Prescription medicine
Ziftomenib Brand names: Komzifti
Ziftomenib (Komzifti) is a prescription medicine with an FDA approval on record since 2025. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the ziftomenib FDA label on DailyMed (effective December 9, 2025, Kura Oncology, Inc.); the NDA 220305 record on Drugs@FDA; every ziftomenib label on DailyMed.
Highlights of the record
FDA label of December 9, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
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 ( 2.5 ), Warnings and Precautions ( 5.1 ), and Adverse Reactions ( 6.1 )]. WARNING: DIFFERENTIATION SYNDROME See full prescribing information for complete boxed warning. Differentiation syndrome, which can be fatal, has occurred with KOMZIFTI. 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.
Used for
From the label: indications and usageKOMZIFTI is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 ( NPM1 ) mutation who have no satisfactory alternative treatment options [see Dosage and Administration ( 2.1 ), Clinical Pharmacology ( 12.1 ), and Clinical Studies ( 14 )].
Forms and strengths
- 200 mg
Capsule.
On the market
- Earliest approval on file
- November 13, 2025 Komzifti, Kura; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- July 16, 2044 Komzifti capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 48 through July 30, 2026
What is ziftomenib used for?
From the label: indications and usageKOMZIFTI is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 ( NPM1 ) mutation who have no satisfactory alternative treatment options [see Dosage and Administration ( 2.1 ), Clinical Pharmacology ( 12.1 ), and Clinical Studies ( 14 )]. KOMZIFTI is a menin inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 ( NPM1 ) mutation who have no satisfactory alternative treatment options.
Conditions named in the indications of ziftomenib's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Menin Inhibitor.
Source: FDA drug label (Komzifti), Kura Oncology, Inc., effective December 9, 2025 (SPL set b650f696-3391-4274-8b55-a5f5e9d04769), via openFDA; the full label on DailyMed
What does the patient leaflet for ziftomenib say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about KOMZIFTI?KOMZIFTI can cause serious side effects including: Differentiation Syndrome. Differentiation syndrome is a condition that affects your blood cells that is common during treatment with KOMZIFTI and can be life-threatening or lead to death if not treated. Differentiation syndrome can happen as early as 3 days after you start KOMZIFTI treatment and can also happen later during treatment with KOMZIFTI. Tell your healthcare provider or go to the nearest hospital emergency room right away if you develop any of the following signs or symptoms of differentiation syndrome during treatment with KOMZIFTI: fever joint or bone pain dizziness shortness of breath or trouble breathing cough chest pain rapid weight gain rash decreased urine output swelling of hands, feet, ankles, or legs If you develop signs and symptoms of differentiation syndrome during treatment with KOMZIFTI, your healthcare provider may temporarily stop KOMZIFTI and give you a corticosteroid medicine. Your healthcare provider will monitor you until your signs and symptoms improve. See “ What are the possible side effects of KOMZIFTI? ” for more information about side effects.
From the patient leaflet: How should I store KOMZIFTI?Store KOMZIFTI at room temperature between 68°F to 77°F (20°C to 25°C). KOMZIFTI comes in a container with a child-resistant cap. Keep KOMZIFTI and all medicines out of the reach of children.
Source: FDA drug label (Komzifti), Kura Oncology, Inc., effective December 9, 2025 (SPL set b650f696-3391-4274-8b55-a5f5e9d04769), via openFDA; the full label on DailyMed
Is there a generic for ziftomenib (Komzifti)?
No generic ziftomenib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 8 patents for Komzifti capsules: the compound patent runs to July 16, 2044. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2025 earliest approval on file
- 2044 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the ziftomenib label say about other medicines?
The ziftomenib label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Dexamethasone | warnings and precautions | Prior to starting treatment with KOMZIFTI, reduce the WBC counts to less than 25 x 10⁹/L. If differentiation syndrome is suspected, interrupt KOMZIFTI, initiate oral or intravenous corticosteroids (e.g., dexamethasone 10 mg every 12 hours) for a minimum of 3 days with hemodynamic and laboratory monitoring. |
Source: FDA drug label (Komzifti), Kura Oncology, Inc., effective December 9, 2025 (SPL set b650f696-3391-4274-8b55-a5f5e9d04769), via openFDA; the full label on DailyMed
What do FAERS reports show for ziftomenib?
The FDA Adverse Event Reporting System holds 48 reports that list ziftomenib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 14 are coded as a death and 10 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as ziftomenib?
37 other medicines are given the same way (oral) and in the same FDA class as ziftomenib or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Revumenib | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Lenalidomide | Leukemia, lymphoma and myeloma | 18 labelers | n/a | No current entry |
| Dasatinib | Leukemia, lymphoma and myeloma | 14 labelers | $26.46 per tablet 100 mg tablet | No current entry |
| Pomalidomide | Leukemia, lymphoma and myeloma | 11 labelers | n/a | No current entry |
| Imatinib | Leukemia, lymphoma and myeloma | 20 labelers | $0.624 per tablet 100 mg tablet | No current entry |
| Arsenic trioxide | Leukemia, lymphoma and myeloma | none listed | n/a | A presentation being discontinued |
| Nilotinib | Leukemia, lymphoma and myeloma | 6 labelers | n/a | No current entry |
| Hydroxyurea | Leukemia, lymphoma and myeloma | 10 labelers | $0.184 per capsule 500 mg capsule | No current entry |
Every medicine labeled for the same conditions as ziftomenib
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to ziftomenib
- 37 medicines for the same use
- Other menin inhibitors
- the pharmacologic class, with prices and generics
- Ziftomenib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other