BEC HCl Clinical Trials

Size	Price	Qty
5mg	USD 117
25mg	USD 397

Clinical Trials

Multiple clinical trials sponsored by academic institutions, such as Thammasat University and Temple University, are evaluating therapeutic applications for severe asthma, mild-to-moderate asthma, and acute submassive pulmonary embolism. Active recruitment is currently underway for clinical studies in Thailand assessing remission outcomes in adult asthma patients, whereas an endovascular thrombolysis investigation for pulmonary embolism maintains an unknown recruitment status. Across these trials, phase classifications remain unspecified or listed as not applicable, reflecting ongoing biomedical research into modulating inflammatory airway conditions and managing acute thromboembolic events.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06120179	UNKNOWN	Acute Submassive Pulmonary Embolism	Temple University	2023-11

(data from https://clinicaltrials.gov, updated on 2023-11-07)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

BEC HCl functions as a slow-binding, competitive inhibitor of Arginase I and Arginase II, effectively preventing the enzymatic hydrolysis of L-arginine into L-ornithine and urea to increase local L-arginine availability for nitric oxide synthases. By promoting nitric oxide production and reducing downstream polyamine synthesis, this arginase blockade alleviates vascular hypertonicity and airway inflammation, offering strong mechanistic relevance for managing respiratory diseases such as asthma and thromboembolic disorders like pulmonary embolism.

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>).