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# Ardelyx NDA Accepted for Irritable Bowel Drug
- URL: https://www.fdaweb.com/ardelyx-nda-accepted-for-irritable-bowel-drug/
- Published: 2018-11-13T12:00:00.000Z
- Updated: 2026-09-15T00:44:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142803

FDA has accepted for review an Ardelyx NDA for tenapanor for treating patients with irritable bowel syndrome with constipation. The company says the minimally-systemic small molecule is designed to act locally in the gastrointestinal tract to inhibit the sodium transporter NHE3 and reduce sodium uptake from the gut.

The submission is supported by data from more than 3,100 patients and healthy volunteers who have participated in Ardelyx trials a clinical and preclinical data package supporting the drug’s safety profile, according to the company. “The data include results from the completed IBS-C registration T3MPO program, which consisted of two Phase 3 trials, T3MPO-1 and T3MPO-2, and a long-term safety extension trial, T3MPO-3,” it says. “Both the T3MPO-1 and T3MPO-2 trials achieved statistical significance for their primary endpoint and demonstrated that tenapanor had a durable effect on reducing constipation and abdominal pain that patients with IBS-C experience. The favorable safety profile of tenapanor, which has been shown across all trials, was further supported by the completed T3MPO-3 study.”