Ardelyx Presents Data Supporting IBSRELA® (tenapanor) at Digestive Disease Week 2025 Conference

Core Insights - Ardelyx, Inc. presented data on IBSRELA (tenapanor) and findings from the IBS in America 2024 Real-World Survey at the Digestive Disease Week Conference, highlighting the correlation between IBS-C symptom severity and financial hardship [1][2] Company Overview - Ardelyx, Inc. is a biopharmaceutical company focused on developing innovative medicines to address significant unmet medical needs, with two commercial products approved in the U.S.: IBSRELA and XPHOZAH [13] Product Information - IBSRELA (tenapanor) is approved by the FDA for treating irritable bowel syndrome with constipation (IBS-C) in adults, acting as a sodium/hydrogen exchanger 3 (NHE3) inhibitor to improve intestinal transit and stool consistency [1][6][12] - The drug has shown efficacy in reducing abdominal pain and improving gastrointestinal symptoms in clinical studies [6] Survey Findings - The IBS in America 2024 Real-World Survey revealed that higher severity of IBS-C symptoms is linked to increased financial burden, assessed using the Functional Assessment of Chronic Illness Therapy Measure of Financial Toxicity (FACIT-COST®) [2] - The survey utilized Patient-Reported Outcomes Measurement Information System® (PROMIS®) gastrointestinal symptom scales to evaluate the impact of IBS on patients' quality of life [2] Safety and Tolerability - Interim results from a Phase 3 study indicated that tenapanor was well-tolerated in pediatric patients aged 12 to 18, with diarrhea being the only adverse event related to the drug [3] - A separate pharmacokinetic study found that tenapanor and its major metabolite were not detectable in the breast milk of lactating females after four days of dosing, indicating a favorable safety profile [4] Market Context - IBS-C affects an estimated 12 million people in the U.S., leading to significant economic burden and impaired quality of life, highlighting the need for effective treatments like IBSRELA [7]