Numerous clinical trials spanning early phase 1 through phase 4 evaluate diagnostic and therapeutic applications of DFO for conditions including HER2-positive breast and gastric cancers, prostate cancer, multiple myeloma, amyotrophic lateral sclerosis, beta-thalassemia, and diabetic foot osteomyelitis. Sponsored by academic centers and pharmaceutical collaborators such as AstraZeneca, Eli Lilly, and Genzyme, these investigations assess targeted radiotracers and iron-chelating strategies for PET imaging efficacy and biodistribution. Across this landscape, protocol statuses range from actively recruiting to active but not recruiting and completed.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06447103 | RECRUITING | Clear Cell Renal Cell Carcinoma; Sarcomatoid Renal Cell Carcinoma; Stage II Renal Cell Cancer; Stage III Renal Cell Cancer; Stage IV Renal Cell Cancer |
Jonsson Comprehensive Cancer Center |
2024-08-06 | PHASE2 |
| NCT07664397 | NOT_YET_RECRUITING | Bladder Cancer; Nerve Sheath Tumor; Nerve Sheath Tumors; Solid Tumor Malignancies; Solid Tumor Cancer; Solid Tumor Neoplasms; Advanced Solid Tumor; Bladder Neoplasm; Nerve Sheath Neoplasms; Nerve Sheath Tumor, Nos; Solid Tumor, Adult; Solid Carcinoma |
Robert Flavell, MD, PhD |
2026-08-01 | PHASE1 |
| NCT03546335 | SUSPENDED | Rheumatoid Arthritis |
Robert Flavell, MD, PhD |
2018-10-01 | PHASE1 |
| NCT07179770 | RECRUITING | Metastatic Clear Cell Renal Cell Carcinoma |
NYU Langone Health |
2025-09-15 | PHASE1 |
| NCT06439914 | RECRUITING | Non Small Cell Lung Cancer |
Nerissa T. Viola |
2026-03-09 | PHASE1 |
| NCT06894745 | RECRUITING | Solid Tumor; Solid Carcinoma; Soft Tissue Lesion |
Robert Flavell, MD, PhD |
2025-06-02 | PHASE1 |
| NCT05184816 | RECRUITING | Leptomeningeal Metastases |
Memorial Sloan Kettering Cancer Center |
2021-12-22 | PHASE1 |
| NCT04167969 | RECRUITING | Prostate Cancer |
Memorial Sloan Kettering Cancer Center |
2021-02-17 | PHASE1 |
| NCT07790939 | NOT_YET_RECRUITING | Epithelial Ovarian Cancer; Ovarian Cancer |
Peking University Cancer Hospital & Institute |
2026-09-01 | EARLY_PHASE1 |
| NCT05245006 | ACTIVE_NOT_RECRUITING | Prostate Cancer; Metastatic Castration-resistant Prostate Cancer |
Robert Flavell, MD, PhD |
2022-03-18 | PHASE1 |
| NCT04199741 | RECRUITING | Small Cell Lung Cancer; Small Cell Lung Carcinoma |
Memorial Sloan Kettering Cancer Center |
2019-12-11 | PHASE1; PHASE2 |
| NCT06602037 | RECRUITING | Neoplasms Pancreatic |
RenJi Hospital |
2024-11-20 | |
| NCT06952556 | RECRUITING | Analgesia |
NYU Langone Health |
2025-04-28 | PHASE4 |
| NCT03465618 | ACTIVE_NOT_RECRUITING | Brain Cancer; Pituitary Adenoma |
Memorial Sloan Kettering Cancer Center |
2018-03-07 | PHASE1 |
| NCT05259709 | RECRUITING | Advanced Solid Tumor; Metastatic Solid Tumor |
Regeneron Pharmaceuticals |
2023-02-07 | PHASE1 |
| NCT06337084 | ACTIVE_NOT_RECRUITING | Solid Tumor, Adult; Bladder Cancer; Urothelial Carcinoma; Triple-negative Breast Cancer; Lung Cancer; Colorectal Cancer; Gastric Cancer; Ovarian Cancer; Pancreatic Cancer |
Monopar Therapeutics |
2024-05-30 | PHASE1 |
| NCT03729752 | RECRUITING | HIV-1-infection |
University of California, San Francisco |
2018-11-01 | PHASE1 |
| NCT04235114 | RECRUITING | Lung Cancer; Colorectal Cancer |
University of Saskatchewan |
2020-02-01 | PHASE1; PHASE2 |
| NCT04006522 | ACTIVE_NOT_RECRUITING | Renal Cell Carcinoma |
James Brugarolas |
2019-10-02 | PHASE2 |
| NCT05892393 | RECRUITING | Multiple Myeloma; Plasma Cell Myeloma |
Robert Flavell, MD, PhD |
2023-06-16 | PHASE1 |
| NCT06645808 | RECRUITING | Solid Tumor; Colon Carcinoma; Rectal Carcinoma; Osteosarcoma; Chondrosarcoma; Lung Carcinoma; Head and Neck Squamous Cell Carcinoma; Esophageal Carcinoma; Gastric Carcinoma; Pancreas Carcinoma; Bladder Carcinoma; Glioblastoma; Soft Tissue Sarcoma (STS); Breast Cancer |
Var2 Pharmaceuticals |
2024-12-10 | EARLY_PHASE1 |
| NCT06244979 | COMPLETED | Pulmonary Aspergillosis; Chronic Pulmonary Aspergillosis; Allergic Bronchopulmonary Aspergillosis |
Radboud University Medical Center |
2025-05-01 | PHASE2 |
| NCT06454721 | COMPLETED | Healthy Volunteer |
Biogen |
2025-01-30 | PHASE1 |
| NCT01543659 | COMPLETED | Prostate Cancer |
Memorial Sloan Kettering Cancer Center |
2012-02-21 | PHASE1; PHASE2 |
| NCT04706715 | ACTIVE_NOT_RECRUITING | Metastatic Solid Tumor |
University Medical Center Groningen |
2022-01-18 | PHASE1; PHASE2 |
| NCT06204237 | RECRUITING | Peripheral Arterial Occlusive Disease; Critical Limb Ischemia |
Aplagon Oy |
2024-02-01 | EARLY_PHASE1 |
| NCT04566978 | COMPLETED | Large B-cell Lymphoma; DLBCL |
Memorial Sloan Kettering Cancer Center |
2020-09-11 | EARLY_PHASE1 |
| NCT05955833 | COMPLETED | Breast Cancer; Metastatic Breast Cancer; HER2-positive Breast Cancer; Gastric Cancer; Metastatic Gastric Cancer; HER2-positive Gastric Cancer |
Amsterdam UMC, location VUmc |
2023-06-26 | |
| NCT04883775 | COMPLETED | Pancreatic Cancer; Tumors That Express CA19-9 |
Memorial Sloan Kettering Cancer Center |
2021-05-10 | PHASE1 |
| NCT05974579 | COMPLETED | Amyotrophic Lateral Sclerosis |
Université de Sherbrooke |
2023-11-23 | PHASE1 |
| NCT06066801 | Recruiting | Subjects With Diabetes and DFU With a Suspicion of DFO |
Assistance Publique - Hôpitaux de Paris |
2024-03-14 | Not Applicable |
| NCT06204237 | Recruiting | Peripheral Arterial Occlusive Disease|Critical Limb Ischemia |
Aplagon Oy|TRACER Europe BV |
2024-02-01 | Early Phase 1 |
| NCT05974579 | Recruiting | Amyotrophic Lateral Sclerosis |
Université de Sherbrooke|Eli Lilly and Company|Chorus Wellness Inc.|AL-S Pharma AG |
2023-11-23 | Phase 1 |
| NCT06468423 | COMPLETED | Pateints of β-thalassemia Major With Iron Overload |
RESnTEC, Institute of Research |
2023-01-01 | |
| NCT02023996 | COMPLETED | Esophagogastric Cancer |
Memorial Sloan Kettering Cancer Center |
2013-12 | |
| NCT05955833 | Recruiting | Breast Cancer|Metastatic Breast Cancer|HER2-positive Breast Cancer|Gastric Cancer|Metastatic Gastric Cancer|HER2-positive Gastric Cancer |
Amsterdam UMC location VUmc|AstraZeneca |
2023-06-26 | Phase 1 |
| NCT01774071 | COMPLETED | Prostate Cancer |
Memorial Sloan Kettering Cancer Center |
2013-01 | PHASE1; PHASE2 |
| NCT03746704 | TERMINATED | Advanced PD-L1 Positive Malignancies |
Regeneron Pharmaceuticals |
2019-09-04 | PHASE1 |
| NCT04467281 | WITHDRAWN | Multiple Myeloma |
Memorial Sloan Kettering Cancer Center |
2020-06-30 | PHASE2 |
| NCT03665155 | COMPLETED | Multiple Myeloma |
Memorial Sloan Kettering Cancer Center |
2018-09-05 | PHASE1; PHASE2 |
| NCT07782931 | COMPLETED | Iron Overload Due to Repeated Red Blood Cell Transfusions; Thalassemia Majors (Beta-Thalassemia Major) |
Hamdard University |
2019-02-11 | PHASE3 |
| NCT03109977 | COMPLETED | HER2-positive Carcinoma; HER2-positive Primary Malignancy |
Memorial Sloan Kettering Cancer Center |
2017-03-31 | PHASE1 |
| NCT02687230 | TERMINATED | Pancreatic Carcinoma; Tumors That Express CA19-9 |
BioNTech Research & Development, Inc. |
2016-07-11 | PHASE1 |
| NCT02216513 | TERMINATED | Subarachnoid Hemorrhage |
Brigham and Women's Hospital |
2014-09 | EARLY_PHASE1 |
| NCT01459718 | TERMINATED | Transfusion-dependent β-thalassemia Patients; Cardiac Iron Overload |
Novartis Pharmaceuticals |
2011-01 | PHASE2 |
| NCT01844479 | COMPLETED | Diabetic Foot Ulcer; Diabetic Foot |
University of Michigan |
2012-12 | |
| NCT01511848 | UNKNOWN | Beta-thalassemia Major; Sickle Cell Disease; Iron Hemosiderosis |
Ain Shams University |
2012-02 | PHASE2; PHASE3 |
| NCT00901199 | COMPLETED | Thalassemia; Iron Overload |
Elliott Vichinsky |
2007-09 | PHASE2 |
| NCT01090323 | COMPLETED | Sickle Cell Disease |
Novartis Pharmaceuticals |
2004-07 | PHASE2 |
| 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 |
| NCT00733811 | COMPLETED | Beta-Thalassemia; Thalassemia Major |
Azienda Ospedaliera V. Cervello |
2000-09 | PHASE4 |
| NCT00069862 | COMPLETED | Beta-Thalassemia |
Genzyme, a Sanofi Company |
2003-09 | PHASE1; PHASE2 |
(data from https://clinicaltrials.gov, updated on 2026-06-15)
Check the
DFO
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
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>).
Note: Technical data last updated: Sep 1, 2026.