Julie Khlevner, MD, AGAFAssociate Professor of Pediatrics at Columbia University Medical CenterChair, NASPGHAN Neurogastroenterology and Motility Committee. 

Julie Khlevner, MD, AGAF

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

On May 27, 2026, Ironwood Pharmaceuticals' linaclotide (Linzess)

 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 

. “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.

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

Levy EI, Lemmens R, Vandenplas Y, Devreker T. Functional constipation in children: challenges and solutions. 

Pediatric Health, Medicine and Therapeutics

Videos

Khlevner, MD, discusses the expanded FDA approval of linaclotide for children aged ≥2 years with functional constipation.

Julie Khlevner, MD, AGAF, highlights that FDA approval of linaclotide provides the first pharmacologic therapy for pediatric IBS-C

Julie Khlevner, MD, AGAF, reacts to the FDA approval of linaclotide for pediatric IBS-C

Pediatric gastroenterologists now have a newly approved treatment option for children and adolescents with irritable bowel syndrome with constipation (IBS-C) following the 

FDA’s recent approval of linaclotide (Linzess) capsules for patients ≥7 years of age

. This approval marks the first pharmacologic therapy for IBS-C in this population, expanding on linaclotide’s prior approvals for chronic idiopathic constipation and functional constipation in children.

Julie Khlevner, MD, AGAF, Associate Professor of Pediatrics at Columbia University Medical Center; Chair, NASPGHAN Neurogastroenterology and Motility Committee, discussed news of the approval with 

2025 North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN)

, describing the approval as “Exciting! We have been looking for treatment options for these patients for a really long time, so it’s nice to have an FDA approval in the pharmacological space at this time."

Approval was supported by extrapolation of efficacy from adult studies and a 12-week pediatric trial in patients 7–17 years old who met modified Rome III criteria. The recommended pediatric dosage is 145 mcg orally once daily. The trial’s primary endpoint assessed combined reductions in abdominal pain and increased spontaneous bowel movements, demonstrating improvements consistent with the adult IBS-C population. Safety profiles in pediatric studies mirrored those in adults, with diarrhea being the most commonly reported side effect. 

NASPGHAN 2025: Newly-Approved Linaclotide's Long-Term Safety Data

"In a phase 3 study, pediatric patients with IBS-C, aged 7–17 years, a once-daily treatment with linaclotide 145 μg or 290 μg demonstrated improvement in IBS-C symptoms from baseline. Linaclotide was well tolerated, with a safety profile consistent with that observed in prior pediatric and adult studies," added Khlevner. “And this isn’t just for use by pediatric gastroenterologists — it could be prescribed by pediatricians as well. The more people know that there are options and can utilize them readily, the better off I think our patients will be.” 

Beyond bowel movement frequency, linaclotide may relieve abdominal pain, a hallmark symptom of IBS-C.

“It can help with pain, which is a significant symptom in IBS patients, but also increase stool frequency and improve consistency as well,” said Khlevner. She also emphasized the need for continued research in pediatric therapeutics, stating, “I think the space still requires other therapeutics to be looked into, and we look forward to finding those and treating our patients in a very individualized, multidisciplinary way, utilizing whatever we have to improve their symptomatology and quality of life.” 

Editor's note: Julie Khlevner, MD, AGAF, discloses the following related to the topic of discussion: Consultant: AbbVie/Ironwood Pharmaceuticals 

Brooks A. FDA Approves Linaclotide (Linzess) Capsules for Pediatric IBS-C. HCPLive. Published November 5, 2025. Accessed November 6, 2025. https://www.hcplive.com/view/fda-approves-linaclotide-linzess-capsules-for-pediatric-ibs-c 

US Food and Drug Administration. FDA approves 1st drug for children 7 years and older with irritable bowel syndrome with constipation. November 5, 2025. Accessed November 5, 2025. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-1st-drug-children-7-years-and-older-irritable-bowel-syndrome-constipation 

Julie Khlevner, MD, AGAF, highlights that FDA approval of linaclotide provides the first pharmacologic therapy for pediatric IBS-C.

Julie Khlevner, MD, AGAF

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