Apraglutide
GLP-2 analog
Also FE 203799, FE203799
- Evidence
- BSome human evidence
- FDA status
- In clinical trialsas of 2026-10-27
- Route
- Injection
- Studies cited
- 2 human0 animal or cell
It is a weekly shot being tested for people with short bowel syndrome who need feeding through a vein. One trial of 163 people showed a modest benefit, and it is not yet approved.
Sold for
Apraglutide is discussed as a once-weekly alternative to daily teduglutide for people with short bowel syndrome who depend on intravenous feeding.
Studies say
One 163-patient randomized trial showed a larger reduction in weekly intravenous nutrition volume than placebo over 24 weeks, with a clear effect in patients with a stoma and a non-significant one in those with colon in continuity (grade B).
Why grade B. The main evidence is STARS, a randomized, double-blind, placebo-controlled phase 3 trial in 163 adults with short bowel syndrome dependent on intravenous nutrition, which met its primary endpoint on a surrogate measure (volume of parenteral support); a 9-patient open-label phase 2 study adds absorption data. One phase 3 trial with a surrogate endpoint, a non-significant result in patients with colon in continuity, and no approval yet is grade B. 12
FDA. Apraglutide is an investigational GLP-2 analogue developed by VectivBio and now owned by Ironwood Pharmaceuticals, and is not approved by the FDA or any other regulator. Ironwood did not file a new drug application after the phase 3 STARS trial; a second placebo-controlled phase 3 trial in short bowel syndrome with intestinal failure started in August 2026 and is recruiting, with primary completion expected in October 2028.
Written from 2 cited sources. Fact-checked 2026-10-27: 20 claims checked, 12 corrected. Last refreshed 2026-10-27. Not physician reviewed.
What this means for you
- What people take it for
- Cutting the need for IV feeding in short bowel syndrome
- Can a US doctor prescribe it?
- Not yet; it is still in trials.
- Properly tested in people?
- Partly: some human trials, with gaps. One trial of 163 adults.
Evidence checklist
- Randomised controlled trial STARS phase 3, placebo-controlledyes
- Human study over 100 people STARS, 163 adultsyes
- More than one research group One phase 3 trial; no second group citedno information
- Clinical outcomes, not surrogate markers Surrogate: volume of intravenous nutritionno
- Human safety data beyond case reports Dropout 3.6% vs 1.9% on placebo; polyp concern openyes
Drawn from the cited studies below. A dash means the sources give no information.
What it is
Apraglutide is a lab-made version of glucagon-like peptide-2 (GLP-2). GLP-2 is a hormone made by cells in the lower gut. It helps the intestinal lining grow and repair. Chemists swapped several amino acids in the natural sequence. The changes protect the peptide from the enzyme DPP-4 and let it bind albumin in the blood. The result lasts long enough for one injection a week. 1
Apraglutide was developed for short bowel syndrome with intestinal failure (SBS-IF). In this condition, so much intestine has been removed or damaged that patients cannot absorb enough nutrients and fluid. They depend on parenteral support, which means nutrition and fluids given into a vein. The approved GLP-2 drug for this condition, teduglutide, needs a daily injection. 12
How it works
GLP-2 binds a receptor on cells in the gut wall. This triggers growth factors that lengthen the villi, the finger-like projections that absorb nutrients. GLP-2 also slows gastric emptying, increases blood flow in the gut and reduces secretion. The gut ends up with more surface for absorbing food, and food moves through more slowly. So the body absorbs more of what is eaten and needs less replacement through a vein. Apraglutide activates the same receptor but acts longer than the natural hormone or teduglutide. 1
What human research shows
In the STARS trial, researchers randomized 163 adults with SBS-IF 2:1 to weekly apraglutide injected under the skin (110 patients) or placebo (53). They split patients by whether they had a stoma (80 patients) or colon in continuity (83). At week 24, weekly parenteral support volume had fallen 25.5% with apraglutide versus 12.5% with placebo. Patients on apraglutide were more likely to gain at least one day a week off intravenous support (43% versus 27.5%). Seven patients on apraglutide (6.4%) became fully independent of parenteral support, versus none on placebo. That difference was not statistically significant in the prespecified analysis. 1
The benefit was concentrated in patients with a stoma. Their reduction at week 24 was 25.6% versus 7.8%. Patients with colon in continuity were treated for 48 weeks. Their results all favored apraglutide but were not statistically significant. Volume fell 35.4% versus 23.2%, days off support rose 51.8% versus 44.4%, and enteral autonomy reached 12.5% versus 7.4%. This group also responded more to placebo, which partly explains the gap. 1
Before STARS, an open-label phase 2 study gave apraglutide for 52 weeks to 9 adults with SBS-IF and colon in continuity. Parenteral support volume fell by 52%. Seven of the 9 gained at least one day a week off support. Measured absorption of fluid, energy and carbohydrate rose, and so did small-bowel length on MRI. The study had no control group. So these results show what the drug does in the gut, and they do not prove benefit. 2
| Study | Model | Finding |
|---|---|---|
| STARS phase 3 (Joly 2026) | Humans, n=163 adults with SBS-IF, randomized 2:1 double-blind placebo-controlled, 24 weeks (48 weeks for colon-in-continuity) | Weekly parenteral support volume fell 25.5% with apraglutide versus 12.5% with placebo; 6.4% reached enteral autonomy versus 0%, not statistically significant. 1 |
| STARS stoma and colon subgroups | Humans, prespecified subgroups of STARS | Stoma patients: 25.6% versus 7.8% reduction at week 24; colon-in-continuity patients: 35.4% versus 23.2% at week 48, not significant. 1 |
| Phase 2 metabolic balance study (Verbiest 2024) | Humans, n=9 adults with SBS-IF and colon in continuity, open-label, 52 weeks | Parenteral support volume fell 52% and intestinal absorption and small-bowel length increased. 2 |
Safety
In STARS, 2.7% of patients on apraglutide and 1.9% on placebo stopped treatment because of adverse events. The most frequent adverse events on apraglutide were nausea (13.6%), headache (12.7%) and central catheter infections (12.7%). Abdominal pain, diarrhea and bloating occurred at similar rates to placebo. About 7% of patients in both arms had injection-site reactions. 1
GLP-2 analogues promote growth of gut tissue. So the whole class carries a theoretical concern that polyps or tumours could grow faster in the gut. STARS included colonoscopy checks. They found gut polyps in 3.6% of apraglutide patients and 3.8% of placebo patients, and no cancers. Too few patients have taken apraglutide for too short a time to settle the question. Long-term safety data do not exist. 1
Questions for your clinician
- Is there a second trial confirming the nutrition-volume result?
- Would a colonoscopy be needed before or during treatment with this drug class?
- Is it available through a trial or access programme for short bowel syndrome?
Questions people ask
Is apraglutide FDA-approved?
No. It has completed a phase 3 trial in adults with short bowel syndrome who depend on parenteral support. No regulator has approved it anywhere. 12
How does apraglutide differ from teduglutide?
Both are GLP-2 analogues for short bowel syndrome. Teduglutide (Gattex) is approved and is injected daily. Apraglutide is modified to last longer, so it is injected once a week. No one has compared them head to head. 1
Did patients get off intravenous nutrition?
A few did. In STARS, 6.4% of patients on apraglutide became fully independent of parenteral support at 24 weeks, versus none on placebo. And 43% gained at least one day a week off it. The difference in independence was not statistically significant. Most patients still needed some intravenous support. 1
Who responded best?
Patients with a stoma. In patients who still had the colon connected, the difference from placebo was smaller. It was not statistically significant at 24 or 48 weeks. The placebo group in that subgroup also improved, which partly explains it. 1