insulin ludefen

Insulin ludefen (code name: GZR4) is an investigational, ultra-long-acting, once-weekly basal insulin analog developed by Gan & Lee Pharmaceuticals for the treatment of type 2 diabetes mellitus (T2DM). It is a fourth-generation basal insulin designed with three amino acid substitutions in the human insulin main chain (A14E, B16H, and B25H), removal of the B30 threonine, and conjugation of a 22-carbon fatty diacid to the B29 position via a 12-unit oligomeric ethylene glycol (OEG) spacer. These modifications enable reversible binding to circulating albumin, resulting in a prolonged half-life and a smooth, stable pharmacokinetic profile. In pivotal Phase III clinical trials (including SUPER-1, SUPER-2, and SUPER-3), once-weekly insulin ludefen demonstrated superior HbA1c reduction compared to once-daily basal insulins (such as insulin glargine U100 and insulin degludec) with a favorable safety and tolerability profile and a low risk of severe hypoglycemia.

Other names

GZR4 InjectionGZR-4 InjectionGZR 4 Injection