Loureirin B Clinical Trials

Size	Price	Qty
1mg	USD 147

Clinical Trials

Several Phase 1 and Phase 2 clinical trials, sponsored by industry and academic entities including LG Chem, the University of California San Francisco, and The Netherlands Cancer Institute, are evaluating regimens associated with this entry. Ranging from not yet recruiting to active recruitment, these investigations assess dosage safety, pharmacokinetics, and combination strategies. Targeted indications encompass advanced solid malignancies—including non-small cell lung cancer, head and neck squamous cell carcinoma, renal cell carcinoma, urothelial carcinoma, malignant melanoma, and metastatic microsatellite-stable colorectal cancer—as well as heart failure with reduced ejection fraction and HIV infections.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06332755	Not yet recruiting	Non-small Cell Lung Cancer(NSCLC)\|Head and Neck Squamous Cell Carcinoma(HNSCC)\|Renal Cell Carcinoma(RCC)\|Urothelial Carcinoma\|Malignant Melanoma	LG Chem	2024-05	Phase 1
NCT06029712	Recruiting	Heart Failure With Reduced Ejection Fraction\|HIV Infections	University of California San Francisco	2024-02-27	Phase 2
NCT06012734	Not yet recruiting	Metastatic Microsatellite-stable Colorectal Cancer	The Netherlands Cancer Institute	2023-12	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Loureirin B functions as an inhibitor of plasminogen activator inhibitor-1 (PAI-1) and suppresses TGF-β1-induced ERK and JNK phosphorylation, which alters ATP-sensitive potassium current and intracellular calcium influx. This blockade of downstream signaling pathways attenuates cell proliferation and fibrotic extracellular remodeling, providing mechanistic relevance to clinical trials investigating therapeutic strategies in solid tumors such as non-small cell lung cancer and colorectal cancer.

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>).