FDA

FDA OKs first drug for pediatric IBS-C

November 7, 2025

FDA approved Linzess (linaclotide) capsules for pediatric patients ≥7 years of age with irritable bowel syndrome with constipation (IBS-C). Linzess is the first treatment approved for IBS-C in pediatric patients.

Linzess had previously been approved for the treatment of:

• IBC-C in adults
• chronic idiopathic constipation in adults
• functional constipation in pediatric patients ≤6 years of age

Efficacy

The efficacy of Linzess for the treatment of IBS-C in pediatric patients 7 to 17 years of age was established in a 12-week double-blind, parallel-group, randomized, multicenter, clinical trial (NCT04026113). A total of 108 patients were randomized to receive treatment with Linzess 145 mcg once daily or a higher than recommended dosage of Linzess. The higher Linzess dosage group didn’t demonstrate additional treatment benefit compared with Linzess 145 mcg once daily. A total of 53 patients who received Linzess 145 mcg once daily were evaluated for efficacy. The evaluated patients had a mean age of 13 years (range, 7-17 years); 57% were female; 34% identified as Hispanic or Latino; 72% identified as White, 25% as Black or African American, and 4% as Asian.

The primary endpoint was the proportion of patients who achieved at least a 30% reduction in abdominal pain and an increase of at least two spontaneous (i.e., naturally occurring) bowel movements per week from baseline for at least 6 weeks of the 12-week treatment period. The efficacy results were consistent with results demonstrated in the adult IBS-C population.

Safety

The most common adverse effect reported in pediatric patients 7 to 17 years with IBS-C was diarrhea. If severe diarrhea occurs, patients should discontinue Linzess and be rehydrated. Patients younger than 2 years can be at risk of serious dehydration and should not take Linzess for any indication, nor should patients with known or suspected mechanical GI obstruction.

Sources:

FDA approves 1st drug for children 7 years and older with irritable bowel syndrome with constipation. [News release]. 2025. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-1st-drug-children-7-years-and-older-irritable-bowel-syndrome-constipation

Linzesse (linaclotide) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/202811s022lbl.pdf Revised November 2025. Accessed November 6, 2025.