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A Phase 3, open-label study to evaluate NS-32 in subjects with iron deficiency anemia associated with postpartum hemorrhage

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Trial Profile

A Phase 3, open-label study to evaluate NS-32 in subjects with iron deficiency anemia associated with postpartum hemorrhage

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Jun 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

  • 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, gastrointestinal bleeding, and this trial.
  • 04 Jan 2022 New trial record

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