Baloxavir marboxil (Xofluza™; baloxavir) is an oral cap-dependent endonuclease 
inhibitor that has been developed by Roche and Shionogi. The drug blocks 
influenza virus proliferation by inhibiting the initiation of mRNA synthesis. In 
February 2018, baloxavir received its first global approval in Japan for the 
treatment of influenza A or B virus infections. Phase III development is 
underway in the USA, EU and other countries for this indication. This article 
summarized the milestones in the development of baloxavir leading to this first 
global approval for influenza A or B virus infections.