XL147 analogue Clinical Trials

Size	Price	Qty
10mg	USD 170
50mg	USD 470

Clinical Trials

Multiple Phase 1 clinical trials sponsored by Sanofi, including a study conducted in collaboration with Merrimack Pharmaceuticals, evaluated the XL147 analogue (SAR245408) in patients with advanced oncological conditions, including solid tumors, malignant neoplasms, and primary central nervous system malignancies such as glioblastoma or grade IV astrocytoma. These completed evaluations assessed the compound's safety, pharmacokinetics, and pharmacodynamics, investigating both daily oral single-agent dosing and combination regimens with other therapeutic agents.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01943838	Completed	Neoplasm Malignant	Sanofi	2013-10	Phase 1
NCT01436565	Completed	Solid Tumor Cancers	Sanofi\|Merrimack Pharmaceuticals	2011-11	Phase 1
NCT01392924	Completed	Neoplasm Malignant	Sanofi	2011-08	Phase 1
NCT01357330	Completed	Solid Tumors	Sanofi	2011-05	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 XL147 analogue product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

XL147 analogue reversibly binds to class I PI3K isoforms in an ATP-competitive manner, thereby inhibiting the production of phosphatidylinositol 3,4,5-trisphosphate and suppressing downstream signaling to induce tumor cell apoptosis. This blockade of PI3K-dependent survival signaling inhibits tumor growth and proliferation, providing the mechanistic rationale for evaluating the compound in clinical trials targeting solid tumors, malignant neoplasms, and recurrent 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>).