KT-474 (SAR444656) Clinical Trials

Size	Price	Qty
1mg	USD 197
5mg	USD 347

Clinical Trials

Multiple phase 2, double-blind clinical trials sponsored by Sanofi and Kymera Therapeutics Inc. are currently recruiting adult participants to evaluate KT-474 (SAR444656) for inflammatory skin conditions, specifically atopic dermatitis and hidradenitis suppurativa. These studies assess the safety and therapeutic potential of the compound, aiming to validate targeted IRAK4 degradation as a novel strategy for TLR/IL-1R–driven autoimmune dermatological diseases.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06058156	Recruiting	Atopic Dermatitis	Sanofi\|Kymera Therapeutics Inc.	2023-11-09	Phase 2
NCT06028230	Recruiting	Hidradenitis Suppurativa	Sanofi\|Kymera Therapeutics Inc.	2023-09-29	Phase 2

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

Check the KT-474 (SAR444656) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

KT-474 (SAR444656) acts as a selective small-molecule degrader targeting interleukin-1 receptor-associated kinase 4 (IRAK4), which promotes proteasomal degradation of the target kinase and disrupts downstream Toll-like receptor (TLR) and interleukin-1 receptor (IL-1R) signaling cascades. This blockade suppresses R848- and lipopolysaccharide-induced interleukin-6 (IL-6) and interleukin-8 (IL-8) production in peripheral blood mononuclear cells, thereby blunting pathological inflammatory responses associated with atopic dermatitis and hidradenitis suppurativa.

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>).