Nintedanib

Nintedanib
Nintedanib
Clinical data
Trade namesVargatef, Ofev
Other namesBIBF 1120
AHFS/Drugs.comMonograph
MedlinePlusa615009
License data
Pregnancy
category
Routes of
administration		By mouth
ATC code
Legal status
Legal status
Pharmacokinetic data
Bioavailability4.7%
Protein binding97.8%
MetabolismEsterases, glucuronidation
Elimination half-life10–15 hrs
Excretion93% via faeces
Identifiers
IUPAC name
  • Methyl (3Z)-3-{[(4-{methyl[(4-methylpiperazin-1-yl)acetyl]amino}phenyl)amino](phenyl)methylidene}-2-oxo-2,3-dihydro-1H-indole-6-carboxylate
CAS Number
PubChem CID
IUPHAR/BPS
DrugBank
ChemSpider
UNII
KEGG
ChEBI
ChEMBL
PDB ligand
CompTox Dashboard (EPA)
ECHA InfoCard100.237.441
Chemical and physical data
FormulaC31H33N5O4
Molar mass539.636 g·mol−1
3D model (JSmol)
SMILES
  • COC(=O)c1ccc2c(c1)NC(=O)/C2=C(\Nc1ccc(N(C)C(=O)CN2CCN(C)CC2)cc1)c1ccccc1
InChI
  • InChI=1S/C31H33N5O4/c1-34-15-17-36(18-16-34)20-27(37)35(2)24-12-10-23(11-13-24)32-29(21-7-5-4-6-8-21)28-25-14-9-22(31(39)40-3)19-26(25)33-30(28)38/h4-14,19,32H,15-18,20H2,1-3H3,(H,33,38)/b29-28-
  • Key:XZXHXSATPCNXJR-ZIADKAODSA-N
 NY (what is this?)  (verify)
Nintedanib
Properties
Appearance Light yellow to yellow solid [6]
Except where otherwise noted, data are given for materials in their standard state (at 25 °C [77 °F], 100 kPa).
Infobox references

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.[5]

In March 2020, it was approved for use in the United States to treat chronic fibrosing (scarring) interstitial lung diseases (ILD) with a progressive phenotype (trait).[7] It is the first treatment for this group of fibrosing lung diseases that worsen over time that was approved by the U.S. Food and Drug Administration (FDA).[7]

Common side effects include abdominal pain, vomiting, and diarrhea.[8] It is a small molecule tyrosine-kinase inhibitor, targeting vascular endothelial growth factor receptor, fibroblast growth factor receptor and platelet derived growth factor receptor.[5]

Ofev was developed by Boehringer Ingelheim. It received U.S. Food and Drug Administration (FDA) approval for use for idiopathic pulmonary fibrosis in 2014 – one of only two drugs available for treating IPF – and numerous studies since have demonstrated its effectiveness in slowing the progressive, terminal lung disease.[9]

  1. ^ "Nintedanib (Ofev) Use During Pregnancy". Drugs.com. 16 September 2019. Archived from the original on 27 January 2021. Retrieved 9 March 2020.
  2. ^ "Prescription medicines: registration of new chemical entities in Australia, 2015". Therapeutic Goods Administration (TGA). 21 June 2022. Archived from the original on 10 April 2023. Retrieved 10 April 2023.
  3. ^ "Health Canada New Drug Authorizations: 2015 Highlights". Health Canada. 4 May 2016. Archived from the original on 20 February 2020. Retrieved 7 April 2024.
  4. ^ "Ofev- nintedanib capsule". DailyMed. Archived from the original on 23 April 2021. Retrieved 22 April 2021.
  5. ^ a b c "Vargatef EPAR". European Medicines Agency (EMA). 20 January 2020. Archived from the original on 9 August 2020. Retrieved 9 March 2020.
  6. ^ "Nintedanib (BIBF 1120)". MedChemExpress. Retrieved 8 June 2025.
  7. ^ a b "FDA Approves First Treatment for Group of Progressive Interstitial Lung Diseases". U.S. Food and Drug Administration (FDA) (Press release). 9 March 2020. Archived from the original on 10 March 2020. Retrieved 9 March 2020. This article incorporates text from this source, which is in the public domain.
  8. ^ "Nintedanib Side Effects". Archived from the original on 10 April 2019. Retrieved 24 October 2015.
  9. ^ "Nintedanib". Archived from the original on 28 February 2021. Retrieved 24 December 2019.
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