Glepaglutide for short bowel syndrome
Glepaglutide is a long-acting GLP-2 analog that is stable in aqueous solution. Zealand is developing glepaglutide as a ready-to-use, fixed dose product designed for subcutaneous delivery via auto-injector for the potential treatment of short bowel syndrome (SBS). The Phase 3 program, named EASE, includes four clinical trials evaluating the potential for glepaglutide to reduce or eliminate the need for parenteral support in SBS patients with intestinal failure. Efficacy and safety data from these trials formed the basis of the New Drug Application (NDA) submitted to the US FDA in December 2023. FDA has granted orphan drug designation to glepaglutide for the treatment of SBS.
Glepaglutide is an investigational candidate, not yet approved by the U.S. Food & Drug Administration (“FDA”) for short bowel syndrome, and the safety and effectiveness of glepaglutide has not yet been established.