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A Double-Blind Phase 3 Extension Trial Assessing the Long Term Safety and Efficacy of Glepaglutide in Patients With Short Bowel Syndrome (SBS)

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Trial Profile

A Double-Blind Phase 3 Extension Trial Assessing the Long Term Safety and Efficacy of Glepaglutide in Patients With Short Bowel Syndrome (SBS)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 06 Jun 2025

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At a glance

  • Drugs Glepaglutide (Primary)
  • Indications Short bowel syndrome
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms EASE SBS 2; EASE-2
  • 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).
  • 19 Sep 2024 Planned End Date changed from 31 Dec 2024 to 31 Oct 2026.
  • 19 Sep 2024 Planned primary completion date changed from 31 Dec 2024 to 31 Oct 2026.

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