At NASPGHAN 2025, investigators presented 52-week safety data from an ongoing phase 3 trial of linaclotide, the first approved treatment for patients aged 7 and older with IBS-C.
Among pediatric patients aged 7 to 17 years, newly-approved linaclotide (Linzess; Ironwood Pharmaceuticals) for irritable bowel syndrome with constipation (IBS-C) was well tolerated with a low incidence of diarrhea, according to 52-week data presented at the 2025 North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) Annual Meeting in Chicago, Illinois.1,2
Approval was granted to linaclotide by the FDA on November 5, 2025, making it the first FDA-approved treatment for patients 7 years and older with IBS-C.
According to a November 5, 2025, release from the FDA, the approval for pediatric IBS-C was supported by extrapolation of efficacy from adequate and well-controlled studies in adults and a 12-week double-blind, randomized, parallel-group trial in pediatric patients 7-17 years of age who met modified Rome III criteria for child/adolescent IBS-C. The recommended dosage for this indication is 145 mcg orally once daily.1
In the trial, the primary endpoint was the proportion of patients who achieved ≥ 30% reduction in abdominal pain and an increase of ≥ 2 spontaneous bowel movements per week from baseline for ≥ 6 weeks of the 12-week treatment period. Of note, the efficacy results were consistent with results demonstrated in the adult IBS-C population.1
According to a release from the Agency, the safety of linaclotide in these clinical studies was similar in adult and pediatric patients. The most common side effect reported in pediatric patients 7-17 years of age with IBS-C was diarrhea.
Longer-term data were presented at the 2025 NASPGHAN Annual Meeting, demonstrating similar findings with the known safety profile. Data from the abstract "Long-term Safety of Linaclotide in Treating Pediatric Patients Aged 7-17 years with Irritable Bowel Syndrome with Constipation: Interim Results from a Phase 3 Study," are from an ongoing phase 3 trial (NCT04166058).
The trial assesses once-daily linaclotide for 52 weeks among patients aged 7 to 17 years weighing ≥18 kg who met modified Rome III criteria for pediatric IBS-C and had completed the treatment period in studies NCT02559817 or NCT04026113.
"NCT02559817 completers received open-label linaclotide 290 μg, except for those who had received linaclotide ≤145 μg or placebo, who had the option to receive open-label linaclotide 145 μg. NCT04026113 completers had the option to remain on the same blinded linaclotide dose or to receive open-label linaclotide 290 μg," wrote the study authors, led by Miguel Saps, MD, Pediatric Gastroenterology, University of Miami Health System.3
In all, 98 patients with IBS-C were enrolled, with 22 patients receiving linaclotide 145 μg and 76 receiving linaclotide 290 μg. Median age of those enrolled was 14 years, of which 61.2% were female and 71.4% were White.1
There were 34 patients who had treatment-emergent adverse events (TEAEs) and 10 patients who had treatment-related TEAEs. Incidence of diarrhea as a TEAE was low (6.1%) according to the study authors. Eighteen patients discontinued treatment, with "withdrawal by patient" being the most common reason (11 of 18). No patients discontinued treatment owing to TEAEs.
"In pediatric patients aged 7–17 years with IBS-C, linaclotide was well tolerated, with findings consistent with the known safety profile," the study authors concluded.
This article was originally published by our sister publication HCP Live.
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