Pirfenidone

Generic Name: Pirfenidone

Brand Names: Esbriet, Pirfenidone axunio (previously Pirfenidone AET), Pirfenidone Viatris

Drug Type: Small Molecule

Chemical Formula: C_₁₂H_₁₁NO

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

Clinical Trials

Safety and Tolerability Study of Pirfenidone in Combination With Nintedanib in Participants With Idiopathic Pulmonary Fibrosis (IPF)

Phase 4

Completed

Conditions: Idiopathic Pulmonary Fibrosis

Interventions: Drug: Nintedanib
Drug: Pirfenidone

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

and more 35 locations

Safety, Tolerability and PK of Nintedanib in Combination With Pirfenidone in IPF

Phase 4

Completed

Conditions: Idiopathic Pulmonary Fibrosis

Interventions: Drug: Nintedanib
Drug: Pirfenidone

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

and more 20 locations

Pirfenidone Effect on the Recovery of Renal Function in Septic Acute Kidney Injury

Phase 4

Conditions: Acute Kidney Injury
Sepsis

Interventions: Drug: Pirfenidone extended release
Drug: Placebo equivalent

First Posted Date: 2015-08-21

Last Posted Date: 2015-08-21

Lead Sponsor: Hospital Civil de Guadalajara

Target Recruit Count: 90

Registration Number: NCT02530359

A Bioequivalence Study Comparing Pirfenidone Tablet and Capsule Dosage Forms in Healthy Adult Participants

Phase 1

Completed

Conditions: Healthy Volunteer

Interventions: Drug: Pirfenidone

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

Phase 2

Conditions: Alveolitis Extrinsic Allergic
Pulmonary Fibrosis

Interventions: Drug: Pirfenidone
Drug: Placebo

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

Phase 1

Completed

Conditions: Fibrosis
Chronic Kidney Disease

Interventions: Drug: Pirfenidone

First Posted Date: 2015-04-03

Last Posted Date: 2015-04-03

Lead Sponsor: University of Guadalajara

Target Recruit Count: 30

Registration Number: NCT02408744

Safety and Efficacy Study of Pirfenidone to Treat Grade 2 or Above Radiation-induced Lung Injury

Phase 2

Conditions: Radiation Pneumonitis

Interventions: Drug: Pirfenidone

First Posted Date: 2014-11-20

Last Posted Date: 2014-11-20

Lead Sponsor: Beijing Continent Pharmaceutical Co, Ltd.

Target Recruit Count: 48

Registration Number: NCT02296281

European Trial of Pirfenidone in BOS, A European Multi-center Study

Phase 2

Completed

Conditions: Disorder Related to Lung Transplantation
CLAD, Bronchiolitis Obliterans

Interventions: Drug: Placebo
Drug: Pirfenidone

First Posted Date: 2014-10-13

Last Posted Date: 2020-01-18

Lead Sponsor: Rigshospitalet, Denmark

Target Recruit Count: 90

Registration Number: NCT02262299

Locations: 🇳🇱
Groningen University Medical Center, Lung Transplant Team, Groningen, Netherlands
🇩🇪
Medizinische Hochschule Hannover, Klinik für Pneumonologie, Hannover, Germany
🇩🇪
Klinikum Grosshadern, Division of Pulmonary Diseases, Munich, Germany

and more 6 locations