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FDA expands LINZESS to pediatric IBS-C patients ages 7 and older

Regulatory / securities filing · FDA

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Site published: 2026-11-03 · Updated: 2026-11-03

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Findings and limitationsIndustry implicationsRelated developments

What changed

FDA approved oral linaclotide for irritable bowel syndrome with constipation in children ages 7 and older. Evidence included extrapolation from adult studies and a 12-week randomized pediatric trial. This gut-acting, disulfide-constrained peptide is not an example of high systemic oral absorption. Diarrhea remains an important adverse reaction, and use in children younger than 2 is contraindicated.

Why it may matter

Illustrates indication expansion for gut-acting peptides while separating local intestinal activity from the delivery requirements of systemically active oral macrocycles.

The interpretation above is analysis, not a conclusion attributed to the original source.

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