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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: 26 Aug 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

    • 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.
    • 22 Dec 2023 According to a Zealand Pharma media release, the company has submitted NDA to US FDA for glepaglutide, for the treatment of adult patients with short bowel syndrome (SBS) dependent on parenteral support, based on data from EASE clinical trial program (EASE-1, EASE-2, EASE-3 and EASE-4).
    • 17 Oct 2023 Results of safety and efficacy of Glepaglutide, presented at the 31st United European Gastroenterology Week

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