Glepaglutide
Glepaglutide is a long-acting GLP-2 analogue investigated for short bowel syndrome with intestinal failure and dependence on parenteral support.
At a glance
- Evidence stage
- Early human
- Regulatory status
- Investigational; FDA issued a Complete Response Letter in December 2024. The current developer page states that glepaglutide remains unapproved for short bowel syndrome.
- Research context
- Glepaglutide is a long-acting GLP-2 analogue investigated for short bowel syndrome with intestinal failure and dependence on parenteral support.
What this is
- Glepaglutide is a long-acting GLP-2 analogue investigated for short bowel syndrome with intestinal failure and dependence on parenteral support.
What this isn't
- A recommendation to use, prepare, combine, or administer a product
- Evidence that a related molecule or a differently formulated product has the same effects
Key terms
Glepaglutide is a long-acting GLP-2 analogue investigated for short bowel syndrome with intestinal failure and dependence on parenteral support.
GLP-2 receptor signaling promotes intestinal absorption and adaptation. Glepaglutide aims to reduce the fluid and nutrition that must be supplied outside the digestive tract. Its clinical program addresses severe loss of bowel function; the mechanism should not be translated into general digestive wellness, appetite suppression, or treatment of nonspecific gastrointestinal symptoms.
Evidence limits
How to read the evidence
The sponsor's regulatory report documents FDA's December 2024 Complete Response Letter. A positive endpoint therefore should not be confused with approval. Protocol-directed support adjustments and individual bowel anatomy influence results. Extensions follow selected participants and cannot recreate a randomized comparator. Neither those extensions nor another GLP-2 analogue's approval establishes durable independence or approval for glepaglutide itself.
Sources appraised 2026-10-28. Educational information; not medical advice. Study findings apply to the populations, preparations and outcomes described.
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