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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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| respiratory tract diseases | D012140 |
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 |
|---|---|---|
| ofev | New Drug Application | 2024-10-15 |
Indications
FDA
EMA
No data
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
201 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pulmonary fibrosis | D011658 | — | — | 7 | 13 | 9 | 8 | 22 | 59 |
| Idiopathic pulmonary fibrosis | D054990 | — | J84.112 | 7 | 12 | 9 | 6 | 20 | 53 |
| Fibrosis | D005355 | — | — | 4 | 12 | 9 | 6 | 18 | 49 |
| Lung diseases | D008171 | HP_0002088 | J98.4 | 2 | 1 | 9 | 3 | 9 | 23 |
| Interstitial lung diseases | D017563 | HP_0006530 | J84.89 | 2 | 1 | 9 | 2 | 9 | 22 |
| Pneumonia | D011014 | EFO_0003106 | — | — | 2 | — | 1 | 1 | 4 |
| Covid-19 | D000086382 | — | — | — | 1 | — | 2 | — | 3 |
| Myositis | D009220 | EFO_0000783 | G72.49 | — | — | — | 1 | 1 | 2 |
| Disease progression | D018450 | — | — | — | — | — | 1 | — | 1 |
| Coronavirus infections | D018352 | EFO_0007224 | B34.2 | — | — | — | 1 | — | 1 |
Show 4 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Non-small-cell lung carcinoma | D002289 | — | — | 15 | 7 | 3 | — | 4 | 26 |
| Neoplasms | D009369 | — | C80 | 12 | 1 | 1 | — | — | 14 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 3 | 4 | 1 | — | — | 8 |
| Colorectal neoplasms | D015179 | — | — | 1 | 4 | 1 | — | — | 6 |
| Recurrence | D012008 | — | — | 1 | 6 | 1 | — | — | 6 |
| Systemic scleroderma | D012595 | EFO_0000717 | M34.0 | 1 | — | 2 | — | 1 | 4 |
| Diffuse scleroderma | D045743 | EFO_0000404 | — | 1 | — | 2 | — | 1 | 4 |
| Peritoneal neoplasms | D010534 | — | — | 1 | 1 | 1 | — | — | 3 |
| Malignant mesothelioma | D000086002 | — | — | — | 3 | 1 | — | — | 3 |
| Mesothelioma | D008654 | — | C45 | — | 3 | 1 | — | — | 3 |
Show 6 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 15 | 1 | — | — | — | 16 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | 4 | 8 | — | — | 1 | 11 |
| Carcinoma | D002277 | — | C80.0 | 4 | 7 | — | — | — | 10 |
| Adenocarcinoma | D000230 | — | — | 5 | 6 | — | — | — | 8 |
| Ovarian epithelial carcinoma | D000077216 | — | — | 1 | 4 | — | — | — | 5 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 2 | 3 | — | — | — | 4 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | 3 | — | — | — | 4 |
| Leukemia | D007938 | — | C95 | 2 | 2 | — | — | — | 3 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 2 | 2 | — | — | — | 3 |
| Myeloid leukemia | D007951 | — | C92 | 2 | 2 | — | — | — | 3 |
Show 52 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Drug interactions | D004347 | — | — | 2 | — | — | — | — | 2 |
| Female genital neoplasms | D005833 | — | — | 1 | — | — | — | — | 1 |
| Liver failure | D017093 | HP_0001399 | K72.9 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
| Multiple myeloma | D009101 | — | C90.0 | 1 | — | — | — | — | 1 |
| Plasma cell neoplasms | D054219 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Dyspnea | D004417 | HP_0002094 | R06.0 | — | — | — | — | 3 | 3 |
| Diarrhea | D003967 | HP_0002014 | R19.7 | — | — | — | — | 2 | 2 |
| Connective tissue diseases | D003240 | EFO_1001986 | M35 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Nintedanib |
| 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) | 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 | — |
| ChEMBL ID | CHEMBL502835 |
| ChEBI ID | 85164 |
| PubChem CID | 9809715 |
| DrugBank | DB09079 |
| UNII ID | G6HRD2P839 (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
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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22,051 adverse events reported
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