OFEV

Peak

nintedanib

NDAORALCAPSULEPriority Review
Approved
Oct 2014
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
20

Mechanism of Action

(RTKs) and non-receptor tyrosine kinases (nRTKs). Nintedanib inhibits the following RTKs: platelet-derived growth factor receptor (PDGFR) α and β, fibroblast growth factor receptor (FGFR) 1-3, vascular endothelial growth factor receptor (VEGFR) 1-3, colony stimulating factor 1 receptor (CSF1R), and…

Clinical Trials (5)

NCT07194382Phase 2Not Yet Recruiting

AURA-IPF: A Randomized Phase 2 Study to Evaluate the Safety and Efficacy of AP02 (Nintedanib Solution) in IPF

Started Jan 2026
NCT07015398Phase 1Completed

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

Started Jun 2025
NCT06912659N/AActive Not Recruiting

The BALANCE Study: A Study in Spain to Find Out Whether a Patient Support Program Helps People With Pulmonary Fibrosis Who Take Nintedanib

Started Jun 2025
157 enrolled
Pulmonary Fibrosis
NCT07080125N/AActive Not Recruiting

A Study Using a Disease Registry to Observe the Long-term Effects of Nintedanib in People With Scleroderma-related Lung Fibrosis

Started Jun 2025
2,000 enrolled
Interstitial Lung DiseasesSystemic Sclerosis Associated Interstitial Lung Disease
NCT06625489Phase 1Completed

A Study to Evaluate the Safety, Tolerability and Blood Levels of GSK3915393 Administered to Healthy Participants of Chinese, Japanese and European Ancestry and to Assess Effects of GSK3915393 on Nintedanib

Started Oct 2024
50 enrolled
Idiopathic Pulmonary Fibrosis

Loss of Exclusivity

LOE Date
Dec 7, 2029
45 months away
Patent Expiry
Dec 7, 2029
Exclusivity Expiry
Mar 6, 2027

Patent Records (5)

Patent #ExpiryTypeUse Code
6762180
Oct 1, 2025Expired
SubstanceProduct
10154990
Jan 8, 2026Expired
U-2620
6762180*PED
Apr 1, 2026
10154990*PED
Jul 8, 2026
10105323
Jun 4, 2029
Product