NDAORALCAPSULEPriority Review
Approved
Oct 2014
Lifecycle
Peak
Competitive Pressure
38/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
Drug data last refreshed 1h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OFEV (nintedanib) is an oral small-molecule tyrosine kinase inhibitor approved in 2014 for idiopathic pulmonary fibrosis (IPF) and other progressive fibrosing interstitial lung diseases. It works by inhibiting multiple receptor tyrosine kinases involved in fibrosis pathways, slowing disease progression. The drug is administered as oral capsules and represents a foundational treatment option in the IPF therapeutic landscape.
$1.8BPart D
Peak3.5 years to LOEOFEV remains at peak commercial performance with $1.8B in Part D spending, indicating a mature, well-established franchise with sustained demand and established team infrastructure.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
AURA-IPF: A Randomized Phase 2 Study to Evaluate the Safety and Efficacy of AP02 (Nintedanib Solution) in IPF
Started Mar 2026
160 enrolled
Idiopathic Pulmonary Fibrosis (IPF)
A Study of the Pharmacokinetic Interaction Between Pirfenidone, Nintedanib, and Nalbuphine Extended Release (NAL ER) in Healthy Participants
Started Jun 2025
132 enrolled
Healthy Participants
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
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
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
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.