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Clinical Trials

Ofev (nintedanib)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved September 2019

Specific Treatments:

systemic sclerosis-associated interstitial lung disease

General Information

Ofev (nintedanib) is a kinase inhibitor.

Ofev is specifically indicated to slow the rate of decline in pulmonary function in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD).

Ofev is supplied as a capsule for oral administration. The recommended dose for SSC-ILD is 150 mg twice daily administered approximately 12 hours apart.
Ofev capsules should be taken with food and swallowed whole with liquid. Ofev capsules should not be chewed or crushed because of a bitter taste. The effect of chewing or crushing of the capsule on the pharmacokinetics of nintedanib is not known. If a dose of Ofev is missed, the next dose should be taken at the next scheduled time. Advise the patient to not make up for a missed dose. Do not exceed the recommended maximum daily dosage of 300 mg.

Clinical Results

FDA Approval

The FDA approval of Ofev for systemic sclerosis-associated interstitial lung disease was based on SENSCIS, a Phase III double-blind, randomized, placebo-controlled trial, which enrolled 576 patients from 194 trial sites across 32 countries. The primary endpoint was the annual rate of decline in FVC in patients with SSc-ILD. Results shows that Ofev slowed the loss of pulmonary function by 44% (41 mL/year) in patients with SSc-ILD relative to placebo, as measured by FVC over 52 weeks. FVC is measured by the amount of air that can be forcibly exhaled after taking the deepest breath.

Side Effects

Adverse effects associated with the use of Ofev may include, but are not limited to, the following:



abdominal pain


liver enzyme elevation

decreased appetite


weight decreased


Mechanism of Action

Ofev (nintedanib) is a 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) 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 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.

Additional Information

For additional information regarding Ofev or systemic sclerosis-associated interstitial lung disease, please visit the Ofev web page.

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