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Ardelyx Gets IBS-C Approval, But Focus Remains On Hyperphosphatemia

Executive Summary

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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While not an outright rejection, the Deficiencies Preclude Discussion letter came as a surprise given the expectation of the drug’s approval for hyperphosphatemia in adults with chronic kidney disease on dialysis.

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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.

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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.

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