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LINZESS functional-constipation indication expands to children ages 2 and older

Company / institutional announcement · Ironwood Pharmaceuticals

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

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What changed

Ironwood announced FDA approval of linaclotide for functional constipation in children ages 2 and older, extending the previous indication covering ages 6 and older. A 12-week, placebo-controlled Phase 3 trial in children ages 2–5 supported the decision, with improved spontaneous bowel-movement frequency at 72 micrograms. This concerns a gut-acting oral peptide, rather than systemic peptide delivery.

Why it may matter

Shows the importance of age-specific evidence and practical administration for oral peptides; local action remains distinct from achieving systemic exposure.

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

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Oral cyclic peptides

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