Ofev, Vargatef(nintedanib esylate)
Ofev, Vargatef (nintedanib esylate) is a small molecule pharmaceutical. Nintedanib esylate 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. 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, fibroblast growth factor receptor 3, and vascular endothelial growth factor receptor 3.
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Commercial
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 |
|---|---|---|---|---|
| OFEV | Boehringer Ingelheim | N-205832 RX | 2014-10-15 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| ofev | New Drug Application | 2020-11-09 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
NINTEDANIB ESYLATE, OFEV, BOEHRINGER INGELHEIM | |||
| 2026-09-06 | ODE-261 | ||
| 2023-03-09 | I-825 | ||
HCPCS
No data
Clinical
Clinical Trials
32 clinical trials
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Subarachnoid hemorrhage | D013345 | EFO_0000713 | I60 | 2 | 1 | 1 | — | 4 | 8 |
| Poisoning | D011041 | EFO_0008546 | T65.91 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infertility | D007246 | EFO_0000545 | — | 1 | — | — | 1 | 2 | |
| Cocaine-related disorders | D019970 | F14 | 1 | 1 | — | — | — | 2 | |
| Epilepsy | D004827 | EFO_0000474 | G40.9 | — | 1 | — | — | — | 1 |
| Delirium | D003693 | R41.0 | — | 1 | — | — | — | 1 | |
| Electroconvulsive therapy | D004565 | — | 1 | — | — | — | 1 | ||
| Acoustic neuroma | D009464 | HP_0009588 | — | 1 | — | — | — | 1 | |
| Aneurysm | D000783 | HP_0002617 | I72.9 | 1 | 1 | — | — | — | 1 |
| Intracranial aneurysm | D002532 | EFO_0003870 | I67.1 | 1 | 1 | — | — | — | 1 |
| Traumatic subarachnoid hemorrhage | D020206 | S06.6 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Biological availability | D001682 | 1 | — | — | — | — | 1 | ||
| Healthy volunteers/patients | — | 1 | — | — | — | — | 1 | ||
| Schizophrenia | D012559 | EFO_0000692 | F20 | 1 | — | — | — | — | 1 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 1 | — | — | — | — | 1 |
| Aids dementia complex | D015526 | EFO_0002608 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | — | — | — | — | 1 | 1 |
| Intracranial vasospasm | D020301 | EFO_1000994 | G45.9 | — | — | — | — | 1 | 1 |
| Atrial flutter | D001282 | EFO_0003911 | — | — | — | — | 1 | 1 | |
| Atrioventricular block | D054537 | I44.3 | — | — | — | — | 1 | 1 | |
| Tachycardia | D013610 | HP_0001649 | R00.0 | — | — | — | — | 1 | 1 |
| Bundle-branch block | D002037 | EFO_0004138 | I44.7 | — | — | — | — | 1 | 1 |
| Atrial premature complexes | D018880 | HP_0006699 | I49.1 | — | — | — | — | 1 | 1 |
| Ventricular premature complexes | D018879 | I49.3 | — | — | — | — | 1 | 1 | |
| Pre-eclampsia | D011225 | EFO_0000668 | O14 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | NINTEDANIB ESYLATE |
| INN | nintedanib |
| 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 class | angiogenesis inhibitors |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CCS(=O)(=O)O.COC(=O)c1ccc2c(c1)NC(=O)/C2=C(\Nc1ccc(N(C)C(=O)CN2CCN(C)CC2)cc1)c1ccccc1 |
Identifiers
| PDB | — |
| CAS-ID | 656247-17-5 |
| RxCUI | 1592737 |
| ChEMBL ID | CHEMBL3039504 |
| ChEBI ID | 85170 |
| PubChem CID | 9809715 |
| DrugBank | DB09079 |
| UNII ID | G6HRD2P839 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
PDGFRB
PDGFRB
KDR
KDR
FGFR2
FGFR2
FLT1
FLT1
FGFR1
FGFR1
PDGFRA
PDGFRA
FGFR4
FGFR4
FGFR3
FGFR3
FLT4
FLT4
Organism
Homo sapiens
Gene name
PDGFRB
Gene synonyms
PDGFR, PDGFR1
NCBI Gene ID
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
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:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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454 adverse events reported
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