Trial Profile

A phase 3 randomized, double-blind, placebo-controlled study to confirm the efficacy of a single dose of baloxavir marboxil in the prevention of influenza virus infection

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 07 Jul 2023

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At a glance

04 Jul 2023 According to a Shionogi media release, the company has filed for a supplemental new drug application (sNDA) of Xofluza (baloxavir marboxil) in Taiwan for treatment and post-exposure prophylaxis for influenza virus infection for pediatrics aged 5 to under 12 years.
11 Aug 2022 According to a Genentech media release, Dr. Pedro Piedra is the investigator of the study
11 Jan 2021 According to a Roche media release, the European Commission (EC) has approved Xofluza (baloxavir marboxil) for the treatment of uncomplicated influenza in patients aged 12 years and above. In addition, the EC has approved Xofluza for post-exposure prophylaxis of influenza in individuals aged 12 years and above.

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