IBSRELA (tenapanor) - (ACCEL)
- Indication
- Chronic idiopathic constipation (CIC)
- Stage
- phase3
- Event
- End of Phase Meeting
- Details
Nov. 3, 2026: Ardelyx, Inc. (NASDAQ: ARDX) said it completed full enrollment ahead of schedule in the Phase 3 ACCEL trial of IBSRELA (tenapanor) for chronic idiopathic constipation (CIC) in adults, with topline data expected in the second half of 2027.
ACCEL is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study evaluating twice-daily tenapanor over 26 consecutive weeks. The primary endpoint is durable efficacy in relieving constipation. The company said the program is intended to assess IBSRELA in a broader adult constipation-related population.
The release notes IBSRELA is currently approved in the U.S. for irritable bowel syndrome with constipation (IBS-C) in adults, but is not approved for CIC. Ardelyx also said it recently presented the ACCEL trial design and rationale at the American College of Gastroenterology Annual Scientific Meeting, citing post hoc analyses from two prior Phase 3 tenapanor studies in IBS-C and the symptom continuum between CIC and IBS-C as support for further evaluation in CIC.
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