For chronic kidney disease (CKD) on dialysis as add-on therapy. NDA 213931, held by Ardelyx Inc. Tenapanor Hydrochloride.
As of Nov 13, 2026, NDA 213931 (Xphozah), held by Ardelyx Inc, was first approved by FDA on Oct 17, 2023, with 2 approved supplements and 1 published complete response letter.
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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 17, 2023 | Original applicationNew indication · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Jul 28, 2021 | Tenapanor hydrochlorideClinical | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| XphozahEQ 10MG BASE · tablet;oral | Tenapanor Hydrochloride | DiscontinuedReference drug |
| XphozahEQ 20MG BASE · tablet;oral | Tenapanor Hydrochloride | RxReference drug |
| XphozahEQ 30MG BASE · tablet;oral | Tenapanor Hydrochloride | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 16, 2025 | Supplement 5Labeling · Standard review | Approved | |
| Mar 21, 2025 | Supplement 2Labeling · Standard review | Approved | |
| Oct 17, 2023 | Original applicationNew indication · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
