Overview
Ferric pyrophosphate citrate is a soluble iron replacement product. Free iron presents several side effects as it can catalyze free radical formation and lipid peroxidation as well as the presence of interactions of iron in plasma. The ferric ion is strongly complexed by pyrophosphate and citrate. FPC is categorized in Japan as a second class OTC drug. This category is given to drugs with ingredients that in rare cases may cause health problems requiring hospitalization or worst. It is also FDA approved since 2015.
Background
Ferric pyrophosphate citrate is a soluble iron replacement product. Free iron presents several side effects as it can catalyze free radical formation and lipid peroxidation as well as the presence of interactions of iron in plasma. The ferric ion is strongly complexed by pyrophosphate and citrate. FPC is categorized in Japan as a second class OTC drug. This category is given to drugs with ingredients that in rare cases may cause health problems requiring hospitalization or worst. It is also FDA approved since 2015.
Indication
Ferric pyrophosphate citrate is indicated for the treatment of iron loss or iron deficiency to maintain hemoglobin and to reduce the prescribed dose of erythropoiesis-stimulating agent (ESA) required to maintain desired hemoglobin levels. Iron deficiency appears when the dietary intake does not meet the body's requirement or when there is chronic external blood loss. During acute blood loss, body iron stores are sufficient for accelerated erythropoiesis and restoration of iron homeostasis. But when the altered homeostasis remains for weeks to months then some supplement is needed. Some causes of iron deficiency include ectoparasitism, endoparasitism, hematuria, epistaxis, hemorrhagic skin, coagulopathy, thrombocytopenia, thrombocytopathia and gastrointestinal hemorrhage.
Associated Conditions
- Iron Deficiency (ID)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/11/08 | Phase 2 | UNKNOWN | |||
2020/12/30 | Phase 4 | Completed | |||
2020/06/01 | Phase 1 | Completed | |||
2020/01/27 | Phase 3 | UNKNOWN | |||
2019/08/01 | Phase 1 | Completed | |||
2017/10/05 | Phase 1 | Completed | |||
2016/12/16 | Not Applicable | Completed | |||
2016/09/21 | Phase 1 | Completed | |||
2016/09/19 | Phase 2 | Terminated | |||
2016/05/10 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Rockwell Medical Inc. | 57278-318 | INTRAVENOUS | 1.5 mg in 1 mL | 9/15/2020 | |
| Rockwell Medical, Inc | 57278-315 | INTRAVENOUS | 272 mg in 1 1 | 9/15/2020 | |
| Rockwell Medical, Inc | 57278-314 | HEMODIALYSIS | 5.44 mg in 1 mL | 9/15/2020 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
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 |
|---|---|---|---|---|---|
| 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. | |||||