Brand Name
Komzifti
Generic Name
Ziftomenib
View Brand Information FDA approval date: November 13, 2025
Form: Capsule
What is Komzifti (Ziftomenib)?
KOMZIFTI is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 mutation who have no satisfactory alternative treatment options [see Dosage and Administration.
Approved To Treat
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Related Clinical Trials
Phase 1 Study to Determine the Safety and Tolerability of Ziftomenib Combinations for the Treatment of KMT2A-rearranged or NPM1-mutant Relapsed/Refractory Acute Myeloid Leukemia
Summary: The safety, tolerability, and antileukemic response of ziftomenib in combination with standard of care treatments for patients with relapsed/refractory acute myeloid leukemia will be examined with the following agents: FLAG-IDA, low-dose cytarabine, and gilteritinib.
Phase 3 Randomized, Double-blind, Placebo-controlled Studies Assessing Ziftomenib in Combination With Either Standard of Care Nonintensive (Venetoclax+Azacitidine) or Intensive (7+3) Therapy in Patients With Untreated NPM1 Mutated or KMT2A Rearranged Acute Myeloid Leukemia
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An Open Label Phase I Study of Ziftomenib as Maintenance Therapy Following Allogeneic Hematopoietic Cell Transplantation
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Brand Information
Komzifti (ziftomenib)
WARNING: DIFFERENTIATION SYNDROME
Differentiation syndrome, which can be fatal, has occurred with KOMZIFTI. Signs and symptoms may include fever, joint pain, hypotension, hypoxia, dyspnea, rapid weight gain or peripheral edema, pleural or pericardial effusions, pulmonary infiltrates, acute kidney injury, and rashes. If differentiation syndrome is suspected, interrupt KOMZIFTI and initiate oral or intravenous corticosteroids with hemodynamic and laboratory monitoring until symptom resolution; resume KOMZIFTI upon symptom improvement [see Dosage and Administration (.
1INDICATIONS AND USAGE
KOMZIFTI is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (
2DOSAGE FORMS AND STRENGTHS
Capsules of ziftomenib are available in 200 mg strength. The capsules are white and are imprinted with “ZIF 200” in black ink.
3CONTRAINDICATIONS
None.
4ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Differentiation Syndrome
- QTc Interval Prolongation
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
5DESCRIPTION
KOMZIFTI contains ziftomenib, a menin inhibitor.
The chemical name is (
The chemical structure is:
The molecular formula is C
Ziftomenib is a white to off-white powder and is highly soluble in aqueous solution at pH 1.2 and practically insoluble at pH ≥4.
KOMZIFTI (ziftomenib) is available as a 200 mg capsule for oral administration.
Each KOMZIFTI capsule contains 200 mg ziftomenib and the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, and sodium lauryl sulfate. The capsule shells, imprinted with black ink, contain the following inactive ingredients: hypromellose and titanium dioxide.
6CLINICAL STUDIES
The efficacy of KOMZIFTI was evaluated in an open-label, single-arm, multicenter clinical trial (Study KO-MEN-001, NCT04067336; KOMET-001) in 112 adult patients with relapsed or refractory AML with an
The baseline demographic and disease characteristics for the 112 treated patients are shown in
Efficacy was established based on the rate of complete remission (CR) plus CR with partial hematological recovery (CRh), the duration of CR+CRh, and the rate of conversion from transfusion dependence to transfusion independence. The median follow-up was 4.2 months (range, 0.1 to 41.2 months).
The efficacy results are shown in
For patients who achieved a CR or CRh, the median time to first response was 2.7 months (range, 0.9 to 15 months). Of the 24 patients who achieved a response of CR or CRh, 21 (88%) patients did so within 6 months of initiating KOMZIFTI.
Among the 66 patients who were dependent on red blood cell (RBC) and/or platelet transfusions at baseline, 14 (21.2%) became independent of RBC and platelet transfusions during any 56-day post-baseline period. Of the 46 patients who were independent of both RBC and platelet transfusions at baseline, 12 (26.1%) patients remained transfusion independent during any 56-day post-baseline period.
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (