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Phase 3 study of Nangibotide for Septic Shock

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Trial Profile

Phase 3 study of Nangibotide for Septic Shock

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 12 Jan 2024

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At a glance

  • Drugs Nangibotide (Primary)
  • Indications Septic shock
  • Focus Registrational; Therapeutic Use
  • Acronyms ACCURATE
  • Sponsors Inotrem

    • Most Recent Events

    • 08 Jan 2024 According to an Inotremm media release, the company announced the outcome of its regulatory interactions with the US Food and Drug Administration (FDA) to finalize the design of a single Phase 3 registration trial (ACCURATE) for nangibotide in septic shock, ACCURATE will run globally and enroll patients in about 100 sites in the Americas, Europe and Japan, primary analysis group of trial is 900 patients
    • 17 Oct 2022 New trial record
    • 13 Oct 2022 According to an Inotremm media release, based on data from ASTONISH trial, the company expect to initiate this study and look forward to discussing next steps with regulatory authorities.

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