|Product name:||FG4592 aka ASP1517, roxadustat BULK POWDER 500 mg (PICTURE IS FOR ILLUSTRATION ONLY – as appeared in the news, product is a bulk powder)|
|Packing:||Packed according to the customer’s requirement|
|Remarks:||For Research Use Only|
|Molecular Structure:||Chemical Name: Glycine, N-[(4-hydroxy-1-methyl-7-phenoxy-3-isoquinolinyl)carbonyl]- M.Wt: 352.11 Formula:C19H16N2O5 Solubility: DMSO Purity: >98% Storage: at -20℃ 2 years 5G in stockBiological Activity: FG-4592, received Clinical Trial Application (CTA) approval from the Chinese State Food and Drug Administration (SFDA) to commence clinical development for the treatment of anemia associated with chronic kidney disease (CKD) in the People’s Republic of China. FG-4592 is a first-in-class hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitor (PHI) entering Phase 2b clinical development in the US and Europe for the treatment of CKD anemia. SFDA approved protocols for both Phase 1 and 2 studies. The first of these studies of FG-4592 in China will begin in the fourth quarter of 2010.References: FG-4592 oral anemia therapy receives CTA approval from SFDA
FibroGen is developing orally active HIF-PHI for treatment of anemia and is the first company to demonstrate proof of principle for oral anemia therapy in human clinical studies. FibroGen believes there are many potential advantages of HIF-PHI over erythropoiesis stimulating agents (ESAs) currently used to treat anemia and that significant opportunity exists to expand the market for anemia therapy with HIF-PHI.
HIF-PHIs work through an entirely different mechanism of action than ESAs do. HIF-PHIs stabilize HIF, the key regulatory protein that coordinates all elements of erythropoiesis necessary for proper formation of mature red blood cells plump with iron-rich, oxygen-carrying hemoglobin molecules. HIF also down-regulates hepcidin, a regulatory hormone that limits iron availability and thus suppresses erythropoiesis under conditions of inflammation.
The safety of long-term HIF activation is supported by examples from medicine and nature, such as congenital polycythemia (too many red blood cells), which is a disorder that can be caused by genetic mutations in the oxygen-sensing system leading to chronic HIF activation.
Available data suggests that HIF-PHI may offer several safety and efficacy advantages over current ESA therapy including correction of anemia with normal physiological levels of erythropoietin and correction of anemia without increasing blood pressure and treatment of dialysis patients who are hyporesponsive to ESAs.
Although ESAs were introduced nearly two decades ago, the chronic kidney disease anemia market in the US is still limited to treatment of dialysis patients. Oral bioavailability of HIF-PHI may increase access to anemia therapy for the largely underserved population of patients with anemia of chronic kidney disease who are not yet on dialysis and has the potential to successfully treat ESA-hyporesponsive dialysis patients.
FG-4592, FibroGen’s first two erythropoietic HIF-PHI, have been the subject of clinical studies involving nearly 700 subjects. Proof of principle has been demonstrated in dialysis and non-dialysis settings of anemia associated with chronic kidney disease, and both investigational drugs have been found generally safe and well tolerated in clinical studies conducted to date.
In addition to clinical development, FibroGen has a research program to further exploit certain beneficial properties resulting from the stabilization of HIF. New classes of compounds have been identified, which are considerably more potent for endogenous erythropoietin up-regulation than compounds currently in development. FibroGen expects to advance one or more of these compounds to clinical trials in the near future.
DISCLAIMER: THIS PRODUCT IS NOT INTENDED TO TREAT, CURE OR DIAGNOSE ANY CONDITION OR DISEASE, FOR RESEARCH ONLY