Based on the natural human GLP-1 molecule, the eighth (alanine → alpha-aminobutyric acid) and the 34th amino acid (lysine → arginine) were substituted, while lysine at the 26th was linked to the C18 adipose acid side chain by spacer group. After the modification of human GLP-1 molecule, Smeiglutide can resist the degradation of dipeptidyl peptidase 4 (DPP-4), bind closely to albumin, significantly prolong the half-life in vivo, achieve once a week administration, and retain up to 94% of GLP-1 amino acid sequence homology, with good safety.
In December 2017, the US Food and Drug Administration (FDA) approved Smegalutide injection for the control of blood sugar in adults with type 2 diabetes.
In January 2020, it was approved by the FDA to reduce the risk of major cardiovascular adverse events in adults with type 2 diabetes with cardiovascular disease.
On December 4, 2020, Novo Nordisk submitted to the FDA a marketing application for weight loss with Smeiglutide 2.4mg subcutaneously injected once a week.
In April 2021, it was approved by the State Food and Drug Administration (NMPA) for the treatment of adult type 2 diabetes mellitus and reducing the risk of cardiovascular adverse events in patients with T2DM combined with cardiovascular disease.
On December 3, 2021, it was included in the "National Basic Medical Insurance, industrial injury Insurance and maternity Insurance Drug Catalog (2021)".