Ardelyx Gains Approval for Tenapanor to Treat Hyperphosphatemia
Thursday, February 27, 2025
Ardelyx has announced that China's National Medical Products Administration (NMPA) has approved tenapanor for controlling serum phosphorus levels in dialysis patients with chronic kidney disease (CKD).
XPHOZAH, developed by Ardelyx, is a first-in-class phosphate absorption inhibitor that works locally in the gut by blocking the sodium hydrogen exchanger 3. This mechanism reduces phosphate absorption through the paracellular pathway, which is the primary route of phosphate absorption.
The medication is taken as a single tablet twice daily. Clinical trials have indicated that diarrhoea is the most commonly reported side effect.
This approval is intended for patients who have an inadequate response to or cannot tolerate phosphorus binders.
As part of an agreement between Ardelyx and its partner in China, Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. (Fosun Pharma), this regulatory milestone will result in a $5 million payment to Ardelyx.
The company is also eligible for further developmental and commercialisation milestone payments of up to $100 million, along with tiered royalty payments on net sales ranging from the mid-teens to 20 per cent.
In China, more than one million patients were undergoing maintenance haemodialysis by the end of 2023, with an annual growth rate of approximately 12 per cent. Among these patients, 76 per cent have hyperphosphataemia, yet only 39 per cent achieve target phosphate levels based on the country’s haemodialysis quality control standards (serum phosphate 1.13–1.78 mmol/L).
If the recommended range is adjusted to 0.87–1.45 mmol/L, as per Chinese guidelines for the diagnosis and treatment of Chronic Kidney Disease Mineral and Bone Disorder, the achievement rate falls to 26.7 per cent.
The approval in China was based on data from a pharmacokinetic study and a pivotal trial in CKD patients on dialysis conducted by Fosun Pharma, in addition to clinical studies by Ardelyx.
Fosun Pharma holds exclusive rights to market and distribute tenapanor in China, Hong Kong, and Macau.
The treatment will be sold under the Chinese trade name Wan Ti Le.
Source: ardelyx.com
