TheraRadar
Data updated: May 26, 2026

DEFEROXAMINE MESYLATE

Other Approved 2004-03-17

DEFEROXAMINE MESYLATE is indicated for the treatment of Iron Intoxication; Iron Overload; Chronic Anemia.

Source: FDA Label • Fresenius Kabi

How DEFEROXAMINE MESYLATE Works

Deferoxamine mesylate chelates iron by forming a stable complex (ferrioxamine) that prevents the metal from engaging in further chemical reactions. It selectively chelates iron from ferritin and hemosiderin; however, it does not readily chelate iron from transferrin, nor does it interact with iron found in hemoglobin or cytochromes. The medication does not significantly increase the excretion of electrolytes or other trace metals. Stoichiometrically, 100 mg of deferoxamine mesylate is capable of binding approximately 8.5 mg of ferric iron.

Source: FDA Label
5
Indications
--
Phase 3 Trials
22
Years on Market

Details

Status
Prescription
First Approved
2004-03-17
Routes
INJECTION
Dosage Forms
INJECTABLE

DEFEROXAMINE MESYLATE Approval History

2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
36 FDA actions from 2004 to 2025
May 2025 SUPPL
Label · Labeling
Feb 2024 SUPPL
Label · Labeling
Nov 2023 SUPPL
Label · Labeling

What DEFEROXAMINE MESYLATE Treats

3 indications

DEFEROXAMINE MESYLATE is approved for 3 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Iron Intoxication
  • Iron Overload
  • Chronic Anemia
Source: FDA Label

DEFEROXAMINE MESYLATE Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

1

Same indication, different mechanism — what else might this patient receive?

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

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Clinical Trial Registry

3 trials
Trial Sponsor ID Phase Status Title
NCT06763055 INTERACT5 ACT-GLOBAL_ICH_01 Ph 3 recruiting The Fifth INTEnsive pReventing Secondary Injury in Acute Cerebral Haemorrhage Trial Within ACT-GLOBAL
NCT02175225 results posted 2012P000005 U01NS074425 Ph 2 completed Intracerebral Hemorrhage Deferoxamine Trial - iDEF Ttrial
NCT00598572 DFO In ICH 2007P000288 1R01NS057127-01A1 Ph 1 completed Dose Finding and Safety Study of Deferoxamine in Patients With Brain Hemorrhage
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

DEFEROXAMINE MESYLATE FDA Label Details

Indications & Usage

DEFEROXAMINE MESYLATE is indicated for the treatment of Iron Intoxication; Iron Overload; Chronic Anemia.

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Full clinical data, patents, trials, and competitive landscape for deferoxamine mesylate.

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.