At a glance
- Glepaglutide is not an FDA-approved drug: Drugs@FDA has no record of it.
- PubMed lists 37 publications mentioning it, including 8 randomized controlled trials and 2 animal-only studies.
- ClinicalTrials.gov lists 11 registered studies testing it (2 active).
- FDA's adverse event system (FAERS) holds 2 reports mentioning it; 2 classified as serious. Reports do not prove causation.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
No application found in Drugs@FDA, FDA's database of approved drugs.
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.
Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Latest publications
- Sodium depletion is associated with the response to glepaglutide in short bowel syndrome with chronic intestinal failure.
- Comment on "Outcomes of glepaglutide on intestinal absorption and parenteral support in patients with short bowel syndrome".
- Beyond intestinal failure: Expanding therapeutic frontiers of glucagon-like peptide-2 in gastrointestinal disease.
- Glucagon-like peptide agonists and use in short bowel syndrome - what about the side effects?
- Exploring the disease burden and quality of life in patients with short bowel syndrome with intestinal failure: Insights from exit interviews in the glepaglutide EASE SBS-1 phase 3 trial.
- Investigation of the stool microbiome of short bowel syndrome patients before and after a 24-week treatment with the glucagon-like peptide 2 analog glepaglutide.
- Interpreting pooled GLP-2 analogue effects in chronic intestinal failure transparency, attrition, and real-world generalisability.
- Positive clinical outcomes associated with use of glucagon-like peptide-2 (GLP-2) analogues in patients with intestinal failure: A systematic review and meta-analysis.
- Glucagon-Like Peptide-2 (GLP-2) Analogues in Patients With Short Bowel Syndrome Dependent on Parenteral Support: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
- Outcomes of glepaglutide on intestinal absorption and parenteral support in patients with short bowel syndrome.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 11
- Active
- 2
- With posted results
- 2
Conditions studied
Show 1 more study
| Study | Status | Phase | Start |
|---|---|---|---|
| Healthy Normal Single Ascending Dose and Crohn's Patient Multiple Ascending Dose | Completed | Phase 1 | Jan 2009 |
All 11 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 2
- Serious
- 2
- With death outcome
- 0
Most reported reactions
Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.
Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query
Change history
No changes since monitoring began on October 30, 2026.