PF-04895162 (ICA-105665), a drug in development for the treatment of epilepsy, was terminated after transaminase elevations (up to grade 3) were observed in healthy volunteers (NCT01691274). The human hepatotoxicity was unexpected because liver safety concerns had not been raised in preclinical safety studies (Aleo et al. 2019).
By Vinal V. Lakhani, Grant Generaux, Yuching Yang, Sashi Nadanaciva, Luping Qiu, Keith Riccardi, Li Di, Brett A. Howell, Scott Q. Siler, Paul B. Watkins, Hugh A. Barton, Michael D. Aleo, Lisl K. M. Shoda
Canceled: SOT 59th Annual Meeting & ToxExpo March 15-19. 2020 in Anaheim, California