Tolazoline HCl Clinical Trials

Size	Price	Qty
50mg	USD 97

Clinical Trials

A clinical trial sponsored by the University of California, Davis evaluated the therapeutic application of Tolazoline HCl for erectile dysfunction, specifically examining pelvic angiography in patients resistant to phosphodiesterase-5 inhibitor treatments. Although no formal trial phase was specified, the study successfully completed its recruitment phase. This investigation explored the clinical utility of the compound for this condition.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00574184	Completed	Erectile Dysfunction	University of California Davis	2005-08	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tolazoline HCl acts as a non-selective competitive α-adrenergic receptor antagonist, binding to α-adrenergic receptors to block sympathomimetic vasopressor signaling and promote vascular smooth muscle relaxation. By relieving adrenergic vasoconstriction and enhancing tissue perfusion, this pharmacological action directly relates to its clinical investigation in erectile dysfunction.

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>).