DILI懸念を検出するためのin vitroスクリーニングプロセスの自社化合物を用いた遡及的分析

抄録

Drug-induced liver injury (DILI) is a significant public health problem that has a critical impact on not only patients but also healthcare professionals, pharmaceutical companies and regulatory authorities. It is considered difficult to predict its occurrence due to a complex interaction between chemical properties and patient factors.

Recent technological advances have led to the development of in vitro assays that can improve the predictability of clinical adverse events, and they are now becoming available in the early stages of drug discovery. Based on the concept of "Safety by Design", we have adopted a tiered approach that is stepwise approach from "a simple and high-throughput assay system" to "a complex assay system focused on organ toxicity".

Recently we re-evaluated Takeda legacy compounds including lapaquistat which has been terminated in phase III due to safety concerns in the liver, by the DILI-related assays introduced in the tiered approach, as part of evaluation of the usefulness of these assays for DILI prediction.

In this symposium, we will report the results and would like to discuss the future challenge to improve the predictability of clinical DILI.