A novel phenotype-based drug-induced liver injury causality assessment tool (DILI-CAT) allows for signal confirmation in early drug development.

"Declaration of personal interests: Richard Hermann is a full‐time employee and stockholder at AstraZeneca. Don C. Rockey, Ayaka Suzuki, and Michael Merz have nothing to disclose. Hans L. Tillmann is a stockholder of Abbott, AbbVie and Gilead outside the submitted work. He reports that his wife is a full‐time employee of AbbVie. RH is employee of AstraZeneca and holds stock in AstraZeneca, MM is a consultant to AstraZeneca. DCR and AS have no conflict of interest."

"Funding information DCR was supported by the NIH (grant P30DK 123704). Data were provided by AstraZeneca as an in kind contribution. The corresponding author of this manuscript certifies that the contributors’ and conflicts of interest statements included in this paper are correct and have been approved by all co‐authors."