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
Brand Name | Status | Last Update |
|---|---|---|
| ofev | New Drug Application | 2025-04-29 |
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
No data
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
No data
Variants
No data
Financial
No data
Trends
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Safety
Black-box Warning
No Black-box warning
Adverse Events
0 adverse events reported
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