologics for use in weight management in adults with obesity or overweight and for the treatment of type 2 diabetes (T2D). In June 2025, mazdutide received its first approval, in China, for use (in combination with diet control and increased physical activity) in long-term body weight management in adults with a body-mass index (BMI) of ≥ 28 kg/m2 or with a BMI ≥ 24 kg/m2 together with one or more weight-related comorbidity. Subsequently, in September 2025, mazdutide also received approval in China for use in glycaemic control in adults with T2D. Additionally, mazdutide is under clinical evaluation for use in the treatment of metabolic dysfunction-associated fatty liver disease, obstructive sleep apnoea and alcohol use disorder. This article summarises the milestones in the development of mazdutide leading to this first approval for long-term body weight management in adults with obesity or overweight.

Publication types

  • Review

MeSH terms

  • Anti-Obesity Agents / therapeutic use
  • China
  • Diabetes Mellitus, Type 2* / drug therapy
  • Drug Approval
  • Glucagon-Like Peptide-1 Receptor Agonists
  • Humans
  • Hypoglycemic Agents* / pharmacology
  • Hypoglycemic Agents* / therapeutic use
  • Obesity* / drug therapy
  • Overweight / drug therapy
  • Peptides
  • Receptors, Glucagon / agonists

Substances

  • Glucagon-Like Peptide-1 Receptor Agonists
  • Receptors, Glucagon
  • Hypoglycemic Agents
  • Anti-Obesity Agents
  • mazdutide
  • Peptides