Ardelyx Gets IBS-C Approval, But Focus Remains On Hyperphosphatemia
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.
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The 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.
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.
New Phase III study of tenapanor in hyperphosphatemia will include an active control arm for safety monitoring, per US FDA guidance, slightly lengthening timeline.