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ziftomenib 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| menin interaction inhibitors | 5788 | 2134675-36-6 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Ziftomenib is a menin inhibitor that blocks the interaction of menin and lysine [K]-specific methyltransferase 2A (KMT2A). Acute leukemias can be driven by mutations in NPM1 that recruit the wild-type menin-KMT2A complex to promoters of leukemogenic genes. Pharmacologic disruption of the menin-KMT2A protein-protein interaction by ziftomenib blocks oncogenic activity of mutant NPM1, which induces differentiation of leukemic cells as evidenced by increased expression of differentiation markers. In nonclinical studies, ziftomenib demonstrated in vitro and in vivo antitumor activity in models of NPM1-mutant leukemia.
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. 13, 2025 | FDA | Kura Oncology |
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 |
|---|---|---|
| MeSH PA | D000970 | Antineoplastic Agents |
| FDA EPC | N0000194139 | Menin Inhibitor |
| FDA MoA | N0000194140 | Menin Inhibitors |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Acute myeloid leukemia with a susceptible NPM1 mutation | indication | 91861009 |
🐶 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 200MG | KOMZIFTI | KURA | N220305 | Nov. 13, 2025 | RX | CAPSULE | ORAL | 10174041 | March 16, 2036 | METHOD OF INHIBITING MENIN INTERACTION |
| 200MG | KOMZIFTI | KURA | N220305 | Nov. 13, 2025 | RX | CAPSULE | ORAL | 10174041 | March 16, 2036 | METHOD OF TREATING MENIN-MEDIATED DISEASE |
| 200MG | KOMZIFTI | KURA | N220305 | Nov. 13, 2025 | RX | CAPSULE | ORAL | 10869868 | Jan. 26, 2037 | METHOD OF INHIBITING PROLIFERATION AND/OR INDUCING APOPTOSIS IN A LEUKEMIA CELL WITH A NUCLEOPHOSMIN 1 (NPM1) MUTATION |
| 200MG | KOMZIFTI | KURA | N220305 | Nov. 13, 2025 | RX | CAPSULE | ORAL | 10869868 | Jan. 26, 2037 | METHOD OF TREATING LEUKEMIA WITH A NUCLEOPHOSMIN 1 (NPM1) MUTATION |
| 200MG | KOMZIFTI | KURA | N220305 | Nov. 13, 2025 | RX | CAPSULE | ORAL | 11673898 | March 15, 2037 | METHOD OF INHIBITING MENIN INTERACTION |
| 200MG | KOMZIFTI | KURA | N220305 | Nov. 13, 2025 | RX | CAPSULE | ORAL | 11673898 | March 15, 2037 | METHOD OF TREATING LEUKEMIA |
| 200MG | KOMZIFTI | KURA | N220305 | Nov. 13, 2025 | RX | CAPSULE | ORAL | 11944627 | Sept. 6, 2038 | METHOD OF TREATING ACUTE MYELOID LEUKEMIA |
| 200MG | KOMZIFTI | KURA | N220305 | Nov. 13, 2025 | RX | CAPSULE | ORAL | 11944627 | Sept. 6, 2038 | METHOD OF TREATING ACUTE MYELOID LEUKEMIA WITH ZIFTOMENIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF |
| 200MG | KOMZIFTI | KURA | N220305 | Nov. 13, 2025 | RX | CAPSULE | ORAL | 12410184 | July 16, 2044 | METHOD OF TREATING ACUTE MYELOID LEUKEMIA |
| 200MG | KOMZIFTI | KURA | N220305 | Nov. 13, 2025 | RX | CAPSULE | ORAL | 12410184 | July 16, 2044 | METHOD OF TREATING HEMATOLOGIC MALIGNANCY |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 200MG | KOMZIFTI | KURA | N220305 | Nov. 13, 2025 | RX | CAPSULE | ORAL | Nov. 13, 2030 | NEW CHEMICAL ENTITY |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Menin | Nuclear other | INHIBITOR | IC50 | 7.43 | DRUG LABEL | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| K5O | PDB_CHEM_ID |
| CHEMBL5095038 | ChEMBL_ID |
| C000731960 | MESH_SUPPLEMENTAL_RECORD_UI |
| DB17171 | DRUGBANK_ID |
| 4044419 | VANDF |
| C5667195 | UMLSCUI |
| CHEBI:758624 | CHEBI |
| 11651 | INN_ID |
| D12419 | KEGG_DRUG |
| 138497449 | PUBCHEM_CID |
| 399199 | MMSL |
| 44515 | MMSL |
| d10338 | MMSL |
| 020286 | NDDF |
| 11680 | IUPHAR_LIGAND_ID |
| 4MOD1F4ENC | UNII |
| 2725985 | RXNORM |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Komzifti | HUMAN PRESCRIPTION DRUG LABEL | 1 | 84696-200 | CAPSULE | 200 mg | ORAL | NDA | 32 sections |