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.1,2

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 HCPLive at the 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.

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

"The phase 3 trials looked at two dosages — 145 and 290 micrograms — and both dosages showed promise in terms of efficacy and a fairly good safety profile, very similar to other reported data in functional constipation that we’ve written about in the past," 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.”

Reference:

1. 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
2. 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