FDA Approves Linaclotide (Linzess) for Functional Constipation in Patients 2 Years And Older

The US Food and Drug Administration has approved Ironwood Pharmaceuticals’ linaclotide (Linzess) for pediatric patients ≥ 2 years of age with functional constipation (FC), expanding its previous approval for patients ≥ 6 years of age with FC.

With this expanded indication, linaclotide is now available for children ages 2-5 years with FC and remains the only FDA-approved prescription therapy for pediatric FC.

“Managing functional constipation in young children is especially challenging, as this vulnerable patient population often continues to experience persistent symptoms despite treatment with over-the-counter therapies,” Julie Khlevner, MD, a pediatric gastroenterologist at Columbia University Vagelos College of Physicians and Surgeons, said in a statement. “Clinicians must carefully balance safety, efficacy and the practical realities of what treatments young children are able and willing to take consistently. The availability of an FDA-approved therapy with an established safety profile expands evidence-based treatment options and may support a more tailored therapeutic approach for children aged 2-5 years. Parents can mix the contents of the [linaclotide] capsule with applesauce or water, providing flexibility for administration in young children.”

A guanylate cyclase C agonist, linaclotide increases intestinal fluid secretion, accelerates transit, and decreases the activity of pain-sensing nerves in the intestine. Its initial FDA approval dates back to 2012 for the treatment of chronic idiopathic constipation and IBS-C in adults.

In November 2025, the FDA approved linaclotide for pediatric patients ≥ 7 years of age with IBS-C, making it the first treatment approved for IBS-C in this patient population. The approval for this indication was supported by extrapolation of efficacy from adequate and well-controlled studies in adults and a 12-week double-blind, randomized, parallel-group trial in pediatric patients 7-17 years of age who met modified Rome III criteria for child/adolescent IBS-C.

Now, the Agency has approved linaclotide for use in pediatric patients 2 years of age and older with FC, supported by data from a 12-week phase 3 randomized, placebo-controlled clinical trial evaluating linaclotide in pediatric patients aged 2-5 years 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 from trials in adults with CIC and older pediatric patients with FC.

“This approval extends the use of [linaclotide] to younger patients with functional constipation, addressing an important gap in care for this historically underserved population, as reflected by the FDA’s decision to grant priority review,” said Tom McCourt, chief executive officer of Ironwood. “We see this as a natural progression for [linaclotide] that builds on a well-established safety and efficacy profile to expand the impact of our blockbuster medication in GI care.”

References

1. Ironwood Pharmaceuticals. FDA Approves Use of LINZESS® (linaclotide) in Pediatric Patients Two Years of Age and Older with Functional Constipation (FC). May 27, 2026. Accessed May 27, 2026. https://investor.ironwoodpharma.com/press-releases/press-release-details/2026/FDA-Approves-Use-of-LINZESS-linaclotide-in-Pediatric-Patients-Two-Years-of-Age-and-Older-with-Functional-Constipation-FC/default.aspx
2. Brooks A. FDA Approves Linaclotide (Linzess) Capsules for Pediatric IBS-C. HCPLive. November 5, 2025. Accessed May 27, 2026. https://www.hcplive.com/view/fda-approves-linaclotide-linzess-capsules-for-pediatric-ibs-c