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vimseltinib 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| tyrosine kinase inhibitors | 5764 | 1628606-05-2 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Vimseltinib is a selective small molecule tyrosine kinase inhibitor that targets colony stimulating factor 1 receptor (CSF1R). The CSF1/CSF1R signalling axis has a critical role in the development of TGCT. In vitro enzyme and cell-based assays have shown that vimseltinib inhibited CSF1R autophosphorylation and signalling induced by CSF1 ligand binding, as well as cellular function and proliferation of cells expressing CSF1R. Vimseltinib also inhibited CSF1R expressing cells and blocked downstream signalling in preclinical models in vivo.
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 |
|---|---|---|---|
| Sept. 17, 2025 | EMA | Deciphera Pharmaceuticals (Netherlands) B.V. | |
| Feb. 14, 2025 | FDA | Deciphera 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 | L01EX29 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS PROTEIN KINASE INHIBITORS Other protein kinase inhibitors |
| FDA MoA | N0000020036 | Colony Stimulating Factor Receptor Type 1 (CSF-1R) Inhibitors |
| MeSH PA | D000970 | Antineoplastic Agents |
| MeSH PA | D004791 | Enzyme Inhibitors |
| MeSH PA | D047428 | Protein Kinase Inhibitors |
| FDA EPC | N0000175605 | Kinase Inhibitor |
| FDA MoA | N0000185503 | P-Glycoprotein Inhibitors |
| FDA MoA | N0000187061 | Organic Cation Transporter 2 Inhibitors |
| FDA MoA | N0000190113 | Breast Cancer Resistance Protein Inhibitors |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
Related Drugs by ATC class:
L01EX Other protein kinase inhibitors 21 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Allan-Hernon-Dudley syndrome | indication |
🐶 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 14MG | ROMVIMZA | DECIPHERA PHARMS | N219304 | Feb. 14, 2025 | RX | CAPSULE | ORAL | 12285430 | Dec. 23, 2039 | TREATMENT OF TENOSYNOVIAL GIANT CELL TUMOR |
| 14MG | ROMVIMZA | DECIPHERA PHARMS | N219304 | Feb. 14, 2025 | RX | CAPSULE | ORAL | 12485120 | Dec. 23, 2039 | TREATMENT OF TENOSYNOVIAL GIANT CELL TUMOR |
| 14MG | ROMVIMZA | DECIPHERA PHARMS | N219304 | Feb. 14, 2025 | RX | CAPSULE | ORAL | 12582655 | Dec. 23, 2039 | TREATMENT OF TENOSYNOVIAL GIANT CELL TUMOR |
| 20MG | ROMVIMZA | DECIPHERA PHARMS | N219304 | Feb. 14, 2025 | RX | CAPSULE | ORAL | 12285430 | Dec. 23, 2039 | TREATMENT OF TENOSYNOVIAL GIANT CELL TUMOR |
| 20MG | ROMVIMZA | DECIPHERA PHARMS | N219304 | Feb. 14, 2025 | RX | CAPSULE | ORAL | 12485120 | Dec. 23, 2039 | TREATMENT OF TENOSYNOVIAL GIANT CELL TUMOR |
| 20MG | ROMVIMZA | DECIPHERA PHARMS | N219304 | Feb. 14, 2025 | RX | CAPSULE | ORAL | 12582655 | Dec. 23, 2039 | TREATMENT OF TENOSYNOVIAL GIANT CELL TUMOR |
| 30MG | ROMVIMZA | DECIPHERA PHARMS | N219304 | Feb. 14, 2025 | RX | CAPSULE | ORAL | 12285430 | Dec. 23, 2039 | TREATMENT OF TENOSYNOVIAL GIANT CELL TUMOR |
| 30MG | ROMVIMZA | DECIPHERA PHARMS | N219304 | Feb. 14, 2025 | RX | CAPSULE | ORAL | 12485120 | Dec. 23, 2039 | TREATMENT OF TENOSYNOVIAL GIANT CELL TUMOR |
| 30MG | ROMVIMZA | DECIPHERA PHARMS | N219304 | Feb. 14, 2025 | RX | CAPSULE | ORAL | 12582655 | Dec. 23, 2039 | TREATMENT OF TENOSYNOVIAL GIANT CELL TUMOR |
| 14MG | ROMVIMZA | DECIPHERA PHARMS | N219304 | Feb. 14, 2025 | RX | CAPSULE | ORAL | 11103507 | Feb. 3, 2040 | TREATMENT OF TENOSYNOVIAL GIANT CELL TUMOR |
| 14MG | ROMVIMZA | DECIPHERA PHARMS | N219304 | Feb. 14, 2025 | RX | CAPSULE | ORAL | 11679110 | Feb. 3, 2040 | TREATMENT OF TENOSYNOVIAL GIANT CELL TUMOR |
| 20MG | ROMVIMZA | DECIPHERA PHARMS | N219304 | Feb. 14, 2025 | RX | CAPSULE | ORAL | 11103507 | Feb. 3, 2040 | TREATMENT OF TENOSYNOVIAL GIANT CELL TUMOR |
| 20MG | ROMVIMZA | DECIPHERA PHARMS | N219304 | Feb. 14, 2025 | RX | CAPSULE | ORAL | 11679110 | Feb. 3, 2040 | TREATMENT OF TENOSYNOVIAL GIANT CELL TUMOR |
| 30MG | ROMVIMZA | DECIPHERA PHARMS | N219304 | Feb. 14, 2025 | RX | CAPSULE | ORAL | 11103507 | Feb. 3, 2040 | TREATMENT OF TENOSYNOVIAL GIANT CELL TUMOR |
| 30MG | ROMVIMZA | DECIPHERA PHARMS | N219304 | Feb. 14, 2025 | RX | CAPSULE | ORAL | 11679110 | Feb. 3, 2040 | TREATMENT OF TENOSYNOVIAL GIANT CELL TUMOR |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 14MG | ROMVIMZA | DECIPHERA PHARMS | N219304 | Feb. 14, 2025 | RX | CAPSULE | ORAL | Feb. 14, 2030 | NEW CHEMICAL ENTITY |
| 20MG | ROMVIMZA | DECIPHERA PHARMS | N219304 | Feb. 14, 2025 | RX | CAPSULE | ORAL | Feb. 14, 2030 | NEW CHEMICAL ENTITY |
| 30MG | ROMVIMZA | DECIPHERA PHARMS | N219304 | Feb. 14, 2025 | RX | CAPSULE | ORAL | Feb. 14, 2030 | NEW CHEMICAL ENTITY |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Macrophage colony-stimulating factor 1 receptor | Kinase | INHIBITOR | Kd | 8.64 | DRUG LABEL | DRUG LABEL | |||
| Mast/stem cell growth factor receptor Kit | Kinase | INHIBITOR | IC50 | 7 | IUPHAR | ||||
| Tyrosine-protein kinase Lck | Kinase | IC50 | 5.55 | CHEMBL | |||||
| Platelet-derived growth factor receptor beta | Kinase | IC50 | 5.64 | CHEMBL | |||||
| Protein-tyrosine kinase 6 | Kinase | IC50 | 5.68 | CHEMBL | |||||
| Mast/stem cell growth factor receptor Kit | Kinase | INHIBITOR | IC50 | 7 | IUPHAR | ||||
| Platelet-derived growth factor receptor alpha | Kinase | IC50 | 6.36 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| Z6V | PDB_CHEM_ID |
| CHEMBL5095202 | ChEMBL_ID |
| C000731840 | MESH_SUPPLEMENTAL_RECORD_UI |
| 11190 | IUPHAR_LIGAND_ID |
| 4043751 | VANDF |
| C5446811 | UMLSCUI |
| CHEBI:758781 | CHEBI |
| 11443 | INN_ID |
| D12238 | KEGG_DRUG |
| 86267612 | PUBCHEM_CID |
| 392782 | MMSL |
| 43747 | MMSL |
| d10258 | MMSL |
| 020014 | NDDF |
| PX9FTM69BF | UNII |
| 2705378 | RXNORM |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| ROMVIMZA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73207-302 | CAPSULE | 14 mg | ORAL | NDA | 29 sections |
| ROMVIMZA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73207-303 | CAPSULE | 20 mg | ORAL | NDA | 29 sections |
| ROMVIMZA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 73207-304 | CAPSULE | 30 mg | ORAL | NDA | 29 sections |