Revuforj (revumenib)
An approved treatment for Acute Myeloid Leukemia.
The same compound appears under different names depending on the context. Here is how to identify Revumenib wherever you encounter it, plus the key facts at a glance.
- Generic name
- Revumenib
- Brand name
- Revuforj
- Development code
- SNDX-5613
- Drug class
- Menin inhibitor
- Manufacturer
- Syndax Pharmaceuticals
- How it's taken
- Oral tablets twice daily
The first menin inhibitor, a twice-daily tablet for adults and children 1 year and older with relapsed or refractory acute leukemia carrying a KMT2A translocation (approved November 15, 2024) or relapsed or refractory AML with a susceptible NPM1 mutation and no satisfactory alternative (October 24, 2025). Together these cover roughly a third of adult AML.
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Where Revumenib fits
The first of 2 approved menin inhibitors; Komzifti (ziftomenib) is approved for NPM1-mutated AML only, in adults. Both are used after relapse, and both are being tested with chemotherapy or venetoclax in newly diagnosed disease.
How Revumenib works
In leukemias with a KMT2A rearrangement or an NPM1 mutation, a protein called menin anchors a gene-control complex that keeps blasts from maturing. Revumenib binds menin and blocks that anchoring, which switches off the leukemia gene program and lets the cells differentiate[1]. Because it works by differentiation, it shares the differentiation syndrome risk of the IDH inhibitors and can take 1 to 3 months to produce a remission.
Mechanism: Oral menin inhibitor that breaks the menin-KMT2A interaction leukemia cells with KMT2A rearrangements or NPM1 mutations depend on, so blasts differentiate
Side effects and safety
- QTc prolongation. ECG before starting, weekly for the first 4 weeks and at least monthly after; electrolytes kept normal; lower dose with strong CYP3A4 inhibitors such as azole antifungals.
- Embryo-fetal toxicity. Can harm an unborn baby; contraception during treatment and for 4 months after (women) or 4 months after (men).
- Noninfectious leukocytosis. A rising white count can signal differentiation syndrome and is treated with hydroxyurea.
- White cell count under 25 Gi/L before starting
- ECG schedule above
- Blood counts, electrolytes including phosphate, liver and kidney tests
- Watch for differentiation syndrome from the first week
Revuforj carries a boxed warning for differentiation syndrome, QTc prolongation and torsades de pointes. Differentiation syndrome occurred in 25% of the 241 patients treated at the approved dose (33% of those with KMT2A AML), with fever, breathlessness, low oxygen, swelling, fluid around the lungs or heart, kidney failure, rash or low blood pressure, and it is treated with steroids at once[1].
ECGs and electrolytes are checked and the dose adjusted for QTc changes; strong CYP3A4 inhibitors require a lower dose[1]. The other warning is harm to an unborn baby. The most common side effects (20% or more, including lab changes) were raised phosphate, bleeding, nausea, infections, raised AST, ALT and creatinine, musculoskeletal pain, febrile neutropenia, QT prolongation, low potassium, raised parathyroid hormone, raised alkaline phosphatase, diarrhea, bacterial infection, raised triglycerides, differentiation syndrome, fatigue, swelling, viral infection, low phosphate, decreased appetite and constipation[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 Revumenib
Taken by mouth twice a day, about 12 hours apart, fasted or with a low-fat meal. Adults and children weighing 40 kg or more take 270 mg twice a day, or 160 mg twice a day when a strong CYP3A4 inhibitor is also being taken; smaller children are dosed by body surface area (160 mg/m2 or 95 mg/m2 twice a day)[1]. Treatment does not start until the white cell count is below 25 Gi/L, continues until the leukemia progresses or side effects become unacceptable, and the label recommends at least 6 months to allow a response[1].
Availability and cost
Only available as the brand-name product.
Help paying for Revuforj
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
Revuforj Copay Program: eligible commercially insured patients pay as little as $0 per prescription, with no income restrictions; maximum benefits may apply. Excludes cash-paying patients and Medicare Parts A to D, Medicaid, TRICARE, VA, DoD and other government programs.
For: private insurance · source - Insurance and case manager help
SyndAccess nurses and insurance verification at 1-888-567-SYND (7963), Monday to Friday, 8 AM to 8 PM ET.
For: private insurance, Medicare, Medicaid, TRICARE, no insurance, underinsured · source
Good to know: Phone is 1-888-567-SYND. Syndax's approval release says SyndAccess includes financial assistance for eligible patients, but no free-drug terms were published on the pages read, so none are listed.
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 You are here | 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 | 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
AUGMENT-101 (NCT04065399) is a single-arm Phase 1/2 study. In the KMT2A cohort of 104 adults and children with relapsed or refractory acute leukemia, complete remission or complete remission with partial count recovery was reached by 21% (22/104), including 21% of those with AML (18/86), with a median follow-up of 5.7 months[1][3]. In the NPM1 cohort of 65 adults and children (median age 65, median of 2 prior regimens, 23% with a prior transplant), the combined rate was 23.1% (15/65) with a median duration of 4.5 months, and 11% went on to a transplant[1][2][4].
The Phase 3 REVEAL-ND NPM1 trial (NCT07211958) of revumenib with intensive chemotherapy in newly diagnosed NPM1-mutated AML is recruiting, and Syndax reported at EHA 2026 that revumenib with intensive chemotherapy produced a 97% composite remission rate (34/35) in a Phase 1 study of newly diagnosed NPM1-mutated or KMT2A-rearranged AML; these uses are investigational[5].
Development history
Revumenib (SNDX-5613) was developed by Syndax. The FDA approved it on November 15, 2024 for relapsed or refractory acute leukemia with a KMT2A translocation, the first approval of a menin inhibitor, and on October 24, 2025 for relapsed or refractory NPM1-mutated AML, making it the only drug approved in both groups. It was added to the NCCN AML guidelines for NPM1-mutated disease on September 18, 2025[2][6].
Explore Acute Myeloid Leukemia trials
Other Acute Myeloid Leukemia treatments
Menin inhibitors are the newest targeted class in AML. Revuforj covers KMT2A-rearranged leukemia, which had no targeted drug before, and NPM1-mutated AML, the most common mutation in adults; the frontline Phase 3 trials now running will decide whether they move to first treatment.
Common questions about Revumenib
▸What is Revumenib (Revuforj)?
The first menin inhibitor, a twice-daily tablet for adults and children 1 year and older with relapsed or refractory acute leukemia carrying a KMT2A translocation (approved November 15, 2024) or relapsed or refractory AML with a susceptible NPM1 mutation and no satisfactory alternative (October 24, 2025). Together these cover roughly a third of adult AML.
▸How does Revumenib work?
In leukemias with a KMT2A rearrangement or an NPM1 mutation, a protein called menin anchors a gene-control complex that keeps blasts from maturing. Revumenib binds menin and blocks that anchoring, which switches off the leukemia gene program and lets the cells differentiate[1]. Because it works by differentiation, it shares the differentiation syndrome risk of the IDH inhibitors and can take 1 to 3 months to produce a remission.
▸What are the side effects of Revumenib?
Revuforj carries a boxed warning for differentiation syndrome, QTc prolongation and torsades de pointes. Differentiation syndrome occurred in 25% of the 241 patients treated at the approved dose (33% of those with KMT2A AML), with fever, breathlessness, low oxygen, swelling, fluid around the lungs or heart, kidney failure, rash or low blood pressure, and it is treated with steroids at once[1]. ECGs and electrolytes are checked and the dose adjusted for QTc changes; strong CYP3A4 inhibitors require a lower dose[1]. The other warning is harm to an unborn baby. The most common side effects (20% or more, including lab changes) were raised phosphate, bleeding, nausea, infections, raised AST, ALT and creatinine, musculoskeletal pain, febrile neutropenia, QT prolongation, low potassium, raised parathyroid hormone, raised alkaline phosphatase, diarrhea, bacterial infection, raised triglycerides, differentiation syndrome, fatigue, swelling, viral infection, low phosphate, decreased appetite and constipation[1].
▸How is Revumenib taken?
Taken by mouth twice a day, about 12 hours apart, fasted or with a low-fat meal. Adults and children weighing 40 kg or more take 270 mg twice a day, or 160 mg twice a day when a strong CYP3A4 inhibitor is also being taken; smaller children are dosed by body surface area (160 mg/m2 or 95 mg/m2 twice a day)[1]. Treatment does not start until the white cell count is below 25 Gi/L, continues until the leukemia progresses or side effects become unacceptable, and the label recommends at least 6 months to allow a response[1].
▸Is Revumenib FDA approved?
Yes, Revumenib (Revuforj) is FDA approved (2024) 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.
- Syndax Pharmaceuticals via openFDA · 2026-02-04. Revuforj (revumenib) tablets prescribing information. https://api.fda.gov/drug/label.json?search=set_id:%226eb3cdbc-0e74-477d-82d6-3bb172d3f63f%22
- Syndax Pharmaceuticals · 2025-10-24. Syndax Announces FDA Approval of Revuforj (revumenib) in Adult and Pediatric Patients with Relapsed or Refractory NPM1 Mutated Acute Myeloid Leukemia. https://ir.syndax.com/news-releases/news-release-details/syndax-announces-fda-approval-revuforjr-revumenib-adult-and
- Journal of Clinical Oncology · 2025-01. Menin Inhibition With Revumenib for KMT2A-Rearranged Relapsed or Refractory Acute Leukemia (AUGMENT-101). https://pubmed.ncbi.nlm.nih.gov/39121437/
- Blood · 2025-08-28. Menin inhibition with revumenib for NPM1-mutated relapsed or refractory acute myeloid leukemia: the AUGMENT-101 study. https://pubmed.ncbi.nlm.nih.gov/40332046/
- Syndax Pharmaceuticals · 2026-06-11. Syndax Showcases Revuforj (revumenib) Clinical Activity in Multiple Acute Leukemia Subtypes and Settings at EHA 2026. https://ir.syndax.com/press-releases
- FDA. Revuforj approval history. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218944