Aminoguanidine hydrochloride Clinical Trials

Size	Price	Qty
100mg	USD 97
500mg	USD 297

Clinical Trials

Multiple completed clinical trials, including early-stage evaluations sponsored by academic institutions such as Imperial College London, Radboud University Medical Center, and the University of Minnesota, have assessed aminoguanidine hydrochloride across pulmonary, inflammatory, and microvascular disorders. These investigations focused on nitric oxide dynamics in asthma and chronic obstructive pulmonary disease, selective inducible nitric oxide synthase inhibition during human endotoxemia, and the restoration of retinal vascular responses in diabetic retinopathy.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02099981	COMPLETED	Diabetic Retinopathy	University of Minnesota	2016-07	PHASE1
NCT00180635	COMPLETED	Chronic Obstructive Pulmonary Disease	Imperial College London	2003-10
NCT00184990	COMPLETED	Endotoxemia	Radboud University Medical Center	2005-01	PHASE1
NCT00159380	COMPLETED	Asthma	Imperial College London	2003-09

(data from https://clinicaltrials.gov, updated on 2018-01-18)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Aminoguanidine hydrochloride acts as a dual inhibitor of nitric oxide synthase and diamine oxidase, binding to these enzyme targets to suppress excess nitric oxide synthesis and prevent the accumulation of advanced glycation end products through interactions with 3-deoxyglucosone. This inhibition attenuates vascular dysfunction and hyperinflammatory cascades, offering mechanistic relevance for clinical investigations in endotoxemia, diabetic retinopathy, asthma, and chronic obstructive pulmonary disease.

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>).