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 synthetic analogue of glucagon-like peptide-2 (GLP-2), a hormone made by cells in the lower gut that promotes growth and repair of the intestinal lining. Several amino acids in the natural sequence were swapped to protect the peptide from the enzyme DPP-4 and to make it bind albumin in the blood, giving a half-life long enough for once-weekly injection. 1
It was developed for short bowel syndrome with intestinal failure (SBS-IF), a condition in which so much intestine has been removed or damaged that patients cannot absorb enough nutrients and fluid and depend on parenteral support, meaning nutrition and fluids given into a vein. The approved GLP-2 drug for this condition, teduglutide, requires daily injection. 12
How it works
GLP-2 binds a receptor on cells in the gut wall and triggers release of growth factors that lengthen the intestinal villi, the finger-like projections that absorb nutrients. It also slows gastric emptying, increases intestinal blood flow and reduces secretion. The net effect is a larger absorptive surface and slower transit, so more of what is eaten gets absorbed and less intravenous replacement is needed. Apraglutide activates the same receptor with a longer duration of action than the natural hormone or teduglutide. 1
What human research shows
STARS randomized 163 adults with SBS-IF 2:1 to weekly subcutaneous apraglutide (110 patients) or placebo (53), stratified 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. Participants on apraglutide were more likely to gain at least one day per week off intravenous support (43% versus 27.5%). Seven patients on apraglutide (6.4%) reached complete independence from parenteral support versus none on placebo, a difference that was not statistically significant in the prespecified analysis. 1
The benefit was concentrated in patients with a stoma, where the reduction at week 24 was 25.6% versus 7.8%. Patients with colon in continuity were treated for 48 weeks; their volume reduction (35.4% versus 23.2%), days off support (51.8% versus 44.4%) and enteral autonomy (12.5% versus 7.4%) all favored apraglutide but were not statistically significant, partly because this group responded more to placebo. 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%, 7 of the 9 gained at least one day a week off it, and measured absorption of fluid, energy and carbohydrate rose, along with small-bowel length on MRI. With no control group, these results show what the drug does in the gut rather than proving 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%), and abdominal pain, diarrhea and bloating occurred at similar rates to placebo. Injection-site reactions were reported in about 7% of both arms. 1
GLP-2 analogues promote growth of intestinal tissue, so the class carries a theoretical concern about accelerating growth of polyps or tumours in the gut; STARS included colonoscopy checks, found gut polyps in 3.6% of apraglutide and 3.8% of placebo patients, and recorded no cancers. Apraglutide has been studied in too few patients for too short a time to settle the question, and 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 dependent on parenteral support, but no approval has been granted anywhere. 12
How does apraglutide differ from teduglutide?
Both are GLP-2 analogues for short bowel syndrome. Teduglutide (Gattex) is approved and injected daily. Apraglutide is modified to last longer and is injected once a week. They have not been compared head to head. 1
Did patients get off intravenous nutrition?
A few did. In STARS, 6.4% of patients on apraglutide achieved complete independence from parenteral support at 24 weeks versus none on placebo, and 43% gained at least one day a week off it. The autonomy difference was not statistically significant, and most patients still needed some intravenous support. 1
Who responded best?
Patients with a stoma. In those with the colon still connected, the difference from placebo was smaller and not statistically significant at 24 or 48 weeks, partly because the placebo group in that subgroup also improved. 1