Zealand Pharma Zeydovio (Glepaglutide, Long-Acting GLP-2 Receptor Agonist Peptide) Receives Positive EU CHMP Opinion for Adult Short Bowel Syndrome; First Major SBS Advance in Europe in Over a Decade
Zealand Pharma (NASDAQ: ZEAL; NASDAQ Copenhagen: ZEAL) announced Friday September 18, 2026 that the EMA's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending marketing authorization for Zeydovio (glepaglutide, a long-acting next-generation GLP-2 receptor agonist peptide) for the treatment of adults with short bowel syndrome (SBS). The recommendation is anchored on the registrational Phase 3 EASE-1 trial: 65.7% of patients on glepaglutide achieved at least a 20% reduction in parenteral support volume versus 38.9% on placebo, with approximately 1 in 7 patients weaning off parenteral support entirely at 24 weeks. Zeydovio will be supplied as a 10 mg solution for injection in a pre-filled pen. This is the first major CHMP advance in SBS in more than a decade — the current European standard-of-care GLP-2 analog teduglutide (Takeda's Revestive) has been the only GLP-2 in the EU market since 2012. The European Commission decision is expected within approximately 67 days (mid-November 2026 timeframe). Zealand retains full commercial rights in Europe. Glepaglutide is also under FDA review with a U.S. PDUFA action date targeted for early 2027.