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Phase 2 clinical trial of Ferric Pyrophosphate Citrate in home infusion patients

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Trial Profile

Phase 2 clinical trial of Ferric Pyrophosphate Citrate in home infusion patients

Status: Planning
Phase of Trial: Phase II

Latest Information Update: 29 Jun 2022

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At a glance

  • Drugs Ferric pyrophosphate (Primary)
  • Indications Iron deficiency anaemia
  • Focus Proof of concept; Therapeutic Use

    • Most Recent Events

    • 22 Jun 2022 According to a Rockwell Medical media release, the company progress toward clearance of IND and believe the requested microbial challenge study will have minimal impact on this Phase 2 program timeline or cost as the tests will be conducted in parallel with the clinical study start-up activities.
    • 22 Jun 2022 According to a Rockwell Medical media release, the U.S. Food and Drug Administration (FDA) requested that Rockwell perform a microbial challenge study, a standard study testing the potential for microbial growth. Successful completion of this study will add an additional layer of safety for this clinical trial patients.
    • 22 Jun 2022 According to a Rockwell Medical media release, Ferric Pyrophosphate Citrate (FPC) is Rockwell's novel next-generation parenteral iron is anticipated to enter this Phase II study for the treatment of IDA in the home infusion setting in 2022.

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