Glepaglutide
A next-generation GLP-2 therapy for patients with short bowel syndrome
Glepaglutide is an long-acting GLP-2 analog that is stable in aqueous solution. We are developing glepaglutide as a ready-to-use, fixed dose product designed for subcutaneous delivery via auto-injector.
Glepaglutide is an investigational candidate, not approved by the U.S. Food & Drug Administration (FDA) or any health authority for short bowel syndrome, and the safety and effectiveness of glepaglutide has not yet been established.
- PROGRAM Glepaglutide
- Registration
Development status
The use of glepaglutide administered twice a week for the treatment of short bowel syndrome with intestinal failure is currently under review by the US Food and Drug Administration (FDA). The regulatory submission is based on results from four clinical trials evaluating the potential for glepaglutide to reduce or eliminate the need for parenteral support in short bowel syndrome patients with intestinal failure.
The clinical program to evaluate the potential for glepaglutide to reduce or eliminate the need for parenteral support in short bowel syndrome patients with intestinal failure includes four trials.
The EASE-1 trial investigating glepaglutide compared to placebo administered for 24 weeks and two long-term (104 weeks) safety and efficacy extension trials, EASE-2 and EASE-3. We also conducted a mechanistic trial, EASE-4, to assess the effects of glepaglutide on intestinal fluid and energy uptake.
Scientific publications are available upon request
Please contact investor relations to request references or scientific publications and presentations related to glepaglutide in short bowel syndrome.
Learn about clinical trials involving glepaglutide
Short Bowel Syndrome (SBS)
More about the disease area
Short bowel syndrome (SBS) is a rare, chronic, and debilitating condition resulting in significantly reduced or complete loss of intestinal function.
