At a glance
- Apraglutide is not an FDA-approved drug: Drugs@FDA has no record of it.
- PubMed lists 30 publications mentioning it, including 2 randomized controlled trials and 3 animal-only studies.
- ClinicalTrials.gov lists 12 registered studies testing it (2 active).
- FDA's adverse event system (FAERS) holds 1 report mentioning it; 1 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
- STARS Phase 3 Trial: Once-Weekly Apraglutide Reduces Parenteral Support in Short Bowel Syndrome-Intestinal Failure.
- Pharmacological Strategies for Mitigating Cytarabine-Induced Multi-Organ Toxicity: A Scoping Review on Mechanisms, Efficacy and Clinical Implications.
- Early ecological changes in intestinal microbiota with the long-acting GLP-2 analog apraglutide in short bowel syndrome.
- Glucagon-like peptide agonists and use in short bowel syndrome - what about the side effects?
- Systemic Pharmacokinetic Principles of Therapeutic Peptides.
- Pharmacokinetics and Safety of Single-Dose Apraglutide in Individuals with Normal and Impaired Hepatic Function: A Phase 1, Open-Label Trial.
- 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.
- Emerging novel therapies for steroid-refractory acute graft-versus-host disease: recent advances and future directions.
- Use of glucagon-like polypeptide 2 analogs for intestinal failure.
- The Long-Acting Glucagon-Like Peptide-2 Analog Apraglutide Enhances Intestinal Protection and Survival After Chemotherapy and Allogeneic Transplantation in Mice.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 12
- Active
- 2
- With posted results
- 4
Conditions studied
Show 2 more studies
| Study | Status | Phase | Start |
|---|---|---|---|
| Safety, Efficacy, PD of FE203799 in Short Bowel Syndrome on Parenteral Support | Completed | Phase 1, Phase 2 | May 8, 2018 |
| Metabolic Balance Study of FE203799 in Patients With SBS With Intestinal Insufficiency | Completed | Phase 1, Phase 2 | May 2, 2018 |
All 12 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 1
- Serious
- 1
- 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.