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revumenib 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| menin interaction inhibitors | 5840 | 2169919-21-3 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Revumenib is a small molecule inhibitor of menin. Revumenib disrupts the interaction between menin and mixed lineage leukemia (MLL, also known as KMT2A) fusion proteins. In nonclinical in vitro and in vivo studies, revumenib demonstrated antiproliferative and antitumor activity in leukemia cells harboring KMT2A fusion proteins.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Predicted pharmacokinetic/toxicological properties (PK-AZ):
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Nov. 15, 2024 | FDA | Syndax Pharmaceuticals |
FDA Adverse Event Reporting System (Female)
None
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
None
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | L01XX87 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS OTHER ANTINEOPLASTIC AGENTS Other antineoplastic agents |
| MeSH PA | D000970 | Antineoplastic Agents |
| FDA EPC | N0000194139 | Menin Inhibitor |
| FDA MoA | N0000194140 | Menin Inhibitors |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
Related Drugs by ATC class:
L01XX Other antineoplastic agents 33 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Relapsed or refractory acute leukemia | indication | 91855006 | DOID:12603 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
None
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 110MG BASE | REVUFORJ | SYNDAX | N218944 | Nov. 15, 2024 | RX | TABLET | ORAL | 11479557 | June 8, 2037 | TREATMENT OF RELAPSED OR REFRACTORY ACUTE LEUKEMIA WITH A LYSINE METHYLTRANSFERASE 2A GENE (KMT2A) TRANSLOCATION IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER |
| EQ 110MG BASE | REVUFORJ | SYNDAX | N218944 | Nov. 15, 2024 | RX | TABLET | ORAL | 11479557 | June 8, 2037 | TREATMENT OF RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA WITH A SUSCEPTIBLE NUCLEOPHOSMIN 1 (NPM1) MUTATION IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER |
| EQ 160MG BASE | REVUFORJ | SYNDAX | N218944 | Nov. 15, 2024 | RX | TABLET | ORAL | 11479557 | June 8, 2037 | TREATMENT OF RELAPSED OR REFRACTORY ACUTE LEUKEMIA WITH A LYSINE METHYLTRANSFERASE 2A GENE (KMT2A) TRANSLOCATION IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER |
| EQ 160MG BASE | REVUFORJ | SYNDAX | N218944 | Nov. 15, 2024 | RX | TABLET | ORAL | 11479557 | June 8, 2037 | TREATMENT OF RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA WITH A SUSCEPTIBLE NUCLEOPHOSMIN 1 (NPM1) MUTATION IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER |
| EQ 25MG BASE | REVUFORJ | SYNDAX | N218944 | Nov. 15, 2024 | RX | TABLET | ORAL | 11479557 | June 8, 2037 | TREATMENT OF RELAPSED OR REFRACTORY ACUTE LEUKEMIA WITH A LYSINE METHYLTRANSFERASE 2A GENE (KMT2A) TRANSLOCATION IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER |
| EQ 25MG BASE | REVUFORJ | SYNDAX | N218944 | Nov. 15, 2024 | RX | TABLET | ORAL | 11479557 | June 8, 2037 | TREATMENT OF RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA WITH A SUSCEPTIBLE NUCLEOPHOSMIN 1 (NPM1) MUTATION IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER |
| EQ 110MG BASE | REVUFORJ | SYNDAX | N218944 | Nov. 15, 2024 | RX | TABLET | ORAL | 12564590 | Dec. 18, 2042 | TREATMENT OF RELAPSED OR REFRACTORY ACUTE LEUKEMIA WITH A LYSINE METHYLTRANSFERASE 2A GENE (KMT2A) TRANSLOCATION IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER |
| EQ 110MG BASE | REVUFORJ | SYNDAX | N218944 | Nov. 15, 2024 | RX | TABLET | ORAL | 12564590 | Dec. 18, 2042 | TREATMENT OF RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA WITH A SUSCEPTIBLE NUCLEOPHOSMIN 1 (NPM1) MUTATION IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER |
| EQ 160MG BASE | REVUFORJ | SYNDAX | N218944 | Nov. 15, 2024 | RX | TABLET | ORAL | 12564590 | Dec. 18, 2042 | TREATMENT OF RELAPSED OR REFRACTORY ACUTE LEUKEMIA WITH A LYSINE METHYLTRANSFERASE 2A GENE (KMT2A) TRANSLOCATION IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER |
| EQ 160MG BASE | REVUFORJ | SYNDAX | N218944 | Nov. 15, 2024 | RX | TABLET | ORAL | 12564590 | Dec. 18, 2042 | TREATMENT OF RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA WITH A SUSCEPTIBLE NUCLEOPHOSMIN 1 (NPM1) MUTATION IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER |
| EQ 25MG BASE | REVUFORJ | SYNDAX | N218944 | Nov. 15, 2024 | RX | TABLET | ORAL | 12564590 | Dec. 18, 2042 | TREATMENT OF RELAPSED OR REFRACTORY ACUTE LEUKEMIA WITH A LYSINE METHYLTRANSFERASE 2A GENE (KMT2A) TRANSLOCATION IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER |
| EQ 25MG BASE | REVUFORJ | SYNDAX | N218944 | Nov. 15, 2024 | RX | TABLET | ORAL | 12564590 | Dec. 18, 2042 | TREATMENT OF RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA WITH A SUSCEPTIBLE NUCLEOPHOSMIN 1 (NPM1) MUTATION IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 110MG BASE | REVUFORJ | SYNDAX | N218944 | Nov. 15, 2024 | RX | TABLET | ORAL | Nov. 15, 2029 | NEW CHEMICAL ENTITY |
| EQ 160MG BASE | REVUFORJ | SYNDAX | N218944 | Nov. 15, 2024 | RX | TABLET | ORAL | Nov. 15, 2029 | NEW CHEMICAL ENTITY |
| EQ 25MG BASE | REVUFORJ | SYNDAX | N218944 | Nov. 15, 2024 | RX | TABLET | ORAL | Nov. 15, 2029 | NEW CHEMICAL ENTITY |
| EQ 110MG BASE | REVUFORJ | SYNDAX | N218944 | Nov. 15, 2024 | RX | TABLET | ORAL | Nov. 15, 2031 | TREATMENT OF RELAPSED OR REFRACTORY ACUTE LYMPHOCYTIC LEUKEMIA WITH A LYSINE METHYLTRANSFERASE 2A GENE (KMT2A) TRANSLOCATION IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER |
| EQ 110MG BASE | REVUFORJ | SYNDAX | N218944 | Nov. 15, 2024 | RX | TABLET | ORAL | Nov. 15, 2031 | TREATMENT OF RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA WITH A LYSINE METHYLTRANSFERASE 2A GENE (KMT2A) TRANSLOCATION IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER |
| EQ 110MG BASE | REVUFORJ | SYNDAX | N218944 | Nov. 15, 2024 | RX | TABLET | ORAL | Nov. 15, 2031 | TREATMENT OF RELAPSED OR REFRACTORY MIXED-PHENOTYPE ACUTE LEUKEMIA WITH A LYSINE METHYLTRANSFERASE 2A GENE (KMT2A) TRANSLOCATION IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER. |
| EQ 160MG BASE | REVUFORJ | SYNDAX | N218944 | Nov. 15, 2024 | RX | TABLET | ORAL | Nov. 15, 2031 | TREATMENT OF RELAPSED OR REFRACTORY ACUTE LYMPHOCYTIC LEUKEMIA WITH A LYSINE METHYLTRANSFERASE 2A GENE (KMT2A) TRANSLOCATION IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER |
| EQ 160MG BASE | REVUFORJ | SYNDAX | N218944 | Nov. 15, 2024 | RX | TABLET | ORAL | Nov. 15, 2031 | TREATMENT OF RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA WITH A LYSINE METHYLTRANSFERASE 2A GENE (KMT2A) TRANSLOCATION IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER |
| EQ 160MG BASE | REVUFORJ | SYNDAX | N218944 | Nov. 15, 2024 | RX | TABLET | ORAL | Nov. 15, 2031 | TREATMENT OF RELAPSED OR REFRACTORY MIXED-PHENOTYPE ACUTE LEUKEMIA WITH A LYSINE METHYLTRANSFERASE 2A GENE (KMT2A) TRANSLOCATION IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER. |
| EQ 25MG BASE | REVUFORJ | SYNDAX | N218944 | Nov. 15, 2024 | RX | TABLET | ORAL | Nov. 15, 2031 | TREATMENT OF RELAPSED OR REFRACTORY ACUTE LYMPHOCYTIC LEUKEMIA WITH A LYSINE METHYLTRANSFERASE 2A GENE (KMT2A) TRANSLOCATION IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER |
| EQ 25MG BASE | REVUFORJ | SYNDAX | N218944 | Nov. 15, 2024 | RX | TABLET | ORAL | Nov. 15, 2031 | TREATMENT OF RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA WITH A LYSINE METHYLTRANSFERASE 2A GENE (KMT2A) TRANSLOCATION IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER |
| EQ 25MG BASE | REVUFORJ | SYNDAX | N218944 | Nov. 15, 2024 | RX | TABLET | ORAL | Nov. 15, 2031 | TREATMENT OF RELAPSED OR REFRACTORY MIXED-PHENOTYPE ACUTE LEUKEMIA WITH A LYSINE METHYLTRANSFERASE 2A GENE (KMT2A) TRANSLOCATION IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER. |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Menin | Nuclear other | INHIBITOR | IC50 | 9.82 | DRUG LABEL | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| OQ4 | PDB_CHEM_ID |
| CHEMBL4650827 | ChEMBL_ID |
| C000728983 | MESH_SUPPLEMENTAL_RECORD_UI |
| 4043575 | VANDF |
| C5706576 | UMLSCUI |
| CHEBI:758410 | CHEBI |
| CHEMBL6068395 | ChEMBL_ID |
| CHEMBL4650278 | ChEMBL_ID |
| 11657 | INN_ID |
| 2761046-45-9 | SECONDARY_CAS_RN |
| 132212657 | PUBCHEM_CID |
| 390823 | MMSL |
| 43476 | MMSL |
| d10234 | MMSL |
| 11882 | IUPHAR_LIGAND_ID |
| LZ0M43NNF2 | UNII |
| 2698325 | RXNORM |
| D12728 | KEGG_DRUG |
| 019926 | NDDF |
| 019927 | NDDF |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Revuforj | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73555-500 | TABLET, FILM COATED | 25 mg | ORAL | NDA | 31 sections |
| Revuforj | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73555-500 | TABLET, FILM COATED | 25 mg | ORAL | NDA | 31 sections |
| Revuforj | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73555-501 | TABLET, FILM COATED | 110 mg | ORAL | NDA | 31 sections |
| Revuforj | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73555-501 | TABLET, FILM COATED | 110 mg | ORAL | NDA | 31 sections |
| Revuforj | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73555-502 | TABLET, FILM COATED | 160 mg | ORAL | NDA | 31 sections |
| Revuforj | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73555-502 | TABLET, FILM COATED | 160 mg | ORAL | NDA | 31 sections |