▼SetbackUS8 Apr 20251 min read
Ironwood told to run another trial before filing apraglutide
Despite a phase 3 trial that met its main endpoint, the FDA said a confirmatory study would be needed for a weekly GLP-2 in short bowel syndrome.
Holds at Phase 3 A rejection, a miss or a delay that pushes patients further away.
The readA trial can hit its endpoint and still not be enough. When a regulator questions how a result was measured, the fix is time and money, not a better press release.
What changed
Ironwood said that, after discussions with the FDA, a confirmatory phase 3 trial would be needed to support a US application for apraglutide in short bowel syndrome with intestinal failure (SBS-IF). The company had hoped to file on the strength of STARS, a phase 3 trial that met its primary endpoint on reduced need for intravenous nutrition. The share price fell sharply.
The background
Short bowel syndrome follows surgery that removes much of the small intestine. Many patients depend on parenteral support, nutrition and fluids given into a vein for several nights a week. GLP-2 makes the gut lining grow and absorb more. Teduglutide, a daily GLP-2 analog, has been approved for years; apraglutide and glepaglutide are weekly or twice-weekly attempts to improve on it.
Reading the setback
Ironwood’s statement pointed to questions about how the primary endpoint data were handled. We have not seen the FDA’s own reasoning, and companies summarise such meetings in their own words. Check the original statement for the exact language.
- Stage stays at phase 3; signal down because the filing moved back by years.
- Both weekly GLP-2 programmes on the board now face extra trials.
The design and size of the confirmatory trial, and whether Ironwood funds it alone.
Primary sourceIronwood Pharmaceuticals statement after FDA feedback, 2025
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