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# Regulatory Review Determined for Ardelyx’s Ibsrela
- URL: https://www.fdaweb.com/regulatory-review-determined-for-ardelyxs-ibsrela/
- Published: 2021-04-02T12:00:00.000Z
- Updated: 2026-09-14T16:53:28.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5149027

*Federal Register* notice: FDA has determined for patent extension purposes the regulatory review period for Ardelyx’s Ibsrela (tenapanor hydrochloride), indicated for treating irritable bowel syndrome with constipation in adults. The review period was determined to be 3,219 days, which includes 2,853 days that occurred during the testing phase and 366 days during the approval phase. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-04-01/pdf/2021-06693.pdf?ref=fdaweb.com).