Zealand Pharma announces EU approval of Zeydovio™ (glepaglutide) for the treatment of short bowel syndrome
Key Highlights
- ➤EU authorizes Zeydovio (glepaglutide) for adults with short bowel syndrome
- ➤Zeydovio is the first approved ready-to-use GLP-2 therapy
- ➤EASE-1 twice-weekly treatment reduced weekly parenteral support 5.13 liters versus 2.85 liters placebo
- ➤EASE-5 Phase 3 trial advances toward U.S. registration with recruitment progressing well
- ➤Zealand seeks a commercialization partner for glepaglutide across Europe and beyond
Expert Statements
Adam Steensberg, President and Chief Executive Officer of Zealand Pharma
“The European Commission’s approval of Zeydovio™ is an important milestone for people living with short bowel syndrome in Europe, and the first major advancement in treatment in more than a decade.”
Adam Steensberg, President and Chief Executive Officer of Zealand Pharma
“Zeydovio™ combines proven efficacy with simple twice-weekly dosing, and it has the potential to meaningfully ease the burden of this disease.”
Adam Steensberg, President and Chief Executive Officer of Zealand Pharma
“With this regulatory approval, our focus now turns to finding the right partner to bring Zeydovio(TM) to as many people living with short bowel syndrome as possible across Europe and beyond, and to further advance the ongoing Phase 3 EASE-5 trial to support U.S. registration.”
Zealand Pharma announces EU approval of Zeydovio(TM) (glepaglutide) for the treatment of short bowel syndrome * The approval marks the first major advancement in short bowel syndrome treatment in Europe in more than a decade * Zeydovio(TM) is the first and only ready-to-use GLP-2 therapy to receive regulatory approval * Clinically evidenced efficacy paired with simple delivery, positions Zeydovio(TM) as a transformative therapy for people living with short bowel syndrome * Active enrolment into the Phase 3 EASE-5 trial to support a U.S. NDA to advance glepaglutide toward patients globally Copenhagen, Denmark, November 13, 2026 – Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078), a biotechnology company transforming metabolic health so millions can live without limits, today announces that the European Commission (EC) has granted marketing authorization for Zeydovio(TM) (glepaglutide), a long-acting, next-generation GLP-2 analog, for the treatment of adults with short bowel syndrome (SBS).
Get started
Create a free account to read the full story.