New Phase III study of tenapanor in hyperphosphatemia will include an active control arm for safety monitoring, per US FDA guidance, slightly lengthening timeline.
Ardelyx Inc. plans to start a second Phase III study soon for its first-in-class NH3E inhibitor tenapanor in hyperphosphatemia, which will include an active control arm based on input from the US FDA. The company also announced during a Nov. 21 strategy update that it is canning development of its potassium binder RDX7675 in hyperkalemia.
Ardelyx's lead candidate tenapanor is a small molecule that's being developed for hyperphosphatemia, or high levels of serum phosphorous associated...
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A court order encompassing funding, drug pricing, clinical trials and overall policy implementation aspects is expected to bring about a paradigm shift in the treatment of rare diseases in India. Sarepta, Roche and Sanofi are among the key players that have been part of pricing discussions.
