Voxtalisib (XL765) Clinical Trials

Size	Price	Qty
5mg	USD 157
25mg	USD 497

Clinical Trials

Sanofi has sponsored several completed Phase 1 clinical trials evaluating the safety, pharmacokinetics, pharmacodynamics, and preliminary therapeutic activity of Voxtalisib (SAR245409, XL765). These investigations focused on cancer patients across various indications, including solid malignant neoplasms, hematologic malignancies (indolent non-Hodgkin lymphoma, mantle cell lymphoma, and chronic lymphocytic leukemia), and high-grade central nervous system tumors such as recurrent glioblastoma and grade IV astrocytoma.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01596270	Completed	Neoplasm Malignant	Sanofi	2012-06	Phase 1
NCT01410513	Completed	Indolent Non-Hodgkin Lymphoma\|Mantle Cell Lymphoma\|Chronic Lymphocytic Leukemia	Sanofi	2011-12	Phase 1
NCT01240460	Completed	Glioblastoma\|Astrocytoma Grade IV	Sanofi	2011-01	Phase 1

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

Check the Voxtalisib (XL765) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Voxtalisib functions as a dual inhibitor targeting phosphoinositide 3-kinase (PI3K) isoforms, particularly p110γ, alongside the mechanistic target of rapamycin (mTOR) and DNA-dependent protein kinase. By suppressing these downstream biochemical pathways, the molecule reduces tumor cell survival and growth, demonstrating therapeutic relevance against malignant neoplasms, hematologic malignancies such as non-Hodgkin lymphoma, and glioblastoma.

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>).