Clinical TrialMay 7, 2026, 08:04 AM
Ardelyx Presents Positive XPHOZAH Long-Term Safety Data
AI Summary
Ardelyx announced the presentation of a data analysis at the National Kidney Foundation’s Spring Clinical Meetings, evaluating the long-term impact of XPHOZAH (tenapanor) on serum electrolytes and selected nutrition biomarkers. The analysis, from the NORMALIZE and OPTIMIZE open-label clinical trials, showed that XPHOZAH treatment resulted in no clinically meaningful changes in measured serum electrolyte concentrations (other than phosphate reduction) and no significant changes in nutrition, body mass, or blood pressure. These findings further support the effectiveness and safety of tenapanor for managing serum phosphate in patients with chronic kidney disease and hyperphosphatemia on dialysis.
Key Highlights
- Ardelyx presented a post hoc analysis of NORMALIZE (18-month) and OPTIMIZE (26-week) trials.
- XPHOZAH is the first and only FDA-approved phosphate absorption inhibitor (PAI).
- Tenapanor treatment showed no clinically meaningful changes in serum electrolytes, other than phosphate reduction.
- No significant changes in nutrition, body mass, or blood pressure were observed.
- Diarrhea was the most common side effect (43-53% of patients), mostly mild-to-moderate.
- Severe diarrhea was reported in 5% of XPHOZAH-treated patients in these trials.
- XPHOZAH is indicated to reduce serum phosphorus in adults with CKD on dialysis.
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