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Lokelma FDA Approval History

Last updated by Judith Stewart, BPharm on March 2, 2021.

FDA Approved: Yes (First approved May 18, 2018)
Brand name: Lokelma
Generic name: sodium zirconium cyclosilicate
Dosage form: for Oral Suspension
Company: AstraZeneca
Treatment for: Hyperkalemia

Lokelma (sodium zirconium cyclosilicate) is a potassium binder indicated for the treatment of hyperkalemia in adults.

Lokelma should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action.

Dosage and Administration

Warnings and Precautions

Adverse Reactions

The most common adverse reaction with Lokelma was mild to moderate edema.

Drug Interactions

Lokelma can transiently increase gastric pH. In general, oral medications with pH-dependent solubility should be administered at least two hours before or two hours after Lokelma. Spacing is not needed if it has been determined the concomitant medication does not exhibit pH-dependent solubility.

Development timeline for Lokelma

DateArticle
May 18, 2018Approval FDA Approves Lokelma (sodium zirconium cyclosilicate) for the Treatment of Adults with Hyperkalemia
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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.