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

Prolonged Release Pirfenidone for Advanced Residual Liver Fibrosis (MINERVA).

Phase 2

Recruiting

Conditions: Liver Cirrhosis
Hepatitis C, Chronic
Epigenetic Disorder

Interventions: Drug: Prolonged-Release Pirfenidone

First Posted Date: 2022-09-15

Last Posted Date: 2023-07-06

Lead Sponsor: University of Guadalajara

Target Recruit Count: 60

Registration Number: NCT05542615

Locations: 🇲🇽
Hospital Central Militar, Mexico City, Mexico
🇲🇽
Institute for Molecular Biology in Medicine and Gene Therapy, CUCS, UdeG, Guadalajara, Jalisco, Mexico

Pirfenidone Treat Myocardial Fibrosis After Acute Myocardial Infarction

Phase 2

Active, not recruiting

Conditions: Myocardial Fibrosis

Interventions: Drug: Pirfenidone Oral Capsule
Other: Placebo Oral Capsule

First Posted Date: 2022-09-08

Last Posted Date: 2022-11-10

Lead Sponsor: Shanghai Zhongshan Hospital

Target Recruit Count: 100

Registration Number: NCT05531955

Locations: 🇨🇳
Shanghai Zhongshan Hospital, Shanghai, Shanghai, China

Efficacy and Safety of Pirfenidone in CTD-ILD

Phase 4

Recruiting

Conditions: Pirfenidone
Connective Tissue Diseases
Interstitial Lung Disease

Interventions: Drug: glucocorticoid and immunosuppressant
Drug: Pirfenidone

First Posted Date: 2022-08-17

Last Posted Date: 2022-11-30

Lead Sponsor: Qilu Hospital of Shandong University

Target Recruit Count: 120

Registration Number: NCT05505409

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

Randomized, Crossover, Multi-Dose Pharmacokinetics of EXCL-100 Pirfenidone-Sustained Release Tablet and Esbriet in Healthy Volunteers

Phase 1

Completed

Conditions: Idiopathic Pulmonary Fibrosis

Interventions: Drug: Esbriet 267 MG Oral Capsule
Drug: EXCL-100, 600 MG Oral Tablet

First Posted Date: 2022-06-22

Last Posted Date: 2022-11-14

Lead Sponsor: Excalibur Pharmaceuticals, Inc.

Target Recruit Count: 32

Registration Number: NCT05428150

Locations: 🇺🇸
Medpace Clinical Pharmacology Unit, Cincinnati, Ohio, United States

To Evaluate Drug-drug Interactions Between HEC585 and Pirfenidone or Nintedanib in Healthy Volunteers

Phase 1

Completed

Conditions: Idiopathic Pulmonary Fibrosis

Interventions: Drug: HEC585
Drug: Nintedanib
Drug: Pirfenidone

First Posted Date: 2022-05-19

Last Posted Date: 2022-05-19

Lead Sponsor: Sunshine Lake Pharma Co., Ltd.

Target Recruit Count: 33

Registration Number: NCT05383131

Locations: 🇨🇳
Shanghai Xuhui Central Hospital, Shanghai, China

Safety and Tolerability of Pirfenidone in Acute Pancreatitis

Phase 1

Recruiting

Conditions: Pancreatitis, Acute

Interventions: Drug: Pirfenidone Oral Tablet
Drug: Placebo

First Posted Date: 2022-04-28

Last Posted Date: 2024-08-29

Lead Sponsor: University of Alabama at Birmingham

Target Recruit Count: 60

Registration Number: NCT05350371

Locations: 🇺🇸
UAB, Birmingham, Alabama, United States
🇺🇸
Mayo Clinic, Rochester, Minnesota, United States

LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Phase 2

Active, not recruiting

Conditions: Idiopathic Pulmonary Fibrosis

Interventions: Drug: Deupirfenidone
Drug: Placebo
Drug: Pirfenidone

First Posted Date: 2022-04-11

Last Posted Date: 2025-05-06

Lead Sponsor: PureTech

Target Recruit Count: 240

Registration Number: NCT05321420

Locations: 🇦🇷
Respira Salud Clinica Integral, Godoy Cruz, Argentina
🇦🇷
Instituto Ave Pulmo - Fundacion Enfisema, Mar Del Plata, Argentina
🇦🇷
Polo de Salud Vistalba, Mendoza, Argentina

and more 100 locations