BOSTON — May 27, 2026
Ironwood Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for LINZESS® (linaclotide) for the treatment of functional constipation (FC) in pediatric patients 2 years of age and older. The approval extends the use of LINZESS to children aged 2–5 years, making it the first and only FDA-approved prescription therapy for pediatric functional constipation across this broader age range. Previously, the therapy was approved only for pediatric patients aged 6 years and older with FC. The regulatory decision strengthens Ironwood’s gastrointestinal portfolio while addressing a major unmet need in pediatric digestive care, particularly among younger children who often experience persistent constipation despite treatment with over-the-counter therapies.
LINZESS Expands Treatment Options for Young Children
Functional constipation is a chronic gastrointestinal condition characterized by infrequent, painful, or difficult bowel movements. The disorder is especially common among preschool-aged children and can significantly affect quality of life, eating habits, sleep, and emotional well-being. Physicians frequently face challenges treating younger patients because many therapies lack pediatric-specific approval, long-term safety data, or practical administration options suitable for small children.
The FDA approval was supported by results from a 12-week Phase 3 randomized, placebo-controlled clinical trial evaluating LINZESS 72 mcg in pediatric patients aged 2 to 5 years with functional constipation. Clinical findings demonstrated that LINZESS significantly improved spontaneous bowel movement frequency compared with placebo. The therapy also maintained a safety profile generally consistent with previous studies conducted in adults with chronic idiopathic constipation (CIC) and older pediatric patients with functional constipation.
Experts in pediatric gastroenterology highlighted the importance of the approval for clinicians and families managing chronic constipation in younger children. The ability to administer LINZESS by mixing capsule contents with applesauce or water may improve treatment adherence and provide greater flexibility for caregivers struggling with medication administration in preschool-aged patients.
Advertisement
FDA Approval Strengthens LINZESS Market Leadership
Since its launch in 2012, LINZESS has become one of the leading prescription gastrointestinal therapies in the United States, with more than 5.5 million unique patients treated. The drug currently holds a dominant position in the prescription treatment market for irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC).
LINZESS works through activation of the guanylate cyclase-C (GC-C) receptor in the intestine, increasing intestinal fluid secretion and accelerating gastrointestinal transit. Unlike traditional laxatives, the therapy is classified as a GC-C agonist and is designed to target the underlying mechanisms associated with constipation and bowel dysfunction.
The newly approved pediatric indication further expands the commercial reach of LINZESS and reinforces its importance within the growing gastrointestinal therapeutics market. Ironwood executives described the approval as a natural progression for the brand, building on its established efficacy and safety profile while extending treatment access to an underserved pediatric population.
Ironwood Continues Expanding GI Disease Portfolio
Ironwood Pharmaceuticals continues focusing on gastrointestinal and rare disease innovation, with LINZESS remaining a cornerstone product within its commercial portfolio. The company co-develops and co-commercializes LINZESS in the United States alongside AbbVie and maintains additional international partnerships with Astellas Pharma and AstraZeneca for global commercialization efforts.
In addition to LINZESS, Ironwood is advancing new gastrointestinal and rare disease therapies including apraglutide, a long-acting GLP-2 analog under development for short bowel syndrome. With the expanded FDA approval for pediatric functional constipation, Ironwood strengthens its position in the GI therapeutics sector while continuing to expand evidence-based treatment options for both adult and pediatric patients.
Source: Ironwood Pharmaceuticals press release
