In a landmark move, the U.S. FDA has approved Linzess (linaclotide) for pediatric patients aged 7 years and above with irritable bowel syndrome with constipation (IBS-C) — making it the first-ever therapy approved for children with this condition.
The approval was based on adult efficacy data supported by a 12-week clinical trial in children aged 7–17, which showed significant reductions in abdominal pain and improved bowel movement frequency. Safety outcomes mirrored adult results, with diarrhea being the most common side effect.
The recommended dosage for children is 145 mcg once daily. However, Linzess is not approved for patients under 2 years, due to risks of serious dehydration.
This decision marks a major milestone in pediatric gastroenterology, offering a long-awaited treatment option for families managing IBS-C in children.