Last reviewed 2026-04-20 · How we verify

Ofev (NINTEDANIB)

Ofev works by blocking enzymes that promote fibrosis and tumor growth.

Ofev (Nintedanib) is a small molecule kinase inhibitor developed by Boehringer Ingelheim, targeting the receptor-type tyrosine-protein kinase FLT3. It is FDA-approved for the treatment of idiopathic pulmonary fibrosis, interstitial fibrosis, non-small cell lung cancer, and systemic sclerosis-associated interstitial lung disease. Ofev works by inhibiting the activity of certain enzymes that contribute to fibrosis and tumor growth. As a patented medication, Ofev is not yet available as a generic. Key safety considerations include gastrointestinal and respiratory side effects.

At a glance

Mechanism of action

Nintedanib is small molecule that inhibits multiple receptor tyrosine kinases (RTKs) and non-receptor tyrosine kinases (nRTKs). Nintedanib inhibits the following RTKs: platelet-derived growth factor receptor (PDGFR) and fibroblast growth factor receptor (FGFR) 1-3, vascular endothelial growth factor receptor (VEGFR) 1-3, colony stimulating factor receptor (CSF1R), and Fms-like tyrosine kinase-3 (FLT-3). These kinases except for FLT-3 have been implicated in pathogenesis of interstitial lung diseases (ILD). Nintedanib binds competitively to the adenosine triphosphate (ATP) binding pocket of these kinases and blocks the intracellular signaling cascades, which have been demonstrated to be involved in the pathogenesis of fibrotic tissue remodeling in ILD. Nintedanib also inhibits the following nRTKs: Lck, Lyn and Src kinases. The contribution of FLT-3 and nRTK inhibition to nintedanib efficacy in ILD is unknown.

Approved indications

• Idiopathic pulmonary fibrosis
• Interstitial fibrosis
• Non-small cell lung cancer
• Systemic sclerosis associated interstitial lung disease

Common side effects

• Diarrhea
• Nausea
• Abdominal pain
• Vomiting
• Liver enzyme elevation
• Decreased appetite
• Headache
• Weight decreased
• Hypertension
• Pneumonia
• Myocardial infarction
• Bronchitis

Key clinical trials

• Efficacy and Safety of Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD) (PHASE3)
• A Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung Fibrosis (PHASE3)
• Safety And Efficacy of BIBF 1120 in Idiopathic Pulmonary Fibrosis (PHASE2)
• Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis Patients (PHASE3)
• Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis Patients II (PHASE3)
• Correlation Between Changes in Lung Function and Changes in Cough and Dyspnoea in Nintedanib-treated Connective Tissue Disease Interstitial Lung Disease (CTD-ILD) Patients
• Double Immunosuppression With or Without Anti-fibrotic in Scleroderma ILD
• A Prospective, Multicenter Exploratory Clinical Study on Consolidation Therapy With Tislelizumab Combined With Nintedanib for Limited-stage Small Cell Lung Cancer (PHASE4)

Patents

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Ofev CI brief — competitive landscape report
• Ofev updates RSS · CI watch RSS
• Boehringer Ingelheim portfolio CI