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Pivotal Phase 3 trial of FDY 5301 for the treatment of reperfusion injury

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Pivotal Phase 3 trial of FDY 5301 for the treatment of reperfusion injury

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 26 Mar 2021

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At a glance

  • Drugs FDY 5301 (Primary)
  • Indications Reperfusion injury
  • Focus Registrational; Therapeutic Use
  • Sponsors Faraday Pharmaceuticals

    • Most Recent Events

    • 25 Mar 2021 According to a Faraday Pharmaceuticals media release, the company plans to initiate this study in the second half of 2021.
    • 25 Mar 2021 According to a Faraday Pharmaceuticals media release, The study is powered to show a 30% relative reduction in cardiovascular (CV) death and heart failure with a two-sided p-value of less than 0.05, which, if successful, would support a regulatory submission for marketing approval.
    • 25 Mar 2021 According to a Faraday Pharmaceuticals media release, has reached agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) on the protocol design and statistical analysis approach for this Phase 3 cardiovascular outcomes study evaluating FDY-5301 for the treatment of acute ST-segment elevation myocardial infarction (STEMI) in patients undergoing percutaneous intervention (PCI).

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