Numerous clinical trials evaluate iohexol as an exogenous filtration marker to assess renal function across Phase 1 through Phase 4 studies, including early Phase 1 protocols. Sponsored by academic medical centers, government organizations, and pharmaceutical entities such as Eli Lilly and Mayo Clinic, these protocols range from completed to actively recruiting. They examine plasma clearance in conditions including type 2 diabetes, chronic kidney disease, acute decompensated heart failure, HIV, and kidney transplantation, underscoring iohexol's essential role in quantifying precise glomerular filtration rates across nephrology, cardiology, and metabolic disease research.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07246265 | RECRUITING | Sickle Cell Disease; Glomerular Hyperfiltration; Sickle Cell Nephropathy; Vaso-Occlusive Crises; Acute Chest Syndrome |
University Hospital, Tours |
2026-03-05 | |
| NCT07643467 | NOT_YET_RECRUITING | Augmented Renal Clearance; Critical Illness |
Aaron Cook |
2026-09 | PHASE4 |
| NCT03997370 | ACTIVE_NOT_RECRUITING | Malignant Solid Neoplasm |
NRG Oncology |
2020-01-15 | PHASE1 |
| NCT07042698 | NOT_YET_RECRUITING | Kidney Diseases; Tomography; X-Ray Computed |
Assistance Publique - Hôpitaux de Paris |
2025-07-15 | |
| NCT05065372 | RECRUITING | Type 1 Diabetes; Diabetic Kidney Disease; Cardiovascular Diseases; Endothelial Dysfunction; Insulin Sensitivity |
Kalie Tommerdahl |
2022-07-01 | PHASE1 |
| NCT07339722 | RECRUITING | Healthy |
Eli Lilly and Company |
2026-01-15 | PHASE1 |
| NCT07174440 | RECRUITING | Pain |
University Hospitals Cleveland Medical Center |
2025-09-15 | |
| NCT07349797 | RECRUITING | Glomerular Filtration Rate; Heart Failure |
MediBeacon |
2026-08-10 | |
| NCT04126824 | ACTIVE_NOT_RECRUITING | Uterine Fibroids; Adenomyosis |
University of California, Los Angeles |
2022-01-06 | EARLY_PHASE1 |
| NCT06709521 | COMPLETED | Bacterial Infection |
National Institute of Allergy and Infectious Diseases (NIAID) |
2025-02-12 | PHASE4 |
| NCT05754749 | TERMINATED | Breast Cancer |
UNC Lineberger Comprehensive Cancer Center |
2023-03-13 | EARLY_PHASE1 |
| NCT04776486 | COMPLETED | Augmented Renal Clearance; Critically Ill |
Assistance Publique - Hôpitaux de Paris |
2020-09-03 | |
| NCT06820320 | COMPLETED | Chylous Ascites; Abdominal Neoplasm; Pelvic Neoplasms; Retroperitoneal Lymph Node Metastasis; Retroperitoneal Lymphadenectomy; Extended Lymphadenectomy |
Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
2025-02-15 | PHASE2 |
| NCT06259422 | UNKNOWN | Kidney Function Issue; Diagnosis; Chronic Kidney Diseases |
University Medical Center Groningen |
2024-06-01 | |
| NCT04649229 | COMPLETED | Heart Failure |
Yale University |
2021-05-27 | PHASE4 |
| NCT04113109 | COMPLETED | Heart Failure |
Vanderbilt University Medical Center |
2019-11-01 | PHASE4 |
| NCT05136963 | UNKNOWN | Kidney Function Test |
Centre Hospitalier Universitaire de Saint Etienne |
2024-06 | PHASE1 |
| NCT06238310 | UNKNOWN | Acute Kidney Injury; Chronic Kidney Insufficiency |
Katalin Kiss |
2023-08-01 | |
| NCT05967117 | UNKNOWN | Pulmonary Disease |
Jung Im Jung |
2023-11-24 | PHASE4 |
| NCT03620773 | COMPLETED | Type 2 Diabetes Mellitus; Obesity; Bariatric Surgery Candidate; Nephropathy; Diabetic Kidney Disease; Diabetes Mellitus, Type 2; Diabetes Mellitus; Diabetes Complications; Weight Loss; Diabetic Nephropathies; Adolescent Obesity; Pediatric Obesity |
University of Colorado, Denver |
2018-10-01 | PHASE1; PHASE2 |
| NCT05672134 | COMPLETED | Heart Failure With Preserved Ejection Fraction |
Amsterdam UMC, location VUmc |
2023-04-26 | PHASE2 |
| NCT03631771 | WITHDRAWN | Hypothyroidism |
GE Healthcare |
2022-03 | PHASE4 |
| NCT05136963 | Not yet recruiting | Kidney Function Test |
Centre Hospitalier Universitaire de Saint Etienne |
2024-06 | Phase 1 |
| NCT06244758 | Recruiting | Type2diabetes |
University of Erlangen-Nürnberg Medical School|Bayer |
2024-01-18 | Phase 3 |
| NCT06110299 | UNKNOWN | Ureteral Obstruction |
Assiut University |
2023-10-29 | |
| NCT06036914 | Enrolling by invitation | Heart Failure; With Decompensation |
Mayo Clinic |
2023-11-27 | Phase 2 |
| NCT05105009 | COMPLETED | Chronic Kidney Failure |
Instituto Nacional de Cardiologia Ignacio Chavez |
2020-03-03 | PHASE1 |
| NCT03584217 | ACTIVE_NOT_RECRUITING | Type 2 Diabetes Mellitus; Obesity; Nephropathy; Adolescent Obesity |
University of Colorado, Denver |
2018-10-01 | PHASE1; PHASE2 |
| NCT02276066 | COMPLETED | Sepsis |
University of Florida |
2015-02 | |
| NCT05065073 | COMPLETED | Coronary Artery Disease; Contrast Media Reaction |
Minneapolis Heart Institute Foundation |
2021-09-30 | PHASE4 |
| NCT04627831 | WITHDRAWN | Contrast-induced Nephropathy |
Ligand Pharmaceuticals |
2022-01 | PHASE2 |
| NCT05536804 | Recruiting | Overweight|Obesity|Chronic Kidney Disease|Type 2 Diabetes|T2D |
Eli Lilly and Company |
2023-02-08 | Phase 2 |
| NCT05615467 | COMPLETED | Healthy |
Eli Lilly and Company |
2022-11-15 | PHASE1 |
| NCT05580250 | WITHDRAWN | Healthy |
Eli Lilly and Company |
2022-11-22 | PHASE1 |
| NCT02961478 | COMPLETED | Acute Renal Failure |
University Hospital, Angers |
2017-02-10 | PHASE3 |
| NCT04742816 | COMPLETED | Transgender; Renal Function; Hormone Replacement Therapy |
University of California, San Diego |
2020-09-17 | PHASE4 |
| NCT02772276 | COMPLETED | Acute Kidney Injury |
MediBeacon |
2016-05-11 | PHASE2 |
| NCT05179564 | COMPLETED | Iohexol; Pharmacokinetics; Renal Function; Critically Ill Children; Acute Kidney Injury; Augmented Renal Clearance |
University Hospital, Ghent |
2018-05-20 | |
| NCT04008992 | COMPLETED | Healthy Participants |
Bristol-Myers Squibb |
2019-06-18 | PHASE1 |
| NCT03912012 | COMPLETED | Diabetes Mellitus, Type 1; Type1diabetes |
Hospices Civils de Lyon |
2019-07-09 | |
| NCT04156750 | COMPLETED | Healthy |
Eli Lilly and Company |
2019-11-20 | PHASE1 |
| NCT03618420 | COMPLETED | Diabetes Mellitus, Type 1; Nephropathy; Diabetic Nephropathies; Juvenile Diabetes; Diabetes Mellitus Complication; Autoimmune Diabetes; Type 1 Diabetes Mellitus |
University of Colorado, Denver |
2018-10-01 | PHASE1; PHASE2 |
| NCT03769597 | COMPLETED | Cirrhosis Renal |
University Hospital, Limoges |
2019-01-02 | PHASE4 |
| NCT03869983 | COMPLETED | Contrast-induced Nephropathy; Coronary Angiography |
CyDex Pharmaceuticals, Inc. |
2019-04-12 | |
| NCT03826602 | COMPLETED | Drug-drug Interaction |
Seagen Inc. |
2019-02-12 | PHASE1 |
| NCT02133599 | COMPLETED | ALL |
Ann & Robert H Lurie Children's Hospital of Chicago |
2014-07-24 | |
| NCT03545087 | WITHDRAWN | Renal Insufficiency |
Eli Lilly and Company |
2018-06 | PHASE1 |
| NCT03415997 | COMPLETED | Contrast Media Dosing |
Nova Scotia Health Authority |
2018-02-21 | PHASE4 |
| NCT01188486 | TERMINATED | Lung Cancer; Lung Cancer Non-Small Cell Cancer (NSCLC); Lung Cancer Small Cell Lung Cancer (SCLC); Mesothelioma |
Stanford University |
2010-08 | |
| NCT02884089 | COMPLETED | Healthy |
Eli Lilly and Company |
2016-08 | PHASE1 |
| NCT01839526 | TERMINATED | Fabry Disease |
Genzyme, a Sanofi Company |
2013-05 | PHASE1 |
| NCT02050269 | COMPLETED | Acute Circulatory Failure |
University Hospital, Tours |
2014-01 | PHASE3 |
| NCT02246998 | COMPLETED | HIV-1 Infection |
Gilead Sciences |
2014-12-15 | PHASE4 |
| NCT02202512 | COMPLETED | Healthy |
Boehringer Ingelheim |
2014-09 | PHASE1 |
| NCT01978314 | COMPLETED | Chronic Kidney Disease; Acute Kidney Injury |
FAST BioMedical |
2013-08 | |
| NCT02098187 | COMPLETED | Glomerular Filtration Rate; Acute Kidney Injury |
MediBeacon |
2014-03 | PHASE1 |
| NCT02420041 | COMPLETED | Sacroiliitis |
United States Naval Medical Center, San Diego |
2012-10 | |
| NCT02098174 | COMPLETED | Glomerular Filtration Rate; Acute Kidney Injury |
MediBeacon |
2013-11 | PHASE1 |
| NCT02522338 | COMPLETED | HIV |
Centre Hospitalier Universitaire de Saint Etienne |
2011-02 | PHASE4 |
| NCT01790139 | COMPLETED | Colorectal Neoplasms |
Asan Medical Center |
2013-02 | |
| NCT01214993 | COMPLETED | Infections, Human Immunodeficiency Virus and Tuberculosis |
ViiV Healthcare |
2010-10 | PHASE1 |
| NCT01392313 | WITHDRAWN | Carnitine Ingestion |
Montefiore Medical Center |
2010-05 |
(data from https://clinicaltrials.gov, updated on 2026-03-10)
Check the
Iohexol
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.