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Company also explores strategic options with Goldman Sachs amid regulatory hurdles  Ironwood Pharmaceuticals, a U.S.-based biotechnology firm, announced it will initiate a confirmatory Phase 3 trial for its investigational drug, apraglutide, following recent discussions with the U.S. Food and Drug Administration (FDA). The trial is a necessary step for the company to seek regulatory approval of apraglutide for patients with short bowel syndrome with intestinal failure (SBS-IF) who rely on parenteral support. 

Apraglutide, a once-weekly, long-acting GLP-2 analog, is designed to improve the lives of patients suffering from rare gastrointestinal disorders. It is the only GLP-2 analog so far to demonstrate a statistically significant reduction in parenteral support volume with weekly dosing in patients with SBS-IF—a condition that requires long-term nutritional support due to insufficient functional small intestine. 

The decision to conduct another Phase 3 trial stems from pharmacokinetic data revealing that drug exposure in the initial STARS Phase 3 trial was lower than intended due to challenges in dose preparation and administration. Despite strong safety and efficacy outcomes, the FDA has indicated that a confirmatory study is required before it can consider an approval.  Ironwood says it plans to collaborate closely with the FDA on designing the new trial while continuing to gather data from its ongoing long-term extension study. The company emphasized that findings from the STARS trial will remain a cornerstone of the eventual New Drug Application (NDA). 

“We are disappointed in this outcome, as we firmly believe apraglutide has the potential to provide tremendous value to patients with SBS-IF, who suffer from increased mortality and reduced quality of life,” said Ironwood CEO Tom McCourt. “However, we remain committed to advancing this important therapy and believe it still holds blockbuster potential.”  In parallel, Ironwood has engaged Goldman Sachs to explore strategic alternatives aimed at maximizing value for shareholders. While specifics were not disclosed, such strategies often include mergers, acquisitions, or asset divestitures. 

Apraglutide's potential was underscored by the STARS trial, the largest clinical study conducted to date in SBS-IF. In the long-term extension phase, 27 patients treated with apraglutide achieved enteral autonomy—meaning they were able to discontinue parenteral support entirely. This milestone represents a transformative outcome for patients facing lifelong dependence on intravenous nutrition. 

A Challenging Condition Short bowel syndrome with intestinal failure is a debilitating condition caused by the loss or dysfunction of a significant portion of the small intestine, usually due to surgical resection. Patients often require daily parenteral nutrition infusions, sometimes lasting 10 to 15 hours, leading to heightened risks of infection, organ damage, and reduced quality of life. An estimated 18,000 adults in the U.S., Europe, and Japan suffer from chronic SBS-IF. 

Ironwood’s Broader Pipeline Alongside apraglutide, Ironwood is known for developing LINZESS® (linaclotide), the market-leading prescription treatment in the U.S. for adults with irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC). LINZESS is also approved for pediatric use in functional constipation.  Founded in 1998 and headquartered in Boston, Ironwood continues to focus its research and commercialization efforts on high-need gastrointestinal and rare diseases, keeping patients at the center of its innovation strategy.