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# FDA Questions Ardelyx’ Tenapanor
- URL: https://www.fdaweb.com/fda-questions-ardelyx-tenapanor/
- Published: 2022-11-15T12:00:00.000Z
- Updated: 2026-09-14T18:06:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153199

In a briefing document released in advance of an 11/16 meeting of the Cardiovascular and Renal Drugs Advisory Committee, FDA medical reviewers continue to raise questions about the Ardelyx NDA for tenapanor to control serum phosphorous in adults with chronic kidney disease on dialysis. The [document](https://www.fda.gov/media/163150/download?ref=fdaweb.com) says the agency issued a complete response letter to the NDA on 7/28/21 citing questions about the magnitude and clinical significance of the drug’s treatment effect. Following a meeting with FDA to discuss the letter, Ardelyx pursued two formal dispute resolution requests. The second request resulted in a referral to the advisory committee.

A chart in the briefing paper lays out the reviewers’ evidence and uncertainties about the drug’s benefit/risk framework when compared to existing treatment options. The paper also has several draft points for the committee’s consideration involving the level of the treatment effect of tenapanor as monotherapy and in combination with existing phosphate binder treatment. The advisors were also asked to comment on the safety and tolerability of diarrhea as the most common adverse reaction. Finally, they were asked to weigh whether the drug’s benefits outweigh its risks, both when administered as monotherapy and in combination with other agents.