This section highlights FDA-related milestones and regulatory updates for drugs developed by Ironwood Pharmaceuticals (IRWD).
Over the past two years, Ironwood Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
apraglutide, linaclotide, and SBS-IF. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
apraglutide - FDA Regulatory Timeline and Events
apraglutide is a drug developed by Ironwood Pharmaceuticals for the following indication: For patients with short bowel syndrome (SBS) with intestinal failure (IF).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- apraglutide
- Announced Date:
- April 14, 2025
- Indication:
- For patients with short bowel syndrome (SBS) with intestinal failure (IF)
Announcement
Ironwood Pharmaceuticals, Inc announced that, based on a recent discussion with the U.S. Food and Drug Administration (FDA), a confirmatory Phase 3 trial is needed to seek approval of apraglutide for patients with short bowel syndrome (SBS) with intestinal failure (IF) who are dependent on parenteral support.
AI Summary
Ironwood Pharmaceuticals announced that, after a recent discussion with the FDA, a confirmatory Phase 3 trial is required for apraglutide’s approval. Apraglutide is a once‐weekly, long-acting GLP-2 analog designed to help patients with short bowel syndrome and intestinal failure (SBS-IF) who depend on parenteral support. Although the STARS Phase 3 trial showed promising safety and efficacy results, issues with dosing—resulting in lower than expected exposure—led the FDA to request additional confirmatory data before approval can be considered.
The company plans to work with the FDA on the design of this new trial, aiming to build upon the existing data and ensure sufficient evidence for apraglutide’s benefits. Meanwhile, Ironwood is engaging Goldman Sachs to explore strategic alternatives that could maximize value for its stockholders.
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linaclotide - FDA Regulatory Timeline and Events
linaclotide is a drug developed by Ironwood Pharmaceuticals for the following indication: For the treatment of functional constipation in this pediatric population.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- linaclotide
- Announced Date:
- February 27, 2025
- Indication:
- For the treatment of functional constipation in this pediatric population.
Announcement
Ironwood Pharmaceuticals, Inc. announced recent business performance.
AI Summary
Ironwood Pharmaceuticals recently reported encouraging business performance results. In its open-label extension study for apraglutide, data showed that more patients achieved enteral autonomy over time, with 27 patients reaching this important milestone. This positive trend reinforces the company’s confidence in apraglutide, which they are now advancing through the regulatory process. Ironwood has initiated a rolling NDA submission for apraglutide, with plans to complete the process by the third quarter of 2025. Additionally, the company noted an 11% year-over-year growth in LINZESS prescription demand for full-year 2024. Financially, Ironwood posted 2024 revenue of $351 million, a GAAP net income of $2 million, and an adjusted EBITDA of $101 million. These results demonstrate Ironwood’s strategic efforts to streamline operations, enhance clinical development, and position itself for future growth in gastrointestinal therapies.
Read Announcement- Drug:
- linaclotide
- Announced Date:
- September 10, 2024
- Indication:
- For the treatment of functional constipation in this pediatric population.
Announcement
AbbVie announced that Health Canada has approved CONSTELLA® (linaclotide) as a once-daily oral treatment for children and adolescents 6 to 17 years of age with functional constipation.
AI Summary
AbbVie recently announced that Health Canada has approved CONSTELLA® (linaclotide) as a once-daily oral treatment for children and adolescents aged 6 to 17 years with functional constipation. This marks a significant milestone as CONSTELLA is the first and only Health Canada-approved prescription therapy for functional constipation in this age group.
The approval is based on positive Phase 3 clinical trial data, which showed that patients treated with linaclotide (72 mcg) experienced a meaningful increase in the frequency of spontaneous bowel movements. Since functional constipation is a common condition in young patients—often causing pain, discomfort, and challenges in daily activities—this new treatment option is expected to significantly improve quality of life for affected children and offer much-needed relief for their families.
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SBS-IF - FDA Regulatory Timeline and Events
SBS-IF is a drug developed by Ironwood Pharmaceuticals for the following indication: Digestive Disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SBS-IF
- Announced Date:
- May 21, 2024
- Indication:
- Digestive Disease
Announcement
Ironwood Pharmaceuticals, Inc will present late-breaking data during the 2024 Digestive Disease Week® (DDW) meeting from its pivotal Phase III clinical trial, STARS, which evaluated the efficacy and safety of once-weekly subcutaneous apraglutide in adult patients with short bowel syndrome with intestinal failure (SBS-IF).
AI Summary
Ironwood Pharmaceuticals, Inc. will present late-breaking data at the 2024 Digestive Disease Week meeting from its pivotal Phase III STARS trial. This study evaluated the once‐weekly subcutaneous administration of apraglutide in adults with short bowel syndrome with intestinal failure (SBS‑IF). The trial, the largest GLP‑2 study to date, showed significant improvements in the primary endpoint by reducing weekly parenteral support volume in both stoma and colon‑in‑continuity patients compared to placebo. Additional secondary endpoints indicated that more apraglutide‐treated patients achieved extra days off parenteral support and even reached enteral autonomy. Importantly, the findings also supported the safety and tolerability profile of apraglutide. Based on these promising results, Ironwood plans to submit a new drug application to the FDA and pursue approvals with additional regulatory agencies, potentially offering a new treatment option for adults burdened with SBS‑IF.
Read Announcement- Drug:
- SBS-IF
- Announced Date:
- May 1, 2024
- Indication:
- Digestive Disease
Announcement
Ironwood Pharmaceuticals announced today that the company will present new data from studies evaluating apraglutide in adults with short bowel syndrome with intestinal failure (SBS-IF), a condition in which patients are dependent on parenteral support (PS), during the 2024 Digestive Disease Week® (DDW) meeting. DDW is held from May 18-21, 2024, in Washington, D.C.
AI Summary
Ironwood Pharmaceuticals announced that it will present new data from studies evaluating apraglutide in adults with short bowel syndrome with intestinal failure (SBS-IF) at the 2024 Digestive Disease Week® (DDW) meeting. This condition forces patients to rely on parenteral support. The data comes from the pivotal Phase III STARS study, which examines the safety and efficacy of once-weekly apraglutide in reducing parenteral support dependence. The oral presentation is scheduled for May 21, 2024, at 10:30 am ET, during the conference held from May 18-21, 2024, in Washington, D.C. The presentation is part of Ironwood’s broader effort to highlight the potential of apraglutide as a once-weekly treatment option, and the company is preparing to submit a new drug application to the FDA based on these encouraging results.
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