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MAY 27 2026
APPROVED · 7 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 chronic digestive condition where bowel movements become infrequent, difficult, or painful, often causing bloating and discomfort without an underlying medical cause. Linzess (linaclotide) is a peptide that activates receptors in the gut lining, increasing fluid secretion and speeding up intestinal movement. This action may help relieve constipation by softening stools and promoting more regular bowel movements in patients struggling with the condition.

Pivotal trial

NCT04026113 Phase 3 completed NCT04026113

The objective of LIN-MD-64 is to evaluate the safety and efficacy of 12 weeks of linaclotide therapy (72 μg daily) in comparison with placebo in pediatric participants, 6 to 17 years of age, who fulfill modified Rome III Criteria for child/adolescent FC. The objective of LIN-MD-64 is to evaluate the safety and efficacy of 12 weeks of linaclotide therapy (145 μg or 290 μg daily) in pediatric participants 7 to 17 years of age, who fulfill the Rome III criteria for child/adolescent IBS and modif...

Source: ClinicalTrials.gov

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