Europe greenlights glepaglutide for rare intestinal condition short-bowel syndrome

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending glepaglutide (Zeydovio, Zealand Pharma) for marketing authorization in the EU. The drug is indicated for adults with short-bowel syndrome (SBS) who are clinically stable after postsurgical intestinal adaptation — and must be initiated under the care of an SBS-experienced healthcare professional.

SBS is a rare, chronic condition caused by extensive surgical removal of the small intestine, leaving patients unable to absorb enough nutrients and fluids on their own. Many become dependent on parenteral (IV) nutrition. Glepaglutide, a long-acting GLP-2 analog, addresses this by boosting intestinal blood flow, slowing gut motility, and stimulating mucosal growth — essentially helping the remaining bowel work harder.

By the Numbers:

• 106 adults enrolled in the phase 3 EASE-1 trial
• All required parenteral support ≥3 days/week at baseline
• At 24 weeks, twice-weekly glepaglutide 10 mg significantly reduced weekly parenteral support volume vs. placebo
• Common side effects: injection-site reactions, GI stoma complications, abdominal pain, nausea, and fluid overload

Why it matters: For SBS patients, IV nutrition dependency is burdensome and carries serious long-term risks. A therapy that can meaningfully reduce — or potentially eliminate — that dependence is a significant quality-of-life win for a population with very few options.