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

Pirfenidone to Prevent Fibrosis in Ards.

Phase 3

Recruiting

Conditions: Acute Respiratory Distress Syndrome (ARDS)

Interventions: Drug: Pirfenidone
Drug: Placebo

First Posted Date: 2021-10-12

Last Posted Date: 2025-02-04

Lead Sponsor: Università Vita-Salute San Raffaele

Target Recruit Count: 130

Registration Number: NCT05075161

Locations: 🇮🇹
IRCCS San Raffaele Scientific Institute, Milan, MI, Italy
🇮🇹
ASST Spedali Civili di Brescia, Brescia, Italy
🇮🇹
Ospedale San Giovanni di Dio - Azienda Ospedaliera Universitaria di Cagliari, Cagliari, Italy

and more 7 locations

Phase ll Study of HEC585 in Patients With IPF

Phase 2

Recruiting

Conditions: Idiopathic Pulmonary Fibrosis

Interventions: Drug: HEC585
Drug: Placebo
Drug: Pirfenidone

First Posted Date: 2021-09-29

Last Posted Date: 2023-08-18

Lead Sponsor: Sunshine Lake Pharma Co., Ltd.

Target Recruit Count: 270

Registration Number: NCT05060822

Locations: 🇨🇳
China-Japan Friendship Hospital, Beijing, Beijing, China

Drug-drug Interaction Study With GLPG4716 and Nintedanib and Pirfenidone in Healthy Subjects

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Pirfenidone
Drug: Nintedanib
Drug: GLPG4716

First Posted Date: 2021-07-21

Last Posted Date: 2022-06-02

Lead Sponsor: Galapagos NV

Target Recruit Count: 58

Registration Number: NCT04971746

Locations: 🇩🇪
Nuvisan GmbH, Neu-Ulm, Germany

Dedicated Drug-Drug Interaction (DDI) Study in Healthy Volunteers

Phase 1

Completed

Conditions: Drug Drug Interaction

Interventions: Drug: Nintedanib 150 mg Oral Capsule
Drug: Pirfenidone 267 mg Oral Tablet
Drug: BLD-0409 750 mg Oral Tablet

First Posted Date: 2021-06-25

Last Posted Date: 2022-04-15

Lead Sponsor: Blade Therapeutics

Target Recruit Count: 86

Registration Number: NCT04939467

Locations: 🇺🇸
Advanced Pharma, Miami, Florida, United States

Immunosuppressant Combined With Pirfenidone in CTD-ILD

Phase 4

Active, not recruiting

Conditions: Interstitial Lung Disease
Pirfenidone
Connective Tissue Diseases

Interventions: Drug: Pirfenidone
Drug: DMARDs

First Posted Date: 2021-06-16

Last Posted Date: 2023-11-18

Lead Sponsor: Qilu Hospital of Shandong University

Target Recruit Count: 200

Registration Number: NCT04928586

Locations: 🇨🇳
Qilu Hospital, Jinan, Shandong, China

To Evaluate Drug-drug Interactions Between DWN12088 and Pirfenidone or Nintedanib in Healthy Volunteers

Phase 1

Completed

Conditions: Idiopathic Pulmonary Fibrosis

Interventions: Drug: DWN12088
Drug: Pirfenidone
Drug: Nintedanib

First Posted Date: 2021-05-17

Last Posted Date: 2021-09-23

Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Target Recruit Count: 48

Registration Number: NCT04888715

Locations: 🇰🇷
Cha Unitersity Bundang Medical Center, Seongnam-si, Korea, Republic of

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

Evaluation of the Efficacy of Pirfenidone in Progressive Chronic Hypersensitivity Pneumonitis

Phase 2

Completed

Conditions: Hypersensitivity Pneumonitis

Interventions: Drug: Standard care
Drug: Oral pirfenidone

First Posted Date: 2020-12-19

Last Posted Date: 2020-12-19

Lead Sponsor: Zagazig University

Target Recruit Count: 40

Registration Number: NCT04675619

Locations: 🇪🇬
Eman Shebl, Zagazig, Egypt

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

Drug Development Updates

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