Ardelyx completes Phase 3 ACCEL enrollment early, reports Q3 2026 results

Ardelyx said on November 3, 2026 that it completed enrollment ahead of schedule in its Phase 3 clinical trial, ACCEL, evaluating tenapanor for the treatment of chronic idiopathic constipation (CIC) in adults¹. The company said it is on track to announce topline data in the second half of 2027¹.

On the regulatory side, Ardelyx disclosed that the United States Patent and Trademark Office notified the company that on November 10, 2026, it will issue U.S. Patent No. 12,788,750 titled "Oral Formulation of a Therapeutic Compound," with an expiration date of December 6, 2041, covering the company's commercial formulations of both IBSRELA and XPHOZAH.¹

The company also presented real-world data at two medical meetings in October. At the American College of Gastroenterology meeting, it presented real world data showing that gastrointestinal-related healthcare resource utilization dropped after adults with IBS-C started IBSRELA¹. At the American Society of Nephrology Kidney meeting, it presented real-world data showing reductions in serum phosphate following XPHOZAH initiation in adults on dialysis with or without phosphate binders¹.

Financially, total product revenue for the quarter ended September 30, 2026 was $125.5 million, compared to $105.5 million for the quarter ended September 30, 2025, reflecting 19% growth, driven by increased demand¹. Revenue for IBSRELA during the third quarter of 2026 was $96.3 million, reflecting year-over-year growth of 23%¹, while revenue for XPHOZAH during the third quarter of 2026 was $29.2 million, reflecting year-over-year growth of 7%¹.

On cash position, as of September 30, 2026, the company had total cash, cash equivalents and short-term investments of $285.3 million, compared to $264.7 million as of December 31, 2025¹. Ardelyx reiterated full-year guidance of $350 to $370 million for IBSRELA, $110 to $120 million for XPHOZAH, and operating expenses below $500 million¹.