FDA Expansion of Linaclotide for Children 2-5 Years With Functional Constipation

On May 27, 2026, Ironwood Pharmaceuticals' linaclotide (Linzess) received expanded approval from the US Food and Drug Administration (FDA) for pediatric patients aged ≥2 years with functional constipation (FC).

Previously approved for FC in children aged ≥6 years, the expanded indication extends access to linaclotide for children aged 2–5 years with FC. Linaclotide remains the only FDA-approved prescription therapy for pediatric FC.

“Functional constipation is one of the most common conditions we treat, and younger children unfortunately have very limited evidence-based treatment options across multiple disorders and diseases,” Julie Khlevner, MD, a pediatric gastroenterologist at Columbia University Vagelos College of Physicians and Surgeons and an associate professor at Columbia University Medical Center, said in an interview with HCPLive. “This is especially important for functional constipation when dietary changes, behavioral interventions, and over-the-counter laxatives are just not enough.”

FC in pediatric patients accounts for roughly 3% of general pediatric visits and up to 25% of pediatric gastroenterology referrals. Peak incidence occurs between ages 2 and 4 years and affects up to 35% of children aged <6 years.

Linaclotide is a guanylate cyclase-C agonist designed to increase intestinal fluid secretion, accelerate intestinal transit, and decrease the activity of pain-sensing nerves in the intestine.

The FDA approval for children aged 2–5 years was supported by data from a 12-week phase 3 randomized, placebo-controlled clinical trial evaluating linaclotide in pediatric patients with FC. In the study, linaclotide 72 mcg demonstrated improvement in spontaneous bowel movement frequency compared with placebo.

The safety profile of linaclotide observed in the trial was generally consistent with the established safety profile seen in adults with chronic idiopathic constipation and older pediatric patients with FC. Khlevner emphasized the importance of clinicians discussing potential adverse events with patients and caregivers.

“Counseling families on the possible side effects is always important. Caregivers should understand both the expected therapeutic effects and the signs that warrant medical attention. Providing clear guidance on when to contact the healthcare team can help ensure prompt management of any adverse event.”

Editor’s Note: Khlevner reports relevant disclosures with AbbVie and Ironwood.

References

1. Brooks A. FDA Approves Linaclotide (Linzess) for Functional Constipation in Patients 2 Years And Older. HCPLive. Published May 27, 2026. Accessed June 3, 2026. https://www.hcplive.com/view/fda-approves-linaclotide-linzess-for-functional-constipation-in-patients-2-years-and-older

2. Levy EI, Lemmens R, Vandenplas Y, Devreker T. Functional constipation in children: challenges and solutions. Pediatric Health, Medicine and Therapeutics. 2017;8(8):19-27. doi:https://doi.org/10.2147/PHMT.S110940