Zealand Pharma Gains Positive CHMP Opinion for Zeydovio
Zealand Pharma announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending marketing authorization for Zeydovio™ (glepaglutide) for adults with short bowel syndrome (SBS). The long-acting, next-generation GLP-2 analog is designed to improve intestinal function and reduce dependence on parenteral support in patients with intestinal failure. The recommendation represents a major European regulatory milestone for glepaglutide, with the European Commission expected to issue a final decision within approximately 67 days.
Glepaglutide Reduces Dependence on Parenteral Support
The positive CHMP opinion is supported by data from the Phase 3 EASE clinical program, including the pivotal EASE-1 study. In EASE-1, twice-weekly glepaglutide significantly reduced weekly parenteral support volume compared with placebo at 24 weeks. Among patients receiving twice-weekly treatment, 65.7% achieved at least a 20% reduction in weekly parenteral support volume, compared with 38.9% for placebo, while 51.4% achieved a reduction of at least one parenteral-support day per week. Nine patients receiving glepaglutide achieved complete weaning from parenteral support, including 14% of patients in the twice-weekly treatment group. Interim results from the long-term EASE-2 study and mechanistic findings from EASE-4 further supported the candidate’s effects on intestinal absorption and sustained treatment response.
Zeydovio Offers Twice-Weekly Autoinjector Administration
Glepaglutide is being developed for twice-weekly subcutaneous administration using a ready-to-use, single-dose autoinjector, providing a simplified delivery approach for patients managing chronic SBS. The candidate has a long half-life and high stability in aqueous solution and is intended to improve intestinal absorption, potentially reducing the volume and frequency of parenteral support. EASE-4 provided mechanistic evidence of improvements in intestinal fluid, energy, electrolyte and macronutrient absorption, while longer-term findings showed reductions in parenteral support requirements. The EASE-2 and EASE-3 studies were completed in 2026, with results expected to be presented at scientific meetings in 2027..
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Zealand Advances Global Development of Glepaglutide
The CHMP opinion moves Zeydovio toward potential European approval while Zealand Pharma continues development for the U.S. market. The company is actively enrolling patients in EASE-5 (NCT07197944), a randomized, double-blind, placebo-controlled Phase 3 study designed to confirm the efficacy and safety of twice-weekly glepaglutide and support a potential U.S. regulatory submission. If approved by the European Commission, the marketing authorization would apply across EU member states as well as Iceland, Liechtenstein and Norway. Zealand is also engaging in partnership discussions for potential global commercialization of glepaglutide, while continuing to advance its broader peptide-based drug development strategy in metabolic health.
Source:Zealand Pharma, press release
