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Glepaglutide

Also called ZP1848

EvidenceModerate research

ClassGLP-2 analog

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.

Reviewed by: William Maish, MD MBA MPH, Clinical Product Lead
Published: October 5, 2026
Last updated: October 5, 2026

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

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 receptor¹ 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?

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?

The main evidence is one Phase 3 trial with a mixed result. According to PubMed, the two studies found:

Study	Design	Result
EASE¹ 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 study²	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.

More for digestive & weight

Sources: the EASE Phase 3 trial (Jeppesen et al., Gastroenterology, 2025, DOI: 10.1053/j.gastro.2024.11.023¹) and a Phase 3b metabolic-balance study (Pinar et al., Clinical Nutrition ESPEN, 2025, DOI: 10.1016/j.clnesp.2025.08.006²), 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.