Ardelyx Plans Mid-2020 NDA Filing For Tenapanor In Hyperphosphatemia

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.

Aredlyx's tenapanor was successful in a second Phase III trial • Source: Shutterstock

Ardelyx Inc. expects to file a new drug application with the US Food and Drug Administration for tenapanor for the treatment of hyperphosphatemia in patients on dialysis in mid-2020 after data from a second Phase III trial read out positively. The company announced the positive results of the Phase III PHREEDOM trial testing the first-in-class NH3E inhibitor as a monotherapy on 3 December.

The company is ramping up to launch tenapanor in 2021 independently for hyperphosphatemia, even though it is still seeking a...

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