EMA committee recommends approval of glepaglutide for short-bowel syndrome

On September 21, 2026, the European Medicines Agency's Committee for Medicinal Products for Human Use recommended Zeydovio (glepaglutide), developed by Zealand Pharma A/S, for marketing authorization in the European Union. Zeydovio is a long-acting glucagon-like peptide 2 analog designed to treat adults with short-bowel syndrome. In the phase 3 EASE-1 trial of 106 adults, twice-weekly subcutaneous injections of 10-mg glepaglutide significantly reduced weekly parenteral support volume over 24 weeks compared to placebo.

EMA approval recommendation for glepaglutide

• ▪Zeydovio (glepaglutide) will be supplied as a 10-mg solution for injection in a prefilled pen for subcutaneous administration.
• ▪The European Medicines Agency's Committee for Medicinal Products for Human Use recommended Zeydovio (glepaglutide) for marketing authorization in the European Union on September 21, 2026.
• ▪Zeydovio (glepaglutide) treatment must be initiated under the supervision of a healthcare professional experienced in managing short-bowel syndrome.
• ▪Zeydovio (glepaglutide), developed by Zealand Pharma A/S, is recommended for treating adults with short-bowel syndrome who are clinically stable following postsurgical intestinal adaptation.

Short-bowel syndrome pathophysiology

• ▪Short-bowel syndrome is a rare, chronic, and severe condition resulting from extensive surgical resection of the small intestine, leading to malabsorption of nutrients, fluids, and electrolytes.
• ▪Patients with severe short-bowel syndrome require intravenous parenteral support to meet their nutritional and hydration needs due to intestinal failure.

GLP-2 analog mechanism of action

• ▪Pharmacologic therapy for short-bowel syndrome aims to promote intestinal adaptation and strengthen the absorptive capacity of the remaining bowel to reduce dependence on parenteral support.
• ▪Glepaglutide is a long-acting analog of glucagon-like peptide 2 that increases blood flow, inhibits gastric acid secretion, and slows intestinal motility to promote structural growth of the intestinal mucosa.

EASE-1 trial efficacy results

• ▪The Committee for Medicinal Products for Human Use identified the main benefit of Zeydovio (glepaglutide) as a greater reduction in weekly parenteral support volume over 24 weeks compared with placebo.
• ▪In the phase 3 EASE-1 trial of 106 adults with short-bowel syndrome, twice-weekly 10-mg glepaglutide significantly reduced weekly parenteral support volume compared with placebo at 24 weeks.

Glepaglutide safety profile

• ▪The most common adverse effects of glepaglutide include injection-site reactions, gastrointestinal stoma complications, abdominal pain, abdominal distension, nausea, fluid retention or overload, and vomiting.
• ▪Detailed recommendations for Zeydovio (glepaglutide) use will be published in the Summary of Product Characteristics following official marketing authorization by the European Commission.