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 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: -

Clinical Trials

Pirfenidone vs. Nintedanib for Fibrotic Lung Disease After Coronavirus Disease-19 Pneumonia

Phase 4

Active, not recruiting

Conditions: Novel Coronavirus-induced Lung Fibrosis

Interventions: Drug: Pirfenidone
Drug: Nintedanib

First Posted Date: 2021-04-22

Last Posted Date: 2022-10-03

Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

Target Recruit Count: 48

Registration Number: NCT04856111

Locations: 🇮🇳
Postgraduate Institute of Medical Education and Research, Chandigarh, India

Treatment With Pirfenidone for COVID-19 Related Severe ARDS

Not Applicable

Completed

Conditions: Covid19
ARDS

Interventions: Other: Standard of care
Drug: Pirfenidone

First Posted Date: 2020-12-04

Last Posted Date: 2023-05-23

Lead Sponsor: Soroka University Medical Center

Target Recruit Count: 26

Registration Number: NCT04653831

Locations: 🇮🇱
Soroka Medical Center, Be'er Sheva, Israel

Pirfenidone Compared to Placebo in Post-COVID19 Pulmonary Fibrosis COVID-19

Phase 2

Conditions: Fibrotic Pulmonary Sequelae Post-COVID19 Infection

Interventions: Drug: Placebo
Drug: Pirfenidone

First Posted Date: 2020-10-29

Last Posted Date: 2021-12-30

Lead Sponsor: Institut d'Investigació Biomèdica de Bellvitge

Target Recruit Count: 148

Registration Number: NCT04607928

Locations: 🇪🇸
Hospital Germans Trias i Pujol, Badalona, Spain
🇪🇸
University Hospital of Bellvitge, Hospitalet de Llobregat, Barcelona, Spain
🇪🇸
Hospital Clínic, Barcelona, Spain

and more 5 locations

Examination of Pirfenidone (Esbriet®) Therapy in Coal Workers' Pneumoconiosis With Pulmonary Fibrosis

Phase 2

Completed

Conditions: Coal Workers' Pneumoconiosis (Complicated)

Interventions: Drug: Pirfenidone

First Posted Date: 2020-07-08

Last Posted Date: 2024-07-16

Lead Sponsor: Pulmonary Research of Abingdon, LLC

Target Recruit Count: 50

Registration Number: NCT04461587

Locations: 🇺🇸
Pulmonary Research of Abingdon, LLC, Abingdon, Virginia, United States

A Study to Evaluate the Efficacy and Safety of Pirfenidone With Novel Coronavirus Infection

Phase 3

Conditions: Novel Coronavirus Pneumonia
Pneumonia
Pirfenidone

Interventions: Drug: pirfenidone

First Posted Date: 2020-02-25

Last Posted Date: 2020-02-25

Lead Sponsor: Huilan Zhang

Target Recruit Count: 294

Registration Number: NCT04282902

Locations: 🇨🇳
Tongji hospital affiliated to huazhong university of science and technology, Wuhan, Hubei, China

Trial of Pirfenidone to Prevent Progression in Chronic Kidney Disease

Phase 2

Recruiting

Conditions: Chronic Kidney Disease

Interventions: Drug: Pirfenidone
Drug: matching placebo

First Posted Date: 2020-02-06

Last Posted Date: 2022-04-27

Lead Sponsor: Veterans Medical Research Foundation

Target Recruit Count: 200

Registration Number: NCT04258397

Locations: 🇺🇸
VA San Diego Healthcare System, San Diego, California, United States
🇺🇸
University of California, San Francisco, San Francisco, California, United States

Efficacy and Safety of Pirfenidone Treatment in HPS-ILD

Phase 2

Conditions: Interstitial Lung Disease
Hermansky Pudlak Syndrome

Interventions: Drug: Pirfenidone

First Posted Date: 2019-12-10

Last Posted Date: 2019-12-10

Lead Sponsor: Jesse Roman

Target Recruit Count: 50

Registration Number: NCT04193592

Locations: 🇵🇷
Mayaguez Medical Center, Mayaguez, Puerto Rico
🇺🇸
Thomas Jefferson University, Philadelphia, Pennsylvania, United States

Pirfenidone and Advanced Liver Fibrosis.

Phase 2

Completed

Conditions: Liver Fibrosis
Chronic Liver Disease

Interventions: Drug: Pirfenidone
Other: Standard of care

First Posted Date: 2019-09-23

Last Posted Date: 2024-04-02

Lead Sponsor: Grupo Mexicano para el Estudios de las Enfermedades Hepaticas

Target Recruit Count: 122

Registration Number: NCT04099407

Locations: 🇲🇽
Liver Clinic 1, Mexico City, Mexico

A Study of the Pharmacokinetic Interaction Between Pirfenidone and BMS-986278 in Healthy Participants

Phase 1

Completed

Conditions: Idiopathic Pulmonary Fibrosis (IPF)

Interventions: Drug: BMS-986278
Drug: Pirfenidone

First Posted Date: 2019-06-10

Last Posted Date: 2020-05-15

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 22

Registration Number: NCT03981094

Locations: 🇺🇸
PRA Health Sciences - Salt Lake, Salt Lake City, Utah, United States

A Study Based on Medical Records That Looks at the Characteristics of Idiopathic Pulmonary Fibrosis Patients Grouped by the Type of Medication They Are Taking

Completed

Conditions: Idiopathic Pulmonary Fibrosis

Interventions: Drug: Nintedanib
Drug: Pirfenidone
Other: Untreated Cohort

First Posted Date: 2019-05-21

Last Posted Date: 2021-11-15

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 13264

Registration Number: NCT03958071

Locations: 🇺🇸
Plymouth Meeting, Plymouth, Pennsylvania, United States

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