Apraglutide
Also known as: FE 203799, Once-weekly GLP-2 analog, VectivBio apraglutide
Key Facts: Apraglutide
- Category
- Healing
- FDA Status
- Not FDA Approved
- Clinical Status
- Investigational, not approved anywhere. Phase 3 STARS met its primary endpoint (2024), but the FDA required a confirmatory trial (April 2025). STARS-2 (NCT07742735) began recruiting June 2026.
- Banned in Sport (WADA)
- Not named on the WADA list, but WADA's S0 catch-all (non-approved substances) covers any substance without human therapeutic approval, which includes apraglutide. Prohibited at all times.
- Administration
- Subcutaneous injection once weekly
- Typical Dose
- 2.5-5 mg once weekly by body weight (trial dose)
- Frequency
- Once weekly
- Duration
- 24-week primary endpoint, with treatment continued to week 48 and beyond in STARS
How does Apraglutide work?
Like teduglutide and glepaglutide, apraglutide activates GLP-2 receptors in the gut, signaling the intestinal lining to grow and absorb more. It was engineered for very low clearance and high plasma protein binding, which gives it a much longer half-life. In rat studies its IV half-life was about 159 minutes versus 19 for teduglutide and 16 for glepaglutide, and it kept more gut-growth activity when dosed less often. That is the basis for once-weekly dosing in humans. Same class caveat as the others: long-term stimulation of gut tissue growth carries a theoretical polyp and tumor risk that requires monitoring.
What does the research show?
STARS (NCT04627025) randomized 164 adults with SBS and intestinal failure 2:1 to weekly apraglutide (2.5 mg or 5 mg by body weight) or placebo. Topline results in February 2024: weekly parenteral support volume fell 25.5% versus 12.5% on placebo at week 24 (p=0.001). In stoma patients the gap was bigger (25.6% vs 7.8%), and 43% vs 27.5% gained at least one day a week off IV support. But the colon-in-continuity endpoints missed, and enteral autonomy at week 48 (12.5% vs 7.4%) was not significant. Discontinuation for side effects was low (3.6% vs 1.9%). While preparing the NDA, Ironwood found exposure in STARS was lower than intended because of dose preparation and administration, and in April 2025 said the FDA required a confirmatory trial. STARS-2 is a 24-week, placebo-controlled trial of about 124 patients (NCT07742735), started June 2026. So: a positive phase 3 on paper, with a dosing problem that undercuts confidence, and no approval in sight before the end of the decade.
What doses have been studied?
Typical Dosingⓘ
Community experience
2.5-5 mg once weekly by body weight (trial dose)
2.5-5 mg once weekly
Once weekly
These are phase 3 trial doses for adults with SBS on IV support, given under specialist supervision. Ironwood itself found the STARS doses delivered less exposure than planned, so even the trial doses are not settled. Not a recommendation.
Research Dosingⓘ
Scientific studies
Trial doses only (no approved dose exists)
Doses from Studies
2.5 mg or 5 mg once weekly by body weight
Phase 3 RCT (trial dose) - STARS, NCT04627025 (DDW 2024 presentation) ↗
Weekly subcutaneous
Company press release - Ironwood STARS topline results, February 2024 ↗
Duration
24-week primary endpoint, with treatment continued to week 48 and beyond in STARS
Administration
Subcutaneous injection once weekly
When and how is Apraglutide taken?
Best Time to Take
Same day each week (trial schedule)
Once weekly subcutaneous injection
Food Recommendation
With or without food
Why This Timing?
Its long half-life is designed for steady weekly dosing. The trials did not tie it to a time of day.
What are the side effects of Apraglutide?
Not everyone experiences these effects. Individual responses vary based on dosage, duration, and personal factors.
- ●Reported as generally well tolerated in STARS (detailed adverse event tables not yet published in full)
- ●Discontinuation for adverse events 3.6% vs 1.9% placebo
- ●Expected GLP-2 class effects: abdominal pain, distension, nausea, injection site reactions, stoma changes
- ●Fluid overload risk as absorption improves (class effect)
- ●Theoretical acceleration of intestinal polyps or tumors (class concern)
References
- https://www.biospace.com/ironwood-pharmaceuticals-announces-positive-topline-results-from-global-phase-iii-trial-of-once-weekly-apraglutide-in-adults-with-short-bowel-syndrome-with-intestinal-failure-sbs-if
- https://conferences.medicom-publishers.com/specialisation/gastroenterology/ddw-2024/stars-apraglutide-shows-efficacy-in-short-bowel-syndrome-with-intestinal-failure
- https://fidelity.com/news/article/investing-ideas/202504141419BENZINGAFULLNGTH44798343
- https://s201.q4cdn.com/848984577/files/doc_financials/2026/q2/v2/Ironwood-Pharmaceuticals-Q22026-Investor-Update-FINAL-08-04-26-PDF.pdf
- https://jpet.aspetjournals.org/content/jpet/373/2/193.full.pdf
Research This Peptide Further
Frequently Asked Questions
What does Apraglutide do?
Apraglutide is a once-weekly GLP-2 analog for short bowel syndrome, originally from VectivBio and now owned by Ironwood Pharmaceuticals. Its phase 3 STARS trial hit its main goal in 2024, but in April 2025 Ironwood said the FDA wanted a confirmatory trial, partly because patients in STARS got less drug exposure than planned due to how doses were prepared and given. That new trial, STARS-2, started in June 2026, so approval is years away (a submission before end of 2029 has been mentioned).
How does Apraglutide work?
Like teduglutide and glepaglutide, apraglutide activates GLP-2 receptors in the gut, signaling the intestinal lining to grow and absorb more. It was engineered for very low clearance and high plasma protein binding, which gives it a much longer half-life. In rat studies its IV half-life was about 159 minutes versus 19 for teduglutide and 16 for glepaglutide, and it kept more gut-growth activity when dosed less often. That is the basis for once-weekly dosing in humans. Same class caveat as the others: long-term stimulation of gut tissue growth carries a theoretical polyp and tumor risk that requires monitoring.
Is Apraglutide FDA approved?
No, Apraglutide is not currently FDA approved. Current status: Investigational, not approved anywhere. Phase 3 STARS met its primary endpoint (2024), but the FDA required a confirmatory trial (April 2025). STARS-2 (NCT07742735) began recruiting June 2026.
Is Apraglutide banned in sport?
Not named on the WADA list, but WADA's S0 catch-all (non-approved substances) covers any substance without human therapeutic approval, which includes apraglutide. Prohibited at all times.
What are the side effects of Apraglutide?
Reported side effects include: Reported as generally well tolerated in STARS (detailed adverse event tables not yet published in full), Discontinuation for adverse events 3.6% vs 1.9% placebo, Expected GLP-2 class effects: abdominal pain, distension, nausea, injection site reactions, stoma changes, Fluid overload risk as absorption improves (class effect), Theoretical acceleration of intestinal polyps or tumors (class concern). Individual responses vary based on dosage, duration, and personal health factors.
What is the typical dose of Apraglutide?
Community-reported common dose: 2.5-5 mg once weekly by body weight (trial dose) (Once weekly). Range: 2.5-5 mg once weekly. Administration: Subcutaneous injection once weekly. Community-reported doses. Not medical advice. Consult healthcare provider.
Related Peptides
Peptides commonly compared with Apraglutide or used in similar applications.
Thymosin Beta-4
Clinical TrialsThymosin beta-4 (Tbeta4) is a small 43 amino acid peptide found in nearly every cell in the body, originally isolated from the thymus. Its main job is binding and sequestering G-actin, the building block of the cell's internal scaffolding, which lets it influence cell movement, wound repair, and tissue regeneration. It is researched heavily for healing of skin, cornea, and heart tissue, but it is not an FDA-approved drug. (The injectable sold as TB-500 is a synthetic fragment marketed as related to Tbeta4, not the full natural peptide.)
HealingB7-33
PreclinicalB7-33 is a 27-amino-acid, single-chain peptide cut down from the B-chain of human relaxin-2, the hormone that loosens tissue during pregnancy. Relaxin itself has strong anti-scarring effects but is a complex two-chain molecule that is hard and expensive to make, so an Australian group (Hossain and colleagues, 2016) designed B7-33 as a simpler version. In rodent models it reduced heart and lung fibrosis about as well as full relaxin. It has never been tested in humans.
HealingGlepaglutide
Clinical TrialsGlepaglutide is Zealand Pharma's long-acting GLP-2 analog for short bowel syndrome, built to be injected once or twice a week instead of daily like teduglutide. Its path has been bumpy. The FDA rejected it in December 2024 because the single phase 3 trial only worked at the twice-weekly dose, but Europe went the other way: in September 2026 the EMA's CHMP recommended approval under the name Zeydovio. As of late October 2026 the final European Commission decision is still pending, and the US needs another trial.
HealingBPC-157
PreclinicalBPC-157 is a synthetic 15-amino-acid peptide (sequence Gly-Glu-Pro-Pro-Pro-Gly-Lys-Pro-Ala-Asp-Asp-Ala-Gly-Leu-Val) based on a fragment of a protective protein found in human gastric juice. It is studied almost entirely in animals for tendon, ligament, gut, and tissue healing, and it has racked up hundreds of preclinical papers. The catch: it is not approved by any regulator for any use, and the human evidence is a handful of small pilot studies, not real clinical proof.
HealingTB-500
PreclinicalTB-500 is a synthetic peptide that copies the active region of thymosin beta-4, a natural protein that controls how cells build and move their internal skeleton. Most TB-500 products reproduce the short LKKTETQ sequence (residues 17 to 23) responsible for binding actin and driving cell migration, which is why it gets marketed for tendon, muscle, and wound repair. Here is the honest part: there are essentially no completed human trials of the TB-500 fragment itself, and almost all the human clinical data is for the full-length thymosin beta-4 molecule, which is related but not the same thing.
HealingPentadecapeptide
PreclinicalPentadecapeptide almost always means BPC-157, a synthetic 15-amino-acid chain (Gly-Glu-Pro-Pro-Pro-Gly-Lys-Pro-Ala-Asp-Asp-Ala-Gly-Leu-Val) derived from a protein found in human gastric juice. It is one of the most hyped 'healing' peptides online, marketed for tendon, gut, and muscle repair, but here is the catch: essentially all of the supporting evidence is from rats and mice. There is no FDA approval and no completed human clinical trial proving it does any of this.
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