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 |
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. | |||||