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: Australia, Canada, France, Georgia, Germany, Israel, Italy, Lithuania, Netherlands, Puerto Rico, Romania, South Korea, Spain, United Kingdom, United States
Active Clinical Trial Count: 16
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Syndax presented P1 Acute Myeloid Leukemia results on 2026-06-11 for Revumenib
- Clinical Outcomes Reported - Syndax presented P1 Acute Leukemia|Acute Myeloid Leukemia results on 2026-06-02 for Revumenib
- Clinical Outcomes Reported - Syndax presented P2 Acute Leukemia|Acute Myeloid Leukemia results on 2026-06-02 for Revumenib
Highest Development Phases
Phase 3: Acute Myeloid Leukemia
Phase 2: Acute Lymphoid Leukemia|Biphenotypic Acute Leukemia|Colorectal Cancer|Leukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Stem Cell Transplant
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 |
50% |
2025-12-17 |
Primary Endpoints|Treatments |
NCT06177067 |
RAVAML | P1 |
Recruiting |
Biphenotypic Acute Leukemia|Acute Myeloid Leukemia |
2026-10-01 |
50% |
2026-05-05 |
|
NCT07563010 |
MENTAIN | P2 |
Not yet recruiting |
Acute Myeloid Leukemia|Stem Cell Transplant |
2031-06-01 |
12% |
2026-05-02 |
Primary Endpoints|Treatments |
NCT04065399 |
AUGMENT-101 | P2 |
Recruiting |
Precursor Cell Lymphoblastic Leukemia-Lymphoma|Biphenotypic Acute Leukemia|Acute Lymphoid Leukemia|Acute Myeloid Leukemia |
2027-12-15 |
12% |
2026-02-18 |
|
NCT06229912 |
NCI-2024-00534 | P2 |
Recruiting |
Leukemia |
2026-12-01 |
12% |
2025-01-14 |
Patient Enrollment|Primary Endpoints|Start Date|Treatments |
NCT05731947 |
SNDX-5613-0706 | P2 |
Completed |
Colorectal Cancer |
2025-06-30 |
12% |
2026-01-30 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT05360160 |
SAVE | P2 |
Recruiting |
Acute Myeloid Leukemia |
2026-12-01 |
12% |
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 |
|
2025-522279-27-00 |
SNDX-5613-0710 | P3 |
Not yet recruiting |
Acute Myeloid Leukemia |
2030-04-30 |
9% |
||
NCT07211958 |
REVEAL-ND NPM1 | P3 |
Recruiting |
Acute Myeloid Leukemia |
2029-06-01 |
9% |
2026-05-21 |
Primary Endpoints|Treatments |
NCT07212023 |
REVEAL-ND KMT2A | P2 |
Not yet recruiting |
Acute Myeloid Leukemia |
2030-07-01 |
12% |
2025-10-09 |
Primary Endpoints|Treatments |
NCT06284486 |
NCI-2024-01721 | P2 |
Recruiting |
Acute Myeloid Leukemia |
2026-12-30 |
12% |
2025-05-22 |
Primary Endpoints|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 |
Recruiting |
Acute Myeloid Leukemia |
2027-02-01 |
50% |
2024-04-23 |
Primary Endpoints|Start Date|Treatments |
NCT05406817 |
SNDX-5613-0705 | P1 |
Completed |
Unknown |
2024-11-18 |
32% |
2025-01-11 |
|
NCT05326516 |
AUGMENT-102 | P1 |
Completed |
Acute Myeloid Leukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Acute Lymphoid Leukemia |
2024-07-29 |
30% |
2024-08-14 |
Primary Endpoints |