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MAY 27 2026
APPROVED · 65 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 condition characterized by infrequent, hard stools and a frequent feeling of incomplete bowel evacuation. Linzess (linaclotide) is a capsule that works inside the intestine to increase fluid secretion and accelerate bowel movements. This action may help relieve the persistent symptoms of constipation, including straining and abdominal discomfort.

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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