Ardelyx's Tenapanor Data Challenge Phosphate Binders In Hyperphosphatemia
Although rate of diarrhea was higher for first-in-class tenapanor compared to phosphate binders in the first pivotal trial, drop-out rate is what counts and that was lower, say analysts, happy with the overall dataset.
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Tenapanor approved for IBS-C as Ibsrela, but Ardelyx is still seeking a commercial partner for that indication – and is maintaining focus on same molecule in hyperphosphatemia.
Astellas builds on a 2013 collaboration by acquiring Mitobridge. Ardelyx is partnering with Kyowa Hakko Kirin to bring tenapanor to market in Japan. Meanwhile, Depomed, Xoma and Bristol all offload programs before the end of the year.
New Phase III study of tenapanor in hyperphosphatemia will include an active control arm for safety monitoring, per US FDA guidance, slightly lengthening timeline.