Pirfenidone
- Generic Name
- Pirfenidone
- Brand Names
- Esbriet, Pirfenidone axunio (previously Pirfenidone AET), Pirfenidone Viatris
- Drug Type
- Small Molecule
- Chemical Formula
- C12H11NO
- CAS Number
- 53179-13-8
- Unique Ingredient Identifier
- D7NLD2JX7U
- Background
Pirfenidone is a synthetic pyridone drug. It is an antifibrotic agent with anti-inflammatory and antioxidant properties that is used to treat idiopathic pulmonary fibrosis (IPF), which is a chronic, progressive form of interstitial pneumonia. While its mechanism of action is not yet fully understood, pirfenidone is proposed to primarily regulate tumor necrosis factor (TNF) pathways and modulate cellular oxidation. The FDA first approved pirfenidone alongside nintedanib as one of the first drugs to treat IPF.
- Indication
Pirfenidone is indicated for the treatment of idiopathic pulmonary fibrosis (IPF). In Canada and Europe, it is approved in adults only.
- Associated Conditions
- Idiopathic Pulmonary Fibrosis (IPF), Mild Idiopathic Pulmonary Fibrosis, Moderate Idiopathic Pulmonary Fibrosis
Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis
- First Posted Date
- 2006-02-07
- Last Posted Date
- 2017-05-22
- Lead Sponsor
- Genentech, Inc.
- Target Recruit Count
- 435
- Registration Number
- NCT00287716
- Locations
- 🇺🇸
InterMune, Inc., Brisbane, California, United States
Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis
- First Posted Date
- 2006-02-07
- Last Posted Date
- 2017-04-17
- Lead Sponsor
- Genentech, Inc.
- Target Recruit Count
- 344
- Registration Number
- NCT00287729
- Locations
- 🇺🇸
InterMune, Inc., Brisbane, California, United States
Safety Study of Oral Pirfenidone in Patients With Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis
- Conditions
- Idiopathic Pulmonary FibrosisPulmonary Fibrosis
- Interventions
- First Posted Date
- 2004-03-26
- Last Posted Date
- 2017-04-17
- Lead Sponsor
- Genentech, Inc.
- Target Recruit Count
- 83
- Registration Number
- NCT00080223
Pirfenidone in Children and Young Adults With Neurofibromatosis Type I and Progressive Plexiform Neurofibromas
- First Posted Date
- 2004-01-14
- Last Posted Date
- 2018-04-23
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 36
- Registration Number
- NCT00076102
- Locations
- 🇺🇸
Johns Hopkins Oncology Center, Baltimore, Maryland, United States
🇺🇸Childrens Hospital, Philadelphia, Philadelphia, Pennsylvania, United States
🇺🇸St. Louis Children's Hospital, Saint Louis, Missouri, United States
Pirfenidone: A New Drug to Treat Kidney Disease in Patients With Diabetes
- First Posted Date
- 2003-07-02
- Last Posted Date
- 2009-11-04
- Lead Sponsor
- Sharma, Kumar, M.D.
- Target Recruit Count
- 77
- Registration Number
- NCT00063583
- Locations
- 🇺🇸
National Institute of Diabetes and Digestive and Kidney Disease (NIDDK), Bethesda, Maryland, United States
🇺🇸Mayo Clinic, Rochester, Minnesota, United States
🇺🇸The Center for Diabetic Kidney Disease at Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Pirfenidone in Treating Young Patients With Neurofibromatosis Type 1 and Plexiform Neurofibromas
- Conditions
- Neurofibromatosis Type 1Precancerous Condition
- First Posted Date
- 2003-02-06
- Last Posted Date
- 2015-04-30
- Lead Sponsor
- National Cancer Institute (NCI)
- Registration Number
- NCT00053937
- Locations
- 🇺🇸
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
🇺🇸Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States
🇺🇸Children's National Medical Center, Washington, District of Columbia, United States
Pirfenidone in Treating Patients With Fibrosis Caused by Radiation Therapy for Cancer
- Conditions
- Radiation Fibrosis
- First Posted Date
- 2003-01-27
- Last Posted Date
- 2013-06-19
- Lead Sponsor
- National Cancer Institute (NCI)
- Registration Number
- NCT00020631
- Locations
- 🇺🇸
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda, Maryland, United States
Pirfenidone to Treat Hypertrophic Cardiomyopathy
- Conditions
- Hypertrophic Cardiomyopathy
- First Posted Date
- 2001-02-12
- Last Posted Date
- 2008-03-04
- Target Recruit Count
- 50
- Registration Number
- NCT00011076
- Locations
- 🇺🇸
National Heart, Lung and Blood Institute (NHLBI), Bethesda, Maryland, United States
Pirfenidone to Treat Kidney Disease (Focal Segmental Glomerulosclerosis)
- Conditions
- FibrosisProteinuriaFocal GlomerulosclerosisKidney FailureNephrotic Syndrome
- First Posted Date
- 2000-01-19
- Last Posted Date
- 2014-05-26
- Target Recruit Count
- 21
- Registration Number
- NCT00001959
- Locations
- 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States
Oral Pirfenidone for the Pulmonary Fibrosis of Hermansky-Pudlak Syndrome
- Conditions
- Inborn Errors of MetabolismPlatelet Storage Pool DeficiencyOculocutaneous AlbinismAlbinismPulmonary Fibrosis
- Interventions
- Drug: Placebo
- First Posted Date
- 1999-11-04
- Last Posted Date
- 2017-10-16
- Lead Sponsor
- William Gahl, M.D.
- Target Recruit Count
- 35
- Registration Number
- NCT00001596
- Locations
- 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States
Drug Development Updates
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