Absentia’s Digital Kidney Model Joins its Multi-Organ Safety Platform
The AI-driven Drug-Induced Renal Injury (DIRI) Model is the latest Absentia organ-system model accepted into FDA’s ISTAND qualification pathway, following its liver and cardiac milestones. The model is designed to evaluate how kidney-specific drug exposure and features, including regional pH, contribute to renal injury risk.
Module
Digital Kidney Module
Status
Accepted into FDA’s ISTAND qualification pathway
Focus
Kidney-specific drug exposure and regional conditions
Readouts
Cytotoxicity, cell stress and renal-specific mechanisms
Kidney safety is difficult to predict using conventional preclinical signals.
Drug-induced renal injury can emerge late in development despite an apparently reassuring early safety profile. Kidney exposure can reach up to 100 times plasma levels as waste is concentrated into urine. Clinical DIRI biomarkers often do not become reliably significant until injury is severe. No ISTAND-qualified NAMs exist for predicting DIRI. In vivo preclinical models often fail to predict chronic exposure damage and maladaptive repair mechanisms. These may not be identified until Phase 3 clinical trials.
UP TO 100x
Kidney exposure versus plasma, as waste is concentrated into urine.
ABOUT 19%
Of small-molecule toxic failures in Phase 3 are DIRI.
0
No ISTAND-qualified NAMs for DIRI.
Why kidney exposure and injury mechanisms require different readouts
Absentia’s DIRI Model evaluates how changes in drug concentration and local microenvironmental factors drive renal injury risk.
Cytotoxicity / cell stress
01
Mitochondrial and bioenergetic dysfunction
02
Oxidative stress and redox imbalance
03
Reactive metabolites and bioactivation
04
Autophagy and lysosomal dysfunction
05
Convergent cell death mechanisms
Interested in evaluating Absentia’s Digital Kidney Model?
Talk to our team about drug-induced renal injury, kidney-specific exposure and injury mechanisms, or a scientific collaboration. Share your kidney safety questions using the form or contact Jeff directly.
Explore other safety modules.
Kidney safety is the newest module in Absentia’s predictive safety platform. See every module, and what is coming next, on the Technology page.
