Pirfenidone

Pirfenidone
Clinical data
Trade namesEsbriet, Pirespa, Etuary
AHFS/Drugs.comMonograph
MedlinePlusa615008
License data
Pregnancy
category
Routes of
administration		By mouth
ATC code
Legal status
Legal status
Pharmacokinetic data
Protein binding50–58%[7]
MetabolismLiver (70–80% CYP1A2-mediated; minor contributions from CYP2C9, CYP2C19, CYP2D6 and CYP2E1)[7]
Elimination half-life2.4 hours[7]
ExcretionUrine (80%)[7]
Identifiers
  • 5-Methyl-1-phenylpyridin-2-one
CAS Number
PubChem CID
DrugBank
ChemSpider
UNII
KEGG
ChEBI
ChEMBL
CompTox Dashboard (EPA)
ECHA InfoCard100.150.129 Edit this at Wikidata
Chemical and physical data
FormulaC12H11NO
Molar mass185.226 g·mol−1
3D model (JSmol)
Solubility in water10mg/mL at 60 °C
  • CC1=CN(C(=O)C=C1)C2=CC=CC=C2
  • InChI=1S/C12H11NO/c1-10-7-8-12(14)13(9-10)11-5-3-2-4-6-11/h2-9H,1H3
  • Key:ISWRGOKTTBVCFA-UHFFFAOYSA-N
 ☒NcheckY (what is this?)  (verify)

Pirfenidone, sold under the brand name Pirespa among others, is a medication used for the treatment of idiopathic pulmonary fibrosis. It works by reducing lung fibrosis through downregulation of the production of growth factors and procollagens I and II.

It was first approved in Japan for the treatment of people with idiopathic pulmonary fibrosis after clinical trials in 2008. It was approved for use in the European Union in 2011,[8][6] in Canada in 2012,[4] and in the United States in October 2014.[5][9]

It is available as a generic medication.[10]

  1. ^ a b "Esbriet® (pirfenidone) Film coated tablets". Roche Products Pty Limited. medsinfo.com.au. Archived from the original on 8 January 2023. Retrieved 8 January 2023.
  2. ^ "Esbriet® (pirfenidone) Capsules". Roche Products Pty Limited. medsinfo.com.au. Archived from the original on 8 January 2023. Retrieved 8 January 2023.
  3. ^ "Prescription medicines: registration of new chemical entities in Australia, 2016". Therapeutic Goods Administration (TGA). 21 June 2022. Archived from the original on 10 April 2023. Retrieved 10 April 2023.
  4. ^ a b "Esbriet Product information". Health Canada. 25 April 2012. Archived from the original on 8 January 2023. Retrieved 8 January 2023.
  5. ^ a b "Esbriet- pirfenidone capsule Esbriet- pirfenidone tablet, coated". DailyMed. 14 December 2022. Archived from the original on 8 January 2023. Retrieved 8 January 2023.
  6. ^ a b "Esbriet EPAR". European Medicines Agency. 17 September 2018. Archived from the original on 24 November 2020. Retrieved 19 June 2020.
  7. ^ a b c d "Esbriet 267 mg hard capsules". electronic Medicines Compendium. Intermune UK & I Ltd. 3 January 2014. Archived from the original on 12 October 2013. Retrieved 6 March 2014.
  8. ^ "InterMune: Pirfenidone". InterMune. Archived from the original on 21 October 2020. Retrieved 17 December 2015.
  9. ^ "Drug Approval Package: Esbriet (pirfenidone) Capsules NDA #022535". U.S. Food and Drug Administration. 24 December 1999. Archived from the original on 3 January 2021. Retrieved 19 June 2020.
  10. ^ "2022 First Generic Drug Approvals". U.S. Food and Drug Administration (FDA). 3 March 2023. Archived from the original on 30 June 2023. Retrieved 30 June 2023.