Certara's Simcyp Simulator Enables FDA Approval of Asciminib for Chronic Myeloid Leukemia Treatment

Certara's Simcyp Simulator has enabled PBPK modeling predictions to support the FDA's approval of asciminib, a treatment for Chronic Myeloid Leukemia (CML). The simulator replaced at least ten human trials by accurately characterizing asciminib's pharmacokinetics across diverse patient populations and dosing regimens. This collaboration exemplifies the scientific partnership enabled by the Simcyp Simulator and demonstrates its value in drug development.