Overview
Iron sucrose (sucroferric oxyhydroxide or iron saccharate) is used as a source of iron in patients with iron deficiency anemia with chronic kidney disease (CKD), including those who are undergoing dialysis (hemodialysis or peritoneal) and those who do not require dialysis. Due to less side effects than iron dextran, iron sucrose is more preferred in chronic kidney disease patients.
Background
Iron sucrose (sucroferric oxyhydroxide or iron saccharate) is used as a source of iron in patients with iron deficiency anemia with chronic kidney disease (CKD), including those who are undergoing dialysis (hemodialysis or peritoneal) and those who do not require dialysis. Due to less side effects than iron dextran, iron sucrose is more preferred in chronic kidney disease patients.
Indication
Iron sucrose is elemental iron as an injection. It replenishes body iron stores in patients with iron deficiency.
Associated Conditions
- Hyperphosphataemia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/11/15 | Phase 4 | Completed | |||
2024/04/16 | Phase 3 | Recruiting | |||
2023/09/29 | Phase 4 | Not yet recruiting | |||
2023/04/05 | Phase 2 | Recruiting | |||
2019/11/07 | Phase 1 | Completed | |||
2018/08/23 | Phase 3 | Completed | Vifor Fresenius Medical Care Renal Pharma | ||
2018/01/24 | N/A | Terminated | |||
2017/03/28 | Phase 1 | Completed | |||
2016/04/07 | Phase 3 | Completed | Zeria Pharmaceutical | ||
2016/02/22 | N/A | Completed | Vifor Fresenius Medical Care Renal Pharma |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
No FDA approvals found for this drug. |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 8/26/2014 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Iron Sucrose for Injection | 国药准字H20090367 | 化学药品 | 注射剂 | 10/11/2024 | |
Iron Sucrose Injection | 国药准字HJ20130636 | 化学药品 | 注射剂 | 12/20/2023 | |
Iron Sucrose Injection | 国药准字H20046043 | 化学药品 | 注射剂 | 6/1/2020 | |
Iron Sucrose Injection | 国药准字H20064471 | 化学药品 | 注射剂 | 6/1/2021 | |
Iron Sucrose Injection | 国药准字H20055756 | 化学药品 | 注射剂(注射液) | 4/24/2020 | |
Iron Sucrose Injection | 国药准字H20057617 | 化学药品 | 注射剂 | 8/25/2020 | |
Iron Sucrose Injection | 国药准字H20113004 | 化学药品 | 注射剂 | 6/1/2020 |
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 |
---|---|---|---|---|---|
VELPHORO sucroferric oxyhydroxide 2500 mg (equivalent to iron 500 mg) chewable tablet blister | 216701 | Medicine | A | 11/27/2014 | |
VELPHORO sucroferric oxyhydroxide 2500 mg (equivalent to iron 500 mg) chewable tablet bottle | 216702 | Medicine | A | 11/27/2014 |