Also known as: Revuforj
Revumenib is marketed as REVUFORJ, an oral menin inhibitor for relapsed or refractory acute leukemias with KMT2A translocation or susceptible NPM1-mutated AML in patients aged 1 year and older. The prescribing information describes inhibition of menin-KMT2A interactions, affecting leukemogenic transcriptional pathways in these leukemia subtypes. U.S. initial approval was in 2024.
Syndax Pharmaceuticals announced a collaboration to expand global access to Revuforj while reporting strong commercial performance for its two marketed products, with Revuforj generating $125 million and Niktimvo $152 million in the first 11 months of sales.
Syndax Pharmaceuticals partnered with World Orphan Drug Alliance to launch a Managed Access Program for Revuforj in multiple regions. A price target was raised to $28 while maintaining a Buy rating.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07563010 |
Menin-Inhibitor Targeted Maintenance in AML |
NOT_YET_RECRUITING | PHASE2 |
| NCT07498465 |
A Study to Find the Highest Dose of SNDX-5613 (Revumenib) as a Treatment Option After Hematopoietic Stem Cell Transplant in Children With Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, and Mixed Phenotype Acute Leukemia |
WITHDRAWN | PHASE1 |
| NCT07356154 |
A Study of Revumenib and Mezigdomide in People With Leukemia |
RECRUITING | PHASE1/PHASE2 |
| NCT07283640 |
A Phase IB Trial of Subcutaneous Blinatumomab in Combination With Revumenib for Patients With KMT2A-rearranged Acute Lymphoblastic Leukemia |
NOT_YET_RECRUITING | PHASE1 |
| NCT07211958 |
Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) With a NPM1 Mutation |
RECRUITING | PHASE3 |
| NCT07052994 |
A Phase Ia/Ib Trial of Revumenib Combined With Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin (GO) in Frontline and Relapsed /Refractory Pediatric Acute Leukemia Patients |
NOT_YET_RECRUITING | PHASE1 |
| NCT06652438 |
Revumenib in Combination With Azacitidine + Venetoclax in Patients NPM1-mutated or KMT2A-rearranged AML |
RECRUITING | PHASE3 |
| NCT06575296 |
Revumenib for the Treatment of Acute Leukemia in Patients Post-Allogeneic Stem Cell Transplant |
RECRUITING | PHASE1 |
| NCT06313437 |
Revumenib in Combination With 7+3 + Midostaurin in AML |
RECRUITING | PHASE1 |
| NCT06284486 |
A Multi-Site Break Through Cancer Trial: Phase II Study Investigating Dual Inhibition of BCL2 and Menin in AML MRD Using the Combination of Venetoclax and Revumenib |
RECRUITING | PHASE1/PHASE2 |
