Ardelyx Gets IBS-C Approval, But Focus Remains On Hyperphosphatemia

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.

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Ardelyx got its first drug approval, but has no plans to launch Ibsrela on its own • Source: Shutterstock

Ardelyx Inc.’s first drug approval makes it a commercial-stage company, but the cardiorenal disease-focused firm has no intention of marketing Ibsrela on its own for constipation-predominant irritable bowel syndrome (IBS-C). It wants a commercial partner to pay significant upfront money to take over the IBS-C indication, while Ardelyx completes a Phase III program with the same molecule, tenapanor, in hyperphosphatemia.

The US Food and Drug Administration approved Ibsrela – a locally acting sodium/hydrogen exchanger 3 (NHE3) inhibitor – on 12 September, roughly a week after Ardelyx detailed tenapanor’s success in...

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