Ardelyx announced on May 6, 2025, the presentation of new data supporting IBSRELA (tenapanor) at the Digestive Disease Week Conference (DDW). The data included interim, blinded safety results from the Phase 3 R-ALLY study of tenapanor in pediatric patients aged 12 to less than 18 years old with IBS-C.
The pediatric study reported no serious adverse events or unexpected safety signals, with diarrhea being the only adverse event related to the study drug, consistent with tenapanor’s mechanism of action. This positive safety profile could support future expansion into the pediatric population.
Additionally, a Phase 1 pharmacokinetic study showed that neither tenapanor nor its major metabolite were detected in the breast milk of healthy lactating females after four days of dosing. This finding suggests potential for safe use in lactating patients, broadening the drug's applicability.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.