Skip to Content

ZS-9 Approval Status

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.

Development Status and FDA Approval Process for ZS-9

DateArticle
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

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide