Digestive & weight GLP-2 analog
Apraglutide
Regulatory status
Status at a glance
503A compounding status
Not nominated
We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.
- FDA approval
- Not FDA-approved for any use
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- Not on the WADA Prohibited List
- DEA schedule
- Not a controlled substance
About peptide status
Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.
This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.
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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
Summary
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.
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 receptor 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?
Safety note
Status: Investigational peptide, not approved by the FDA
Category: In clinical trials · Primary body area: Digestive & weight
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?
Editor’s note
Evidence strength: Moderate research (2 human · 0 animal/cell studies)
It has one adequately powered, positive Phase 3 trial supported by Phase 2 data, but the result is from a single unreplicated trial, and the FDA has required a confirmatory trial.
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 |
|---|---|---|
| STARS 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 study | 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.
Sources: the STARS Phase 3 trial (Joly et al., Clinical Gastroenterology and Hepatology, 2026, DOI: 10.1016/j.cgh.2026.08.026) and a Phase 2 metabolic-balance study (Verbiest et al., Clinical Nutrition, 2024, DOI: 10.1016/j.clnu.2024.10.011), 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.
Registered human trials
2 registered human trials on ClinicalTrials.gov that we reviewed
Sources
- [1]
- [2]
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