Written By: Pharmacally Medical News Desk
The US Food and Drug Administration (FDA) has granted approval for Linzess (linaclotide) to treat irritable bowel syndrome with constipation (IBS-C) in children aged 7 years and older, making it the first-ever FDA-approved medication for pediatric IBS-C. This approval represents a major advancement for children suffering from chronic abdominal pain and constipation. Linzess is co-marketed by Ironwood Pharmaceuticals and AbbVie, which jointly hold the marketing authorization for this pharmaceutical innovation.
Clinical Studies
Linzess’s pediatric approval is based on a pivotal 12-week, double-blind, randomized, parallel-group Phase 3 trial (NCT04026113) involving children aged 7 to 17 years who met modified Rome III criteria for IBS-C. The trial’s primary endpoint was a composite of at least a 30% reduction in abdominal pain and at least two additional spontaneous bowel movements per week from baseline, sustained for at least six weeks of the 12-week study period. Results showed that those treated with linaclotide experienced clinically significant improvements in bowel movement frequency and abdominal pain, outcomes consistent with adult populations. The recommended pediatric dose is 145 mcg orally once daily.
Safety Profile in Pediatrics
The safety profile of linaclotide in children is similar that in adults, with diarrhea most commonly reported as an adverse event. Severe diarrhea may require discontinuation of treatment and rehydration. Linaclotide is contraindicated for children under 2 years and those with mechanical gastrointestinal obstruction due to the risk of serious dehydration and complications. No new safety concerns emerged in pediatric studies, confirming linaclotide’s tolerability in this age group.
About Linzess
Linzess contains the active ingredient linaclotide, a peptide that acts as a guanylate cyclase-C (GC-C) agonist within the intestinal epithelium. By activating GC-C, linaclotide increases cyclic guanosine monophosphate (cGMP), promoting secretion of electrolytes and water into the intestinal lumen through CFTR channels. This mechanism increases intestinal fluid, softens stool, accelerates transit, and decreases pain signals in the gut. Systemic exposure is negligible due to localized action in the GI tract.
About IBS-C in Pediatrics
Irritable bowel syndrome with constipation (IBS-C) is a chronic gastrointestinal disorder affecting both children and adults, presenting with abdominal pain, bloating, and infrequent, hard-to-pass stools. The condition can significantly impair quality of life, school attendance, and emotional wellbeing. There is no clear organic cause, with stress, diet, and gut motility playing key roles in disease onset.
Key Opinions
Julie Khlevner, MD, AGAF, indicated that this approval addresses a substantial treatment gap for children and families, affirming the importance of having new, evidence-based treatment options for young patients. Medical professionals anticipate improved quality of life and symptom relief for affected children.
References
FDA approves 1st drug for children 7 years and older with irritable bowel syndrome with constipation, 05 Nov 2025, US FDA, https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-1st-drug-children-7-years-and-older-irritable-bowel-syndrome-constipation
Linaclotide Safety and Efficacy in Pediatric Participants, 6 to 17 Years of Age, With Irritable Bowel Syndrome with Constipation (IBS-C) or Functional Constipation (FC), ClinicalTrials.gov ID NCT04026113, https://www.clinicaltrials.gov/study/NCT04026113
Di Lorenzo C, Efficacy and safety of linaclotide in treating functional constipation in paediatric patients: a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial. Lancet Gastroenterol Hepatol. 2024 Mar;9(3):238-250. Doi: 10.1016/S2468-1253(23)00398-9. Epub 2024 Jan 8. PMID: 38211604.
Julie Khlevner, MD, AGAF, Reacts to the FDA Approval of Linaclotide for Pediatric IBS-C, 07 November 2025, HCP Live, https://join.hcplive.com/view/julie-khlevner-md-agaf-reacts-to-the-fda-approval-of-linaclotide-for-pediatric-ibs-c#:~:text=Beyond%20bowel%20movement%20frequency%2C%20linaclotide,as%20well%2C%E2%80%9D%20said%20Khlevner.