Tenapanor is filed in Japan for the improvement of hyperphosphatemia in patients with chronic kidney disease undergoing dialysis
Kyowa Kirin has filed a new drug application in Japan for tenapanor, a compound licensed from Ardelyx, for the improvement of hyperphosphatemia in patients with chronic kidney disease undergoing dialysis
The filing of the drug, also known as KHK 7791, is based on the results of four PIII trials carried out in Japan targeting patients with hyperphosphatemia on maintenance dialysis. In these studies, tenapanor as a monotherapy reduced serum phosphorus levels by a statistically significant margin versus placebo. In addition, the drug both as a single agent and an add-on to phosphate binders, demonstrated a significant serum phosphorus reduction in patients whose serum phosphorus levels were poorly controlled with conventional phosphate binders alone.
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