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Revumenib

Alternative Names: Revumenib, sndx-5613, sndx5613, sndx 5613, REVUFORJ
Latest Update: 2025-03-11
Latest Update Note: Clinical Trial Update

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|Leukemia
Fast Track - Acute Leukemia|Leukemia
Orphan Drug - Acute Leukemia|Acute Myeloid Leukemia|Leukemia|Myeloid Leukemia *

Approval Status: Approved

Approved Countries: None

Approved Indications: None

Known Adverse Events: None

Company: Syndax
Company Location: WALTHAM MA 02451
Company CEO: Michael A. Metzger
Additonal Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Revumenib

Countries in Clinic: Australia, Canada, France, Germany, Israel, Italy, Lithuania, Netherlands, Puerto Rico, Spain, United States

Active Clinical Trial Count: 12

Highest Development Phases

Phase 2: Acute Lymphoid Leukemia|Acute Myeloid Leukemia|Biphenotypic Acute Leukemia|Colorectal Cancer|Leukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

AUGMENT-101

P2

Recruiting

Biphenotypic Acute Leukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Acute Lymphoid Leukemia|Acute Myeloid Leukemia

2027-12-15

SNDX-5613-0708

P1

Recruiting

Acute Myeloid Leukemia

2027-02-01

NCI-2024-01721

P2

Recruiting

Acute Myeloid Leukemia

2026-12-30

SAVE

P2

Recruiting

Acute Myeloid Leukemia

2026-12-01

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