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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 Application2024-10-15
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
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 fibrosisD011658——713982259
Idiopathic pulmonary fibrosisD054990—J84.112712962053
FibrosisD005355——412961849
Lung diseasesD008171HP_0002088J98.42193923
Interstitial lung diseasesD017563HP_0006530J84.892192922
PneumoniaD011014EFO_0003106——2—114
Covid-19D000086382———1—2—3
MyositisD009220EFO_0000783G72.49———112
Disease progressionD018450—————1—1
Coronavirus infectionsD018352EFO_0007224B34.2———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 carcinomaD002289——1573—426
NeoplasmsD009369—C801211——14
Ovarian neoplasmsD010051EFO_0003893C56341——8
Colorectal neoplasmsD015179——141——6
RecurrenceD012008——161——6
Systemic sclerodermaD012595EFO_0000717M34.01—2—14
Diffuse sclerodermaD045743EFO_0000404—1—2—14
Peritoneal neoplasmsD010534——111——3
Malignant mesotheliomaD000086002———31——3
MesotheliomaD008654—C45—31——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———151———16
Lung neoplasmsD008175HP_0100526C34.9048——111
CarcinomaD002277—C80.047———10
AdenocarcinomaD000230——56———8
Ovarian epithelial carcinomaD000077216——14———5
Renal cell carcinomaD002292EFO_0000376—23———4
Breast neoplasmsD001943EFO_0003869C5023———4
LeukemiaD007938—C9522———3
Myeloid leukemia acuteD015470—C92.022———3
Myeloid leukemiaD007951—C9222———3
Show 52 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Drug interactionsD004347——2————2
Female genital neoplasmsD005833——1————1
Liver failureD017093HP_0001399K72.91————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
DyspneaD004417HP_0002094R06.0————33
DiarrheaD003967HP_0002014R19.7————22
Connective tissue diseasesD003240EFO_1001986M35————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
Image (chem structure or protein)Loading
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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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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22,034 adverse events reported
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