VLX1570 Clinical Trials

Size	Price	Qty
5mg	USD 370
25mg	USD 970

Clinical Trials

Multiple Phase 1 and Phase 2 clinical trials sponsored by Vivolux AB and Theradex have evaluated VLX1570 in combination with low-dose dexamethasone for patients with relapsed or refractory multiple myeloma. These early-phase investigations were designed to assess the safety and efficacy of targeted proteasomal inhibition in hematologic malignancies. Currently, recruitment across these clinical trials is documented as terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02372240	TERMINATED	Multiple Myeloma	Vivolux AB	2015-04-08	PHASE1; PHASE2
NCT02372240	Terminated	Multiple Myeloma	Vivolux AB\|Theradex	2015-04-08	Phase 1\|Phase 2

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

Check the VLX1570 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

VLX1570 functions as a competitive inhibitor of proteasome deubiquitinating enzyme activity, which blocks the clearance of polyubiquitinated protein substrates and induces acute proteotoxic stress leading to apoptotic cell death. By disrupting protein homeostasis and triggering cellular toxicity in malignant plasma cells, this targeted mechanism provides the biological rationale for evaluating the compound in multiple myeloma.

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>).