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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

DateArticle
Jul 29, 2021Ardelyx Receives Complete Response Letter from U.S. FDA for New Drug Application for Tenapanor for the Control of Serum Phosphorus in Adult Patients with CKD on Dialysis
Jul 19, 2021Ardelyx Provides Regulatory Update on New Drug Application for Tenapanor for the Control of Serum Phosphorus in Adult Patients with CKD on Dialysis
Sep 15, 2020Ardelyx Announces FDA Acceptance for Filing of its New Drug Application of Tenapanor for the Control of Serum Phosphorus in Adult Patients with CKD on Dialysis
Jun 30, 2020Ardelyx Announces Submission of New Drug Application to the U.S. FDA for Tenapanor for the Control of Serum Phosphorus in Adult Patients with CKD on Dialysis
Jun 15, 2020Ardelyx Announces Positive Second Data Analysis from Ongoing NORMALIZE Phase 4 Study Evaluating Tenapanor in CKD Patients on Dialysis
Dec  3, 2019Ardelyx Announces Positive Topline Results from Pivotal Phase 3 PHREEDOM Study Evaluating Tenapanor in CKD Patients on Dialysis
Sep  3, 2019Ardelyx Announces Positive Results from the Pivotal Phase 3 AMPLIFY Study Evaluating Tenapanor in Dialysis Patients Who Have Uncontrolled Hyperphosphatemia Despite Phosphate Binder Treatment

Further information

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