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pirfenidone

Trade name: esbriet

Small moleculeapprovedOrphan Drug FDAFast Track FDABreakthrough Therapy FDA

Approved

Oct 15, 2014

Pirfenidone is a synthetic antifibrotic agent indicated for the treatment of idiopathic pulmonary fibrosis as Esbriet. Pirfenidone inhibits fibroblast, epidermal, platelet-derived, and transforming beta-1 growth factors. It also inhibits DNA synthesis and the production of mRNA for collagen types I and III, resulting in a reduction in radiation-induced fibrosis. Pirfenidone has demonstrated activity in multiple fibrotic conditions however the exact mechanism of action of pirfenidone in the treatment of IPF has not been established. — NCATS

Clinical trial activity

114 trials · 98 clinical orgs · 23 marketing orgs

Phase 1
30
Phase 2
71
Phase 3
21
Phase 4
12

Earliest trial started Dec 1, 1999 (NCT00001959)

Timeline

1990s

  1. Jan 1, 1999

    Earliest Phase 2 Sponsor(trial)

2000s

  1. Jan 1, 2002

    Earliest Phase 1 Sponsor(trial)

  2. Mar 5, 2004

    Orphan Drug Designation

  3. Jan 1, 2006

    Genentech — Earliest Phase 3 Sponsor(trial)

2010s

  1. Oct 15, 2014

    InterMune — Earliest FDA Approval

  2. Oct 15, 2014

    Genentech — NDA Secondary Org

  3. Oct 15, 2014

    InterMune — NDA Secondary Org

  4. Oct 15, 2014

    InterMune — NDA Organization

  5. Oct 15, 2014

    Roche — NDA Secondary Org

  6. Oct 15, 2014

    LEGACY PHARMA — Marketing Organization

  7. Oct 29, 2019

    Apotex — Marketing Organization

2020s

  1. Jun 4, 2020

    Micro Labs Ltd India — Marketing Organization

  2. Aug 28, 2020

    Zoetis — Marketing Organization

  3. Mar 26, 2021

    Sandoz — Marketing Organization

  4. May 12, 2021

    Granules India — Marketing Organization

  5. Jan 3, 2022

    Amneal Pharmaceuticals — Marketing Organization

  6. Jan 20, 2022

    Accord Research — Marketing Organization

  7. Jan 25, 2022

    Teva — Marketing Organization

  8. Apr 28, 2022

    Novartis — Marketing Organization

  9. May 20, 2022

    Alembic — Marketing Organization

  10. May 24, 2022

    MSN Laboratories — Marketing Organization

  11. Jul 19, 2022

    Laurus Labs Ltd — Marketing Organization

  12. Jul 21, 2022

    Aizant — Marketing Organization

  13. Aug 1, 2022

    Sciegen Pharmaceticals — Marketing Organization

  14. Sep 21, 2022

    Hetero Labs Ltd — Marketing Organization

  15. Aug 23, 2023

    Lupin — Marketing Organization

  16. Aug 23, 2023

    Chartwell Pharmaceuticals — Marketing Organization

  17. Dec 18, 2024

    Macleods Pharmaceuticals, Ltd — Marketing Organization

  18. Aug 11, 2025

    Aurobindo Pharma — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

  • Unspecified targetOTHER

    Unknown

Approval history

  • approvedPriority reviewFast trackBreakthroughOct 15, 2014

Chemistry & pharmacology

Loading structure…

SMILES

CC1=CN(C(=O)C=C1)C2=CC=CC=C2
Mol. weight
185.2218 g/mol
Lipinski Ro5
Pass
Rule of 3
Yes
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

First in class

Sources

Also known as

  • 5-methyl-1-phenyl-2-(1h)-pyridone
  • amr-69
  • amr-69
  • deskar
  • esbriet
  • esbriet
  • esbriet
  • esbriet
  • glaspia
  • pirfenidone
  • pirfenidone
  • pirfenidone
  • pirfenidone
  • pirfenidone
  • pirfenidone
  • pirfenidone
  • pirfenidone
  • pirfenidone
  • pirfenidone
  • pirfenidone

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07284602Phase 3Apr 30, 2026PureTech
NCT07268677Phase 2Dec 1, 2025Fudan University
NCT07229716Phase 1Nov 30, 2025Hengrui Therapeutics, Inc.
NCT07082842Phase 3Oct 9, 2025Sunshine Lake Pharma Co., Ltd.
NCT07141810Phase 4Oct 1, 2025Huazhong University of Science and Technology
NCT07161791Phase 1/Phase 2 (Phase 2)Sep 15, 2025Harbin Medical University
NCT06928272Phase 3Sep 10, 2025University of Western Ontario
NCT06912763Phase 2Aug 8, 2025University of Texas at Houston
NCT07015398Phase 1Jun 30, 2025Trevi Therapeutics
NCT06951217Phase 2Apr 17, 2025Avalyn Pharma Inc.
NCT06871904Phase 1/Phase 2 (Phase 2)Apr 1, 2025University of Karachi, Ziauddin University
NCT06241560Phase 2Nov 8, 2024Boehringer Ingelheim
NCT06569381Phase 1Aug 23, 2024Overseas Pharmaceuticals, Ltd., Qingdao University, Shanghai ShouYan Clinical Development Co.,Ltd.
NCT06484153Phase 1/Phase 2 (Phase 2)Jul 22, 2024Huazhong University of Science and Technology
NCT06253117Phase 2Jun 27, 2024Department of Defense, University of Alabama, Birmingham
NCT06588517Phase 1Apr 8, 2024Overseas Pharmaceuticals, Ltd., Qingdao University, Shanghai ShouYan Clinical Development Co.,Ltd.
NCT06329401Phase 2Apr 3, 2024Avalyn Pharma Inc., DevPro Biopharma
NCT06224790Phase 4Mar 10, 2024King Edward Medical University
NCT06142318Phase 2Nov 15, 2023Southern Medical University
NCT06070610Phase 1Nov 8, 2023Boehringer Ingelheim
Showing 20 of 114 trials
Page 1 / 6

Organizations

Research & Development (98)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
GenentechFor profit14742003
RocheFor profit13852003
GNI GroupFor profit9632015
National Institutes of Health (NIH)Government6321999
University of GuadalajaraAcademic/Hospital6622005
Boehringer IngelheimFor profit5532011
Huazhong University of Science and TechnologyAcademic/Hospital5442011
University of California, San FranciscoAcademic/Hospital4222018
Grupo Medifarma, S. A. de C. V.For profit3112015
National Cancer Institute (NCI)Government3332001
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government3111999
Overseas Pharmaceuticals, Ltd.For profit3312023
Qingdao UniversityAcademic/Hospital3012023
Sunshine Lake Pharma Co., Ltd.For profit3332021
University of MichiganAcademic/Hospital3122017
Avalyn Pharma Inc.For profit2212024
Cell PharmaFor profit2012014
Cell Therapy And Technology, S.a. De C.v.Academic/Hospital2012005
Fudan UniversityAcademic/Hospital2212022
Grupo Mexicano para el Estudios de las Enfermedades HepaticasAcademic/Hospital2212015
98 organizations
Page 1 / 5

Marketing (28)

OrganizationOrg typeRelationshipDate
Accord ResearchFor profitMKTGJan 20, 2022
AizantFor profitMKTGJul 21, 2022
AlembicFor profitMKTGMay 20, 2022
AlembicFor profitSYNMay 20, 2022
Amneal PharmaceuticalsFor profitMKTGJan 3, 2022
ApotexFor profitSYNMay 31, 2023
ApotexFor profitMKTGOct 29, 2019
Aurobindo PharmaFor profitMKTGAug 11, 2025
Chartwell PharmaceuticalsFor profitMKTGAug 23, 2023
GenentechFor profitNDA2Oct 15, 2014
Granules IndiaFor profitMKTGMay 12, 2021
Hetero Labs LtdFor profitMKTGSep 21, 2022
InterMuneFor profitNDA2Oct 15, 2014
InterMuneFor profitNDAOct 15, 2014
LEGACY PHARMAFor profitMKTGOct 15, 2014
Laurus Labs LtdFor profitMKTGJul 19, 2022
LupinFor profitMKTGAug 23, 2023
MSN LaboratoriesFor profitMKTGMay 24, 2022
Macleods Pharmaceuticals, LtdFor profitMKTGDec 18, 2024
Micro Labs Ltd IndiaFor profitSYNMay 18, 2022
Micro Labs Ltd IndiaFor profitMKTGJun 4, 2020
NovartisFor profitMKTGApr 28, 2022
RocheFor profitNDA2Oct 15, 2014
SandozFor profitSYNApr 28, 2022
SandozFor profitMKTGMar 26, 2021
Sciegen PharmaceticalsFor profitMKTGAug 1, 2022
TevaFor profitMKTGJan 25, 2022
ZoetisFor profitMKTGAug 28, 2020