Varoglutamstat (PQ912) Clinical Trials

Size	Price	Qty
5mg	USD 489
25mg	USD 1,469

Clinical Trials

The clinical trial landscape for varoglutamstat (PQ912) includes a clinical trial evaluating targeted glutaminyl cyclase inhibition for the treatment of early Alzheimer's disease and broader neurodegenerative disorders. Sponsored by Vivoryon Therapeutics N.V., this Phase 2, double-blind, placebo-controlled study was designed to assess safety, efficacy, and the reduction of neurotoxic amyloid species in affected patients. However, the recruitment status for this study is currently marked as terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03919162	TERMINATED	Alzheimer Disease	Vivoryon Therapeutics N.V.	2021-11-15	PHASE2

(data from https://clinicaltrials.gov, updated on 2025-12-12)

Check the Varoglutamstat (PQ912) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Varoglutamstat (PQ912) selectively inhibits human glutaminyl cyclase with a Ki of 25 nM, blocking the catalysis of N-truncated amyloid-beta peptides into pyroglutamyl-Aβ species. By preventing the accumulation of these neurotoxic pyroglutamyl-Aβ aggregates, the compound limits downstream neuroinflammation and neurodegeneration, providing clinical relevance for therapeutic development in Alzheimer's 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>).