Overview
Iron deficiency is an extremely common condition and is the most frequent cause of anemia worldwide. Iron deficiency results when iron intake, iron stores, and loss of iron from the body do not adequately support production of erythrocytes, also known as red blood cells. Though it is generally considered non life-threatening, iron deficiency may considerably affect quality of life. Ferric derisomaltose is a form of iron used in the treatment of iron deficiency. This drug is a complex of iron (III) hydroxide and derisomaltose. The latter is an iron carbohydrate oligosaccharide that works to release iron. Ferric derisomaltose was developed by Pharmacosmos Therapeutics ad was granted FDA approval in January 2020. Clinical trials show that it is non-inferior to iron sucrose, another form of iron that is often administered in iron deficiency, and less likely to cause serious hypersensitivity that is associated with other forms of injectable iron.
Indication
This drug is indicated for the treatment of iron deficiency anemia in adult patients who have experienced intolerance to oral iron preparations or insufficient clinical response to orally administered iron. Ferric derisomaltase is also indicated for patients with non-hemodialysis dependent chronic kidney disease. In Australia and United Kingdom, ferric derisomaltase is indicated for cases in which rapid delivery of iron is required.
Associated Conditions
- Iron Deficiency Anemia (IDA)
- Requirement for rapid iron delivery
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/04/16 | Phase 3 | Not yet recruiting | |||
2025/03/27 | Phase 4 | Recruiting | Soren Overgaard | ||
2024/08/07 | N/A | Recruiting | |||
2023/08/14 | Phase 4 | Recruiting | China-Japan Friendship Hospital | ||
2023/08/02 | Phase 4 | Recruiting | China-Japan Friendship Hospital | ||
2023/07/03 | Phase 4 | Recruiting | |||
2023/03/15 | Phase 3 | Recruiting | |||
2023/03/10 | Early Phase 1 | Not yet recruiting | |||
2023/02/06 | Phase 4 | Recruiting | |||
2022/07/20 | Phase 3 | UNKNOWN | Alberta Health Services, Calgary |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Pharmacosmos Therapeutics Inc. | 73594-9301 | INTRAVENOUS | 100 mg in 1 mL | 1/16/2024 | |
Pharmacosmos Therapeutics Inc. | 73594-9310 | INTRAVENOUS | 1000 mg in 10 mL | 1/16/2024 | |
Pharmacosmos Therapeutics Inc. | 73594-9305 | INTRAVENOUS | 500 mg in 5 mL | 1/16/2024 |
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 |
---|---|---|---|---|---|
MONOFER® SOLUTION FOR INJECTION OR INFUSION 100 MG/ML | SIN15855P | INJECTION, SOLUTION | 100 mg/ml | 11/14/2019 |
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 |
---|---|---|---|---|---|
MONOFER iron (as ferric derisomaltose) 100 mg/1 mL solution for injection vial | 280666 | A Menarini Australia Pty Ltd | Medicine | A | 12/4/2017 |
MONOFER iron (as ferric derisomaltose) 500 mg/5 mL solution for injection vial | 290833 | A Menarini Australia Pty Ltd | Medicine | A | 12/4/2017 |
MONOFER iron (as ferric derisomaltose) 1000 mg/10 mL solution for injection vial | 290834 | A Menarini Australia Pty Ltd | Medicine | A | 12/4/2017 |
MONOFER iron (as ferric derisomaltose) 200 mg/2 mL solution for injection vial | 290832 | A Menarini Australia Pty Ltd | Medicine | A | 12/4/2017 |
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