VS-5584 (SB2343) Clinical Trials

Size	Price	Qty
10mg	USD 197
50mg	USD 670

Clinical Trials

Verastem Inc. sponsored several Phase 1 clinical trials evaluating the safety and dose escalation of VS-5584 across advanced oncology indications, including non-hematologic malignancies, metastatic cancer, lymphoma, and relapsed malignant mesothelioma. These terminated studies investigated VS-5584 both as monotherapy and in combination with the focal adhesion kinase inhibitor VS-6063.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02372227	Terminated	Relapsed Malignant Mesothelioma	Verastem Inc.	2015-01	Phase 1
NCT01991938	Terminated	Non Hematologic Cancers\|Metastatic Cancer\|Lymphoma	Verastem Inc.	2013-11	Phase 1

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

Check the VS-5584 (SB2343) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

VS-5584 functions as a potent dual PI3K/mTOR inhibitor that selectively binds class I PI3K isoforms and mTOR, thereby blocking downstream AKT signaling cascades to suppress cell proliferation and induce apoptosis in neoplastic cells. This targeted disruption of primary survival and growth pathways provides the biological basis for investigating VS-5584 against advanced non-hematologic malignancies, lymphoma, and relapsed malignant mesothelioma.

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>).