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Phase III Win In Kidney Disease For Ardelyx's Tenapanor

 
• By Kevin Grogan

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.

Burden
Tenapanor could reduce high pill burden for hyperphosphatemia patients • Source: Shutterstock

A week before a decision is due from the US Food and Drug Administration on tenapanor for irritable bowel syndrome, Ardelyx Inc. has seen its shares jump following more positive Phase III results for the first-in-class NH3E inhibitor as a treatment for hyperphosphatemia in patients with end-stage renal disease.

The California-headquartered biotech has presented data from the AMPLIFY trial evaluating tenapanor in combination with phosphate binders in patients with chronic kidney disease on dialysis whose hyperphosphatemia was not previously controlled with binders alone

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