FDA grants Astellas ASP1128 fast-track eligibility
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Last Update: 2020-06-07
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Source: Internet
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Author: User
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recently, Japanese drug maker Astellas announced that the U.SFood andDrug(http://Administration (
FDA(http://) has granted ASP11128 fast-track eligibility for the treatment of patients with increased risk of moderate to severe acute renal injury (AKI) after coronary artery bypass and/or valve (CABG/V) surgeryAbout ASP1128
ASP1128 is a powerful, highly selective PPAR regulator and a potentially pioneering therapy for AKIASP1128 is thought to protect renal cells under cellular stress after CABG/V surgery by promoting the oxidation of fatty acids in mitochondriaIn addition, ASP1128 may have the potential to reduce systemic and local inflammatory responses and oxidative stressPreclinical data show that after acute ischemic re-perfusion injury, intervention for ASP1128 can improve mitochondrial function, overall energy metabolism and kidney performanceIn the AKI animal model, ASP1128 improved renal function, histopathology and injury biomarkersCurrently, asP11128 Phase II Of Concept Study 1128-CL-0201 is in progress, a randomized, double-blind, placebo-controlled study in the United States in about 220 patients
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