Apraglutide
Also known as: FE 203799
Apraglutide is an investigational long-acting GLP-2 analog for short bowel syndrome with intestinal failure. Positive support-reduction findings coexist with a requirement for another confirmatory Phase 3 study.
Quick Facts
A weekly GLP-2 analog under development
Ironwood Pharmaceuticals is developing apraglutide, code FE 203799, to improve intestinal adaptation and absorption in short bowel syndrome with intestinal failure. It is designed for once-weekly injection to reduce dependence on long-term parenteral nutrition, and is not approved.
Gut growth, transit and absorption
Activation of intestinal GLP-2 receptors promotes mucosal growth/adaptation, slows gastric emptying and transit and increases fluid/nutrient uptake. The intended result is more absorption through the remaining bowel and less IV support. Those mechanisms are separate from measured trial results.
Supporting references: GLP-2 receptor.
Sources: [1]
STARS and supporting evidence
| Study | Context | Result |
|---|---|---|
| STARS | Phase 3 in adults with short bowel syndrome | Primary endpoint met: greater weekly IV-support-volume reduction than placebo, with more participants achieving at least one day weekly without support |
| Supporting study | Phase 2 | Improved absorption and lower parenteral requirements over one year |
Supporting references: study.
Sources: [2]
Confirmatory-trial requirement
Ironwood began a rolling FDA submission, but company disclosures report FDA communication that an additional confirmatory Phase 3 trial is needed before approval can be sought. The company also disclosed a drug-exposure issue in the pivotal study. The single pivotal result has not been replicated, and submission activity is not approval.
References and further reading
This reference draws on Superpower’s Peptide Library and the research linked below. Peptide Dossier’s editorial team adapted and integrated the material on .
- 10.1016/j.cgh.2026.08.026Gut growth, transit and absorptionCited in: Gut growth, transit and absorption
- 10.1016/j.clnu.2024.10.011STARS and supporting evidenceCited in: STARS and supporting evidence
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Disclaimer: This article is for informational and educational purposes only. It is not intended as medical advice. The information presented is based on published research and should not be used as a substitute for professional medical guidance. Always consult a qualified healthcare provider before starting any peptide protocol. Some peptides discussed may not be approved for human use by the FDA or equivalent regulatory bodies.