Background Nintedanib (formerly known as BIBF 1120) is an intracellular inhibitor that
targets multiple tyrosine kinases. A phase 2 trial suggested that treatment with 150 mg of
nintedanib twice daily reduced lung-function decline and acute exacerbations in patients
with idiopathic pulmonary fibrosis. Methods We conducted two replicate 52-week,
randomized, double-blind, phase 3 trials (INPULSIS-1 and INPULSIS-2) to evaluate the
efficacy and safety of 150 mg of nintedanib twice daily as compared with placebo in patients …

Idiopathic pulmonary fibrosis (IPF) is chronic, and ultimately fatal, lung scarring of unknown
etiology characterized by dyspnea and progressive loss of lung function. Nintedanib is an
intracellular inhibitor of various tyrosine kinases shown in a phase 2 trial to decrease the
rate of decline of FVC in IPF (2). The INPULSIS study group conducted two replicate phase 3
trials (INPULSIS-1 and INPULSIS-2) to determine the efficacy and safety of nintedanib (150
mg twice daily) in patients with IPF. These trials were multinational, randomized, double …