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

Expanded Access Program (EAP): Allow Patients in the US With Idiopathic Pulmonary Fibrosis Access to Pirfenidone

Conditions: Idiopathic Pulmonary Fibrosis

First Posted Date: 2014-05-19

Last Posted Date: 2015-07-13

Lead Sponsor: Genentech, Inc.

Registration Number: NCT02141087

Clinical Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis

Phase 2

Completed

Conditions: Idiopathic Pulmonary Fibrosis

Interventions: Drug: Pirfenidone
Drug: placebo

First Posted Date: 2014-05-13

Last Posted Date: 2014-05-13

Lead Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

Target Recruit Count: 160

Registration Number: NCT02136992

Safety and Tolerability of Pirfenidone in Participants With Systemic Sclerosis-Related Interstitial Lung Disease (SSc-ILD) (LOTUSS)

Phase 2

Completed

Conditions: Systemic Sclerosis

Interventions: Drug: Pirfenidone

First Posted Date: 2013-09-02

Last Posted Date: 2016-08-04

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 63

Registration Number: NCT01933334

Locations: 🇺🇸
University of Cincinnati, Cincinnati, Ohio, United States
🇺🇸
University of California, Los Angeles, Los Angeles, California, United States
🇺🇸
Northwestern University, Chicago, Chicago, Illinois, United States

and more 19 locations

Evaluate the Safety and Efficacy of FG-3019 (Pamrevlumab) in Participants With Idiopathic Pulmonary Fibrosis (IPF)

Phase 2

Completed

Conditions: Idiopathic Pulmonary Fibrosis

Interventions: Drug: Placebo
Drug: Pamrevlumab

First Posted Date: 2013-07-01

Last Posted Date: 2020-09-04

Lead Sponsor: FibroGen

Target Recruit Count: 160

Registration Number: NCT01890265

Locations: 🇺🇸
Pensacola Research Consultants, Inc., d.b.a. Avanza Medical Research Center, Pensacola, Florida, United States
🇺🇸
Columbia University Medical Center, New York, New York, United States
🇦🇺
Concord Repatriation, Concord, New South Wales, Australia

and more 39 locations

A Study of Lebrikizumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)

Phase 2

Completed

Conditions: Idiopathic Pulmonary Fibrosis

Interventions: Drug: Lebrikizumab
Drug: Pirfenidone
Drug: Placebo

First Posted Date: 2013-06-07

Last Posted Date: 2018-08-24

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 505

Registration Number: NCT01872689

Locations: 🇺🇸
Pulmonary Consultants, Tacoma, Washington, United States
🇦🇺
Box Hill Hospital; Eastern Clinical Research Unit, Box Hill, Victoria, Australia
🇫🇷
Hopital Bichat Claude Bernard ; Service de Pneumologie, Paris, France

and more 109 locations