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Ardelyx's Adjusted Trial Design May Expedite NDA Filing For Lead Candidate

The first-in-class NHE3 inhibitor tenapanor is in Phase III for IBS-C, as well as in Phase II for hyperphosphatemia in end-stage renal disease patients. Agreement with FDA may accelerate filing for the latter indication.

Ardelyx Inc. has agreed to a design change in a Phase IIb study for its lead candidate, the first-in-class NHE3 inhibitor tenapanor, in hyperphosphatemia in end-stage renal disease patients that may enable a quicker NDA filing in that indication than previously anticipated.

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