Ardelyx Initiates Phase 3 ACCEL Trial for IBSRELA in Chronic Idiopathic Constipation
核心洞察
Ardelyx has dosed the first patient in ACCEL, a Phase 3 clinical trial evaluating IBSRELA (tenapanor) for chronic idiopathic constipation in adults.
The multicenter, randomized, double-blind, placebo-controlled study aims to enroll approximately 700 patients over 26 weeks with topline data expected in the second half of 2027.
Chronic idiopathic constipation affects more than 34 million Americans and is associated with significantly impaired quality of life and high healthcare costs.
Ardelyx has announced the dosing of the first patient in ACCEL (ten-03-301), a Phase 3 clinical trial designed to evaluate the safety and efficacy of IBSRELA® (tenapanor) for treating chronic idiopathic constipation (CIC) in adults. The milestone marks a significant step in the company's efforts to expand the therapeutic applications of its approved gastrointestinal medication.
Trial Design and Objectives
ACCEL is structured as a multicenter, randomized, double-blind, placebo-controlled study that will assess tenapanor administered twice daily for 26 consecutive weeks. The Phase 3 clinical trial is designed to enroll approximately 700 patients with CIC, with the primary endpoint evaluating patient-reported outcomes in constipation.
"Today marks an important milestone for our team and the patients we are committed to serving," said Laura Williams, M.D., M.P.H, chief patient officer and interim chief medical officer of Ardelyx. "We are pleased to announce that the first patient has been dosed in the ACCEL Phase 3 clinical trial, an integral step to bringing IBSRELA and its differentiated mechanism of action to patients with chronic idiopathic constipation."
Timeline and Enrollment
Enrollment in ACCEL is expected to continue throughout 2026, with topline data readout anticipated in the second half of 2027. The trial represents important progress in Ardelyx's goal of expanding the patient population who may benefit from IBSRELA beyond its lead indication for irritable bowel syndrome with constipation.
Disease Burden and Unmet Need
Chronic idiopathic constipation is characterized by difficult, infrequent or incomplete bowel movements and is associated with significantly impaired quality of life, disrupted productivity and high healthcare-related costs. The condition is estimated to affect more than 34 million Americans, representing approximately 10-17% of the world population according to NIH data.
Current IBSRELA Profile
IBSRELA is currently indicated for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adults. The drug demonstrated safety, efficacy and tolerability in a comprehensive clinical development plan for its approved indication. In previous IBS-C trials, the most common adverse reactions in IBSRELA-treated patients included diarrhea (16% vs 4% placebo), abdominal distension (3% vs <1%), flatulence (3% vs 1%) and dizziness (2% vs <1%).
Safety Considerations
IBSRELA carries important safety warnings, particularly regarding pediatric use. The drug is contraindicated in patients less than 6 years of age due to the risk of serious dehydration, with deaths observed in young juvenile rats presumed to be due to dehydration following oral administration of tenapanor. The safety and effectiveness of IBSRELA in patients less than 18 years of age have not been established.
Diarrhea was identified as the most common adverse reaction in previous trials, with severe diarrhea reported in 2.5% of IBSRELA-treated patients. Healthcare providers are advised to suspend dosing and rehydrate patients if severe diarrhea occurs.
Company Pipeline
Ardelyx has two commercial products approved in the United States: IBSRELA® (tenapanor) and XPHOZAH® (tenapanor). The company's pipeline includes the Phase 3 development of IBSRELA for chronic idiopathic constipation and RDX10531 (搜索), a next-generation NHE3 (搜索) inhibitor with potential application across multiple therapeutic areas. The company maintains agreements for tenapanor development and commercialization outside the U.S., with Kyowa Kirin commercializing PHOZEVEL® (tenapanor) for hyperphosphatemia in Japan and approved applications in China with Fosun Pharma.