Kyowa Kirin files for tenapanor approval in Japan

31 October 2022

Japanese drugmaker Kyowa Kirin (TYO: 4151) revealed on Friday that is has submitted a New Drug Application (NDA) for tenapanor hydrochloride (KHK7791), a small molecule compound licensed from USA-based Ardelyx (Nasdaq: ARDX), to the Japanese Ministry of Health, Labor and Welfare (MHLW).

The drug is intended for the improvement of hyperphosphatemia in chronic kidney disease patients on dialysis, and analysts have estimated peak sales of up to $750 million for the drug.

“We are pleased that we have submitted an NDA for tenapanor for improvement of hyperphosphatemia in chronic kidney disease patients on dialysis,” said Yoshifumi Torii, executive officer, vice president, head of R&D Division at Kyowa Kirin, adding: “We strongly believe that tenapanor, with its unique mechanism of action, will provide a new treatment option for the improvement of hyperphosphatemia and contribute to the benefit of patients receiving maintenance dialysis.”

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