ARQ 621 Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 497

Clinical Trials

Sponsored by ArQule, Inc., a subsidiary of Merck & Co., Inc., several clinical trials have evaluated the safety, tolerability, and preliminary efficacy of ARQ 621. These Phase 1 dose-escalation evaluations focused on adult patients with metastatic solid tumors or refractory or relapsed hematologic malignancies to assess the compound's safety profile and maximum tolerated dose. Currently, all clinical trial records for ARQ 621 reflect a completed recruitment status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00825487	COMPLETED	Metastatic Solid Tumors, Refractory/Relapsed Hematologic Malignancies	ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)	2009-08	PHASE1
NCT00825487	Completed	Metastatic Solid Tumors Refractory/Relapsed Hematologic Malignancies	ArQule Inc. a subsidiary of Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc. (Rahway NJ USA)	2009-08	Phase 1

(data from https://clinicaltrials.gov, updated on 2011-10-19)

Check the ARQ 621 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

ARQ 621 functions as an allosteric, selective inhibitor of the Eg5 mitotic motor protein, binding to the kinesin motor domain to disrupt bipolar mitotic spindle assembly and induce cell cycle arrest at the G2/M transition. This persistent disruption of mitotic progression triggers apoptotic cell death, ultimately inhibiting tumor cell proliferation in metastatic solid tumors and refractory or relapsed hematologic malignancies.

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>).