At the 2025 North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) Annual Meeting, held November 5-8 at the Sheraton Grand Chicago in Chicago, Illinois, clinicians, researchers, and allied health professionals gathered to share the latest data, clinical updates, and expert perspectives in pediatric gastroenterology, hepatology, and nutrition.
HCPLive provided on-site reporting throughout the meeting, highlighting key findings across oral abstracts, posters, single- topic symposium sessions, and expert-led video interviews.
So far, our coverage has spanned Helicobacter pylori research, new pharmacologic therapies for irritable bowel syndrome with constipation (IBS-C), and long-term outcomes for patients with progressive cholestatic liver diseases. HCPLive will continue to provide coverage and updates fr
Newly-Approved Linaclotide‘s Long-Term Safety Data
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Long-term safety data for linaclotide (Linzess; Ironwood Pharmaceuticals) in pediatric patients aged 7-17 years with IBS-C demonstrated a low incidence of diarrhea and favorable tolerability through 52 weeks of treatment. FDA approval for this population was granted on November 5, 2025, supported by extrapolated adult efficacy data and a 12-week pediatric trial. In an ongoing phase 3 study, 98 patients received once-daily linaclotide at 145 μg or 290 μg, with safety findings consistent with adult studies and no discontinuations due to adverse events.
Click here to watch this discussion of H. pylori.
Highlights from NASPGHAN 2024
Linaclotide FDA Approval for Children with Chronic Constipation
The FDA recently approved linaclotide for the treatment of chronic idiopathic constipation (CIC) in children aged 6-17 years. This approval marks a critically important advancement in pediatric gastroenterology, offering a new therapeutic option for a common and frequently enough debilitating condition. Julie Khlevner provides insights into the implications of this approval.
Click here to watch Julie Khlevner offer thoughts on the linaclotide’s FDA approval.
Discussing Safety, Tolerability of tenapanor in Pediatric IBS-C Patients, with Thomas Wallach, MD
Interim data from the phase 3 R-ALLY trial and its open-label extension showed that tenapanor, a sodium/hydrogen exchanger isoform 3 (NHE3) inhibitor, was safe and well-tolerated in adolescents with IBS-C. Wallach highlighted that no serious treatment-related adverse events occurred and that the safety profile was consistent with adult data. He noted the potential utility of tenapanor in managing pediatric constipation while emphasizing that efficacy data are still under examination.
Click here to watch our full interview with Thomas Wallach, MD.
NASPGHAN 2025: Odevixibat Shows Sustained Pruritus and Bile Acid Improvements in FIC1 Deficiency
Post hoc analyses of PEDFIC 1 and PEDFIC 2 demonstrated that odevixibat provided sustained reductions in serum bile acids and improvements in pruritus in patients with FIC1 deficiency (PFIC1).Among 35 patients, long-term treatment up to 96 weeks maintained clinically meaningful improvements, supporting odevixibat’s
Odevixibat Shows Sustained Improvements in Pruritus, Bile Acid Levels, and Quality of Life for Patients with Cholestatic Liver Diseases
Odevixibat continues to demonstrate significant benefits for patients suffering from cholestatic liver diseases, including progressive familial intrahepatic cholestasis type 3 (PFIC3) due to FIC1 deficiency and Alagille syndrome. Recent data highlights sustained improvements in pruritus (itching), bile acid levels, and overall quality of life with long-term treatment.
Odevixibat Efficacy in FIC1 Deficiency
In patients with FIC1 deficiency, odevixibat treatment has been shown to provide sustained relief from pruritus and improvements in bile acid metabolism. https://www.hcplive.com/view/vixibat-shows-sustained-pruritus-and-bile-acid-improvements-in-fic1-deficiency
Improved Quality of Life and Sleep in Alagille Syndrome
Data from the ASSERT and ASSERT-EXT studies reveal that odevixibat treatment leads to long-term improvements in sleep quality and caregiver-reported quality of life (QoL) for individuals with Alagille syndrome. These improvements were sustained over a 96-week period, encompassing multiple sleep parameters and pediatric Quality of life Inventory scores. https://www.hcplive.com/view/odevixibat-improves-long-term-quality-of-life-sleep-in-patients-with-alagille-syndrome These findings build upon previous data demonstrating odevixibat’s effectiveness in reducing pruritus associated with cholestatic liver disease.