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Drug ReportsVimseltinib
Vimseltinib
Romvimza (vimseltinib) is a small molecule pharmaceutical. Vimseltinib was first approved as Romvimza on 2025-02-14.
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FDA approval date
EMA approval date
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Study first post date
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Romvimza
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Vimseltinib
Tradename
Company
Number
Date
Products
ROMVIMZADeciphera PharmaceuticalsN-219304 RX2025-02-14
3 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
romvimzaNew Drug Application2025-02-18
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
VIMSELTINIB, ROMVIMZA, DECIPHERA PHARMS
2030-02-14NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Vimseltinib, Romvimza, Deciphera Pharms
111035072040-02-03U-4145
116791102040-02-03U-4145
91812232034-03-14DS, DP
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
4 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C801112
SynovitisD013585EFO_0008997M67.51112
Giant cell tumorsD0058701112
Pigmented villonodular synovitisD013586EFO_1001106M12.21112
Giant cell tumor of tendon sheathD0000707791112
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Graft vs host diseaseD006086D89.8111
Bronchiolitis obliterans syndromeD000092122D89.81111
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SarcomaD01250911
LeiomyosarcomaD00789011
FibrosarcomaD00535411
LiposarcomaD00808011
Malignant fibrous histiocytomaD05167711
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameVimseltinib
INNvimseltinib
Description
Vimseltinib, sold under the brand name Romvimza, is an anti-cancer medication used for the treatment of tenosynovial giant cell tumor. Vimseltinib is a kinase inhibitor. Vimseltinib is a macrophage colony-stimulating factor receptor antagonist.
Classification
Small molecule
Drug classtyrosine kinase inhibitors
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
Cc1nc(-c2cnc(NC(C)C)n(C)c2=O)ccc1Oc1ccnc(-c2cnn(C)c2)c1
Identifiers
PDB
CAS-ID1628606-05-2
RxCUI
ChEMBL IDCHEMBL5095202
ChEBI ID
PubChem CID86267612
DrugBankDB17520
UNII IDPX9FTM69BF (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
No data
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3 adverse events reported
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