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A phase III trial for combination of Ceftibuten/VNRX-7145.

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Trial Profile

A phase III trial for combination of Ceftibuten/VNRX-7145.

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 12 Oct 2023

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At a glance

  • Drugs Ceftibuten/ledaborbactam etzadroxil (Primary)
  • Indications Bacterial infections; Pyelonephritis; Urinary tract infections
  • Focus Therapeutic Use
  • Sponsors VenatoRx Pharmaceuticals

    • Most Recent Events

    • 10 Oct 2023 According to a VenatoRx Pharmaceuticals media release, The contract will provide funding and technical support for the development activities required for submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing authorization of ceftibuten-ledaborbactam etzadroxil for the treatment of cUTI, including pyelonephritis. The contract will also cover a pediatric program as a post-marketing commitment.
    • 10 Oct 2023 According to a VenatoRx Pharmaceuticals media release, company announced that the Biomedical Advanced Research and Development Authority (BARDA), has awarded the company a contract to support the development of oral ceftibuten-ledaborbactam etzadroxil for the treatment of complicated urinary tract infection (cUTI), including pyelonephritis.
    • 28 Jul 2022 According to a VenatoRx Pharmaceuticals media release, the company look forward to meeting with the FDA to finalize the protocols for Phase 3 clinical trial, which is expect to initiate in the second half of 2022.

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