Iopromide Clinical Trials

Size	Price	Qty
5mg	USD 107

Clinical Trials

Several clinical trials evaluate the diagnostic utility, safety profile, and renal tolerability of iopromide across indications such as contrast-enhanced X-ray examinations, chronic pancreatitis recurrence risk, contrast medium safety, and chronic kidney failure. Spanning Phase IV and unassigned phase designs, these investigations are sponsored by academic medical centers and industry partners like Bayer, with recruitment statuses ranging from completed to not yet recruiting or unknown. These studies collectively refine risk assessments for renal toxicity and anaphylactoid reactions following intravascular administration.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05778929	Not yet recruiting	Pancreatitis Chronic	Peking University People''s Hospital	2023-04-01	--
NCT05428397	Completed	Contrast Enhanced X-ray Based Examination	Bayer	2022-06-30	--
NCT03622801	Completed	Contrast Medium	Bayer	2018-10-12	--
NCT01580046	Unknown status	Kidney Failure Chronic	Yong Huo\|Peking University First Hospital	2012-04	Phase 4

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Iopromide is a low-osmolal, non-ionic triiodinated contrast agent that attenuates X-ray transmission in proportion to the iodine density within intravascular and tissue spaces. By increasing the radiopacity of vascular and parenchymal structures, it produces distinct radiographic contrast that enables diagnostic visualization during contrast-enhanced X-ray examinations and computed tomography, supporting clinical evaluations in conditions such as chronic pancreatitis and chronic kidney failure.

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>).