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.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| respiratory tract diseases | D012140 |
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
No data
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| idiopathic pulmonary fibrosis | — | D054990 | J84.112 |
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
192 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Idiopathic pulmonary fibrosis | D054990 | — | J84.112 | 5 | 9 | 6 | 6 | 18 | 44 |
| Interstitial lung diseases | D017563 | HP_0006530 | J84.89 | — | 1 | 8 | 1 | 9 | 18 |
| Pulmonary fibrosis | D011658 | — | J84.10 | — | 3 | 3 | 1 | 2 | 9 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Non-small-cell lung carcinoma | D002289 | — | — | 14 | 6 | 3 | — | 3 | 24 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 3 | 4 | 1 | — | — | 8 |
| Colorectal neoplasms | D015179 | — | — | — | 4 | 1 | — | — | 5 |
| Peritoneal neoplasms | D010534 | — | — | 1 | 1 | 1 | — | — | 3 |
| Systemic scleroderma | D012595 | EFO_0000717 | M34 | 1 | — | 1 | — | — | 2 |
| Mesothelioma | D008654 | — | C45 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 12 | 1 | — | — | — | 13 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 2 | 3 | — | — | — | 4 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | 3 | — | — | — | 4 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 2 | 2 | — | — | — | 3 |
| Glioblastoma | D005909 | EFO_0000515 | — | 1 | 3 | — | — | — | 3 |
| Prostatic neoplasms | D011471 | — | C61 | 1 | 2 | — | — | — | 3 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 1 | 2 | — | — | — | 3 |
| Hereditary hemorrhagic telangiectasia | D013683 | — | I78.0 | — | 2 | — | — | — | 2 |
| Uterine cervical neoplasms | D002583 | HP_0030159 | — | 1 | 1 | — | — | — | 2 |
| Fallopian tube neoplasms | D005185 | — | — | — | 2 | — | — | — | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 10 | — | — | — | — | 10 |
| Female genital neoplasms | D005833 | — | — | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
| Multiple myeloma | D009101 | — | C90.0 | 1 | — | — | — | — | 1 |
| Drug interactions | D004347 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myositis | D009220 | EFO_0000783 | G72.49 | — | — | — | — | 1 | 1 |
| Lung diseases | D008171 | HP_0002088 | J98.4 | — | — | — | — | 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
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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13,778 adverse events reported
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