Ardelyx Plans Mid-2020 NDA Filing For Tenapanor In Hyperphosphatemia
Executive SummaryThe company reported positive Phase III data from a second trial testing the first-in-class therapy as monotherapy for managing hyperphosphatemia in patients on dialysis.
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Tenapanor approved for IBS-C as Ibsrela, but Ardelyx is still seeking a commercial partner for that indication – and is maintaining focus on same molecule in hyperphosphatemia.
Ahead of a 12 September PDUFA date for irritable bowel syndrome, the US firm's tenapanor has also succeeded in a second trial as a treatment for hyperphosphatemia.