VLX600 Clinical Trials

Size	Price	Qty
5mg	USD 97
25mg	USD 297

Clinical Trials

Multiple clinical trials have evaluated VLX600 to assess its safety and tolerability in patients with refractory advanced solid tumors. Sponsored by industry and clinical research organizations, specifically Vivolux AB and Theradex, these Phase 1 evaluations focused on establishing safety parameters for the drug. According to clinical trial registries, recruitment for these early-stage studies has been terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02222363	TERMINATED	Refractory Cancer	Vivolux AB	2015-02-18	PHASE1
NCT02222363	Terminated	Refractory Cancer	Vivolux AB\|Theradex	2015-02-18	Phase 1

(data from https://clinicaltrials.gov, updated on 2018-05-11)

Check the VLX600 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

VLX600 functions as an iron-chelating inhibitor of oxidative phosphorylation, which disrupts mitochondrial bioenergetics and triggers autophagy under conditions of nutrient starvation. This severe metabolic impairment and radiosensitizing effect suppress cell survival in dense microenvironments, providing a rationale for investigating its therapeutic potential against refractory advanced solid tumors.

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>).