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Ferric derisomaltose

Generic Name
Ferric derisomaltose
Drug Type
Small Molecule
Chemical Formula
C18H34FeO16
CAS Number
1345510-43-1
Unique Ingredient Identifier
AHU547PI9H

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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