Zabedosertib Clinical Trials

Size	Price	Qty
5mg	USD 159

Clinical Trials

Several completed clinical trials sponsored by Bayer have established the early-phase clinical profile of zabedosertib. Phase I trials evaluated the safety, pharmacokinetics, and pharmacodynamics of the drug in healthy volunteers and subjects with psoriasis or inflammatory conditions. Subsequently, a Phase II trial assessed its therapeutic efficacy and safety in patients with atopic dermatitis.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05656911	COMPLETED	Atopic Dermatitis	Bayer	2022-12-21	PHASE2
NCT03493269	Completed	Healthy Volunteers\|Psoriasis	Bayer	2018-04-16	Phase 1
NCT03244462	Completed	Inflammation	Bayer	2017-08-18	Phase 1

(data from https://clinicaltrials.gov, updated on 2025-02-18)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Zabedosertib is a small-molecule inhibitor of interleukin-1 receptor-associated kinase 4 (IRAK4) that selectively targets the enzyme's active site to disrupt downstream signaling cascades originating from Toll-like and interleukin-1 receptors. By blocking IRAK4-mediated signal transduction, the compound inhibits the expression of pro-inflammatory cytokines and suppresses hyperactive immune responses, providing a targeted rationale for treating inflammatory conditions such as psoriasis and atopic dermatitis.

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>).