ESBRIET

Peak

pirfenidone

NDAORALCAPSULEPriority Review
Approved
Oct 2014
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20

Clinical Trials (5)

NCT06241560Phase 2Recruiting

A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in the Blood

Started Mar 2026
20 enrolled
Idiopathic Pulmonary Fibrosis
NCT07015398Phase 1Completed

A Study of the Pharmacokinetic Interaction Between Pirfenidone, Nintedanib, and Nalbuphine Extended Release (NAL ER) in Healthy Participants

Started Jun 2025
NCT06070610Phase 1Completed

A Study in Healthy Men to Test Whether BI 1015550 Influences the Amount of Nintedanib and Pirfenidone in the Blood

Started Nov 2023
14 enrolled
Healthy
NCT04971746Phase 1Completed

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

Started Jul 2021
58 enrolled
Healthy
NCT04258397Phase 2Unknown

Trial of Pirfenidone to Prevent Progression in Chronic Kidney Disease

Started Oct 2020
200 enrolled
Chronic Kidney Disease

Loss of Exclusivity

LOE Date
Aug 30, 2033
91 months away
Patent Expiry
Aug 30, 2033

Patent Records (5)

Patent #ExpiryTypeUse Code
7988994
Sep 22, 2026
Product
U-1602
8753679
Sep 22, 2026
Product
U-1602
7767225
Sep 22, 2026
Product
U-1602
7767700
Dec 18, 2027
U-1601
8420674
Dec 18, 2027
Product
U-1608