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.
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.
