FG-4592 is an orally-available isoquinoline-based inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase for the treatment of anemia and patients with chronic kidney disease. [1] Phase 2 studies indicate that oral administration of FG-4592 three times a week increased mean hemoglobin levels in the first eight weeks, regardless of supplementation with IV or oral iron, or no iron supplementation. FG-4592 is novel in that it allows integration of red blood cell production and efficient iron incorporation simultaneously. [1]

Data from Phase 2 trials comparing with epoetin alpha indicate that treatment with FG-4592 alone results in a sustained reduction of total plasma cholesterol levels by an average of 20%, while no reduction was seen with epoetin alpha. [2, 3]

In December, 2012, Fibrogen and Astellas Pharma announced the initiation of a Phase 3 clinical development program for the treatment of anemia associated with chronic kidney disease in patients not on dialysis and on dialysis. [4]