Phase 2a study of FG-4592 for the treatment of anemia associated with chronic kidney disease (CKD)

FibroGen announced data from its Phase 2a study of FG-4592 (oral anemia therapy) in patients with stage 3-4 chronic kidney disease (CKD) and anemia. This data demonstrated that its first-in-class, investigational oral anemia therapy FG-4592 works differently than erythropoiesis stimulating agents (ESAs) to increase hemoglobin. Advantages of FG-4592 over current ESA therapy show that FG-4592 increases hemoglobin concentration and is expected to do so:

  • with levels of circulating endogenous erythropoietin (EPO) within the physiological range in contrast to supraphysiologic EPO levels resulting from treatment with ESAs;
  • without increase in blood pressure whereas rates of new or worsening hypertension of 25-40% are described in ESA prescribing information;
  • regardless of baseline iron status and without supplemental iron; whereas iron supplementation is required in nearly all ESA-treated patients; and
  • in patients who do not respond well to ESA therapy (“hyporesponders”), who, largely due to inflammation, require up to 20 times the ESA dose utilized by the best responding patients.

FG-4592 is a hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitor (PHI) that stabilizes HIF, the key regulatory protein that coordinates all elements of erythropoiesis necessary for proper formation of mature, iron-rich red blood cells plump with oxygen-carrying hemoglobin molecules.

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