Glepaglutide
A next-generation GLP-2 therapy for patients with short bowel syndrome
Glepaglutide is an long-acting GLP-2 analog that is stable in aqueous solution. We are developing glepaglutide as a ready-to-use, fixed dose product designed for subcutaneous delivery via auto-injector.
Glepaglutide is an investigational candidate, not approved by the U.S. Food & Drug Administration (FDA) or any health authority for short bowel syndrome, and the safety and effectiveness of glepaglutide has not yet been established.
- PROGRAM Glepaglutide
- Phase 3
Development status
In the first Phase 3 trial (EASE-1) in patients with short bowel syndrome – intestinal failure (SBS-IF) requiring parenteral support at least 3 days per week, the efficacy and safety of treatment with glepaglutide was reported: Glepaglutide 10 mg twice-weekly led to greater improvement than placebo measured by change in weekly parenteral support volumes from baseline to week 24 (mean change, −5.13 vs −2.85 L/week; P = .0039; primary end point). The safety profile of glepaglutide was reported as similar to the known safety profile of the GLP-2 class.
The newly initiated EASE-5 trial is our second pivotal Phase 3 trial designed to confirm the efficacy and safety of glepaglutide administered at a dose of 10 mg twice-weekly over 52 weeks of treatment. The trial will randomize 90 patients to receive either glepaglutide or placebo for 52 weeks, followed by a three-year open label, glepaglutide-treated extension phase to evaluate long-term safety. Recruitment in Europe and the United States began in January 2026.
In Q4 2025 the EASE-6 long-term extension trial was initiated in Europe and the United States enabling uninterrupted access to treatment for previous EASE-2 and EASE-3 trial participants while supplementing long-term safety data on glepaglutide 10 mg twice weekly dosing.
Scientific publications are available upon request
Please contact investor relations to request references or scientific publications and presentations related to glepaglutide in short bowel syndrome.
Learn about clinical trials involving glepaglutide
Short Bowel Syndrome (SBS)
More about the disease area
Short bowel syndrome (SBS) is a rare, chronic, and debilitating condition resulting in significantly reduced or complete loss of intestinal function.
