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 necro...

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
Associated Therapies
-

Clinical Trial of Pirfenidone in Adult Patients With Neurofibromatosis 1

Phase 2
Completed
Conditions
First Posted Date
2008-09-18
Last Posted Date
2012-03-19
Lead Sponsor
Mayo Clinic
Target Recruit Count
24
Registration Number
NCT00754780

Open-Label Study of the Long Term Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Phase 3
Completed
Conditions
Interventions
First Posted Date
2008-04-21
Last Posted Date
2017-03-29
Lead Sponsor
Genentech, Inc.
Target Recruit Count
1058
Registration Number
NCT00662038
Locations
🇺🇸

Genentech, Inc., South San Francisco, California, United States

Development of a Non-Invasive Treatment for Uterine Leiomyoma (Fibroids)

Phase 2
Completed
Conditions
First Posted Date
2006-06-01
Last Posted Date
2017-07-02
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Target Recruit Count
32
Registration Number
NCT00332033
Locations
🇺🇸

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

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

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

and more 12 locations

Pirfenidone: A New Drug to Treat Kidney Disease in Patients With Diabetes

Phase 1
Completed
Conditions
Interventions
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

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

and more 12 locations

Pirfenidone in Treating Patients With Fibrosis Caused by Radiation Therapy for Cancer

Not Applicable
Completed
Conditions
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

© Copyright 2024. All Rights Reserved by MedPath