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Apraglutide

EvidenceModerate research

ClassGLP-2 analog

Apraglutide is an investigational once-weekly GLP-2 analog for short bowel syndrome. See how it works, what Phase 3 showed, and where FDA review stands.

Reviewed by: William Maish, MD MBA MPH, Clinical Product Lead
Published: October 5, 2026
Last updated: October 5, 2026

Key takeaway

Apraglutide is an investigational long-acting GLP-2 analog, developed by Ironwood Pharmaceuticals as a once-weekly injection for short bowel syndrome, a condition in which people depend on intravenous nutrition because their intestine cannot absorb enough. In a Phase 3 trial it reduced the need for that intravenous support compared with placebo. As of 2026 it is not approved, and the FDA has asked for an additional confirmatory trial.

At a glance

FDA status	Investigational peptide, not approved by the FDA
What it is	Long-acting GLP-2 analog given as a once-weekly injection for short bowel syndrome
Key trial	Phase 3 trial (STARS) met its primary endpoint, reducing intravenous support
Approval path	FDA has requested an additional confirmatory Phase 3 trial before approval
Evidence strength	Moderate research

What is apraglutide?

Apraglutide is an experimental analog of glucagon-like peptide-2 (GLP-2), a hormone that helps the intestine grow and absorb nutrients. It is designed to last long enough for once-weekly injection and is being developed by Ironwood Pharmaceuticals (development code FE 203799) for short bowel syndrome with intestinal failure, where people rely on long-term intravenous, meaning parenteral, nutrition. It is investigational and not approved.

How does it work?

Apraglutide activates the GLP-2 receptor¹ in the gut. GLP-2 signaling has these effects:

Promotes growth and adaptation of the intestinal lining
Slows how fast the stomach empties and food transits
Increases absorption of fluid and nutrients

In short bowel syndrome, the goal is to help the remaining intestine absorb more so that patients can reduce their dependence on intravenous feeding. This describes the mechanism, separate from the trial outcomes below.

Is it FDA-approved?

No. Apraglutide is investigational and not approved. Ironwood began a rolling submission to the FDA, but according to company disclosures the FDA communicated that an additional confirmatory Phase 3 trial is needed before approval can be sought, and the company also disclosed a drug-exposure issue in the pivotal trial.

What does the research show?

The main evidence is one Phase 3 trial, with a supporting Phase 2 study. According to PubMed, the two studies found:

Study	Phase and population	Result
STARS¹ trial	Phase 3, adults with short bowel syndrome	Met its primary endpoint, with a greater reduction in weekly intravenous support volume on apraglutide than placebo, and more participants achieving at least 1 day per week off intravenous support
Supporting study²	Phase 2	Reported improved absorption and reduced parenteral support over a year

The evidence is from a single pivotal trial that has not been replicated, and the FDA has asked for a confirmatory study.

More for digestive & weight

Sources: the STARS Phase 3 trial (Joly et al., Clinical Gastroenterology and Hepatology, 2026, DOI: 10.1016/j.cgh.2026.08.026¹) and a Phase 2 metabolic-balance study (Verbiest et al., Clinical Nutrition, 2024, DOI: 10.1016/j.clnu.2024.10.011²), both indexed on PubMed; and Ironwood regulatory updates. This document is educational, is not medical advice or a health claim, and is not an offer to sell any product.