DILIrank 2.0: An updated and expanded database for drug-induced liver injury risk based on FDA labeling and a literature review

• Built on DILIrank 1.0, the widely adopted database for DILI classification, the new version 2.0 features updated DILI annotations for existing drugs and new DILI annotations for drugs approved by the FDA through 2021. • DILIrank 2.0 consists of 1336 drugs, a 29% increase from DILIrank 1.0, with 217 Most-DILI-Concern, 351 Less-DILI-Concern, 414 No-DILI-Concern, and 354 Ambiguous-DILI-Concern drugs. • DILIrank 2.0 reveals the significant impact of FDA regulatory actions on the liver safety profiles of approved drugs over time. • DILIrank 2.0 offers a valuable resource for evaluating NAMs aimed at predicting the risk for DILI in humans. Drug-induced liver injury (DILI) is of great concern in drug development and public health. DILIrank 1.0, a widely used public dataset that ranks FDA-approved drugs by their potential to cause DILI, has significantly enabled the development of new methods for improved DILI assessment. Here, we introduce DILIrank2.0, an essential update of DILIrank 1.0, to capture new non-biologics drug and liver-related adverse event data generated since its inception 15 years ago. Using DILIrank 2.0, we also observe changes in the DILI profiles of approved drugs following the introduction of different FDA regulatory programs. DILIrank 2.0 is an up-to-date resource that offers opportunities for supporting DILI safety assessment, predictive model development, and evaluation of new approach methods (NAMs).