Zealand Pharma Receives Positive CHMP Opinion for Zeydovio in SBS Treatment

Copenhagen, Denmark, September 18, 2026, Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078), a biotechnology company transforming the future of metabolic health, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for its drug Zeydovio™ (glepaglutide) for the treatment of short bowel syndrome (SBS). This marks the first major advancement in SBS treatment in Europe in over a decade.

The positive opinion, based on data from the pivotal Phase 3 EASE-1 trial, recommends marketing authorization for Zeydovio™, a long-acting, next-generation GLP-2 analog. The drug significantly reduced parenteral support (PS) volume in SBS patients with intestinal failure, with two-thirds of patients achieving a clinical response of at least a 20% reduction in weekly PS volume, and one in seven patients weaning off PS entirely after 24 weeks of treatment. Glepaglutide’s simple twice-weekly subcutaneous administration via a ready-to-use autoinjector positions it as a transformative therapy for SBS patients.

In the Phase 3 EASE-1 trial, patients were randomized to receive glepaglutide 10 mg once or twice weekly, or placebo. The primary endpoint was the absolute change in weekly PS volume from baseline at 24 weeks. Glepaglutide administered twice weekly significantly reduced the total weekly volume of PS by 5.13 liters/week compared to 2.85 liters/week in the placebo group (p=0.0039). Clinical efficacy was observed in patients with and without colon-in-continuity. Among patients receiving glepaglutide twice weekly, 65.7% achieved a clinical response, defined as at least a 20% reduction in weekly PS volume at 24 weeks (versus 38.9% in the placebo group), and 51.4% of patients achieved a reduction in PS days of at least 1 day/week (versus 19.4% in the placebo group). Nine patients treated with glepaglutide were completely weaned off PS (achieving enteral autonomy), while no placebo-treated patients achieved enteral autonomy. For patients treated twice weekly, 14% (n=5) achieved enteral autonomy.

The CHMP's opinion will now be reviewed by the European Commission, with a final decision on the Marketing Authorization Application (MAA) expected within approximately 67 days. Subject to European Commission approval, the marketing authorization would be valid in all member states of the European Union, as well as Iceland, Liechtenstein, and Norway. Zealand Pharma is actively engaging in partnership discussions for the future global commercialization of glepaglutide for SBS.

The Phase 3 EASE-5 trial, designed to provide further confirmatory evidence to support a regulatory submission in the U.S., is ongoing, with patient recruitment progressing well. The EASE-5 trial is a randomized, double-blind, placebo-controlled Phase 3 trial, followed by a long-term, open-label safety evaluation in SBS patients with intestinal failure.

The positive opinion for Zeydovio™ is based on data from the EASE-1 trial, which demonstrated significant and superior reductions in parenteral support requirements in SBS patients with intestinal failure compared to placebo. The long-term efficacy and safety of glepaglutide will be presented at scientific meetings in 2027.