Xphozah FDA Approval History
Last updated by Judith Stewart, BPharm on Oct 18, 2023.
FDA Approved: Yes (First approved October 17, 2023)
Brand name: Xphozah
Generic name: tenapanor
Dosage form: Tablets
Company: Ardelyx, Inc.
Treatment for: Hyperphosphatemia of Renal Failure
Xphozah (tenapanor) is a sodium hydrogen exchanger 3 (NHE3) inhibitor used to treat hyperphosphatemia in adults with chronic kidney disease.
- Xphozah is indicated to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy.
- Hyperphosphatemia (elevated levels of phosphate in the blood) is a common condition in people with CKD who are on maintenance dialysis. The kidneys are responsible for eliminating excess phosphate and as kidney function declines, phosphate is not adequately eliminated from the body.
- Xphozah works to reduce serum phosphorus by blocking paracellular absorption of phosphate in the gastrointestinal tract.
- Xphozah tablets are administered orally twice daily just before the morning and evening meals.
- Tenapanor was first 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.
- Warnings and precautions associated with Xphozah include severe diarrhea.
- Common adverse reactions include diarrhea.
Development timeline for Xphozah
Further information
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