Komzifti (ziftomenib)
An approved treatment for Acute Myeloid Leukemia.
The same compound appears under different names depending on the context. Here is how to identify Ziftomenib wherever you encounter it, plus the key facts at a glance.
- Generic name
- Ziftomenib
- Brand name
- Komzifti
- Development code
- KO-539
- Drug class
- Menin inhibitor
- Manufacturer
- Kura Oncology (with Kyowa Kirin)
- How it's taken
- Oral capsules once daily on an empty stomach
A once-daily capsule for adults whose NPM1-mutated AML has relapsed or never responded and who have no satisfactory alternative treatment. The FDA granted full approval on November 13, 2025, making it the second menin inhibitor and the first taken once a day. It is not approved for KMT2A-rearranged leukemia.
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Where Ziftomenib fits
The second approved menin inhibitor and the only once-daily one. Revuforj (revumenib) covers both NPM1-mutated AML and KMT2A-rearranged leukemia, including in children; Komzifti is for NPM1-mutated AML in adults. They have not been compared in a trial.
How Ziftomenib works
An NPM1 mutation, the most common gene change in adult AML, makes leukemia cells depend on a protein partnership between menin and KMT2A to keep their immature growth program switched on. Ziftomenib binds menin and breaks that partnership, the growth program shuts down and the blasts mature[1]. Kura published preclinical work in Blood in 2026 describing the drug's binding profile[4].
Mechanism: Oral menin inhibitor that blocks the menin-KMT2A interaction NPM1-mutated leukemia cells depend on, so blasts differentiate
Side effects and safety
- QTc prolongation. ECGs and electrolytes before and during treatment; interrupt if QTc exceeds 500 msec; correct low potassium and magnesium first.
- Embryo-fetal toxicity. Can harm an unborn baby; contraception during treatment and for 6 months after (women) or 3 months after (men).
- Noninfectious leukocytosis. A doubling of the white count in the first 2 weeks or a rise of 10 x 10^9/L is treated with hydroxyurea and checked for differentiation syndrome.
- White cell count below 25 x 10^9/L before the first dose
- ECG and electrolytes before starting and during treatment
- Blood counts and liver tests
- Watch for differentiation syndrome, especially in the first 7 weeks
Komzifti carries a boxed warning for differentiation syndrome, which occurred in 26% of the 112 NPM1-mutated patients at the approved dose, was grade 3 in 13% and fatal in 2; it began between 3 and 46 days after starting (median 15 days) and is managed by interrupting the drug and giving steroids[1]. Among 39 patients with KMT2A-rearranged AML treated in trials there were 4 fatal cases, and the drug is not approved for that group[1][2].
Other warnings are QTc prolongation (interrupt above 500 msec; keep potassium and magnesium normal) and harm to an unborn baby[1]. The most common side effects (20% or more) were infections, bleeding, diarrhea, nausea, fatigue, swelling, bacterial infection, musculoskeletal pain, differentiation syndrome, itching, febrile neutropenia and raised liver enzymes[1].
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Ziftomenib
The dose is 600 mg (capsules) by mouth once a day on an empty stomach, at least 1 hour before or 2 hours after a meal, until the leukemia progresses or side effects become unacceptable; the label recommends at least 6 months of treatment if the disease is not progressing[1]. Capsules are swallowed whole. The white cell count is brought below 25 x 10^9/L before starting.
Availability and cost
Only available as the brand-name product.
Help paying for Komzifti
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Copay help
KOMZIFTI Copay Card: eligible commercially insured patients pay as little as $0; ask the pharmacist for details. No annual cap is stated on the page.
For: private insurance · source - Insurance and case manager help
Kura RxKonnect helps with insurance coverage so you do not have to work it out alone. Call 1-844-587-2777, Monday to Friday, 8 AM to 8 PM ET.
For: private insurance, Medicare, Medicaid, TRICARE, no insurance, underinsured · source
Good to know: No free-drug program is described on Komzifti.com; status is partial until Kura publishes one or confirms there is none.
How the targeted AML pills compare, by mutation
AML has 19 FDA-approved medicines, counting the 3 older chemotherapy drugs. This chart covers the 8 that target a specific gene change, because the result of your mutation test decides which of them could apply to you. Chemotherapy (7+3, Vyxeos), Venclexta, Mylotarg, Onureg, Daurismo and the APL drugs are described on the drug pages instead. Several of these drugs are only approved after relapse, and all of the FLT3, IDH and menin drugs can cause differentiation syndrome, so your leukemia doctor will weigh the mutation, your point in treatment and your heart and liver tests.
Acute Myeloid Leukemia has 8 FDA-approved treatments: Rydapt (midostaurin, approved 2017); Vanflyta (quizartinib, approved 2023); Xospata (gilteritinib, approved 2018); Tibsovo (ivosidenib, approved 2018); Rezlidhia (olutasidenib, approved 2022); Idhifa (enasidenib, approved 2017); Revuforj (revumenib, approved 2024); Komzifti (ziftomenib, approved 2025). Rydapt is typically used as newly diagnosed, with intensive chemotherapy.
| Drug | Mutation it targets | When it is approved | How it's taken | How often | Given with | FDA approved |
|---|---|---|---|---|---|---|
Rydapt midostaurin | FLT3 (ITD or TKD) | Newly diagnosed, with intensive chemotherapy | Oral capsule | Twice daily on days 8 to 21 of each chemotherapy cycle | 7+3 induction and high-dose cytarabine consolidation (hospital-based chemotherapy) | 2017 |
Vanflyta quizartinib | FLT3-ITD only | Newly diagnosed, with intensive chemotherapy, then maintenance | Oral tablet | Once daily, with chemotherapy and then up to 36 months of maintenance | 7+3 induction and cytarabine consolidation, then alone as maintenance (not after transplant) | 2023 |
Xospata gilteritinib | FLT3 (ITD or TKD) | Relapsed or refractory | Oral tablets | Once daily | Taken alone | 2018 |
Tibsovo ivosidenib | IDH1 | Newly diagnosed (older or unfit) and relapsed or refractory | Oral tablets | Once daily | With azacitidine or alone (newly diagnosed, 75+ or unfit); alone at relapse | 2018 |
Rezlidhia olutasidenib | IDH1 | Relapsed or refractory | Oral capsule | Twice daily on an empty stomach | Taken alone | 2022 |
Idhifa enasidenib | IDH2 | Relapsed or refractory | Oral tablet | Once daily | Taken alone | 2017 |
Revuforj revumenib | KMT2A rearrangement (any acute leukemia) or NPM1 mutation (AML) | Relapsed or refractory (NPM1: after other options) | Oral tablets | Twice daily | Taken alone; adults and children 1 year and older | 2024 |
Komzifti ziftomenib You are here | NPM1 mutation | Relapsed or refractory, after other options | Oral capsules | Once daily on an empty stomach | Taken alone; adults only | 2025 |
This chart is for education only and is not medical advice. Approval dates, indications and warnings come from each drug's FDA prescribing information and Drugs@FDA. None of these drugs has been compared head to head with another in the same column, and trial results are not comparable across different studies. A leukemia specialist who has your mutation report will know which, if any, applies to you and whether a clinical trial would fit better.
Clinical trial results
KOMET-001 (NCT04067336), a single-arm study, treated 112 adults with relapsed or refractory NPM1-mutated AML (median of 2 prior regimens; 23% had a prior transplant) at 600 mg daily. Complete remission or complete remission with partial count recovery was reached by 21.4% (24/112), with complete remission in 17.0%, and the median duration of the combined response was 5.0 months[1][5].
In the Phase 1/2 KOMET-007 study (NCT05735184) of ziftomenib added to 7+3 chemotherapy in newly diagnosed disease, Kura and Kyowa Kirin reported on June 11, 2026 a composite remission rate of 96% and 12-month survival of 94% in 49 NPM1-mutated patients, and 90% and 71% in 50 KMT2A-rearranged patients, with grade 3 differentiation syndrome in 4%; this use is investigational[3].
The Phase 3 KOMET-017 program (NCT07007312, about 1,300 patients) is testing ziftomenib with 7+3 and with venetoclax and azacitidine in newly diagnosed NPM1-mutated or KMT2A-rearranged AML and is recruiting[2].
Development history
Ziftomenib (KO-539) was developed by Kura Oncology, which reports the frontline combination data jointly with Kyowa Kirin. The FDA granted full approval on November 13, 2025 for adults with relapsed or refractory NPM1-mutated AML; the first commercial sale was on November 21, 2025, and the NCCN guidelines added it as a category 2A option the same month[2][6].
Explore Acute Myeloid Leukemia trials
Other Acute Myeloid Leukemia treatments
Common questions about Ziftomenib
▸What is Ziftomenib (Komzifti)?
A once-daily capsule for adults whose NPM1-mutated AML has relapsed or never responded and who have no satisfactory alternative treatment. The FDA granted full approval on November 13, 2025, making it the second menin inhibitor and the first taken once a day. It is not approved for KMT2A-rearranged leukemia.
▸How does Ziftomenib work?
An NPM1 mutation, the most common gene change in adult AML, makes leukemia cells depend on a protein partnership between menin and KMT2A to keep their immature growth program switched on. Ziftomenib binds menin and breaks that partnership, the growth program shuts down and the blasts mature[1]. Kura published preclinical work in Blood in 2026 describing the drug's binding profile[4].
▸What are the side effects of Ziftomenib?
Komzifti carries a boxed warning for differentiation syndrome, which occurred in 26% of the 112 NPM1-mutated patients at the approved dose, was grade 3 in 13% and fatal in 2; it began between 3 and 46 days after starting (median 15 days) and is managed by interrupting the drug and giving steroids[1]. Among 39 patients with KMT2A-rearranged AML treated in trials there were 4 fatal cases, and the drug is not approved for that group[1][2]. Other warnings are QTc prolongation (interrupt above 500 msec; keep potassium and magnesium normal) and harm to an unborn baby[1]. The most common side effects (20% or more) were infections, bleeding, diarrhea, nausea, fatigue, swelling, bacterial infection, musculoskeletal pain, differentiation syndrome, itching, febrile neutropenia and raised liver enzymes[1].
▸How is Ziftomenib taken?
The dose is 600 mg (capsules) by mouth once a day on an empty stomach, at least 1 hour before or 2 hours after a meal, until the leukemia progresses or side effects become unacceptable; the label recommends at least 6 months of treatment if the disease is not progressing[1]. Capsules are swallowed whole. The white cell count is brought below 25 x 10^9/L before starting.
▸Is Ziftomenib FDA approved?
Yes, Ziftomenib (Komzifti) is FDA approved (2025) for the treatment of Acute Myeloid Leukemia.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- Kura Oncology via openFDA · 2025-12-09. Komzifti (ziftomenib) capsules prescribing information. https://api.fda.gov/drug/label.json?search=set_id:%22b650f696-3391-4274-8b55-a5f5e9d04769%22
- Kura Oncology · 2026-01-11. Kura Oncology Highlights Recent Accomplishments, Preliminary KOMZIFTI Revenue and Anticipated 2026 Milestones. https://ir.kuraoncology.com/news-releases/news-release-details/kura-oncology-highlights-recent-accomplishments-preliminary
- Kura Oncology · 2026-06-11. Kura Oncology and Kyowa Kirin Report Encouraging Long-Term Results for Ziftomenib / 7+3 Combination in Newly Diagnosed AML. https://ir.kuraoncology.com/news-releases/news-release-details/kura-oncology-and-kyowa-kirin-report-encouraging-long-term
- Kura Oncology. Press releases (through October 13, 2026). https://ir.kuraoncology.com/press-releases
- Journal of Clinical Oncology · 2025-11. Ziftomenib in Relapsed or Refractory NPM1-Mutated AML. https://pubmed.ncbi.nlm.nih.gov/40997296/
- FDA. Komzifti approval history. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220305