Product Description
Revumenib is an orally bioavailable protein-protein interaction (PPI) inhibitor of the menin-mixed lineage leukemia (MLL; myeloid/lymphoid leukemia; KMT2A) proteins, with potential antineoplastic activity. Upon oral administration, revumenib targets and binds to the nuclear protein menin, thereby preventing the interaction between the two proteins menin and MLL and the formation of the menin-MLL complex. This reduces the expression of downstream target genes and results in an inhibition of the proliferation of MLL-rearranged leukemic cells. The menin-MLL complex plays a key role in the survival, growth, transformation and proliferation of certain kinds of leukemia cells. (Sourced from: https://pubchem.ncbi.nlm.nih.gov/compound/Revumenib)
Mechanisms of Action: MEN1 Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: Breakthrough Therapy - Acute Leukemia|LeukemiaFast Track - Acute Leukemia|LeukemiaOrphan Drug - Acute Leukemia|Acute Myeloid Leukemia|Leukemia|Myeloid Leukemia *
Approval Status: Approved
Approved Countries: None
Approved Indications: None
Company: Syndax
Company Location: Eastern America
Company Founding Year: 2005
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Canada, France, Georgia, Germany, Greece, Hungary, Israel, Italy, Lithuania, Malaysia, Netherlands, Poland, Puerto Rico, Romania, Singapore, South Korea, Spain, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 16
Recent & Upcoming Milestones
- Clinical Outcomes Expected - Syndax announced they will present P2 Acute Leukemia results in 4Q26 for Revumenib
- Clinical Outcomes Reported - Syndax announced they will present P1 Acute Leukemia results in 2H26 for Revumenib
- Clinical Outcomes Expected - Syndax announced they will present P1 Myelofibrosis results in 2H27 for Revumenib
Highest Development Phases
Phase 3: Acute Myeloid Leukemia
Phase 2: Acute Lymphoid Leukemia|Biphenotypic Acute Leukemia|Leukemia|Myelofibrosis|Polycythemia Vera|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Thrombocythemia, Essential
Phase 1: Lymphoid Leukemia
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT07283640 |
NCI-2025-09116 | P1 |
Not yet recruiting |
Lymphoid Leukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma |
2029-08-31 |
12% |
2025-12-17 |
Primary Endpoints|Treatments |
NCT06177067 |
RAVAML | P1 |
Recruiting |
Acute Myeloid Leukemia|Biphenotypic Acute Leukemia |
2026-10-01 |
12% |
2026-05-05 |
|
NCT07734077 |
MPN-RC 129 | P2 |
Not yet recruiting |
Myelofibrosis|Polycythemia Vera|Thrombocythemia, Essential |
2028-12-01 |
50% |
2026-07-30 |
Primary Endpoints|Treatments |
NCT06229912 |
NCI-2024-00534 | P2 |
Recruiting |
Leukemia |
2028-12-01 |
39% |
2026-09-12 |
Primary Completion Date|Primary Endpoints|Treatments |
NCT04065399 |
AUGMENT-101 | P2 |
Recruiting |
Acute Myeloid Leukemia|Acute Lymphoid Leukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Biphenotypic Acute Leukemia |
2027-12-15 |
33% |
2026-02-18 |
|
NCT05326516 |
AUGMENT-102 | P1 |
Completed |
Precursor Cell Lymphoblastic Leukemia-Lymphoma|Acute Lymphoid Leukemia|Acute Myeloid Leukemia |
2024-07-29 |
2024-08-14 |
Primary Endpoints |
|
NCT03013998 |
The Beat AML Trial | P3 |
Recruiting |
Acute Myeloid Leukemia |
2032-12-01 |
51% |
2026-09-04 |
Primary Endpoints |
2025-522279-27-00 |
SNDX-5613-0710 | P3 |
Not yet recruiting |
Acute Myeloid Leukemia |
2030-04-30 |
14% |
||
NCT07211958 |
REVEAL-ND NPM1 | P3 |
Recruiting |
Acute Myeloid Leukemia |
2029-06-01 |
14% |
2026-09-26 |
Primary Endpoints|Treatments |
NCT07212023 |
REVEAL-ND KMT2A | P2 |
Not yet recruiting |
Acute Myeloid Leukemia |
2030-07-01 |
2025-10-09 |
Primary Endpoints|Treatments |
|
NCT06284486 |
NCI-2024-01721 | P2 |
Recruiting |
Acute Myeloid Leukemia |
2026-12-30 |
45% |
2025-05-22 |
Primary Endpoints|Treatments |
NCT05360160 |
SAVE | P2 |
Recruiting |
Acute Myeloid Leukemia |
2026-12-01 |
52% |
2024-09-20 |
Primary Completion Date|Primary Endpoints |
2024-513759-34-00 |
SNDX-5613-0700 | P2 |
Active, not recruiting |
Unknown |
2025-04-30 |
2025-05-02 |
Treatments |
|
NCT06313437 |
NCT06313437 | P1 |
Recruiting |
Acute Myeloid Leukemia |
2027-03-02 |
50% |
2026-03-26 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT06226571 |
SNDX-5613-0708 | P1 |
Active, not recruiting |
Acute Myeloid Leukemia |
2027-02-01 |
12% |
2026-09-17 |
Patient Enrollment|Primary Endpoints|Treatments |
NCT05406817 |
SNDX-5613-0705 | P1 |
Completed |
Unknown |
2024-11-18 |
2025-01-11 |