Sodium zirconium cyclosilicate

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.

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
Keeping RAASi Treatment With Optimal Potassium Control	2024/08/29	NCT06578533	Phase 3	Recruiting	Fundación para la Investigación del Hospital Clínico de Valencia
A Clinical Trial to Define the Best Strategy for the Management of Heart Failure in Elderly Patients	2024/08/29	NCT06578078	Phase 3	Recruiting	Fundación para la Investigación del Hospital Clínico de Valencia
Sodium Zirconium Cyclosilicate to Allow Liberal Fruit and Vegetable Intake for Patients with CKD Stage 3b and 4	2024/04/15	NCT06365684	Phase 4	Recruiting	Leiden University Medical Center
A Prospective, Randomized, Open-Label, Cross-Over Study of Lokelma to Control Interdialytic Hyperkalemia	2022/09/10	NCT05535920	Phase 4	Completed	NephroNet, Inc.
Sodium Zirconium Cyclosilicate Lowers Hyperkalemia After Parathyroidectomy	2022/05/19	NCT05382988	Phase 3	Completed	Guangdong Provincial People's Hospital
Lokelma for RAAS Maximisation in CKD & Heart Failure.	2021/08/13	NCT05004363	Phase 3	Recruiting	St George's, University of London
The ORTIZ Study: Optimising RASi Therapy With SZC	2021/07/30	NCT04983979	Phase 2	Terminated	Barts & The London NHS Trust
Study to Assess the Effect of Sodium Zirconium Cyclosilicate on the Pharmacokinetics of Tacrolimus and Cyclosporin in Healthy Subjects	2021/03/09	NCT04788641	Phase 1	Completed	AstraZeneca
OPtimizing Aldosterone Receptor Antagonist Therapy by Sodium Zirconium Cyclosilicate in Heart Failure	2021/03/09	NCT04789239	Phase 2	Active, not recruiting	Michael Fu
Study of the Effect of SZC on Serum Potassium and Serum Bicarbonate in Patients With Hyperkalemia and Metabolic Acidosis Associated With Chronic Kidney Disease	2021/01/27	NCT04727528	Phase 3	Terminated	AstraZeneca

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
LOKELMA	A-S Medication Solutions	50090-6501	ORAL	10 g in 10 g	9/30/2022
LOKELMA	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
Lokelma	AstraZeneca AB,151 85 Sodertalje,Sweden	Authorised	3/22/2018

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
LOKELMA POWDER FOR ORAL SUSPENSION 5G	Sharp Corporation (Primary and Secondary packager), AndersonBrecon Incorporated (Primary and Secondary packager), AstraZeneca Pharmaceuticals LP (DP intermediate)	SIN15961P	POWDER, FOR SUSPENSION	5g/sachet	6/22/2020
LOKELMA POWDER FOR ORAL SUSPENSION 10G	Sharp Corporation (Primary and Secondary packager), AndersonBrecon Incorporated (Primary and Secondary packager), AstraZeneca Pharmaceuticals LP (DP intermediate)	SIN15962P	POWDER, FOR SUSPENSION	10g/sachet	6/22/2020

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

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.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
LOKELMA	astrazeneca canada inc	02490714	Powder For Suspension - Oral	5 G / SACHET	10/17/2019
LOKELMA	astrazeneca canada inc	02490722	Powder For Suspension - Oral	10 G / SACHET	10/17/2019

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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