Clinical Trials

Numerous clinical trials spanning Phase 1, Phase 2, and Phase 4 have evaluated iopamidol under academic and industry sponsorship, encompassing completed, recruiting, terminated, and unknown recruitment statuses. These studies focus on drug safety, patient comfort, and contrast dosing, particularly during diagnostic imaging for peripheral arterial occlusive disease, duodenal and pancreatic neoplasms, and patients with chronic renal impairment, diabetes mellitus, or congestive heart failure.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06411795 RECRUITING
Duodenal Neoplasm; Pancreatic Neoplasm
Masonic Cancer Center, University of Minnesota
 2023-11-10 PHASE2
NCT04870645 COMPLETED
Malignant Solid Neoplasm
M.D. Anderson Cancer Center
 2021-03-30
NCT04930692 UNKNOWN
Breast Neoplasms; Sentinel Lymph Node
Saint Petersburg State University, Russia
 2022-10-01
NCT05489055 UNKNOWN
Contrast Media Adverse Reaction
Chongqing Emergency Medical Center
 2022-02-01
NCT03557385 COMPLETED
Percutaneous Coronary Intervention
Duke University
 2019-01-17 PHASE4
NCT03779906 TERMINATED
Hypothyroidism
Bracco Diagnostics, Inc
 2019-03-26 PHASE4
NCT04504331 TERMINATED
Breast Cancer; HER2-negative Breast Cancer; ER Positive Breast Cancer; PR-Positive Breast Cancer
Jennifer Lee Caswell-Jin
 2020-10-13 PHASE1
NCT03384979 COMPLETED
Contrast Agent With Lean Body Weight
IRCCS Policlinico S. Donato
 2017-12-18 PHASE4
NCT02433665 TERMINATED
CT of the Abdomen and Pelvis With Contrast Material
Duke University
 2015-08
NCT02467075 TERMINATED
Acute Kidney Injury
University of Michigan
 2015-07 PHASE4
NCT01475097 COMPLETED
Drug Safety
GE Healthcare
 2011-10 PHASE4
NCT01402219 TERMINATED
Chronic Renal Disease
Guangdong Provincial People's Hospital
 2008-11 PHASE4
NCT01252810 COMPLETED
Chronic Renal Insufficiency; Diabete Mellitus; Congestive Heart Failure
GE Healthcare
 2010-11 PHASE2
NCT01136915 TERMINATED
Coronary Artery Stenosis
Bracco Diagnostics, Inc
 2010-11 PHASE4
NCT01136876 COMPLETED
Coronary Artery Stenosis
Bracco Diagnostics, Inc
 2010-11 PHASE4
NCT01672996 COMPLETED
Healthy
GE Healthcare
 2012-07 PHASE1; PHASE2
NCT02040285 COMPLETED
Gastrointestinal Complication
Azienda Policlinico Umberto I
 2012-02 PHASE4
NCT01137786 COMPLETED
Coronary Artery Stenosis
Bracco Diagnostics, Inc
 2010-12 PHASE4
NCT01075217 COMPLETED
Peripheral Arterial Occlusive Disease
Bracco Diagnostics, Inc
 2010-04 PHASE4
NCT01475097 Completed
Drug Safety
GE Healthcare|i3 Statprobe
 2011-10 Phase 4
NCT01376089 COMPLETED
Patient Comfort and Safety
GE Healthcare
 2011-05 PHASE4
NCT00209417 TERMINATED
Renal Insufficiency; Diabetes Mellitus
GE Healthcare
 2005-06 PHASE4
NCT01376089 Completed
Patient Comfort and Safety
GE Healthcare|i3 Statprobe
 2011-05 Phase 4
NCT01252810 Completed
Chronic Renal Insufficiency|Diabete Mellitus|Congestive Heart Failure
GE Healthcare|i3 Statprobe|Medpace Inc.|Biomedical Systems|Rules-Based Medicine Inc.
 2010-11 Phase 2
NCT00558792 COMPLETED
Coronary Artery Disease
Bracco Diagnostics, Inc
 2007-11 PHASE2
NCT01075217 Completed
Peripheral Arterial Occlusive Disease
Bracco Diagnostics Inc
 2010-04 Phase 4
NCT00782639 TERMINATED
Chronic Renal Impairment; Diabetes Mellitus
Bracco Diagnostics, Inc
 2009-03 PHASE4
NCT00740207 Completed
Peripheral Arterial Occlusive Disease
Bracco Diagnostics Inc
 2008-09 Phase 4
NCT00292487 COMPLETED
Contrast Induced Nephropathy
Bracco Diagnostics, Inc
 2004-11 PHASE4
NCT00289029 COMPLETED
CIN
Bracco Diagnostics, Inc
 2005-07 PHASE4
NCT00289614 COMPLETED
Kidney Diseases
Bracco Diagnostics, Inc
 2006-01 PHASE4

(data from https://clinicaltrials.gov, updated on 2026-02-03)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a non-ionic, water-soluble tri-iodinated compound, iopamidol significantly increases X-ray attenuation within vascular and parenchymal tissues due to the high atomic mass of its iodine atoms. This radiopaque action generates an enhanced contrast differential between target tissues and surrounding structures, facilitating high-resolution visualization during diagnostic computed tomography and angiography in patients studied for conditions such as peripheral arterial occlusive disease and pancreatic neoplasms.

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.