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
- -
Targeting Residual Activity By Precision, Biomarker-Guided Combination Therapies of Multiple Sclerosis (TRAP-MS)
- Conditions
- Interventions
- First Posted Date
- 2017-04-12
- Last Posted Date
- 2024-12-02
- Target Recruit Count
- 250
- Registration Number
- NCT03109288
- Locations
- 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States
A Study of Pirfenidone in Patients With Unclassifiable Progressive Fibrosing Interstitial Lung Disease
- First Posted Date
- 2017-04-04
- Last Posted Date
- 2021-01-13
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 253
- Registration Number
- NCT03099187
- Locations
- 🇦🇺
John Hunter Hospital; Respiratory Department; Respiratory Department, New Lambton Heights, New South Wales, Australia
🇦🇺Lung Research Queensland, Nundah, Queensland, Australia
🇦🇺Princess Alexandra Hospital, Department of Respiratory and Sleep Medicine, Woolloongabba, Queensland, Australia
Pirfenidone as Treatment of Skin Fibrosis in Systemic Sclerosis
- Conditions
- Interventions
- First Posted Date
- 2017-03-01
- Last Posted Date
- 2017-03-01
- Lead Sponsor
- RenJi Hospital
- Target Recruit Count
- 72
- Registration Number
- NCT03068234
- Locations
- 🇨🇳
RenJi Hospital, Shanghai, Shanghai, China
Post Marketing Surveillance of Nintedanib in Indian Patients With Idiopathic Pulmonary Fibrosis
- First Posted Date
- 2017-02-08
- Last Posted Date
- 2024-08-22
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 21
- Registration Number
- NCT03047031
- Locations
- 🇮🇳
P.D. Hinduja National Hospital, Mumbai, India
🇮🇳Asthma Bhawan, Jaipur, India
🇮🇳CK Birla Hospitals, The Calcutta Medical Research Institute, Kolkata, India
Study of Efficacy and Safety of Pirfenidone in Patients With Fibrotic Hypersensitivity Pneumonitis
- Conditions
- Interventions
- First Posted Date
- 2016-11-08
- Last Posted Date
- 2023-01-09
- Lead Sponsor
- Evans Fernandez Perez
- Target Recruit Count
- 40
- Registration Number
- NCT02958917
- Locations
- 🇺🇸
National Jewish Health, Denver, Colorado, United States
Efficacy, Safety, and Tolerability Study of Pirfenidone in Combination With Sildenafil in Participants With Advanced Idiopathic Pulmonary Fibrosis (IPF) and Intermediate or High Probability of Group 3 Pulmonary Hypertension
- Conditions
- Interventions
- First Posted Date
- 2016-11-01
- Last Posted Date
- 2020-11-12
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 177
- Registration Number
- NCT02951429
- Locations
- 🇳🇱
Vu Medisch Centrum; Afdeling Longziekten, Amsterdam, Netherlands
🇹🇷Yedikule Gogus Hastaliklari ve Gogus Cerrahisi EAH;Gogus Hastaliklari, Istanbul, Turkey
🇿🇦University of Stellenbosch; Respiratory Research, Parow, South Africa
The Efficacy and Safety of Pirfenidone in Patients With Heart Failure and Preserved Left Ventricular Ejection Fraction
- First Posted Date
- 2016-10-13
- Last Posted Date
- 2020-07-02
- Lead Sponsor
- Manchester University NHS Foundation Trust
- Target Recruit Count
- 129
- Registration Number
- NCT02932566
- Locations
- 🇬🇧
Manchester University NHS Foundation Trust, Manchester, Greater Manchester, United Kingdom
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
- Interventions
- 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
- 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
Drug Development Updates
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