Glepaglutide
Also known as: ZP1848
Glepaglutide is an investigational GLP-2 analog for short bowel syndrome with intestinal failure. Its pivotal trial was positive for twice-weekly dosing but not the once-weekly regimen, prompting an additional-trial requirement.
Quick Facts
A GLP-2 analog for intestinal failure
Zealand Pharma developed subcutaneous glepaglutide as ZP1848. It is in the same broad GLP-2 class as investigational apraglutide and approved teduglutide, but each product has its own evidence and regimen. The target setting is short bowel syndrome requiring parenteral nutrition.
Intestinal adaptation and absorption
GLP-2-receptor activation promotes growth/adaptation of remaining intestinal lining and greater nutrient/fluid uptake. The intended outcome is reduced dependence on IV feeding, which must be assessed through the actual support-volume findings rather than inferred from tissue growth alone.
Supporting references: GLP-2 receptor.
Sources: [1]
Regimen-specific trial findings
| Study | Design | Finding |
|---|---|---|
| EASE Phase 3 | Twice-weekly or once-weekly glepaglutide versus placebo | Twice-weekly treatment met the primary weekly IV-support-volume endpoint and key secondary measures; once-weekly treatment did not reach significance |
| Smaller Phase 3b study | Follow-up over one year | Increased energy absorption and reduced parenteral support reported |
Supporting references: study.
Sources: [2]
Complete Response Letter and further study
The drug remains unapproved. Zealand reported a December 2024 FDA Complete Response Letter stating that efficacy and safety of the intended dose were not established, given the negative pivotal once-weekly arm. The company announced another Phase 3 study. One positive arm of a single pivotal trial does not establish both regimens or substitute for the requested confirmatory work.
References and further reading
This reference draws on Superpower’s Peptide Library and the research linked below. Peptide Dossier’s editorial team adapted and integrated the material on .
- 10.1053/j.gastro.2024.11.023Intestinal adaptation and absorptionCited in: Intestinal adaptation and absorption
- 10.1016/j.clnesp.2025.08.006Regimen-specific trial findingsCited in: Regimen-specific trial findings
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Disclaimer: This article is for informational and educational purposes only. It is not intended as medical advice. The information presented is based on published research and should not be used as a substitute for professional medical guidance. Always consult a qualified healthcare provider before starting any peptide protocol. Some peptides discussed may not be approved for human use by the FDA or equivalent regulatory bodies.