Overview
A metallic element found in certain minerals, in nearly all soils, and in mineral waters. It is an essential constituent of hemoglobin, cytochrome, and other components of respiratory enzyme systems. Its chief functions are in the transport of oxygen to tissue (hemoglobin) and in cellular oxidation mechanisms. Depletion of iron stores may result in iron-deficiency anemia. Iron is used to build up the blood in anemia.
Background
A metallic element found in certain minerals, in nearly all soils, and in mineral waters. It is an essential constituent of hemoglobin, cytochrome, and other components of respiratory enzyme systems. Its chief functions are in the transport of oxygen to tissue (hemoglobin) and in cellular oxidation mechanisms. Depletion of iron stores may result in iron-deficiency anemia. Iron is used to build up the blood in anemia.
Indication
Used in preventing and treating iron-deficiency anemia.
Associated Conditions
- Anemia
- Iron Deficiency (ID)
- Iron Deficiency Anemia (IDA)
- Restless Legs Syndrome (RLS)
- Concomitant myelosuppressive chemotherapy
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/26 | Phase 4 | Not yet recruiting | Cardiochirurgia E.H. | ||
2025/05/29 | Not Applicable | Not yet recruiting | |||
2025/04/04 | Phase 4 | Completed | CMH Multan Institute of Medical Sciences | ||
2024/11/25 | Phase 4 | Completed | |||
2024/11/18 | Phase 2 | Recruiting | NanoEcho AB | ||
2024/11/05 | Phase 1 | Completed | |||
2024/11/01 | Phase 4 | Recruiting | |||
2024/10/15 | N/A | Recruiting | |||
2024/10/03 | Not Applicable | Recruiting | Riccardo Pfister | ||
2024/10/01 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| MISSION PHARMACAL COMPANY | 0178-0812 | ORAL | 27 mg in 1 1 | 5/3/2010 | |
| Mission Pharmacal Company | 0178-0813 | ORAL | 88.5 mg in 1 1 | 1/5/2024 | |
| Exeltis USA, Inc. | 0642-7473 | ORAL | 90 mg in 1 1 | 2/14/2023 | |
| Mission Pharmacal Company | 0178-0089 | ORAL | 90 mg in 1 1 | 1/8/2024 | |
| Deseret Biologicals, Inc. | 43742-2108 | ORAL | 12 [hp_X] in 1 mL | 5/27/2025 | |
| American Regent, Inc. | 0517-2325 | INTRAVENOUS | 20 mg in 1 mL | 6/1/2022 | |
| U.S. Pharmaceutical Corporation | 52747-620 | ORAL | 42.5 mg in 1 1 | 7/13/2022 | |
| A-S Medication Solutions | 50090-4541 | INTRAVENOUS | 20 mg in 1 mL | 10/1/2020 | |
| SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS | 73317-8222 | ORAL | 90 mg in 1 1 | 9/25/2020 | |
| U.S. Pharmaceutical Corporation | 52747-621 | ORAL | 17.5 mg in 1 1 | 7/13/2022 |
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 |
|---|---|---|---|---|---|
| FERROCYTE TABLET 50 mg | SIN06142P | TABLET, FILM COATED | 50 mg | 6/17/1991 | |
| MALTOFER DROPS 50 mg/ml | SIN05699P | SOLUTION | 50 mg/ml | 4/8/1991 | |
| AVOFER INJECTION 100MG/5ML | SIN16513P | INJECTION | 100mg/5ml | 6/16/2022 | |
| Velphoro® Chewable Tablets 500mg | SIN14727P | TABLET, CHEWABLE | 500 mg | 1/29/2015 | |
| MALTOFER SYRUP 50mg/5ml | SIN05700P | SYRUP | 50mg/5ml | 4/8/1991 | |
| HAEMO CAPSULE 100MG | SIN16565P | CAPSULE | 100 MG | 8/5/2022 | |
| EUROFER CHEW TABLETS | SIN12633P | TABLET | 100 mg | 12/23/2004 | |
| IBERET-FOLIC-500 TABLET | SIN05447P | TABLET, FILM COATED | 105 mg | 2/19/1991 | |
| VENOFER SOLUTION FOR INJECTION 100 mg/5 ml | SIN11354P | INJECTION | 100 mg/5 ml | 7/20/2000 |
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 |
|---|---|---|---|---|---|
| BIOME IRON + | 464031 | Medicine | A | 10/10/2024 | |
| DANMOT HERBALIX CHELATION FORMULA tablet bulk | 52268 | Danmot Pty Ltd | Medicine | A | 4/18/1995 |
| Conceive Plus Men's Fertility Support | 347978 | Medicine | A | 11/11/2020 | |
| ACTIVATED PROBIOTICS BIOME IRON + | 442603 | Medicine | A | 2/27/2024 | |
| VENOFER iron 100mg/5mL (as iron(III) hydroxide sucrose complex) injection | 98236 | Medicine | A | 5/19/2004 | |
| ACTIVATED PROBIOTICS BIOME IRON + | 315955 | Medicine | A | 3/29/2019 | |
| Vitamin C with Hesperidin Complex | 159838 | Medicine | A | 3/6/2009 |