A single, global, randomized, double-blind, controlled Phase 3 pivotal trial of a 90-day prophylaxis regimen of rezafungin in patients undergoing allogeneic bone marrow transplant

Trial Profile

A single, global, randomized, double-blind, controlled Phase 3 pivotal trial of a 90-day prophylaxis regimen of rezafungin in patients undergoing allogeneic bone marrow transplant

Planning
Phase of Trial: Phase III

Latest Information Update: 16 Nov 2017

At a glance

  • Drugs Rezafungin (Primary)
  • Indications Aspergillosis; Candidiasis
  • Focus Registrational; Therapeutic Use
  • Sponsors Cidara Therapeutics
  • Most Recent Events

    • 16 Nov 2017 New trial record
    • 08 Nov 2017 According to a Cidara Therapeutics media release, this and another Phase III trial (see profile 290385) could suffice for approval of rezafungin for both prophylaxis and treatment of invasive fungal infections.
    • 08 Nov 2017 According to a Cidara Therapeutics media release, based on the FDA and MHRA feedback, the company planned to initiate this trial in mid-2018 and produce topline results in mid-2020, subject to European regulatory feedback. This trial is supported by a planned Phase 3 trial (see profile 290385).
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