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.
Download report
Favorite
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
Mock data
Subscribe for the real data
Subscribe for the real data
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 |
|---|---|---|
| nintedanib | ANDA | 2026-07-30 |
| nintedanib capsules, 100 mg and 150 mg | ANDA | 2026-04-21 |
| nintedanib esylate | ANDA | 2026-08-03 |
| ofev | New Drug Application | 2025-11-20 |
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
223 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pulmonary fibrosis | D011658 | — | J84.10 | — | 6 | 5 | 5 | 17 | 33 |
| Idiopathic pulmonary fibrosis | D054990 | — | J84.112 | — | 5 | 5 | 4 | 17 | 31 |
| Fibrosis | D005355 | — | — | — | 6 | 5 | 4 | 13 | 28 |
| Interstitial lung diseases | D017563 | EFO_0004244 | J84.9 | 1 | — | 6 | 2 | 9 | 18 |
| Covid-19 | D000086382 | — | U07.1 | — | — | — | 1 | — | 1 |
| Respiratory tract diseases | D012140 | — | — | — | — | — | 1 | — | 1 |
| Respiration disorders | D012120 | — | J00-J99 | — | — | — | 1 | — | 1 |
| Cicatrix | D002921 | — | L90.5 | — | — | — | 1 | — | 1 |
| Myositis | D009220 | EFO_0000783 | G72.49 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Non-small-cell lung carcinoma | D002289 | — | — | 12 | 3 | 3 | — | 3 | 20 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | 1 | — | 5 | — | 4 | 10 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 3 | 3 | 1 | — | — | 7 |
| Colorectal neoplasms | D015179 | — | — | 1 | 3 | 1 | — | — | 5 |
| Peritoneal neoplasms | D010534 | — | — | 1 | 1 | 1 | — | — | 3 |
| Systemic scleroderma | D012595 | EFO_0000717 | M34 | 1 | — | 1 | — | — | 2 |
| Diffuse scleroderma | D045743 | EFO_0000404 | — | 1 | — | 1 | — | — | 2 |
| Malignant mesothelioma | D000086002 | — | — | — | 1 | 1 | — | — | 1 |
| Mesothelioma | D008654 | — | C45 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lung neoplasms | D008175 | — | C34.90 | 1 | 4 | — | — | 1 | 6 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 2 | 3 | — | — | — | 4 |
| Ovarian epithelial carcinoma | D000077216 | — | — | 1 | 3 | — | — | — | 4 |
| Carcinoma | D002277 | — | C80.0 | 1 | 3 | — | — | — | 4 |
| Fallopian tube neoplasms | D005185 | — | — | 1 | 2 | — | — | — | 3 |
| Prostatic neoplasms | D011471 | — | C61 | 1 | 2 | — | — | — | 3 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | 1 | 2 | — | — | — | 3 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 1 | 2 | — | — | — | 3 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 2 | 1 | — | — | — | 2 |
| Glioblastoma | D005909 | EFO_0000515 | — | — | 2 | — | — | — | 2 |
Show 29 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 11 | — | — | — | — | 11 |
| Neoplasms | D009369 | — | C80 | 9 | — | — | — | — | 9 |
| Uterine cervical neoplasms | D002583 | — | — | 1 | — | — | — | — | 1 |
| Female genital neoplasms | D005833 | — | — | 1 | — | — | — | — | 1 |
| Liver failure | D017093 | — | K72.9 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
| Multiple myeloma | D009101 | — | C90.0 | 1 | — | — | — | — | 1 |
| Plasma cell neoplasms | D054219 | — | — | 1 | — | — | — | — | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
View more details
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:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 9,999 documents
View more details
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
30,096 adverse events reported
View more details
© 2020-2025 Collaborative Drug Discovery Inc. (CDD) | Terms of Use