Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia Patients
Indication: Relapsed/refractory NPM1-mutated acute myeloid leukemia
Free ziftomenib population PK simulator for relapsed/refractory NPM1-mutated AML. Explore 600 mg QD dosing, food, PPI, strong CYP3A4 inhibitor effects, and KO-739/KO-516 metabolite exposure from Mitra et al. 2026.
Drug Overview
Clinical Context
- Molecular Target
- Menin-KMT2A interaction
- Drug Class
- Menin inhibitor
- Therapeutic Area
- Oncology / Acute myeloid leukemia
- Indication
- Relapsed/refractory NPM1-mutated acute myeloid leukemia
- Route of Administration
- Oral
Model Information
- Model Type
- 2-compartment oral parent model with linked KO-739 and KO-516 metabolites
- Category
- Population PK with linked metabolites
- Reference
- Mitra et al. CPT: Pharmacometrics & Systems Pharmacology 2026
This simulator was built from published pharmacometric literature using PKPDBuilder's AI-powered model extraction pipeline.
Ziftomenib PopPK Model for R/R NPM1-mutated AML
This simulator implements the Mitra et al. 2026 population PK model for oral ziftomenib and its KO-739 / KO-516 metabolites. It supports scientific exploration of the 600 mg once-daily dose and clinically relevant covariate scenarios including food, PPI use, strong CYP3A4 inhibition, and healthy volunteer versus AML patient populations.
Model highlights
- 2-compartment parent ziftomenib model
- First-order absorption with lag time
- Linked KO-739 and KO-516 metabolite compartments
- Food, PPI, and strong CYP3A4 inhibitor covariate switches
- 600 mg QD dose scenario for adult R/R NPM1-mutated AML
Clinical pharmacology context
The published analysis reported flat exposure-response profiles across evaluated efficacy and safety endpoints over the studied exposure range, supporting a wide therapeutic margin.
Read the dedicated Ziftomenib landing page →Pharmacokinetic Parameters
PK Parameters
| Parameter | Value |
|---|---|
| Q | 27.7 L/h |
| CL | 11.6 L/h |
| Ka | 0.0928 1/h |
| Vc | 54.6 L |
| Vp | 1106 L |
Parameters sourced from published population pharmacokinetic models. Values represent typical population estimates; individual patient parameters may vary.
About This Simulator
This interactive pharmacokinetic simulator for Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia Patients allows you to explore concentration-time profiles under different dosing scenarios. The underlying Population PK with linked metabolites model characterizes the pharmacokinetics of this menin inhibitor following oral administration.
Use the simulator to visualize key exposure metrics including AUC (area under the curve), Cmax (peak concentration), and Ctrough (trough concentration).
Built with PKPDBuilder — an AI-powered platform that transforms published pharmacometric literature into interactive, deployable Shiny applications. No coding required.
Frequently Asked Questions
What is ziftomenib?
Ziftomenib is an oral, highly selective menin inhibitor being developed for genetically defined acute myeloid leukemia, including relapsed/refractory NPM1-mutated AML. Menin inhibition disrupts the menin-KMT2A interaction and downstream leukemogenic transcriptional programs.
What dose does this ziftomenib PK simulator emphasize?
The simulator emphasizes 600 mg once daily, the dose supported by the Mitra et al. 2026 population PK and exposure-response analysis in adult relapsed/refractory NPM1-mutated AML patients.
Which covariates can I explore in the ziftomenib simulator?
The simulator includes scenario switches for fed versus fasted dosing, proton pump inhibitor use, strong CYP3A4 inhibition, and healthy volunteer versus AML patient population. It also simulates KO-739 and KO-516 metabolite profiles.
Does the published analysis support ziftomenib dose adjustment with azole antifungals?
The published exposure-response analysis reported that antifungal azoles had no clinically meaningful impact on efficacy or safety profiles in the studied population, supporting co-administration without dose adjustment. This simulator is for research and education, not patient-specific clinical dosing.
What is the Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia Patients PK simulator?
This is a free, interactive pharmacokinetic simulator for Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia Patients used in Relapsed/refractory NPM1-mutated acute myeloid leukemia. It allows researchers, pharmacologists, and students to explore concentration-time profiles, dosing regimens, and exposure metrics based on published population PK models.
What drug class does Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia Patients belong to?
Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia Patients is classified as a Menin inhibitor that targets Menin-KMT2A interaction. It is used in the Oncology / Acute myeloid leukemia therapeutic area.
What route of administration does this model simulate?
This simulator models Oral administration of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia Patients. The pharmacokinetic parameters (absorption rate, bioavailability, volume of distribution) are specific to this route.
What type of PK model is used?
This simulator uses a Population PK with linked metabolites model. This model characterizes the time-course of drug concentrations following dosing.
Is this simulator free to use?
Yes, all PKPDBuilder simulators are completely free. They are built from published pharmacokinetic literature and are intended for research and educational purposes. No login is required to run simulations.
Can I use this for clinical dosing decisions?
No. This simulator is for research and educational purposes only. It should not be used for clinical decision-making or patient dosing. Always consult the prescribing information and clinical pharmacology guidelines for therapeutic drug use.
What is the clearance of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia Patients?
The clearance (CL) of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia Patients is approximately 11.6 L/h. Clearance represents the volume of plasma from which drug is completely removed per unit time and is a key determinant of drug exposure and steady-state concentrations.
Ready to Simulate?
Launch the Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia Patients simulator to explore dosing scenarios and pharmacokinetic profiles interactively.
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⚠️ Disclaimer
This simulator is for research and educational purposes only. It is not intended for clinical decision-making, patient dosing, or therapeutic drug monitoring. Pharmacokinetic parameters are derived from published literature and represent population-level estimates. Individual patient pharmacokinetics may differ significantly. Always consult approved prescribing information and qualified healthcare professionals for clinical decisions.
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