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Open Label Study (Phase III) of NS-32 in Patients with Iron Deficiency Anemia Associated with Gastrointestinal Diseases

Trial Profile

Open Label Study (Phase III) of NS-32 in Patients with Iron Deficiency Anemia Associated with Gastrointestinal Diseases

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Dec 2022

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At a glance

  • Drugs Ferric derisomaltose (Primary)
  • Indications Iron deficiency anaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors Nippon Shinyaku
  • Most Recent Events

    • 01 Dec 2022 Results assessing efficacy and safety of intravenous ferric derisomaltose for iron-deficiency anemia associated with gastrointestinal diseases, published in the International Journal of Hematology.
    • 28 Mar 2022 According to Nippon Shinyaku media release, the Ministry of Health, Labour and Welfare (MHLW) has approved marketing authorization of MonoVer for I.V. injection 500mg/1000mg (ferric derisomaltose/NS-32) for the treatment of iron deficiency anemia based on the results from two Japanese Phase 3 trial for IDA with heavy uterine bleeding, post-partum hemorrhage and this trial.
    • 21 Dec 2021 New trial record
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