A Phase 3, Multicenter, Randomized, Double-blind Study of a Single Dose of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir 75 mg Twice Daily for 5 Days in Otherwise Healthy Patients With Influenza

Trial Profile

A Phase 3, Multicenter, Randomized, Double-blind Study of a Single Dose of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir 75 mg Twice Daily for 5 Days in Otherwise Healthy Patients With Influenza

Completed
Phase of Trial: Phase III

Latest Information Update: 23 Feb 2018

At a glance

  • Drugs Baloxavir-marboxil (Primary) ; Oseltamivir
  • Indications Influenza virus infections
  • Focus Registrational; Therapeutic Use
  • Acronyms CAPSTONE 1
  • Sponsors Shionogi
  • Most Recent Events

    • 23 Feb 2018 According to a Shionogi media release, based on the results from this study , XOFLUZATM (baloxavir marboxil) tablets 10mg/20mg has been approved in Japan by the Ministry of Health, Labour and Welfare for the treatment of Influenza Types A and B.
    • 08 Oct 2017 Results assessing clinical and virologic outcomes of S-033188 compared with placebo by measuring the time to alleviation of symptoms in patients with uncomplicated influenza virus infection, were presented at the IDWeek 2017.
    • 05 Oct 2017 Results presented in a Shionogi Media Release.
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