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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
Background

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

Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy

Phase 3
Recruiting
Conditions
Iron Deficiency Anemia
Pregnancy
Interventions
First Posted Date
2022-07-18
Last Posted Date
2024-08-21
Lead Sponsor
Women and Infants Hospital of Rhode Island
Target Recruit Count
746
Registration Number
NCT05462704
Locations
🇺🇸

Women & Infants Hospital of Rhode Island, Providence, Rhode Island, United States

🇺🇸

Oregon Health and Sciences Uiversity Medical Center, Portland, Oregon, United States

🇺🇸

Heme-on-Call, Miami, Florida, United States

and more 5 locations

Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery)

Phase 3
Recruiting
Conditions
Gynecologic Cancer
Iron-deficiency
Anemia
Interventions
First Posted Date
2022-06-07
Last Posted Date
2025-04-25
Lead Sponsor
AHS Cancer Control Alberta
Target Recruit Count
82
Registration Number
NCT05407987
Locations
🇨🇦

Arthur J.E. Child Comprehensive Cancer Centre, Calgary, Alberta, Canada

Preoperative Monoferric for Abdominal Surgery

Phase 4
Not yet recruiting
Conditions
Anemia
Surgery
Interventions
First Posted Date
2022-02-28
Last Posted Date
2022-10-12
Lead Sponsor
Brigham and Women's Hospital
Target Recruit Count
32
Registration Number
NCT05258825
Locations
🇺🇸

Brigham and Women's Hospital, Boston, Massachusetts, United States

Multi-center Trial of Ferric Derisomaltose in Children 0 to <18 Years of Age With Iron Deficiency Anemia

Phase 3
Recruiting
Conditions
Iron Deficiency, Anaemia in Children
Interventions
First Posted Date
2022-01-05
Last Posted Date
2025-05-22
Lead Sponsor
Pharmacosmos A/S
Target Recruit Count
200
Registration Number
NCT05179226
Locations
🇺🇸

Pharmacosmos Investigational Site, Miami, Florida, United States

A Clinical Trial Assessing the Efficacy of Intravenous Iron for the Treatment of Anemia Following Cardiac Surgery

Phase 4
Completed
Conditions
Anemia Postoperative
Interventions
First Posted Date
2020-10-29
Last Posted Date
2023-06-28
Lead Sponsor
Michael Kremke
Target Recruit Count
110
Registration Number
NCT04608539
Locations
🇩🇰

Aarhus University Hospital, Aarhus, Denmark

Intravenous Iron Treatment in Patients With Heart Failure and Iron Deficiency: IRONMAN

Phase 4
Completed
Conditions
Left Ventricular Systolic Dysfunction
Chronic Heart Failure
Iron Deficiency
Interventions
First Posted Date
2015-12-30
Last Posted Date
2022-10-28
Lead Sponsor
University of Glasgow
Target Recruit Count
1160
Registration Number
NCT02642562
Locations
🇬🇧

New Cross Hospital, Wolverhampton, United Kingdom

🇬🇧

St. George's Hospital, Tooting, United Kingdom

🇬🇧

Torbay Hospital, Torquay, United Kingdom

and more 69 locations
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