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Sodium zirconium cyclosilicate

Generic Name
Sodium zirconium cyclosilicate
Brand Names
Lokelma
Drug Type
Small Molecule
Chemical Formula
Na2O9Si3Zr
CAS Number
17141-74-1
Unique Ingredient Identifier
D652ZWF066

Overview

Sodium zirconium cyclosilicate is approved as the trade product Lokelma developed by AstraZeneca - an insoluble, non-absorbed sodium zirconium silicate, formulated as a powder for oral suspension that acts as a highly selective potassium removing agent. It is administered orally and is odorless, tasteless, and stable at room temperature. Approval of the medication is supported by data from three double-blind, placebo-controlled trials and two open-label trials which showed that the onset of action was approximately 1.0 hour and the median time to achieving normal potassium levels in the blood was 2.2 hours, with 92% of patients achieving normal potassium levels within 48 hours following administration. The treatment effect was maintained for up to 12 months.

Background

Sodium zirconium cyclosilicate is approved as the trade product Lokelma developed by AstraZeneca - an insoluble, non-absorbed sodium zirconium silicate, formulated as a powder for oral suspension that acts as a highly selective potassium removing agent. It is administered orally and is odorless, tasteless, and stable at room temperature. Approval of the medication is supported by data from three double-blind, placebo-controlled trials and two open-label trials which showed that the onset of action was approximately 1.0 hour and the median time to achieving normal potassium levels in the blood was 2.2 hours, with 92% of patients achieving normal potassium levels within 48 hours following administration. The treatment effect was maintained for up to 12 months.

Indication

Sodium zirconium cyclosilicate is a potassium binder indicated for the treatment of hyperkalemia in adult patients.

Associated Conditions

  • Hyperkalemia

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2024/08/29
Phase 3
Recruiting
Fundación para la Investigación del Hospital Clínico de Valencia
2024/08/29
Phase 3
Recruiting
Fundación para la Investigación del Hospital Clínico de Valencia
2024/04/15
Phase 4
Recruiting
Leiden University Medical Center
2022/09/10
Phase 4
Completed
2022/05/19
Phase 3
Completed
2021/08/13
Phase 3
Recruiting
2021/07/30
Phase 2
Terminated
2021/03/09
Phase 1
Completed
2021/03/09
Phase 2
Active, not recruiting
Michael Fu
2021/01/27
Phase 3
Terminated

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
A-S Medication Solutions
50090-6501
ORAL
10 g in 10 g
9/30/2022
A-S Medication Solutions
50090-6502
ORAL
5 g in 5 g
9/30/2022

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
Authorised
3/22/2018

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Sodium Zirconium Cyclosilicate Powder
国药准字HJ20190072
化学药品
散剂
5/31/2024
Sodium Zirconium Cyclosilicate Powder
国药准字HJ20190073
化学药品
散剂
5/31/2024
Sodium Zirconium Cyclosilicate Powder
H20190072
化学药品
散剂
12/30/2019
Sodium Zirconium Cyclosilicate Powder
H20190073
化学药品
散剂
12/30/2019

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.
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