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Drug ReportsNintedanib
Nintedanib
Ofev, Vargatef (nintedanib) is a small molecule pharmaceutical. Nintedanib was first approved as Ofev on 2014-10-15. It is used to treat idiopathic pulmonary fibrosis in the USA. It has been approved in Europe to treat idiopathic pulmonary fibrosis and non-small-cell lung carcinoma. The pharmaceutical is active against vascular endothelial growth factor receptor 3. In addition, it is known to target vascular endothelial growth factor receptor 2, platelet-derived growth factor receptor beta, vascular endothelial growth factor receptor 1, fibroblast growth factor receptor 1, fibroblast growth factor receptor 4, platelet-derived growth factor receptor alpha, fibroblast growth factor receptor 3, and fibroblast growth factor receptor 2.
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Drug
Target
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Financial
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Safety
Events Timeline
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YTD
1Y
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5Y
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
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Completion date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
respiratory tract diseasesD012140
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
No data
Labels
FDA
EMA
Brand Name
Status
Last Update
ofevNew Drug Application2024-10-15
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
NINTEDANIB ESYLATE, OFEV, BOEHRINGER INGELHEIM
2026-09-06ODE-261
2023-03-09I-825
Patent Expiration
Patent
Expires
Flag
FDA Information
Nintedanib Esylate, Ofev, Boehringer Ingelheim
99077562029-06-07DP
101053232029-06-04DP
101549902026-01-08U-2620
67621802025-10-01DS, DP
71190932024-02-21DS, DP
ATC Codes
L: Antineoplastic and immunomodulating agents
L01: Antineoplastic agents
L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
L01EX: Other protein kinase inhibitors in atc
L01EX09: Nintedanib
HCPCS
No data
Clinical
No data
Drug
General
Drug common nameNintedanib
INNnintedanib
Description
Nintedanib, sold under the brand names Ofev and Vargatef, is an oral medication used for the treatment of idiopathic pulmonary fibrosis and along with other medications for some types of non-small-cell lung cancer.
Classification
Small molecule
Drug classangiogenesis inhibitors
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
COC(=O)c1ccc2c(c1)NC(=O)/C2=C(\Nc1ccc(N(C)C(=O)CN2CCN(C)CC2)cc1)c1ccccc1
Identifiers
PDB
CAS-ID656247-17-5
RxCUI
ChEMBL IDCHEMBL502835
ChEBI ID85164
PubChem CID9809715
DrugBankDB09079
UNII IDG6HRD2P839 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
FGFR3
FGFR3
FGFR4
FGFR4
FGFR1
FGFR1
FLT1
FLT1
Organism
Homo sapiens
Gene name
FGFR3
Gene synonyms
JTK4
NCBI Gene ID
Protein name
fibroblast growth factor receptor 3
Protein synonyms
CD333, FGFR-3, fibroblast growth factor receptor 3-S, hydroxyaryl-protein kinase, tyrosine kinase JTK4
Uniprot ID
Mouse ortholog
Fgfr3 (14184)
fibroblast growth factor receptor 3 (Q61851)
Variants
No data
Financial
No data
Trends
No data
Safety
Black-box Warning
No Black-box warning
Adverse Events
0 adverse events reported
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