Quick answers
- What is Revumenib used for?
- The FDA-approved label (Revuforj, Syndax Pharmaceuticals, Inc., February 4, 2026) says: “REVUFORJ is a menin inhibitor indicated for: the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene ( KMT2A ) translocation as determined by an FDA-authorized test in adult and pediatric patients 1 year and older. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Revumenib have a boxed warning?
- Yes. The FDA label for Revuforj has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Revumenib?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Revumenib been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Revumenib?
- 1 company lists prescription products of Revumenib in the FDA NDC Directory, including Syndax Pharmaceuticals, Inc..
What Revumenib is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
REVUFORJ is a menin inhibitor indicated for: the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene ( KMT2A ) translocation as determined by an FDA-authorized test in adult and pediatric patients 1 year and older. …
— FDA label: Revuforj, Syndax Pharmaceuticals, Inc., effective February 4, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
Forms and how it is given
| Dosage forms | Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 3 in the FDA NDC Directory |
| Brand names | Revuforj |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Syndax Pharmaceuticals, Inc.3 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA218944 REVUFORJ | Syndax | November 15, 2024 | 1, latest October 24, 2025 2025: Efficacy |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Revuforj, Syndax Pharmaceuticals, Inc., effective February 4, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →