AT7519 HCl Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

A completed clinical trial evaluated AT7519 as both monotherapy and in combination with bortezomib in patients with previously treated multiple myeloma. Sponsored collaboratively by Astex Pharmaceuticals Inc. and the Multiple Myeloma Research Consortium, this open-label, combined Phase I/II study demonstrated targeted interest in multi-cyclin-dependent kinase inhibition for relapsed or refractory hematologic malignancies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01183949	Completed	Multiple Myeloma	Astex Pharmaceuticals Inc.\|Multiple Myeloma Research Consortium	2010-11	Phase 1\|Phase 2

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

Check the AT7519 HCl product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AT7519 HCl selectively binds to and inhibits cyclin-dependent kinases, including CDK1, CDK2, CDK4, CDK6, and CDK9, thereby blocking key phosphorylation events required for cell cycle transition and active gene transcription. This biochemical inhibition leads to cell cycle arrest and induction of apoptosis, suppressing tumor cell proliferation in clinical indications such as 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>).