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
- -
Evaluation of Long-Term Safety of Pirfenidone (Esbriet) in Participants With Idiopathic Pulmonary Fibrosis (IPF)
- First Posted Date
- 2016-03-04
- Last Posted Date
- 2017-04-21
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 1009
- Registration Number
- NCT02699879
- Locations
- 🇦🇹
Medizinische Universitat Innsbruck; Department of Internal Medicine, Pneumology Centre, Innsbruck, Austria
🇩🇰Aarhus University Hospital; Lungemed afd. B, Aarhus, Denmark
🇦🇹LKH Hohenems; Abteilung für Pulmologie, Hohenems, Austria
Effect of Pirfenidone on Glomerular Filtration Rate and Albuminuria in Patients With Diabetic Nephropathy
- Conditions
- Interventions
- First Posted Date
- 2016-02-24
- Last Posted Date
- 2023-03-14
- Target Recruit Count
- 62
- Registration Number
- NCT02689778
- Locations
- 🇲🇽
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (INCMNSZ), Mexico City, Mexico
A Study of Oral Vismodegib in Combination With Pirfenidone in Participants With Idiopathic Pulmonary Fibrosis
- Conditions
- Interventions
- First Posted Date
- 2016-01-06
- Last Posted Date
- 2017-10-30
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 21
- Registration Number
- NCT02648048
- Locations
- 🇺🇸
Tulane University Medical School, New Orleans, Louisiana, United States
🇺🇸Suburban Lung Associates, Elk Grove, Illinois, United States
🇺🇸Allied Clinical Research, Reno, Nevada, United States
Clinical Progression of Mild to Moderate Idiopathic Pulmonary Fibrosis (IPF) Under a Therapy With Esbriet® (Pirfenidone)
- First Posted Date
- 2015-12-04
- Last Posted Date
- 2017-02-28
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 12
- Registration Number
- NCT02622477
- Locations
- 🇩🇪
Praxis Dr. med. Wilhelm Ammenwerth, Bochum, Germany
🇩🇪Universitätsklinikum Freiburg, Abteilung Pneumologie, Freiburg, Germany
🇩🇪Kliniken der Stadt Köln gGmbH Krankenhaus Merheim, Köln, Germany
A Study to Compare the Amount of Nintedanib and Pirfenidone in the Blood When Nintedanib and Pirfenidone Are Given Separately or in Combination
- Conditions
- Interventions
- First Posted Date
- 2015-11-17
- Last Posted Date
- 2019-03-04
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 37
- Registration Number
- NCT02606877
- Locations
- 🇬🇧
Papworth Hospital, Cambridge, United Kingdom
🇬🇧Glenfield Hospital, Leicester, United Kingdom
🇬🇧Southmead Hospital, Bristol, United Kingdom
Safety and Tolerability Study of Pirfenidone in Combination With Nintedanib in Participants With Idiopathic Pulmonary Fibrosis (IPF)
- Conditions
- Interventions
- First Posted Date
- 2015-11-05
- Last Posted Date
- 2018-06-13
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 89
- Registration Number
- NCT02598193
- Locations
- 🇺🇸
Stanford University School of Medicine ; Pulmonary/Critical Care Medicine, Stanford, California, United States
🇺🇸Mount Sinai School of Medicine, New York, New York, United States
🇺🇸Inova Health Care Services; Advanced Lung Disease Transplant Program, Falls Church, Virginia, United States
Safety, Tolerability and PK of Nintedanib in Combination With Pirfenidone in IPF
- Conditions
- Interventions
- First Posted Date
- 2015-10-19
- Last Posted Date
- 2018-02-13
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 105
- Registration Number
- NCT02579603
- Locations
- 🇺🇸
Western CT Medical Group, P.C., Danbury, Connecticut, United States
🇫🇷HOP Avicenne, Bobigny, France
🇫🇷HOP de la Cavale Blanche, Brest, France
A Bioequivalence Study Comparing Pirfenidone Tablet and Capsule Dosage Forms in Healthy Adult Participants
- First Posted Date
- 2015-08-17
- Last Posted Date
- 2016-11-02
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 44
- Registration Number
- NCT02525484
Pirfenidone in the Chronic Hypersensitivity Pneumonitis Treatment
- Conditions
- Interventions
- First Posted Date
- 2015-07-14
- Last Posted Date
- 2015-07-14
- Lead Sponsor
- Grupo Medifarma, S. A. de C. V.
- Target Recruit Count
- 60
- Registration Number
- NCT02496182
- Locations
- 🇲🇽
Instituto Nacional de Enfermedades Respiratorias, Mexico city, Distrito Federal, Mexico
Utility of Prolonged-release Pirfenidone in the Progression of Chronic Kidney Disease
- First Posted Date
- 2015-04-03
- Last Posted Date
- 2015-04-03
- Lead Sponsor
- University of Guadalajara
- Target Recruit Count
- 30
- Registration Number
- NCT02408744
Drug Development Updates
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