Urapidil Clinical Trials

Size	Price	Qty
25mg	USD 99

Clinical Trials

Multiple clinical trials sponsored by academic and medical institutions, including the First Affiliated Hospital of Sun Yat-Sen University and University Hospital Caen, have evaluated urapidil in acute care settings for anesthesia management, hypoxia, postoperative blood pressure control following brain arteriovenous malformation embolization, and ICU respiratory gas exchange. Characterized by completed or unknown recruitment statuses with phases designated as unspecified or not applicable, these investigations focus on urapidil's clinical utility for hemodynamic stabilization and physiological monitoring.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03076099	Unknown status	Anesthesia	Nan Jiang\|First Affiliated Hospital Sun Yat-Sen University	2016-01-01	Not Applicable
NCT05537194	Completed	Hypoxia	University Hospital Caen	1963-01-01	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Urapidil selectively binds as an antagonist to peripheral alpha1-adrenoreceptors and as an agonist to central 5-HT1A receptors, thereby inhibiting receptor-mediated intracellular calcium mobilization in vascular smooth muscle while reducing central sympathetic drive. This dual inhibition of vascular tone and attenuation of sympathetic output produces arterial vasodilation and lowers systemic vascular resistance, providing the physiological basis for its therapeutic use in managing hemodynamic stability during anesthesia and hypoxic conditions.

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>).