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Confirmatory Open-label Saccharated Iron Oxide-controlled Study of NS-32 in Patients with Iron Deficiency Anemia Associated with Menorrhagia (Phase III)

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Trial Profile

Confirmatory Open-label Saccharated Iron Oxide-controlled Study of NS-32 in Patients with Iron Deficiency Anemia Associated with Menorrhagia (Phase III)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 Nov 2022

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At a glance

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

Most Recent Events

  • 01 Nov 2022 Primary endpoint (The maximum change in hemoglobin concentration from baseline) has been met, as per results published in the International Journal of Hematology.
  • 01 Nov 2022 Results assessing efficacy and safety of intravenous ferric derisomaltose (FDI) versus saccharated ferric oxide (SFO) in Japanese patients with iron deficiency anemia associated with menorrhagia, 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 gastrointestinal bleeding , post-partum hemorrhage and this trial.

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