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# Ironwood Needs Another Apraglutide Trial: FDA
- URL: https://www.fdaweb.com/ironwood-needs-another-apraglutide-trial-fda/
- Published: 2025-04-14T12:00:00.000Z
- Updated: 2026-09-14T14:57:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158999

Ironwood Pharmaceuticals says it will conduct a new Phase 3 clinical trial for its investigational drug apraglutide, following recent discussions with FDA on the drug’s approval path for treating short bowel syndrome with intestinal failure (SBS-IF). FDA is requiring a confirmatory trial after raising concerns with the earlier Phase 3 STARS trial data, the company says, adding that a pharmacokinetic analysis revealed the delivered dose was lower than intended, which prompted the agency action.

Ironwood says Apraglutide is a long-acting, once-weekly synthetic GLP-2 analog aimed at treating rare gastrointestinal conditions, including SBS-IF, which is described as a severe, chronic disorder that impairs nutrient absorption and often necessitates intravenous nutrition support.

In the STARS trial, apraglutide demonstrated a statistically significant reduction in weekly parenteral support volume, according to the company. Long-term extension data showed that 27 patients achieved enteral autonomy, meaning they no longer required intravenous nutrition, a major milestone for those living with SBS-IF, it says.

Ironwood intends to collaborate with FDA on the new trial’s design while continuing to monitor patients in the long-term extension study.