Eprosartan Mesylate Clinical Trials

Size	Price	Qty
50mg	USD 97

Clinical Trials

Several clinical trials have evaluated the therapeutic and physiological effects of eprosartan across cardiovascular and metabolic parameters, focusing on hypertension, stroke risk estimation, and serum uric acid regulation following fructose administration. Sponsored by industry entities such as Abbott and academic institutions including the Medical University of Lodz, these completed studies lacked formal phase designations or were classified as phase not applicable.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01562613	Completed	Hypertension\|Stroke	Abbott	2012-03	--
NCT04954560	Completed	Uric Acid Concentration Serum Quantitative Trait Locus 7	Medical University of Lodz	2008-01-01	Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Eprosartan functions as a nonpeptide antagonist that selectively binds to the angiotensin II type 1 (AT1) receptor, thereby inhibiting angiotensin II-mediated vasoconstriction, aldosterone secretion, and cellular proliferation in vascular smooth muscle. This selective blockade reduces systemic vascular resistance and blood pressure, providing therapeutic efficacy in managing essential hypertension, mitigating stroke risk, and modulating metabolic parameters such as serum uric acid dynamics.

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>).