Overview
Natural product isolated from Streptomyces pilosus. It forms iron complexes and is used as a chelating agent, particularly in the mesylate form.
Indication
Used to treat acute iron or aluminum toxicity (an excess of aluminum in the body) in certain patients. Also used in certain patients with anemia who must receive many blood transfusions.
Associated Conditions
- Aluminum overload
- Chronic Iron Overload
- Chronic aluminum overload
- Iron Overload
Research Report
Deferoxamine (DB00746): A Comprehensive Pharmacological and Clinical Monograph
1.0 Executive Summary & Introduction
1.1 Overview
Deferoxamine, also known by its chemical name desferrioxamine and the brand name Desferal, is a hexadentate chelating agent with a long and established history in clinical medicine.[1] It is classified as a small molecule drug with the DrugBank identification number DB00746 and CAS Number 70-51-9.[2] The primary therapeutic application of Deferoxamine is the management of metal toxicity, specifically as a first-line parenteral antidote for acute iron intoxication and as a cornerstone therapy for chronic iron overload resulting from conditions that necessitate frequent blood transfusions, such as thalassemia and sickle cell disease.[1] Furthermore, it is employed in an off-label capacity for the treatment of aluminum toxicity, particularly in patients with renal failure undergoing dialysis.[1] The molecule itself is a natural siderophore, a high-affinity iron-chelating compound, isolated from the actinomycete
Streptomyces pilosus.[2] This biological origin is fundamental to its potent and specific therapeutic action.
1.2 Historical and Clinical Context
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/06/17 | Phase 2 | Not yet recruiting | |||
2025/01/08 | Phase 3 | Recruiting | |||
2024/06/21 | Not Applicable | Completed | |||
2024/04/08 | Phase 3 | Recruiting | |||
2023/02/28 | N/A | Completed | Aswan University Hospital | ||
2022/03/29 | Phase 2 | Terminated | Sun Yat-sen University | ||
2022/01/11 | Phase 1 | Recruiting | |||
2020/11/18 | Phase 2 | Completed | |||
2020/09/28 | Phase 2 | Recruiting | Aditya S. Pandey, MD | ||
2020/05/15 | Phase 4 | UNKNOWN | Hesham Al-Inany |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Apotex Corp. | 60505-6236 | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 500 mg in 1 1 | 12/1/2023 | |
Hospira, Inc. | 0409-2336 | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 500 mg in 1 1 | 3/1/2023 | |
ApoPharma USA, Inc. | 52609-4505 | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 500 mg in 1 1 | 10/7/2017 | |
Hospira, Inc. | 0409-2337 | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 2 g in 1 1 | 3/1/2023 | |
Alvogen Inc. | 47781-624 | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 2 g in 1 1 | 10/7/2017 | |
Fresenius Kabi USA, LLC | 63323-597 | INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS | 95 mg in 1 mL | 5/16/2017 | |
Apotex Corp. | 60505-6237 | INTRAMUSCULAR, INTRAVENOUS | 2 g in 1 1 | 12/1/2023 | |
Novartis Pharmaceuticals Corporation | 0078-0467 | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 500 mg in 1 1 | 9/9/2022 | |
Alvogen Inc. | 47781-623 | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 500 mg in 1 1 | 10/7/2017 | |
Fresenius Kabi USA, LLC | 63323-599 | INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS | 95 mg in 1 mL | 5/16/2017 |
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 |
---|---|---|---|---|---|
DBL DESFERRIOXAMINE MESYLATE FOR INJECTION BP 500 mg/vial | SIN09794P | INJECTION, POWDER, FOR SOLUTION | 500 mg/vial | 6/4/1998 |
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 |
---|---|---|---|---|---|
Hospira Desferrioxamine Mesilate 500 mg Powder for Injection vial | 137516 | Medicine | A | 4/16/2007 | |
Hospira Deferoxamine Mesylate 500 mg Powder for Injection Vial | 378150 | Medicine | A | 11/17/2021 | |
DBL DESFERRIOXAMINE MESYLATE FOR INJECTION 500mg powder for injection | 53942 | Medicine | A | 1/11/1996 | |
Hospira Desferrioxamine mesilate for Injection BP, 500 mg | 162013 | Medicine | A | 5/27/2009 | |
Desferoxamine Mesylate For Injection 2 g per vial | 315120 | Medicine | A | 3/6/2019 | |
DBL DESFERRIOXAMINE MESYLATE FOR INJECTION BP 2g/vial | 73173 | Medicine | A | 2/24/2000 | |
Hospira Desferrioxamine Mesilate for Injection, BP 500 mg/vial | 144548 | Medicine | A | 9/11/2007 | |
Hospira Desferrioxamine Mesilate for Injection 2g/vial | 67277 | Medicine | A | 12/16/1998 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
DESFERAL 500MG | novartis pharmaceuticals canada inc | 01981242 | Powder For Solution - Intramuscular
,
Intravenous
,
Intraperitoneal
,
Subcutaneous | 500 MG / VIAL | 12/31/1992 |
DESFERAL 2G | novartis pharmaceuticals canada inc | 01981250 | Powder For Solution - Subcutaneous
,
Intramuscular
,
Intraperitoneal
,
Intravenous | 2 G / VIAL | 12/31/1992 |
PMS-DEFEROXAMINE | 02242055 | Powder For Solution - Intravenous
,
Intramuscular
,
Intraperitoneal
,
Subcutaneous | 500 MG / VIAL | 5/24/2000 | |
DEFEROXAMINE MESYLATE FOR INJECTION | 02247022 | Powder For Solution - Subcutaneous
,
Intraperitoneal
,
Intravenous
,
Intramuscular | 2 G / VIAL | 1/12/2004 | |
DEFEROXAMINE MESYLATE FOR INJECTION | 02241600 | Powder For Solution - Intravenous
,
Intramuscular
,
Subcutaneous
,
Intraperitoneal | 500 MG / VIAL | 4/12/2000 | |
DEFEROXAMINE MESYLATE FOR INJECTION | 02261820 | Powder For Solution - Intravenous
,
Subcutaneous
,
Intraperitoneal
,
Intramuscular | 2 G / VIAL | N/A | |
PMS-DEFEROXAMINE | 02243450 | Powder For Solution - Intraperitoneal
,
Intravenous
,
Subcutaneous
,
Intramuscular | 2 G / VIAL | 8/21/2001 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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