Tenapanor FDA Approval Status
Last updated by Judith Stewart, BPharm on July 25, 2021.
FDA Approved: No
Generic name: tenapanor
Company: Ardelyx, Inc.
Treatment for: Hyperphosphatemia of Renal Failure
Tenapanor is a sodium/hydrogen exchanger 3 (NHE3) inhibitor in development for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis.
- Tenapanor works by blocking paracellular absorption of phosphate in the gastrointestinal tract.
- In clinical studies, tenapanor has been shown to reduce phosphorus both as a monotherapy, and as part of a dual-mechanism approach in combination with the phosphate binder sevelamer.
- Tenapanor was approved in 2019 under the brand name Ibsrela for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults. By inhibiting NHE3, tenapanor works to reduce absorption of sodium from the small intestine and colon, resulting in an increase in water secretion into the intestinal lumen, which accelerates intestinal transit time and results in a softer stool consistency in patients with IBS-C.
Development timeline for tenapanor
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