At a glance
| Target | GLP-2 receptor |
|---|---|
| Population | SBS with intestinal failure |
| Studied route | Subcutaneous injection |
| Programs | EASE-1 and EASE-5 |
| Approval | Not approved in current sponsor information |
Overview
The treatment is designed for people whose remaining intestine cannot absorb enough fluid or nutrients without intravenous support. In the EASE-1 study, glepaglutide was tested at two administration frequencies against placebo. The positive results were regimen-specific, an important qualification that disappears in simple claims that the molecule 'worked in phase 3.' The sponsor reports that the EASE-5 confirmatory study began recruiting in January 2026 after a U.S. complete response letter. Current sponsor information explicitly describes glepaglutide as investigational and not approved by FDA or any other health authority.
How it works
Glepaglutide activates GLP-2 receptors to promote intestinal adaptation and increase absorption. Its long-acting design is intended to sustain that response with less frequent administration than daily GLP-2 therapy. Changes in absorptive capacity can alter the balance between oral intake, intestinal losses and parenteral support. The clinical aim is a safe reduction in support, not intestinal growth as an isolated laboratory endpoint.
The intended clinical problem
Patients in the pivotal study required parenteral support on at least three days per week. The program addresses intestinal failure after loss of bowel, rather than ordinary constipation, IBS or a general wish to improve intestinal permeability.
Supporting sources [1]
What EASE-1 demonstrated
Among 106 randomized and treated patients, the twice-weekly trial regimen reduced support volume more than placebo at twenty-four weeks. About 14% in that group achieved complete support independence. The once-weekly regimen did not show significant superiority on primary or key secondary endpoints.
Supporting sources [1]
Why study regimen matters
The efficacy difference between regimens means that one cannot assume every exposure schedule produces the same result. Enteral autonomy in a minority of participants also should not be described as a guaranteed outcome for all patients with short bowel syndrome.
Supporting sources [1]
Long-term assessment
EASE-1 reported generally favorable tolerability, but its size and duration do not settle uncommon or delayed risks. Continued development evaluates sustained support reduction and safety over longer treatment, including the consequences of improved absorption and intestinal trophic activity.
Current development status
The sponsor’s current pipeline page describes EASE-5 as a second pivotal phase 3 study recruiting in Europe and the United States from January 2026. It explicitly states that glepaglutide is investigational and not approved by any health authority.
Supporting sources [2]
Reading this profile
Jurisdiction: Investigational; current sponsor information states no FDA or other health-authority approval.. Molecular class: Long-acting GLP-2 analog peptide.
This profile was written with AI-assisted research and checked against the linked sources. It has not been represented as a clinician’s review. Evidence summaries describe the cited studies and products; they do not establish that a separately purchased preparation is equivalent.
Sources & references
Follow the original material. Product labels define specific formulations and uses; trial registration describes a study and does not by itself establish benefit.
- Glepaglutide, a Long-Acting Glucagon-like Peptide-2 Analogue, Reduces Parenteral Support in Patients With Short Bowel Syndrome: A Phase 3 Randomized Controlled Trial. ↗Original research · Checked 2026-10-27
- Zealand Pharma: Glepaglutide pipeline and EASE-5 status ↗Manufacturer / sponsor · Checked 2026-10-27
- ClinicalTrials.gov: Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS ↗Clinical trial source · Checked 2026-10-27