Pirfenidone information

Pirfenidone
Clinical data
Trade names	Esbriet, Pirespa, Etuary
AHFS/Drugs.com	Monograph
MedlinePlus	a615008
License data	EU EMA: by INN; US DailyMed: Pirfenidone;
Pregnancy; category	AU: B3; ;
Routes of; administration	By mouth
ATC code	L04AX05 (WHO) ;
Legal status
Legal status	AU: S4 (Prescription only); CA: ℞-only; UK: POM (Prescription only); US: ℞-only; EU: Rx-only; In general: ℞ (Prescription only);
Pharmacokinetic data
Protein binding	50–58%
Metabolism	Liver (70–80% CYP1A2-mediated; minor contributions from CYP2C9, CYP2C19, CYP2D6 and CYP2E1)
Elimination half-life	2.4 hours
Excretion	Urine (80%)
Identifiers
	IUPAC name 5-Methyl-1-phenylpyridin-2-one;
CAS Number	53179-13-8;
PubChem CID	40632;
ChemSpider	37115;
UNII	D7NLD2JX7U;
KEGG	D01583 ;
ChEBI	CHEBI:32016 ;
ChEMBL	ChEMBL1256391 ;
CompTox Dashboard (EPA)	DTXSID4045183 ;
ECHA InfoCard	100.150.129
Chemical and physical data
Formula	C12H11NO
Molar mass	185.226 g·mol−1
3D model (JSmol)	Interactive image;
Solubility in water	10mg/mL at 60 °C
	SMILES CC1=CN(C(=O)C=C1)C2=CC=CC=C2;
	InChI 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;
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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]

^ ^a ^b "Archived copy". Archived from the original on 8 January 2023. Retrieved 8 January 2023.{{cite web}}: CS1 maint: archived copy as title (link)
^ "Archived copy". Archived from the original on 8 January 2023. Retrieved 8 January 2023.{{cite web}}: CS1 maint: archived copy as title (link)
^ "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.
^ ^a ^b "Esbriet Product information". Health Canada. 25 April 2012. Archived from the original on 8 January 2023. Retrieved 8 January 2023.
^ ^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.
^ ^a ^b "Esbriet EPAR". European Medicines Agency. 17 September 2018. Archived from the original on 24 November 2020. Retrieved 19 June 2020.
^ ^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.
^ "InterMune: Pirfenidone". InterMune. Archived from the original on 21 October 2020. Retrieved 17 December 2015.
^ "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.
^ "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.

[Esbriet_PI-1] "Archived copy". Archived from the original on 8 January 2023. Retrieved 8 January 2023.{{cite web}}: CS1 maint: archived copy as title (link)

[2] "Archived copy". Archived from the original on 8 January 2023. Retrieved 8 January 2023.{{cite web}}: CS1 maint: archived copy as title (link)

[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.

[CA_Esbriet-4] "Esbriet Product information". Health Canada. 25 April 2012. Archived from the original on 8 January 2023. Retrieved 8 January 2023.

[Esbriet_FDA_label-5] "Esbriet- pirfenidone capsule Esbriet- pirfenidone tablet, coated". DailyMed. 14 December 2022. Archived from the original on 8 January 2023. Retrieved 8 January 2023.

[Esbriet_EPAR-6] "Esbriet EPAR". European Medicines Agency. 17 September 2018. Archived from the original on 24 November 2020. Retrieved 19 June 2020.

[EMC-7] "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.

[Intermune-8] "InterMune: Pirfenidone". InterMune. Archived from the original on 21 October 2020. Retrieved 17 December 2015.

[FDA_approval-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.

Pirfenidone information

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