Peer-Reviewed Publication

CPT Pharmacometrics Syst Pharmacol2026;15(9):e70327.September 1, 2026Journal Article

A Practical Alternative to Refine the Estimate of fmCYP3A4 and Evaluate Drug-Drug Interaction Potential for Ziftomenib Using PBPK Modeling to Inform Labeling.

Ian E Templeton¹, Chara Litou¹, Hannah M Jones¹, Julie Mackey Ahsan², Marilyn Tabachri², Mollie Leoni², Amitava Mitra²

¹PBPK Consultancy, Simcyp Division, Certara UK Ltd, Sheffield, UK.

²Kura Oncology, Inc., San Diego, California, USA.

Abstract

Accurate physiologically based pharmacokinetic (PBPK) simulation of drug-drug interaction (DDI) potential requires estimation of the relative contribution of the impacted pathway. While fraction metabolized by CYP enzymes is usually estimated using dedicated clinical DDI studies with strong CYP inhibitors, this approach might not be available in some situations. In the case of the menin inhibitor,…

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