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Drug ReportsNintedanib esylate
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
neoplasmsD009369
respiratory tract diseasesD012140
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
OFEVBoehringer IngelheimN-205832 RX2014-10-15
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
ofevNew Drug Application2025-04-29
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
idiopathic pulmonary fibrosis—D054990J84.112
Agency Specific
FDA
EMA
Expiration
Code
NINTEDANIB ESYLATE, OFEV, BOEHRINGER INGELHEIM
2026-09-06ODE-261
2023-03-09I-825
Patent Expiration
Patent
Expires
Flag
FDA Information
Nintedanib Esylate, Ofev, Boehringer Ingelheim
99077562029-06-07DP
101053232029-06-04DP
101549902026-01-08U-2620
67621802025-10-01DS, DP
71190932024-02-21DS, DP
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
— L01EX: Other protein kinase inhibitors in atc
— L01EX09: Nintedanib
HCPCS
No data
Clinical
Clinical Trials
206 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 fibrosisD011658—J84.10—6652037
FibrosisD005355———6641632
Idiopathic pulmonary fibrosisD054990—J84.112—5541731
Lung diseasesD008171EFO_0003818J98.41—62817
Interstitial lung diseasesD017563EFO_0004244J84.91—62817
Covid-19D000086382—U07.1———1—1
Respiratory tract diseasesD012140—————1—1
Respiration disordersD012120—J00-J99———1—1
MyositisD009220EFO_0000783G72.49———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-small-cell lung carcinomaD002289——1233—320
NeoplasmsD009369—C809—1——10
Ovarian neoplasmsD010051EFO_0003893C56331——7
Colorectal neoplasmsD015179——131——5
Peritoneal neoplasmsD010534——111——3
Systemic sclerodermaD012595EFO_0000717M341—1—13
Diffuse sclerodermaD045743EFO_0000404—1—1—13
Malignant mesotheliomaD000086002———11——1
MesotheliomaD008654—C45—11——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CarcinomaD002277—C80.034———6
Lung neoplasmsD008175—C34.9014——16
Renal cell carcinomaD002292EFO_0000376—23———4
Ovarian epithelial carcinomaD000077216——13———4
AdenocarcinomaD000230——42———4
Fallopian tube neoplasmsD005185——12———3
Prostatic neoplasmsD011471—C6112———3
Hepatocellular carcinomaD006528—C22.012———3
Liver neoplasmsD008113EFO_1001513C22.012———3
LeukemiaD007938—C9521———2
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———11————11
Uterine cervical neoplasmsD002583——1————1
Female genital neoplasmsD005833——1————1
Liver failureD017093—K72.91————1
Hepatic insufficiencyD048550——1————1
Multiple myelomaD009101—C90.01————1
Plasma cell neoplasmsD054219——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
DyspneaD004417—R06.0————33
Connective tissue diseasesD003240EFO_1001986M35————11
DiarrheaD003967—R19.7————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameNintedanib esylate
INNnintedanib
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 classangiogenesis inhibitors
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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-ID656247-17-5
RxCUI1592737
ChEMBL IDCHEMBL3039504
ChEBI ID85170
PubChem CID9809715
DrugBankDB09079
UNII IDG6HRD2P839 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
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Additional graphs summarizing 372 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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25,762 adverse events reported
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