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

Efficacy and Safety of Pirfenidone in Patient With Dermatomyositis Interstitial Lung Disease (Dm-ILD)

Phase 3

Conditions: Dermatomyositis Interstitial Lung Disease (Dm-ILD)

Interventions: Drug: Pirfenidone
Drug: Placebos

First Posted Date: 2019-02-28

Last Posted Date: 2019-02-28

Lead Sponsor: Beijing Continent Pharmaceutical Co, Ltd.

Target Recruit Count: 152

Registration Number: NCT03857854

Locations: 🇨🇳
Zhang, Ling, Beijing, Beijing, China

Efficacy and Safety of Pirfenidone in Patient With Systemic Sclerosis-associated Interstitial Lung Disease

Phase 3

Conditions: Systemic Sclerosis-associated Interstitial Lung Disease (Ssc-ild)

Interventions: Other: placebo
Drug: Pirfenidone

First Posted Date: 2019-02-27

Last Posted Date: 2019-02-27

Lead Sponsor: Beijing Continent Pharmaceutical Co, Ltd.

Target Recruit Count: 144

Registration Number: NCT03856853

Locations: 🇨🇳
Zhang, Ling, Beijing, Beijing, China

Pirfenidone and Its Role in Burn Wound Healing

Phase 2

Completed

Conditions: Second-degree Burn

Interventions: Drug: Pirfenidone Oral Product

First Posted Date: 2018-05-21

Last Posted Date: 2018-05-21

Lead Sponsor: Universidad Autonoma de Nuevo Leon

Target Recruit Count: 8

Registration Number: NCT03530150

Studying the Treatment Effect of Pirfenidone in Chronic Lung Allograft Dysfunction (STOP-CLAD)

Phase 2

Terminated

Conditions: Disorder Related to Lung Transplantation
Chronic Lung Allograft Dysfunction

Interventions: Drug: Placebo Capsule
Drug: Pirfenidone Capsule

First Posted Date: 2018-03-22

Last Posted Date: 2022-08-17

Lead Sponsor: University of Michigan

Target Recruit Count: 24

Registration Number: NCT03473340

Locations: 🇺🇸
The University of Michigan, Ann Arbor, Michigan, United States

Pilot Study of Pirfenidone in Pulmonary Fibrosis With Anti-myeloperoxydase Antibodies

Phase 2

Completed

Conditions: Pulmonary Fibrosis

Interventions: Drug: Pirfenidone

First Posted Date: 2017-12-28

Last Posted Date: 2021-05-03

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Target Recruit Count: 7

Registration Number: NCT03385668

Locations: 🇫🇷
Cochin Hospital, Paris, France

Pirfenidone for Restrictive Chronic Lung Allograft Dysfunction

Phase 2

Completed

Conditions: Restrictive Chronic Lung Allograft Dysfunction
Lung Transplant Rejection

Interventions: Drug: Pirfenidone

First Posted Date: 2017-12-02

Last Posted Date: 2023-06-29

Lead Sponsor: University of California, San Francisco

Target Recruit Count: 10

Registration Number: NCT03359863

Locations: 🇺🇸
University of California, San Francisco, San Francisco, California, United States

The Safety and Tolerability of Pirfenidone for BOS After HCT

Phase 1

Completed

Conditions: Bronchiolitis Obliterans
Graft Vs Host Disease

Interventions: Drug: Pirfenidone 267 MG [Esbriet]

First Posted Date: 2017-10-20

Last Posted Date: 2022-06-13

Lead Sponsor: Stanford University

Target Recruit Count: 30

Registration Number: NCT03315741

Locations: 🇺🇸
Stanford University School of Medicine, Palo Alto, California, United States

Pirfenidone for Progressive Fibrotic Sarcoidosis

Phase 4

Conditions: Sarcoidosis, Pulmonary

Interventions: Drug: Placebos
Drug: Pirfenidone

First Posted Date: 2017-08-24

Last Posted Date: 2017-09-28

Lead Sponsor: University of Cincinnati

Target Recruit Count: 60

Registration Number: NCT03260556

Locations: 🇺🇸
University of Cincinnati, Cincinnati, Ohio, United States

Non-Interventional Study (NIS) Collecting Experiences For IPF in Taiwan

Completed

Conditions: Pulmonary Fibrosis

Interventions: Drug: nintedanib
Drug: pirfenidone

First Posted Date: 2017-08-08

Last Posted Date: 2021-04-13

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 101

Registration Number: NCT03242759

Locations: 🇨🇳
Chang-Hua Christian Hospital, Changhua, Taiwan
🇨🇳
Chang Gung Memorial Hospital(Linkou), Tao-Yuan, Taiwan
🇨🇳
Taichung Veterans General Hospital, Taichung, Taiwan

and more 7 locations

Scleroderma Lung Study III - Combining Pirfenidone With Mycophenolate

Phase 2

Completed

Conditions: Interstitial Lung Disease
Scleroderma, Systemic

Interventions: Drug: Pirfenidone (PFD)
Drug: Placebo (Plac)
Drug: Mycophenolate Mofetil (MMF)

First Posted Date: 2017-07-18

Last Posted Date: 2023-12-15

Lead Sponsor: Michael Roth

Target Recruit Count: 51

Registration Number: NCT03221257

Locations: 🇺🇸
University of California Los Angeles, Los Angeles, California, United States
🇺🇸
Northwestern University, Chicago, Illinois, United States
🇺🇸
University of Texas Medical School at Houston, Houston, Texas, United States

and more 13 locations

Drug Development Updates

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