Pilaralisib (XL147) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Multiple clinical trials sponsored by pharmaceutical companies Sanofi and Exelixis have evaluated the class I PI3K inhibitor pilaralisib (XL147) across various advanced malignancies. Encompassing Phase 1 dose-escalation and pharmacodynamic evaluations as well as Phase 2 single-agent studies, research has investigated solid tumors including recurrent glioblastoma, advanced or recurrent endometrial carcinoma, non-small cell lung cancer, ovarian carcinoma, and breast cancer. While several clinical trials have been completed, a clinical trial was withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01240460	Completed	Glioblastoma\|Astrocytoma Grade IV	Sanofi	2011-01	Phase 1
NCT01013324	Completed	Endometrial Cancer\|Endometrial Neoplasms	Sanofi	2010-01	Phase 2
NCT00756847	Completed	Cancer\|Non-Small Cell Lung Cancer\|Endometrial Carcinoma\|Ovarian Carcinoma	Sanofi	2008-09	Phase 1
NCT00704392	Withdrawn	Cancer\|Non-small-cell Lung Cancer\|Breast Cancer	Exelixis	2008-06	Phase 1

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

Check the Pilaralisib (XL147) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Pilaralisib (XL147) selectively and reversibly binds to class I phosphoinositide 3-kinase (PI3K) isoforms—specifically PI3Kα, PI3Kδ, and PI3Kγ—inhibiting the conversion of PIP2 to PIP3 and blocking downstream pro-survival AKT/mTOR signaling pathways. This enzymatic blockade suppresses tumor cell proliferation and induces cell death, supporting its clinical investigation in malignancies such as glioblastoma, endometrial carcinoma, and non-small cell lung cancer.

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>).