Glepaglutide FDA Approval Status
FDA Approved: No
Generic name: glepaglutide
Company: Zealand Pharma A/S
Treatment for: Short Bowel Syndrome
Glepaglutide is a long-acting glucagon-like peptide-2 (GLP-2) analog in development for the treatment of short bowel syndrome.
- Short bowel syndrome (SBS) is a condition that develops when the small intestine is shortened or damaged so cannot absorb enough nutrients from food. Patients with SBS are dependent on receiving fluids and nutrition parenterally.
- Glepaglutide is a GLP-2 analog that works by improving intestinal absorptive function to reduce or eliminate the need for parenteral support in SBS patients.
- Glepaglutide is being developed as a liquid product in an autoinjector designed for twice weekly dosing by subcutaneous administration.
- The U.S. Food and Drug Administration (FDA) has granted orphan drug designation for glepaglutide for the treatment of SBS.
Development timeline for glepaglutide
| Date | Article |
|---|---|
| Dec 22, 2023 | Zealand Pharma Submits New Drug Application to the US FDA for Glepaglutide in Short Bowel Syndrome |
Further information
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