Pegozafermin (BIO89-100) is a long-acting, glycopegylated FGF21 analog developed for the treatment of nonalcoholic steatohepatitis and hypertriglyceridemia. [1] [2] [3] [4]

2023年6月24日 · Pegozafermin is a long-acting glycopegylated (pegylated with the use of site-specific glycosyltransferases) fibroblast growth factor 21 (FGF21) analogue in development for the treatment of...

Pegozafermin, a long-acting glycopegylated analog of human fibroblast growth factor 21, is in development for the treatment of severe hypertriglyceridemia (SHTG) and nonalcoholic...

Pegozafermin is an investigational FGF21 analog engineered using glycoPEGylation technology with site-specific mutations designed to recapitulate the activity profile and prolong the half-life of the native FGF21 hormone, which may address underlying metabolic issues that drive liver and cardiometabolic diseases, such as MASH and SHTG (severe ...

2024年3月12日 · ENLIGHTEN-Fibrosis is a global Phase 3, randomized, double-blind, placebo-controlled trial of pegozafermin for the treatment of patients with biopsy-confirmed non-cirrhotic MASH.

2024年3月12日 · Pegozafermin was granted Breakthrough Therapy Designation for MASH with fibrosis by the US Food and Drug Administration (FDA) on September 21, 2023, supported by data from the ENLIVEN phase 2b trial.

2022年8月26日 · Among patients with severe hypertriglyceridemia in the ENTRIGUE trial, treatment with subcutaneous pegozafermin, an FGF21 analog, significantly reduced triglycerides across all dose groups versus placebo without serious treatment adverse effects.

2023年5月2日 · A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects with Severe Hypertriglyceridemia (SHTG): the ENTRUST Study.

2023年6月30日 · Pegozafermin, a long-acting glycopegylated fibroblast growth factor 21 (FGF21) analogue, is in development for treatment of both NASH and severe hypertriglyceridemia. Findings for the latter were presented at the 2023 American College …

2023年9月26日 · The US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to pegozafermin (89bio Inc.) for the treatment of patients with nonalcoholic steatohepatitis (NASH), according to a September 21, 2023, announcement from …