AT7519 Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Multiple Phase I and Phase I/II clinical trials have evaluated AT7519 as monotherapy or in combination regimens with agents such as bortezomib or an HSP90 inhibitor. These studies investigated indications including multiple myeloma, lymphoma, and advanced, metastatic, or unresectable solid neoplasms. Sponsored by industry and government organizations—including Astex Pharmaceuticals Inc., the Multiple Myeloma Research Consortium, the NCIC Clinical Trials Group, and the National Cancer Institute—all of these trials have completed recruitment.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02503709	COMPLETED	Advanced Malignant Solid Neoplasm; Metastatic Malignant Solid Neoplasm; Unresectable Solid Neoplasm	National Cancer Institute (NCI)	2016-09-30	PHASE1
NCT00390117	COMPLETED	Lymphoma; Unspecified Adult Solid Tumor, Protocol Specific	NCIC Clinical Trials Group	2007-01-05	PHASE1
NCT01183949	Completed	Multiple Myeloma	Astex Pharmaceuticals Inc.\|Multiple Myeloma Research Consortium	2010-11	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2025-02-10)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

AT7519 selectively binds to and inhibits cyclin-dependent kinases, thereby blocking downstream phosphorylation of RNA polymerase II and downregulating the anti-apoptotic protein Mcl-1. This targeted inhibition induces cell cycle arrest and triggers apoptosis, suppressing cellular proliferation in clinical conditions such as multiple myeloma, lymphoma, and 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>).