Digestive & weight GLP-2 analog
Glepaglutide
Regulatory status
Status at a glance
503A compounding status
Not nominated
We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.
- FDA approval
- Not FDA-approved for any use
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- Not on the WADA Prohibited List
- DEA schedule
- Not a controlled substance
About peptide status
Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.
This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.
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Key takeaway
Glepaglutide is an investigational long-acting GLP-2 analog, developed by Zealand Pharma as a subcutaneous injection for short bowel syndrome. In its Phase 3 trial the twice-weekly regimen reduced the need for intravenous nutrition, but the once-weekly regimen did not, and the FDA issued a Complete Response Letter in 2024 asking for more evidence. As of 2026 it is not approved.
At a glance
- FDA status
- Investigational peptide, not approved by the FDA
- What it is
- Long-acting GLP-2 analog given by subcutaneous injection for short bowel syndrome
- Phase 3 result
- Twice-weekly arm was positive but the once-weekly arm was not
- FDA review
- Complete Response Letter issued in 2024; an additional Phase 3 is planned
- Evidence strength
- Moderate research
Summary
Glepaglutide is an investigational GLP-2 analog for short bowel syndrome. See how it works, what its Phase 3 trial showed, and why the FDA has not approved it.
What is glepaglutide?
Glepaglutide is an experimental analog of glucagon-like peptide-2 (GLP-2), the hormone that supports intestinal growth and absorption. It is developed by Zealand Pharma under the code ZP1848 and is given by subcutaneous injection for short bowel syndrome with intestinal failure, where people depend on intravenous nutrition. It is in the same drug class as apraglutide and the approved GLP-2 drug teduglutide, and it is investigational and not approved.
How does it work?
Glepaglutide activates the GLP-2 receptor in the intestine. This signaling promotes growth and adaptation of the intestinal lining and increases nutrient and fluid absorption, with the goal of reducing dependence on intravenous feeding in short bowel syndrome. This describes the mechanism, separate from the trial results below.
Is it FDA-approved?
Safety note
Status: Investigational peptide, not approved by the FDA
Category: In clinical trials · Primary body area: Digestive & weight
No. Glepaglutide is investigational and not approved. According to company disclosures, the FDA issued a Complete Response Letter in December 2024, stating the application did not establish efficacy and safety of the intended dose, since the pivotal trial's once-weekly arm was not positive. Zealand has said it will run an additional Phase 3 trial.
What does the research show?
Editor’s note
Evidence strength: Moderate research (2 human · 0 animal/cell studies)
Its pivotal Phase 3 was positive for the twice-weekly regimen only, the once-weekly arm was null, and the FDA issued a Complete Response Letter requiring further evidence.
The main evidence is one Phase 3 trial with a mixed result. According to PubMed, the two studies found:
| Study | Design | Result |
|---|---|---|
| EASE trial | Phase 3, testing glepaglutide twice weekly, once weekly, or placebo | The twice-weekly regimen met the primary endpoint, reducing weekly intravenous support volume versus placebo and improving key secondary measures, but the once-weekly regimen did not reach significance |
| Smaller study | Phase 3b | Reported increased energy absorption and reduced parenteral support over a year |
The evidence rests on a single pivotal trial in which one of the two tested regimens was negative.
Sources: the EASE Phase 3 trial (Jeppesen et al., Gastroenterology, 2025, DOI: 10.1053/j.gastro.2024.11.023) and a Phase 3b metabolic-balance study (Pinar et al., Clinical Nutrition ESPEN, 2025, DOI: 10.1016/j.clnesp.2025.08.006), both indexed on PubMed; and Zealand Pharma regulatory updates. This document is educational, is not medical advice or a health claim, and is not an offer to sell any product.
Registered human trials
2 registered human trials on ClinicalTrials.gov that we reviewed
Sources
- [1]
- [2]
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