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Ofev, Vargatef(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 platelet-derived growth factor receptor beta, vascular endothelial growth factor receptor 2, fibroblast growth factor receptor 2, vascular endothelial growth factor receptor 1, fibroblast growth factor receptor 1, platelet-derived growth factor receptor alpha, fibroblast growth factor receptor 4, and fibroblast growth factor receptor 3.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
respiratory tract diseasesD012140
Trade Name
FDA
EMA
Ofev
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Nintedanib esylate
Tradename
Company
Number
Date
Products
OFEVBoehringer IngelheimN-205832 RX2014-10-15
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
ofevNew Drug Application2020-11-09
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
idiopathic pulmonary fibrosis—D054990J84.112
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
Clinical Trials
164 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Idiopathic pulmonary fibrosisD054990J84.1123336924
Interstitial lung diseasesD017563EFO_0004244J84.89——71917
Pulmonary fibrosisD011658J84.10—33129
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-small-cell lung carcinomaD0022891463——21
Ovarian neoplasmsD010051EFO_0003893C56341——8
Colorectal neoplasmsD015179—41——5
Peritoneal neoplasmsD010534111——3
Systemic sclerodermaD012595EFO_0000717M341—1——2
MesotheliomaD008654C45—11——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—121———13
Renal cell carcinomaD00229223———4
Myeloid leukemia acuteD015470C92.022———3
GlioblastomaD005909EFO_000051513———3
Prostatic neoplasmsD011471C6112———3
Breast neoplasmsD001943EFO_0003869C5012———3
Liver neoplasmsD008113EFO_1001513C22.012———3
Hereditary hemorrhagic telangiectasiaD013683I78.0—2———2
Uterine cervical neoplasmsD00258311———2
Fallopian tube neoplasmsD005185—2———2
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C808————8
Female genital neoplasmsD0058331————1
Hepatic insufficiencyD0485501————1
Multiple myelomaD009101C90.01————1
Drug interactionsD0043471————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MyositisD009220EFO_0000783G72.49————11
Lung diseasesD008171EFO_0003818J98.4————11
Epidemiology
Epidemiological information for investigational and approved indications
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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)
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
PDB3C7Q
CAS-ID656247-17-5
RxCUI1592737
ChEMBL IDCHEMBL502835
ChEBI ID85164
PubChem CID9809715
DrugBankDB09079
UNII IDG6HRD2P839 (ChemIDplus, GSRS)
Target
Agency Approved
FLT4
FLT4
Organism
Homo sapiens
Gene name
FLT4
Gene synonyms
VEGFR3
NCBI Gene ID
2324
Protein name
vascular endothelial growth factor receptor 3
Protein synonyms
Feline McDonough Sarcoma (FMS)-like tyrosine kinase 4, FLT-4, fms related tyrosine kinase 4, Fms-like tyrosine kinase 4, primary congenital lymphedema, Tyrosine-protein kinase receptor FLT4, VEGF receptor-3
Uniprot ID
P35916
Mouse ortholog
Flt4 (14257)
vascular endothelial growth factor receptor 3 (P35917)
Alternate
PDGFRB
PDGFRB
KDR
KDR
FGFR2
FGFR2
FLT1
FLT1
FGFR1
FGFR1
PDGFRA
PDGFRA
FGFR4
FGFR4
FGFR3
FGFR3
Organism
Homo sapiens
Gene name
PDGFRB
Gene synonyms
PDGFR, PDGFR1
NCBI Gene ID
5159
Protein name
platelet-derived growth factor receptor beta
Protein synonyms
Activated tyrosine kinase PDGFRB, Beta platelet-derived growth factor receptor, Beta-type platelet-derived growth factor receptor, CD140 antigen-like family member B, CD140b, NDEL1-PDGFRB, PDGF-R-beta, PDGFR-1, PDGFR-beta, Platelet-derived growth factor receptor 1, platelet-derived growth factor receptor, beta polypeptide
Uniprot ID
Q8N5L4
Mouse ortholog
Pdgfrb (18596)
platelet-derived growth factor receptor beta (P05622)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 6,682 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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12,825 adverse events reported
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