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A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Glepaglutide in Patients With Short Bowel Syndrome (SBS)

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Trial Profile

A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Glepaglutide in Patients With Short Bowel Syndrome (SBS)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 24 Dec 2024

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At a glance

  • Drugs Glepaglutide (Primary)
  • Indications Short bowel syndrome
  • Focus Registrational; Therapeutic Use
  • Acronyms EASE SBS 1; EASE-1
  • Sponsors Zealand Pharma

    • Most Recent Events

    • 19 Dec 2024 According to a Zealand Pharma media release, company expects to proceed with current plans for a European Marketing Authorization Application submission in 2025.
    • 19 Dec 2024 According to a Zealand Pharma media release, company announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the company's New Drug Application (NDA) for glepaglutide under development for the treatment of adult patients with short bowel syndrome (SBS) with intestinal failure (IF) who are dependent on parenteral support, the submitted NDA included data from phase 3 EASE study.
    • 27 Feb 2024 According to a Zealand Pharma media release, the company expects to receive notification of a PDUFA date in the coming weeks following acceptance of the filing.

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