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
Efficacy of Intralesional Triamcinolone and 8% Topical Pirfenidone for Treatment of Keloid Scars
- Conditions
- Keloid
- Interventions
- First Posted Date
- 2016-07-06
- Last Posted Date
- 2017-07-14
- Lead Sponsor
- Centro Dermatológico Dr. Ladislao de la Pascua
- Target Recruit Count
- 102
- Registration Number
- NCT02823236
- Locations
- 🇲🇽
Centro Dermatológico "Dr. Ladislao de la Pascua", Mexico City, Mexico
Pirfenidone in Progressive Interstitial Lung Disease Associated With Clinically Amyopathic Dermatomyositis
- First Posted Date
- 2016-07-01
- Last Posted Date
- 2016-07-01
- Lead Sponsor
- RenJi Hospital
- Target Recruit Count
- 57
- Registration Number
- NCT02821689
- Locations
- 🇨🇳
Department of Rheumatology, Ren Ji Hospital South Campus, School of Medicine, Shanghai JiaoTong University, Shanghai, Shanghai, China
Phase ll Study of Pirfenidone in Patients With RAILD (TRAIL1)
- Conditions
- Rheumatoid Arthritis Interstitial Lung Disease
- Interventions
- Drug: Placebo
- First Posted Date
- 2016-06-22
- Last Posted Date
- 2022-08-16
- Lead Sponsor
- Brigham and Women's Hospital
- Target Recruit Count
- 123
- Registration Number
- NCT02808871
- Locations
- 🇺🇸
Weill Cornell Medicine, New York, New York, United States
🇨🇦University of Calgary Cummings School of Medicine, Calgary, Alberta, Canada
🇬🇧Royal Brompton and Harefield NHS Foundation Trust, London, United Kingdom
A Study to Assess the Safety and Tolerability of N-Acetylcysteine When Administered With Pirfenidone to Participants With Idiopathic Pulmonary Fibrosis (IPF)
- Conditions
- Idiopathic Pulmonary Fibrosis
- Interventions
- First Posted Date
- 2016-03-14
- Last Posted Date
- 2016-05-20
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 123
- Registration Number
- NCT02707640
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
- Diabetic NephropathyAlbuminuria
- Interventions
- Drug: Placebo
- First Posted Date
- 2016-02-24
- Last Posted Date
- 2023-03-14
- Lead Sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- 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
- Idiopathic Pulmonary Fibrosis
- 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
Efficacy of Pirfenidone Plus MODD in Diabetic Foot Ulcers
- Conditions
- Diabetic Foot Ulcer
- Interventions
- First Posted Date
- 2015-12-17
- Last Posted Date
- 2015-12-17
- Lead Sponsor
- University of Guadalajara
- Target Recruit Count
- 60
- Registration Number
- NCT02632877
- Locations
- 🇲🇽
Molecular Biology and Gene Therapy Institute, Guadalajara, Jalisco, Mexico
🇲🇽Hospital Valentín Gómez Farías, Zapopan, Jalisco, Mexico
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
- Idiopathic Pulmonary Fibrosis
- 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
Drug Development Updates
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