Ardelyx will start dosing sufferers within the Section III trial for CIC

Ibsrela is presently indicated for the therapy of irritable bowel syndrome with constipation in adults. Credit score: Prostock studio / Shutterstock.com.

Ardelyx has dosed the primary affected person within the ACCEL (ten-03-301) Section III medical trial evaluating Ibsrela (tenapanor) for the therapy of persistent idiopathic constipation (CIC) in adults.

The multicenter, randomized, double-blind, placebo-controlled research goals to guage the efficacy and security of tenapanor for the therapy of CIC when administered twice each day for 26 consecutive weeks.

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It plans to enroll roughly 700 adults with CIC, with the first endpoint assessing patient-reported constipation outcomes.

Affected person enrollment for ACCEL is predicted to proceed by means of 2026, and Ardelyx expects key knowledge from the research within the second half of 2027.

The Section III medical trial represents progress in Ardelyx’s purpose to broaden the potential of Ibsrela past the present indication for irritable bowel syndrome with constipation. Earlier research have demonstrated the efficacy, tolerability and security of Ibsrela by means of an in depth medical improvement plan.

Ardelyx Chief Affected person Officer and Interim Chief Medical Officer Laura Williams mentioned: “As we speak marks an necessary milestone for our staff and the sufferers we intention to assist. We’re happy to announce that the primary affected person has acquired a dose within the ACCEL Section III medical trial, an integral step in making Ibsrela and its differentiated mechanism of motion out there to sufferers with persistent idiopathic constipation.

“This achievement displays the dedication of our researchers, medical workers, inside staff and, most significantly, the sufferers and households who entrust us with their care.

“We stay targeted on conducting this analysis with the very best requirements of security, integrity and scientific rigor, and we sit up for the insights it can present for the long run well being of our sufferers.”