Nintedanib (Ofev(®)) is an orally available, small, multiple receptor tyrosine 
kinase inhibitor developed by Boehringer Ingelheim for the treatment of 
idiopathic pulmonary fibrosis (IPF) and cancer. Nintedanib received its first 
global approval in the US in October 2014 for the treatment of IPF. Nintedanib 
has received a positive opinion from the European Medicines Agency's Committee 
for Medicinal Products for Human Use for the treatment of IPF, and for the 
second-line treatment in combination with docetaxel of locally advanced, 
metastatic or locally recurrent non-small cell lung cancer of adenocarcinoma 
tumour histology. Phase 3 development programmes are also underway for 
colorectal cancer and ovarian cancer. Phase 2 investigation is being conducted 
for a variety of other solid tumours, including hepatocellular carcinoma, 
mesothelioma, prostate cancer, glioblastoma, renal cell carcinoma and 
endometrial cancer. This article summarizes the milestones in the development of 
nintedanib leading to this first approval for IPF.