4SC-203 Clinical Trials

Size	Price	Qty
5mg	USD 470
25mg	USD 1,417

Clinical Trials

A completed Phase I clinical trial sponsored by 4SC AG evaluated the investigational drug 4SC-203 to support its development for acute myeloid leukemia. This first-in-human, randomized, double-blind, placebo-controlled study assessed the safety, tolerability, and pharmacokinetic profile of single escalating doses in healthy subjects.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01054937	Completed	Acute Myeloid Leukemia	4SC AG	2010-01	Phase 1

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

Check the 4SC-203 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

4SC-203 functions as a selective multikinase inhibitor that directly targets FMS-related tyrosine kinase 3 (FLT3), mutant FLT3 variants, and vascular endothelial growth factor receptors (VEGFRs). By blocking downstream oncogenic signaling cascades, the compound suppresses tumor cell proliferation and disrupts tumor-associated angiogenesis, providing the mechanistic rationale for its clinical investigation in acute myeloid leukemia.

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>).