Evaluating linaclotide for the treatment of functional constipation in children and adolescents

INTRODUCTION: Pediatric functional constipation is a highly prevalent disorder associated with significant morbidity and impaired quality of life. Despite widespread use of osmotic and stimulant laxatives, a substantial proportion of children remain symptomatic, highlighting an unmet need for novel therapies. AREAS COVERED: This review provides an overview of the mechanism of action, pharmacokinetics, safety, and clinical efficacy of linaclotide for the treatment of functional constipation in children. Evidence from phase 2 dose-finding studies, a pivotal phase 3 randomized controlled trial, and real-world data is summarized. Prior pediatric experience with other prosecretory and prokinetic agents is discussed to contextualize the current therapeutic landscape. A focused literature review was conducted using PubMed/MEDLINE and regulatory sources (U.S. Food and Drug Administration FDA), prioritizing pediatric clinical trials and observational studies evaluating linaclotide in functional constipation. EXPERT OPINION: Linaclotide may represent a mechanism-based therapeutic option for pediatric patients with functional constipation who remain symptomatic despite optimized conventional therapy. By targeting guanylate cyclase-C - mediated epithelial secretion, linaclotide is associated with improvements in bowel habits and a predominantly gastrointestinal safety profile. However, the pediatric evidence base remains relatively limited, and further studies are needed to define long-term outcomes, predictors of response, and its role within treatment algorithms.