Is Apraglutide legal in the US?
No. It is not approved, and a second phase 3 trial is under way.
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.
No. It has finished one phase 3 trial in adults with short bowel syndrome who depend on parenteral support. No regulator has approved it anywhere. Ironwood did not file an application after that trial, and a second phase 3 trial started in August 2026. 123
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Citations
- Joly 2026, Clinical Gastroenterology and Hepatology: STARS phase 3 trial of once-weekly apraglutide in SBS-IF doi.org
- Verbiest 2024, Clinical Nutrition: open-label phase 2 metabolic balance study of apraglutide in SBS-IF with colon-in-continuity doi.org
- ClinicalTrials.gov: NCT07742735, second phase 3 trial of apraglutide clinicaltrials.gov
Reference information only, not medical advice. Drawn from the Apraglutide article, fact-checked against the cited sources. No dosing anywhere on this site.