Abstract
The identification of biomarkers of drug-induced kidney injury is an area of intensive focus in drug development. Traditional markers of renal function, including blood urea nitrogen and serum creatinine, are not region-specific and only increase significantly after substantial kidney injury. Therefore, more sensitive markers of kidney injury are needed. The ideal biomarkers will identify nephrotoxicity early in the drug-discovery process, resulting in decreased development costs and safer drugs. Metabolomics, the study of the small biochemicals present in a biological sample, has become a promising player in the nephrotoxicity arena. In this review, we describe the current status of the identification of metabolic biomarkers for drug-induced kidney toxicity screening. Many of these markers have been confirmed across multiple studies and can detect nephrotoxicity earlier than the traditional clinical chemistry and histopathology methods. Upon further validation, such markers will offer clear benefits for the pharmaceutical industry and regulatory agencies.
Financial & competing interests disclosure
Kurt Boudonck, Donald Rose, Edward Karoly, Douglas Lee and Kay Lawton are current or former employees of and Paula Lapinskas has been a consultant for Metabolon, Inc. and, as such, have affiliations with or financial involvement (e.g., employment, consultancies, honoraria, stock ownership or options, grants and patents received or pending) with Metabolon, Inc. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
No writing assistance was utilized in the production of this manuscript.