Ardelyx Launches Phase 3 ACCEL Trial of IBSRELA® In Chronic Idiopathic Constipation, Targeting 700 Patients With Topline Data Expected In Late 2027

Ardelyx, Inc., a biopharmaceutical company focused on discovering, developing, and commercializing innovative first-in-class medicines to address significant unmet medical needs, announced that the first patient has been dosed in its Phase 3 ACCEL clinical trial. The study is designed to evaluate the safety and effectiveness of IBSRELA® (tenapanor) for the treatment of chronic idiopathic constipation (CIC) in adults.

The ACCEL trial is a multicenter, randomized, double-blind, placebo-controlled study that will assess tenapanor when administered twice daily for 26 weeks. Approximately 700 patients with CIC are expected to participate. The primary goal of the study is to evaluate patient-reported outcomes related to constipation. Enrollment is anticipated to continue throughout 2026, with topline data expected in the second half of 2027.

Laura Williams, M.D., M.P.H., Chief Patient Officer and Interim Chief Medical Officer of Ardelyx, said that dosing the first patient represents an important milestone for both the company and the patients it serves. She emphasized that this trial is a critical step toward bringing IBSRELA, with its differentiated mechanism of action, to individuals living with chronic idiopathic constipation. Dr. Williams also expressed gratitude to the investigators, clinical teams, internal staff, and the patients and families participating in the trial. She added that Ardelyx remains committed to conducting the study with the highest standards of safety, scientific rigor, and integrity and looks forward to the insights it will provide.

The Phase 3 ACCEL study reflects Ardelyx’s ongoing efforts to expand access to IBSRELA beyond its current approved indication for irritable bowel syndrome with constipation. The therapy has previously demonstrated safety, efficacy, and tolerability in a comprehensive clinical development program, and this trial represents an important step in reaching a broader population of patients who may benefit from tenapanor.