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MAY 27 2026
APPROVED · 125 DAYS AGO

Ironwood Pharmaceuticals — Linzess (linaclotide) $IRWD

for Functional constipation

NDA

FDA approved Linzess (linaclotide) for pediatric patients aged 2+ with functional constipation.

About

Functional constipation is a condition in which the bowel moves too slowly or inefficiently, causing fewer than three bowel movements a week, hard stools, straining, a sense of blockage, and incomplete emptying, with no underlying structural cause. Linzess (linaclotide) is a once-daily oral medicine that binds to receptors in the gut lining and delivers a signal that speeds fluid secretion and movement through the intestine. By prompting the bowel to move more regularly, linaclotide may ease the straining and discomfort that make functional constipation so disruptive to daily life.

Pivotal trial

NCT04166058 Phase 3 completed NCT04166058

LIN-MD-66 is a Phase 3 open-label study with 24 weeks (Functional Constipation participants) or 52 weeks (Irritable bowel syndrome with constipation participants) of linaclotide exposure that will enroll pediatric participants (6-17 years of age) with FC or IBS-C who completed study intervention in studies LIN-MD-62, LIN-MD-63, or LIN-MD-64 based on the individual study criteria.

Source: ClinicalTrials.gov

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