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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: 12 Mar 2026

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At a glance

  • Drugs Apraglutide (Primary)
  • Indications Intestinal failure; Short bowel syndrome
  • Focus Pharmacokinetics; Registrational
  • Acronyms STARS-2
  • Sponsors Ironwood Pharmaceuticals

Most Recent Events

  • 25 Feb 2026 According to an Ironwood Pharmaceuticals media release, Key elements of confirmatory Phase 3 clinical trial design of apraglutide in short bowel syndrome with intestinal failure (SBS-IF) have been finalized with site initiations expected to begin in the second quarter of 2026.
  • 02 Jan 2026 According to an Ironwood Pharmaceuticals media release, in the fourth quarter company met with the FDA to align on a confirmatory Phase 3 trial design of apraglutide for the treatment of short bowel syndrome with intestinal failure (SBS-IF). Based on this meeting, company on track to initiate a confirmatory trial in the first half of 2026 and expect to provide details on the trial design in fourth quarter and full-year 2025 update later this quarter.
  • 07 Aug 2025 According to an Ironwood Pharmaceuticals media release, company has been finalizing a confirmatory Phase 3 trial design and plan to align with the FDA in the fourth quarter. Pending alignment with the FDA, Ironwood expects to initiate a confirmatory Phase 3 trial in the first half of 2026.

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