A Practical Alternative to Refine the Estimate of fmCYP3A4 and Evaluate Drug-Drug Interaction Potential for Ziftomenib Using PBPK Modeling to Inform Labeling. (PubMed, CPT Pharmacometrics Syst Pharmacol) - Sep 3, 2026 - "Moderate or weak interaction (2.6-fold and 1.4-fold increase in AUC) was predicted with itraconazole and isavuconazole, respectively. Approximately 80% reduction in ziftomenib AUC was predicted with rifampicin. Ziftomenib was predicted to be a weak CYP3A4 inhibitor, causing a 1.9-fold increase in midazolam exposure. In the absence of data from dedicated DDI clinical trials, these results were used to support regulatory interactions with the US FDA regarding concomitant administration of ziftomenib with other medications such as CYP3A4 modulators. These modeling results ultimately supported a range of DDI language in ziftomenib label."
Journal • Acute Myelogenous Leukemia • Infectious Disease
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Amitava Mitra; Chara Litou; Hannah M Jones; Ian E Templeton; Julie Mackey Ahsan; Marilyn Tabachri; Mollie Leoni
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