Zealand Pharma's Zeydovio (Glepaglutide), a Long-Acting GLP-2 Analog, Receives Positive CHMP Opinion for Short Bowel Syndrome
Zealand Pharma announced on Friday, September 18, 2026 that the EMA's CHMP recommended approval of Zeydovio (glepaglutide) for short bowel syndrome. Zeydovio is a long-acting GLP-2 analog given twice weekly by subcutaneous injection from a ready-to-use, single-dose autoinjector. In the Phase 3 EASE-1 trial of 106 patients dependent on parenteral support, two thirds of patients on glepaglutide had at least a 20% reduction in weekly parenteral support volume at 24 weeks and one in seven weaned off it entirely; twice-weekly glepaglutide cut weekly parenteral support by 5.13 liters versus 2.85 liters on placebo. Zealand called the opinion the first major advance in short bowel syndrome treatment in Europe in more than a decade and expects a European Commission decision in about 67 days. In the U.S., the EASE-5 trial is ongoing, and glepaglutide has FDA orphan drug designation.