---
schema_version: "secwatch.filing_event.v1"
accession: "0001628280-23-034537"
form_type: "8-K"
ticker: "ARDX"
cik: "0001437402"
company_name: "ARDELYX, INC."
filed_at: "2023-10-18T23:59:59+00:00"
generated_at: "2026-06-09T21:47:19.231431+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Ardelyx announces FDA approval of XPHOZAH (tenapanor) for hyperphosphatemia in dialysis patients

## Summary
- FDA approved XPHOZAH to reduce serum phosphorus in adults with CKD on dialysis as add-on therapy.
- Indicated for patients with inadequate response to phosphate binders or intolerant of any dose.
- XPHOZAH is a single tablet taken twice daily with a first-in-class mechanism blocking phosphate absorption.
- Approval date: October 17, 2023.

## SEC filing metadata
- accession: 0001628280-23-034537
- form_type: 8-K
- ticker: ARDX
- cik: 0001437402
- company_name: ARDELYX, INC.
- filed_at: 2023-10-18T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1437402/000162828023034537/0001628280-23-034537-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1437402/000162828023034537/ardx-20231017.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001628280-23-034537
- JSON: https://secwatch.observer/filing/0001628280-23-034537.json
- Plain text: https://secwatch.observer/filing/0001628280-23-034537.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.