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A randomized, double-blind, placebo-controlled, phase 2 study of S-033188 in otherwise healthy adult patients with influenza

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Trial Profile

A randomized, double-blind, placebo-controlled, phase 2 study of S-033188 in otherwise healthy adult patients with influenza

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 26 May 2022

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At a glance

  • Drugs Baloxavir-marboxil (Primary)
  • Indications Influenza virus infections
  • Focus Proof of concept; Registrational; Therapeutic Use
  • Sponsors Shionogi

    • Most Recent Events

    • 18 May 2022 Results by deriving data from JapicCTI-153090, NCT02954354; NCT02949011, NCT03959332; KCT0003535, developing pharmacokinetics-time to alleviation of symptoms (PK-TTAS) model to study Baloxavir Marboxil Clinical Efficacy in Different Ethnic Groups with Influenza A or B.published in the Clinical Pharmacology and Therapeutics
    • 24 Jun 2021 Results of comparative analysis of baloxavir pharmacokinetics and simulated efficacy in chinese individuals and asian patients by using data of baloxavir clinical trials (a Phase I study (NCT03959332), a Phase II study (OwH; T0821), and Phase III studies in OwH (NCT02954354) and high risk (NCT02949011)), presented at the World Microbe Forum 2021
    • 29 Aug 2019 According to an Shionogi media release, the company announced that Xofluza has been approved in Taiwan for the treatment of acute influenza Types A and B in patients 12 years of age and older on August 28, 2019.
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