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A confirmatory Phase 3 trial of apraglutide for patients with short bowel syndrome (SBS) with intestinal failure (IF) who are dependent on parenteral support

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Trial Profile

A confirmatory Phase 3 trial of apraglutide for patients with short bowel syndrome (SBS) with intestinal failure (IF) who are dependent on parenteral support

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 20 Apr 2025

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At a glance

  • Drugs Apraglutide (Primary)
  • Indications Intestinal failure; Short bowel syndrome
  • Focus Pharmacokinetics; Registrational
  • Sponsors Ironwood Pharmaceuticals

Most Recent Events

  • 20 Apr 2025 New trial record
  • 14 Apr 2025 According to an Ironwood Pharmaceuticals media release, the company announced that, based on a recent discussion with the U.S. Food and Drug Administration (FDA), a confirmatory Phase 3 trial is needed to seek approval. The company plans to work with the FDA on the design of a confirmatory Phase 3 trial and the regulatory path forward.

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