Glepaglutide

Safety Profile

How It Works

Glepaglutide mimics a natural gut hormone called GLP-2 that helps the intestine grow and absorb nutrients better. When injected under the skin, it slowly releases active compounds that tell the intestinal lining to grow taller finger-like projections (villi), which increases the surface area available to absorb food and water. It also slows down how fast food moves through the gut, giving the body more time to absorb nutrients. This is especially important for people with short bowel syndrome who have had large portions of their intestine surgically removed and struggle to absorb enough nutrition from food alone.

Studied Dosages

This was the only dosing regimen that achieved statistical significance vs placebo in the Phase 3 EASE SBS 1 trial (PMID 39708985).

Studies

Evidence tier 2 is assigned because Glepaglutide has positive Phase 3 RCT data.

Legal Status

Not FDA-approved. Glepaglutide is an investigational drug currently in clinical development by Zealand Pharma A/S. No FDA approval application has been filed as of available data. It does not appear in the FDA Drugs@FDA database or FDA bulk substance list. ClinicalTrials.gov lists a confirmatory Phase 3 trial (NCT07197944, recruiting) and an extension trial (NCT07228403, enrolling by invitation).