Apraglutide: a medicine in development for short bowel syndrome
Clinical review pending
Apraglutide aims to improve absorption in the remaining intestine. Its proposed mechanism, study findings and unanswered questions about its development.
What is apraglutide?
Apraglutide is an experimental analogue of glucagon-like peptide-2, or GLP-2. This hormone promotes intestinal growth and nutrient absorption. The medicine was designed to make a once-weekly injection sufficient. Ironwood Pharmaceuticals is studying it under the development code FE 203799 for short bowel syndrome with intestinal failure. People with this condition depend on long-term intravenous, or parenteral, nutrition. According to the source text, apraglutide remains investigational and is not approved. Source
How does apraglutide work?
Apraglutide activates the GLP-2 receptor in the intestine 1. GLP-2 signaling has several effects:
- It promotes growth and adaptation of the intestinal lining.
- It slows stomach emptying and the movement of food through the gut.
- It increases the absorption of fluid and nutrients.
In short bowel syndrome, these effects are intended to help the remaining intestine absorb more. The aim is to reduce the need for intravenous nutrition. Clinical trials must establish whether this mechanism produces enough benefit in everyday life.
Is apraglutide FDA-approved?
According to the source text, apraglutide remains an unapproved investigational medicine. Ironwood began a rolling submission to the US Food and Drug Administration. Company statements indicate, however, that the agency requested another confirmatory phase 3 trial before an approval application could be made. The company also reported a problem with drug exposure in the pivotal trial.
What do the studies show?
The main evidence comes from a phase 3 trial and a supporting phase 2 study. The publications cited in the source text report the findings summarized in the table below.
The pivotal findings come from a single study and have not yet been independently confirmed. According to the source text, this is why the FDA is requesting another confirmatory study.
Studies at a glance
| Study | Phase and participants | Finding |
|---|---|---|
| STARS trial [1] | Phase 3, adults with short bowel syndrome | The primary endpoint was met: the weekly volume of intravenous support fell more with apraglutide than with placebo. More participants also achieved at least 1 day per week without intravenous support. |
| Supporting study [2] | Phase 2 | Improved absorption and a reduced need for parenteral support were reported over one year. |
References cited in the source text
Sources: the STARS Phase 3 trial (Joly et al., Clinical Gastroenterology and Hepatology, 2026, DOI: 10.1016/j.cgh.2026.08.026 1) and a Phase 2 metabolic-balance study (Verbiest et al., Clinical Nutrition, 2024, DOI: 10.1016/j.clnu.2024.10.011 2), both indexed on PubMed; and Ironwood regulatory updates.
Provenance and editorial review status
Adapted for Nutrient Desk from the source article. The claims and source attributions in the original text still require clinical review. This draft has not been cleared for indexing.