SAR405838 Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 797

Clinical Trials

Several clinical trials have evaluated SAR405838 in patients with malignant neoplasms and advanced solid tumors, all representing completed early-phase studies. Industry-sponsored research led by Sanofi, in collaboration with Merck KGaA, established the compound's safety, tolerability, pharmacokinetics, and biological activity as a monotherapy and in combination with the MEK inhibitor pimasertib. Overall, these completed investigations demonstrate an industry-led effort to translate SAR405838 into a viable oncology therapeutic.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01636479	COMPLETED	Neoplasm Malignant	Sanofi	2012-07-13	PHASE1
NCT01985191	COMPLETED	Neoplasm Malignant	Sanofi	2013-11	PHASE1
NCT01985191	Completed	Neoplasm Malignant	Sanofi\|Merck KGaA Darmstadt Germany	2013-11	Phase 1
NCT01636479	Completed	Neoplasm Malignant	Sanofi	2012-07-13	Phase 1

(data from https://clinicaltrials.gov, updated on 2018-05-17)

Check the SAR405838 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

SAR405838 functions as a potent, orally available MDM2 antagonist with a Ki of 0.88 nM that disrupts the interaction between MDM2 and p53, thereby preventing MDM2-mediated ubiquitin degradation of p53 and restoring wild-type p53 signaling. This reactivation of p53 downstream pathways induces cell cycle arrest and apoptosis in p53-wild-type cancer cells, providing the mechanistic foundation for its therapeutic evaluation in clinical trials for malignant neoplasms.

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>).