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On October 17, 2023, Ardelyx Inc announced the FDA approval of tenapanor (Xphozah) for reducing serum phosphorus in adults with chronic kidney disease on dialysis as add-on therapy.
“Finally!” Piper Sandler analysts cheered in a research note on Ardelyx Inc., which after spending three years battling the U.S. FDA, secured approval of Xphozah (tenapanor) for treating hyperphosphatemia in adults with chronic kidney disease (CKD). The company will waste no time getting to market, aiming to have the NHE3 inhibitor available to patients next month, marking the first new treatment class for hyperphosphatemia in 30 years.
Excess phosphorus can remove calcium from bones and other parts of the body, which in turn can cause brittle bones, joint pain, muscle cramps and itchy skin. The FDA has approved the drug for use in patients who have had an inadequate response or intolerance to phosphate binder therapies, the current standard-of-care treatment for the condition.