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A multicenter, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of apraglutide in adult subjects with short bowel syndrome and intestinal failure (SBS-IF)

Trial Profile

A multicenter, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of apraglutide in adult subjects with short bowel syndrome and intestinal failure (SBS-IF)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 Apr 2025

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At a glance

  • Drugs Apraglutide (Primary)
  • Indications Intestinal disorders; Intestinal failure; Short bowel syndrome
  • Focus Registrational; Therapeutic Use
  • Acronyms STARS
  • Sponsors Ironwood Pharmaceuticals; VectivBio

Most Recent Events

  • 14 Apr 2025 According to an Ironwood Pharmaceuticals media release, in preparation for the NDA submission, pharmacokinetic analysis from this study indicated that the exposure and dose delivered were lower than planned due to dose preparation and administration. Consistent with FDA discussions, Ironwood plans to continue the long-term extension trial and believes the data from the this trial will continue to be an integral part of an NDA submission package.
  • 28 Oct 2024 According to an Ironwood Pharmaceuticals media release, the company will present new findings at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting and Postgraduate Course from subgroup analyses of the primary endpoint of the pivotal Phase III clinical trial.
  • 28 Oct 2024 Results presented in an Ironwood Pharmaceuticals Media Release.

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