Ironwood Pharma's LINZESS wins FDA approval for functional constipation in children ages 2-5

[출처/시간] Briefing.com - 10:04 AM ET, 05/27/2026

IRWD announced that the U.S. Food and Drug Administration (FDA) has approved the use of LINZESS (linaclotide) in pediatric patients 2 years of age and older with functional constipation (FC). LINZESS was previously approved for pediatric patients 6 years and older with FC. With this expanded indication, LINZESS is now available for children ages 2-5 years with FC and remains the only FDA-approved prescription therapy for pediatric FC.The FDA approval for pediatric patients ages 2-5 was supported by data from a 12-week Phase 3 randomized, placebo-controlled clinical trial evaluating LINZESS in pediatric patients aged 2-5 years with FC. In the study, LINZESS 72 mcg demonstrated improvement in spontaneous bowel movement frequency compared with placebo. The safety profile of LINZESS observed in the trial was generally consistent with the established safety profile from trials in adults with chronic idiopathic constipation (CIC) and older pediatric patients with FC.