30 June 2020 - Application is supported by three positive Phase 3 clinical trials for tenapanor for hyperphosphataemia, a condition which affects approximately 85% of CKD patients on dialysis.

Ardelyx today announced the submission of a new drug application for tenapanor to the U.S. FDA for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis.

The submission is supported by three successful Phase 3 trials involving over 1,000 patients that evaluated the use of tenapanor, which included: two monotherapy trials, including a long-term study, to control serum phosphorus in patients with CKD on dialysis, and one trial using a dual-mechanism approach in dialysis patients who had difficult-to-control hyperphosphatemia (≥5.5 mg/dL) despite phosphate binder therapy.

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