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A Single-Center Phase 3b Trial Investigating the Long-term Effect on Intestinal Absorption, Nutritional Status and Long-Term Safety of treatment with Glepaglutide in Patients with Short Bowel Syndrome (SBS)

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Trial Profile

A Single-Center Phase 3b Trial Investigating the Long-term Effect on Intestinal Absorption, Nutritional Status and Long-Term Safety of treatment with Glepaglutide in Patients with Short Bowel Syndrome (SBS)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Jun 2025

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At a glance

  • Drugs Glepaglutide (Primary)
  • Indications Intestinal failure; Short bowel syndrome
  • Focus Registrational; Therapeutic Use
  • Acronyms EASE SBS 4; EASE-4
  • Sponsors Zealand Pharma

Most Recent Events

  • 02 Jun 2025 According to a Zealand Pharma media release, company announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for glepaglutide, based on results from a pivotal Phase 3 trial (EASE-1), supported by interim results from two ongoing long-term extension trials (EASE-2 and EASE-3) and results from a mechanistic trial (EASE-4).
  • 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).

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