U.S. FDA grants fast track designation to Astellas for the development of ASP1128 for patients at risk for acute kidney injury


28 October 2019 - Astellas Pharma today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of ASP1128 for patients at increased risk of developing moderate to severe acute kidney injury (AKI) after coronary artery bypass and/or valve (CABG/V) surgery. 

ASP1128 is an investigational compound that is a potent and highly selective PPARδ modulator. ASP1128 is believed to have protective effects on kidney cells that are under cellular stress following CABG/V surgery by promoting fatty acid oxidation in the mitochondria. Further, ASP1128 may have the potential to reduce systemic and local inflammatory responses and oxidative stress. The 1128-CL-0201 proof of concept Phase 2 study is ongoing. 

The study design is a randomised, double-blind, placebo controlled study enrolling approximately 220 patients across the United States.

Read Astellas press release

Michael Wonder

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Michael Wonder

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Medicine , US , Fast track