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ZS-9 Approval Status

  • FDA approved: No
  • Brand name: ZS-9
  • Generic name: sodium zirconium cyclosilicate
  • Company: AstraZeneca
  • Treatment for: Hyperkalemia

ZS-9 (sodium zirconium cyclosilicate) is a crystalline lattice potassium ion-trap in development for the treatment of hyperkalemia.

In May 2016, AstraZeneca announced the receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) advising the company that the New Drug Application (NDA) for sodium zirconium cyclosilicate (ZS-9) had not been approved. The CRL referred to observations arising from a pre-approval manufacturing inspection. A second CRL was issued by the FDA in March 2017.

Development Status and FDA Approval Process for ZS-9

Mar 17, 2017AstraZeneca Receives Complete Response Letter from US FDA for ZS-9 (sodium zirconium cyclosilicate) for Hyperkalemia
Oct 18, 2016FDA Accepts for Review New Drug Application for Sodium Zirconium Cyclosilicate (ZS-9) for the Treatment of Hyperkalemia
May 27, 2016AstraZeneca Receives Complete Response Letter from FDA for Sodium Zirconium Cyclosilicate (ZS-9) for Hyperkalemia
Jul 29, 2015ZS Pharma Announces FDA Acceptance of ZS-9 New Drug Application
May 26, 2015ZS Pharma Submits NDA for ZS-9 for the Treatment of Hyperkalemia

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