The US Food and Drug Administration (FDA) has rejected Tenapanor for Control of Phosphorus in Kidney Disease, asking for another clinical trial that indicates the drug’s greater benefits before approval. Ardelyx devleoped Tenapanor, an oral inhibitor of the sodium-proton exchanger NHE3. for the control of serum phosphorus in adult patients on dialysis with chronic kidney disease (CKD). In their response letter, Ardelyx said the FDA characterized the data showing tenapanor’s efficacy in lowering serum phosphorus in patients with CKD as “substantial evidence” but that the extent of the drug’s ability to treat the disease is “unclear”. No safety issues were raised by the FDA.
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