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AP0025 is a long-acting recombinant protein analog of fibroblast growth factor 21 (FGF21) currently in Phase II development by Protheragen. FGF21 is a metabolic hormone that plays a critical role in regulating glucose and lipid metabolism, insulin sensitivity, and energy expenditure. By acting as an agonist at the FGF21 receptor complex (comprising FGFR1c, FGFR2c, or FGFR3c and the co-receptor β-Klotho), AP0025 aims to reduce hepatic steatosis, inflammation, and fibrosis. The drug is being investigated for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), formerly known as non-alcoholic steatohepatitis (NASH), and severe hypertriglyceridemia (SHTG). Its long-acting profile is designed to provide sustained therapeutic effects with a reduced dosing frequency compared to native FGF21.
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