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 |
---|---|---|---|---|---|
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 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
LOKELMA POWDER FOR ORAL SUSPENSION 5G | SIN15961P | POWDER, FOR SUSPENSION | 5g/sachet | 6/22/2020 | |
LOKELMA POWDER FOR ORAL SUSPENSION 10G | SIN15962P | POWDER, FOR SUSPENSION | 10g/sachet | 6/22/2020 |
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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