Revumenib

Summary

Revumenib (CHEMBL4650827) is an approved small molecule; indicated across 6 conditions including acute myeloid leukemia and neoplasm; with CIViC clinical evidence for 10 variant-indication associations (e.g. KMT2A Translocation in acute leukemia).

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Small molecule
• Indications: 6 conditions
• Clinical trials: 24
• Precision-oncology evidence (CIViC): 10 variant–indication associations
• Chemistry: 630.8 Da · C32H47FN6O4S

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL4650827
Name	Revumenib
Type	Small molecule
Max phase	4
FDA approved	no
PubChem CID	132212657
Molecular formula	C32H47FN6O4S
Molecular weight	630.8
InChIKey	FRVSRBKUQZKTOW-UHFFFAOYSA-N

SMILES: CCN(C(C)C)C(=O)C1=C(C=CC(=C1)F)OC2=CN=CN=C2N3CC4(C3)CCN(CC4)CC5CCC(CC5)NS(=O)(=O)CC

IUPAC name: N-ethyl-2-[4-[7-[[4-(ethylsulfonylamino)cyclohexyl]methyl]-2,7-diazaspiro[3.5]nonan-2-yl]pyrimidin-5-yl]oxy-5-fluoro-N-propan-2-ylbenzamide

Also known as: Revumenib, SNDX-50613 FREE BASE, SNDX-5613 Free Base, SNDX50613 FREE BASE, SNDX5613 FREE BASE, REVUMENIB, SNDX-5613

Parent form; salt/anhydrous children: CHEMBL4650278, CHEMBL6068395

Patent coverage: 40 distinct patent families (72 SureChEMBL compound mentions), from 2 matched compound structure(s). One matched structure accounts for 66 (92%) of the total. Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.

Targets

Targets

Broader ChEMBL bioactivity targets: 2 (assay-derived). Sample: Menin/Histone-lysine N-methyltransferase MLL, Voltage-gated inwardly rectifying potassium channel KCNH2.

Bioactivity

ChEMBL activities: 2 potent at pChembl ≥ 5 of 2 total. Top 30 by potency (10 = 0.1 nM, 6 = 1 µM):

Target	pChembl	Type	Value	Unit	Activity ID
MEN1	7.81	IC50	15.52	nM	CHEMBL_ACT_29123497
KCNH2	5.3	IC50	5000	nM	CHEMBL_ACT_29160591

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

6 indications (0 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
acute myeloid leukemia	2	MONDO:0018874	EFO:0000222
neoplasm	2	MONDO:0005070	EFO:0000616
leukemia	2	MONDO:0005059	EFO:0000565
acute lymphoblastic leukemia	1	MONDO:0004967	EFO:0000220
colorectal neoplasm	1	MONDO:0005335	MONDO:0005575
acute biphenotypic leukemia	1	MONDO:0020322	MONDO:0019460

Clinical trials

Total trials: 24.

Phase distribution

Phase	Trials
PHASE1	11
PHASE1/PHASE2	6
PHASE2	4
PHASE3	2
Not specified	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT06652438	PHASE3	RECRUITING	Revumenib in Combination With Azacitidine + Venetoclax in Patients NPM1-mutated or KMT2A-rearranged AML
NCT07211958	PHASE3	RECRUITING	Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) With a NPM1 Mutation
NCT03013998	PHASE1/PHASE2	RECRUITING	Study of Biomarker-Based Treatment of Acute Myeloid Leukemia
NCT04065399	PHASE1/PHASE2	RECRUITING	A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation
NCT05360160	PHASE1/PHASE2	RECRUITING	A Phase I-II Study Investigating the All-Oral Combination of the Menin Inhibitor SNDX-5613 With Decitabine/Cedazuridine (ASTX727) and Venetoclax in Acute Myeloid Leukemia (SAVE)
NCT05761171	PHASE2	ACTIVE_NOT_RECRUITING	A Study of Revumenib in Combination With Chemotherapy for Patients Diagnosed With Relapsed or Refractory Leukemia
NCT06229912	PHASE2	RECRUITING	A Phase II Study of the Menin Inhibitor Revumenib in Leukemia Associated With Upregulation of HOX Genes
NCT06284486	PHASE1/PHASE2	RECRUITING	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
NCT07356154	PHASE1/PHASE2	RECRUITING	A Study of Revumenib and Mezigdomide in People With Leukemia
NCT07563010	PHASE2	NOT_YET_RECRUITING	Menin-Inhibitor Targeted Maintenance in AML
NCT07605949	PHASE2	NOT_YET_RECRUITING	Revumenib, Azacitidine, and VENetoclax in Newly Diagnosed KMT2A-Rearranged AML
NCT05731947	PHASE1/PHASE2	COMPLETED	Evaluation of Revumenib in Participants With Colorectal Cancer and Other Solid Tumors
NCT05886049	PHASE1	RECRUITING	Testing the Addition of an Anti-cancer Drug, SNDX-5613, to the Standard Chemotherapy Treatment (Daunorubicin and Cytarabine) for Newly Diagnosed Patients With Acute Myeloid Leukemia That Has Changes in NPM1 or MLL/KMT2A Gene
NCT06177067	PHASE1	RECRUITING	Study of Revumenib, Azacitidine, and Venetoclax in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia
NCT06222580	PHASE1	RECRUITING	SNDX-5613 and Gilteritinib for the Treatment of Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia and Concurrent MLL-Rearrangement or NPM1 Mutation
NCT06226571	PHASE1	RECRUITING	A Study of SNDX-5613 in Combination With Intensive Chemotherapy in Participants With Acute Myeloid Leukemias
NCT06313437	PHASE1	RECRUITING	Revumenib in Combination With 7+3 + Midostaurin in AML
NCT06575296	PHASE1	RECRUITING	Revumenib for the Treatment of Acute Leukemia in Patients Post-Allogeneic Stem Cell Transplant
NCT07283640	PHASE1	NOT_YET_RECRUITING	A Phase IB Trial of Subcutaneous Blinatumomab in Combination With Revumenib for Patients With KMT2A-rearranged Acute Lymphoblastic Leukemia
NCT05326516	PHASE1	COMPLETED	A Study of Revumenib in Combination With Chemotherapy in Participants With R/R Acute Leukemia
NCT05406817	PHASE1	COMPLETED	Study of Radiolabeled Revumenib in Adults With Acute Leukemia
NCT07052994	PHASE1	WITHDRAWN	A Phase Ia/Ib Trial of Revumenib Combined With Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin (GO) in Frontline and Relapsed /Refractory Pediatric Acute Leukemia Patients
NCT07498465	PHASE1	WITHDRAWN	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
NCT05918913	Not specified	NO_LONGER_AVAILABLE	Expanded Access Program for Revumenib

Clinical evidence (CIViC)

Variant × indication × effect (10 predictive associations from 10 curated evidence items):

Variant	Indication	Effect	Therapy	Level	CIViC
KMT2A Translocation	Acute Leukemia	Sensitivity/Response	Revumenib	CIViC A	EID12214
NPM1 MUTATION	Acute Myeloid Leukemia	Sensitivity/Response	Revumenib	CIViC B	EID12743
NPM1 MUTATION AND ( IDH2 Mutation OR IDH1 Mutation )	Acute Myeloid Leukemia	Sensitivity/Response	Revumenib	CIViC B	EID12744
MEN1 G326D	Acute Leukemia	Resistance	Revumenib + VTP-50469	CIViC B	EID12737
MEN1 G326R	Acute Leukemia	Resistance	Revumenib + VTP-50469	CIViC B	EID12734
MEN1 M322I	Acute Leukemia	Resistance	Revumenib + VTP-50469	CIViC B	EID12730
MEN1 Mutation	Acute Leukemia	Resistance	Revumenib	CIViC B	EID12717
MEN1 T344M	Acute Leukemia	Resistance	Revumenib + VTP-50469	CIViC B	EID12733
MEN1 S155T	Acute Leukemia	Resistance	Revumenib + VTP-50469	CIViC C	EID12741
MEN1 M322V	Acute Leukemia	Resistance	VTP-50469 + Revumenib	CIViC D	EID12728

Pharmacology

Pharmacogenomics

No CPIC/DPWG dosing guideline or drug-level clinical/variant annotations in PharmGKB for this molecule.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).