Clinical Trials

Numerous clinical trials evaluate deferoxamine mesylate across a broad range of indications, primarily targeting iron overload, beta-thalassemia, subarachnoid hemorrhage, intracerebral hemorrhage, hematologic disorders, COVID-19, and non-resectable hepatocellular carcinoma. Spanning early Phase 1 through Phase 4, these studies are sponsored by academic medical centers, university hospitals, and industry partners such as Novartis Pharmaceuticals. The trial portfolio encompasses completed, actively recruiting, active non-recruiting, terminated, and withdrawn protocols.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06352632 RECRUITING
Stroke
The George Institute
 2024-09-26 PHASE3
NCT07162363 NOT_YET_RECRUITING
Intracerebral Hemorrhage; ICH - Intracerebral Hemorrhage
University of Illinois at Chicago
 2026-03-01 PHASE2; PHASE3
NCT06763055 RECRUITING
Intracerebral Hemorrhage; Spontaneous Intracerebral Hemorrhage; Supratentorial Intracerebral Haemorrhage; Acute Intracerebral Haemorrhage; Acute Stroke
The George Institute
 2025-02-27 PHASE3
NCT05184816 RECRUITING
Leptomeningeal Metastases
Memorial Sloan Kettering Cancer Center
 2021-12-22 PHASE1
NCT04566991 RECRUITING
Aneurysmal Subarachnoid Hemorrhage
Aditya S. Pandey, MD
 2022-03-20 PHASE2
NCT06244979 COMPLETED
Pulmonary Aspergillosis; Chronic Pulmonary Aspergillosis; Allergic Bronchopulmonary Aspergillosis
Radboud University Medical Center
 2025-05-01 PHASE2
NCT07023666 RECRUITING
Sickle Cell Disease
Inova Health Care Services
 2025-10-07 PHASE2
NCT03137966 UNKNOWN
Diabetic Foot Ulcer
Karolinska University Hospital
 2022-12-30 PHASE2
NCT05300958 TERMINATED
Triple Negative Breast Cancer
Sun Yat-sen University
 2022-03-21 PHASE2
NCT04633889 ACTIVE_NOT_RECRUITING
Acute Kidney Injury
Brigham and Women's Hospital
 2021-04-13 PHASE2
NCT02875262 UNKNOWN
Intracranial Aneurysm; Subarachnoid Hemorrhage
Radboud University Medical Center
 2022-12-02 PHASE1; PHASE2
NCT06468423 COMPLETED
Pateints of β-thalassemia Major With Iron Overload
RESnTEC, Institute of Research
 2023-01-01
NCT03652467 UNKNOWN
Hepatocellular Carcinoma Non-resectable
Jinan Military General Hospital
 2018-09-01 PHASE1
NCT04058197 WITHDRAWN
Chronic Cutaneous Ulcer; Sickle Cell Disease
TauTona Group
 2020-07-21 PHASE1; PHASE2
NCT04292314 COMPLETED
Iron Overload; Oxidative Stress; Thalassemia Major
Beni-Suef University
 2019-11-01 PHASE2; PHASE3
NCT04361032 UNKNOWN
COVID19; Intensive Care Unit
Abderrahmane Mami Hospital
 2020-09-04 PHASE3
NCT04333550 UNKNOWN
COVID-19
Kermanshah University of Medical Sciences
 2020-04 PHASE1; PHASE2
NCT07782931 COMPLETED
Iron Overload Due to Repeated Red Blood Cell Transfusions; Thalassemia Majors (Beta-Thalassemia Major)
Hamdard University
 2019-02-11 PHASE3
NCT02041299 TERMINATED
Iron Overload; Sickle Cell Disease; Other Anemias
ApoPharma
 2014-04-17 PHASE4
NCT02175225 COMPLETED
Intracerebral Hemorrhage
Beth Israel Deaconess Medical Center
 2014-10 PHASE2
NCT02367248 UNKNOWN
Intracerebral Hemorrhage
Capital Medical University
 2015-03 PHASE1; PHASE2
NCT02216513 TERMINATED
Subarachnoid Hemorrhage
Brigham and Women's Hospital
 2014-09 EARLY_PHASE1
NCT00870883 COMPLETED
Hypotension; Acute Renal Failure
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
 2009-03 PHASE2
NCT01459718 TERMINATED
Transfusion-dependent β-thalassemia Patients; Cardiac Iron Overload
Novartis Pharmaceuticals
 2011-01 PHASE2
NCT01662895 TERMINATED
Intracerebral Hemorrhage
Beth Israel Deaconess Medical Center
 2013-03-18 PHASE2
NCT01254227 COMPLETED
Cardiac Iron Overload
Novartis Pharmaceuticals
 2011-01 PHASE2
NCT00600938 COMPLETED
Transfusional Iron Overload; Transfusional Hemosiderosis
Novartis Pharmaceuticals
 2007-11 PHASE2
NCT00901199 COMPLETED
Thalassemia; Iron Overload
Elliott Vichinsky
 2007-09 PHASE2
NCT00658411 TERMINATED
Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Myelodysplastic Syndrome
Dana-Farber Cancer Institute
 2008-08
NCT00777140 COMPLETED
Ischemic Stroke, Acute
Germans Trias i Pujol Hospital
 2008-09 PHASE2
NCT00598572 COMPLETED
Intracerebral Hemorrhage
Beth Israel Deaconess Medical Center
 2008-07 PHASE1
NCT00738413 UNKNOWN
Thalassemia
Weill Medical College of Cornell University
 2008-08 PHASE1; PHASE2
NCT01090323 COMPLETED
Sickle Cell Disease
Novartis Pharmaceuticals
 2004-07 PHASE2
NCT00749515 COMPLETED
Transfusion-dependent Hemachromatosis; Thalassemia Major; Sickle Cell Disease
Boston Children's Hospital
 2008-03 PHASE4
NCT00115349 TERMINATED
Cardiovascular Diseases; Heart Diseases; Beta-Thalassemia
Carelon Research
 2005-06 PHASE2
NCT00110617 COMPLETED
Sickle Cell Disease; Iron Overload; Hemolytic Anemia
Novartis Pharmaceuticals
 2005-05 PHASE2
NCT01033747 COMPLETED
Liver Iron Overload
Novartis Pharmaceuticals
 2003-02 PHASE2; PHASE3
NCT00733811 COMPLETED
Beta-Thalassemia; Thalassemia Major
Azienda Ospedaliera V. Cervello
 2000-09 PHASE4
NCT00067080 COMPLETED
Anemia, Sickle Cell
Novartis Pharmaceuticals
 2003-05 PHASE2
NCT00800761 COMPLETED
Iron Overload; Cardiomyopathy
Ospedale Microcitemico
 2001-12 PHASE4
NCT00061763 COMPLETED
Beta-thalassemia; Myelodysplastic Syndromes; Fanconi Syndrome; Anemia, Diamond-Blackfan; Anemia, Aplastic
Novartis Pharmaceuticals
 2003-05 PHASE2
NCT00061750 COMPLETED
Beta-Thalassemia
Novartis Pharmaceuticals
 2003-05 PHASE3
NCT00000595 COMPLETED
Anemia (Iron-Loading); Beta-Thalassemia; Hematologic Diseases; Hemoglobinopathies; Thalassemia; Iron Overload; Hemochromatosis
National Heart, Lung, and Blood Institute (NHLBI)
 1978-01 PHASE2
NCT00105495 COMPLETED
Thalassemia Major; Hemosiderosis
ApoPharma
 2002-12 PHASE4
NCT00103753 UNKNOWN
Beta-Thalassemia
Royal Brompton & Harefield NHS Foundation Trust
 2004-05 PHASE4

(data from https://clinicaltrials.gov, updated on 2026-07-08)

Check the Deferoxamine mesylate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Deferoxamine mesylate acts as an iron-chelating agent that binds free trivalent ferric ions to form stable iron complexes, thereby preventing iron-mediated generation of toxic reactive oxygen species and inhibiting ferroptotic cell death. By reducing cellular iron accumulation and mitigating oxidative tissue injury, this mechanism provides therapeutic efficacy in managing chronic iron overload in conditions such as beta-thalassemia and limiting secondary injury in intracerebral hemorrhage.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.