Voxtalisib (XL765) Analogue Clinical Trials

Size	Price	Qty
5mg	USD 210

Clinical Trials

Multiple completed Phase 1 clinical trials sponsored by Sanofi evaluated the safety, dosage, pharmacokinetics, and therapeutic potential of the compound across diverse oncological indications. These evaluations investigated solid malignant neoplasms, hematologic malignancies—including indolent non-Hodgkin lymphoma, mantle cell lymphoma, and chronic lymphocytic leukemia—and high-grade brain tumors such as glioblastoma and grade IV astrocytoma. Together, these early-phase studies established the agent's pharmacodynamics and therapeutic utility across various tumor types.

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) Analogue product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Voxtalisib (XL765) acts as a potent dual inhibitor of phosphoinositide 3-kinase (PI3K) isoforms—particularly p110γ—and mammalian target of rapamycin (mTOR), effectively blocking downstream AKT/mTOR signaling pathways crucial for oncogenic cell survival and proliferation. By suppressing these key enzymatic cascades, the compound induces apoptosis and inhibits cellular proliferation, which directly contributes to its therapeutic efficacy in solid tumors, hematologic malignancies, and glioblastoma evaluated in clinical trials.

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>).