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
LINZESS, apraglutide, and linaclotide. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
LINZESS (Linaclotide) FDA Regulatory Events
LINZESS (Linaclotide) is a drug developed by Ironwood Pharmaceuticals for the following indication: Functional constipation (FC) in pediatric patients aged 6-17.
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:
- LINZESS (Linaclotide)
- Announced Date:
- May 27, 2026
- Indication:
- Functional constipation (FC) in pediatric patients aged 6-17
Announcement
Ironwood Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the use of LINZESS® (linaclotide) in pediatric patients 2 years of age and older with functional constipation (FC).
AI Summary
Ironwood Pharmaceuticals says the U.S. Food and Drug Administration has approved LINZESS for children 2 years and older with functional constipation. This expands the medicine’s use to younger children, including ages 2 to 5, who often struggle with hard, painful, and infrequent bowel movements. The company says LINZESS is still the first and only FDA-approved prescription treatment for pediatric functional constipation.
LINZESS 72 mcg is taken once a day and is meant to make treatment more accessible for families. Ironwood noted that functional constipation is a common long-term condition in young children and can affect comfort and daily life. The approval gives doctors another option for managing this problem in pediatric patients.
Read Announcement
Apraglutide FDA Regulatory 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 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.
Read Announcement
