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

Long Covid (LC)-REVITALIZE - A Long Covid Repurposed Drug Study

Phase 3

Not yet recruiting

Conditions: Long COVID

Interventions: Drug: Pirfenidone
Drug: Placebo for pirfenidone
Drug: Upadacitinib
Drug: Placebo for upadacitinib

First Posted Date: 2025-04-15

Last Posted Date: 2025-04-15

Lead Sponsor: Douglas D. Fraser

Target Recruit Count: 348

Registration Number: NCT06928272

Fibrosis-Modulating Effects of Metformin and Pirfenidone in Oral Submucous Fibrosis

Phase 1

Recruiting

Conditions: Oral Submucous Fibrosis

Interventions: Drug: Pirfenidone (PFD)
Drug: Metformin Hydrochloride 500Mg Tablet
Drug: Beclomaethasone and Vitamin E

First Posted Date: 2025-03-12

Last Posted Date: 2025-05-04

Lead Sponsor: Ziauddin University

Target Recruit Count: 45

Registration Number: NCT06871904

Locations: 🇵🇰
Ziauddin University, Karachi, Sindh, Pakistan

Comparative Pharmacokinetic Study of Pirfenidone Modified-Release Tablets and Pirfenidone Tablets in Healthy Subjects Under Fed Conditions

Phase 1

Completed

Conditions: Idiopathic Pulmonary Fibrosis

Interventions: Drug: Pirfenidone Modified-Release Tablets
Drug: Pirfenidone Tablets

First Posted Date: 2024-09-10

Last Posted Date: 2024-09-10

Lead Sponsor: Overseas Pharmaceuticals, Ltd.

Target Recruit Count: 24

Registration Number: NCT06589921

Locations: 🇨🇳
The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China

Comparative Pharmacokinetic(PK) Study of Pirfenidone Modified-Release Tablets and Pirfenidone Tablets in Healthy Subjects Under Fed Conditions

Phase 1

Completed

Conditions: Idiopathic Pulmonary Fibrosis

Interventions: Drug: Pirfenidone Tablets
Drug: Pirfenidone Modified-Release Tablets

First Posted Date: 2024-09-09

Last Posted Date: 2024-09-09

Lead Sponsor: Overseas Pharmaceuticals, Ltd.

Target Recruit Count: 12

Registration Number: NCT06588517

Locations: 🇨🇳
The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China

Pirfenidone LP or Collagen-polyvinylpyrrolidone in COVID-19

Phase 2

Completed

Conditions: COVID 19

Interventions: Drug: Pirfenidone 1200 mg
Drug: Collagen-polyvinylpyrrolidone

First Posted Date: 2024-09-05

Last Posted Date: 2024-09-05

Lead Sponsor: Materno-Perinatal Hospital of the State of Mexico

Target Recruit Count: 36

Registration Number: NCT06585319

Locations: 🇲🇽
Monica Pretelini Saenz Maternal Perinatal Hospital, Toluca, State of Mexico, Mexico

Comparative Pharmacokinetic Study of Pirfenidone Modified-Release Tablets in Healthy Subjects Under Fasting and Fed Conditions

Phase 1

Completed

Conditions: Idiopathic Pulmonary Fibrosis

Interventions: Drug: Pirfenidone Modified-Release Tablets

First Posted Date: 2024-08-26

Last Posted Date: 2025-03-20

Lead Sponsor: Overseas Pharmaceuticals, Ltd.

Target Recruit Count: 18

Registration Number: NCT06569381

Locations: 🇨🇳
The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China

Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Advanced or Metastatic pMMR/MSS Colorectal Carcinoma

Phase 1

Not yet recruiting

Conditions: To Evaluate the Efficacy of Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Colorectal Carcinoma
To Evaluate Whether Pirfenidone Can Reshape the Tumor Microenvironment in Colorectal Cancer
Combination of Fruquintinib and Anti-PD-1 Antibody Was Reported to Improve Patient Prognosis in Colorectal Cancer