Zimlovisertib (PF-06650833) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 397

Clinical Trials

Multiple Phase 1 and Phase 2 clinical trials evaluate the safety, pharmacokinetics, bioavailability, and clinical efficacy of the IRAK4 inhibitor zimlovisertib (PF-06650833) in healthy volunteers and patients with inflammatory or autoimmune conditions, including rheumatoid arthritis, acne inversa, COVID-19, and COVID-19 pneumonia. Sponsored by Pfizer alongside academic and individual investigators such as Yale University and Dr. Giovanni Franchin, these protocols feature predominantly completed studies alongside terminated and unknown trials.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04933799	UNKNOWN	COVID-19 Pneumonia	Giovanni Franchin, M.D, Ph.D	2021-01-06	PHASE2
NCT04413617	COMPLETED	Rheumatoid Arthritis	Pfizer	2020-07-29	PHASE2
NCT04092452	COMPLETED	Acne Inversa	Pfizer	2019-12-02	PHASE2
NCT05064332	COMPLETED	Healthy	Pfizer	2021-10-08	PHASE1
NCT04575610	TERMINATED	COVID-19	Yale University	2020-11-27	PHASE2
NCT03827668	COMPLETED	Healthy	Pfizer	2019-02-07	PHASE1
NCT02996500	COMPLETED	Rheumatoid Arthritis	Pfizer	2016-11-10	PHASE2
NCT03308110	COMPLETED	Healthy	Pfizer	2017-09-08	PHASE1
NCT03308110	Completed	Healthy	Pfizer	2017-09-08	Phase 1
NCT02936154	COMPLETED	Healthy	Pfizer	2016-08	PHASE1
NCT02485769	COMPLETED	Healthy	Pfizer	2015-06	PHASE1
NCT02609139	COMPLETED	Healthy	Pfizer	2015-11	PHASE1
NCT02609139	Completed	Healthy	Pfizer	2015-11	Phase 1
NCT02224651	COMPLETED	Healthy	Pfizer	2014-09	PHASE1
NCT02485769	Completed	Healthy	Pfizer	2015-06	Phase 1

(data from https://clinicaltrials.gov, updated on 2021-06-22)

Check the Zimlovisertib (PF-06650833) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Zimlovisertib (PF-06650833) functions as a potent and selective inhibitor of interleukin-1 receptor-associated kinase 4 (IRAK4) with an IC50 of 0.2 nM, disrupting MyD88-dependent signaling downstream of Toll-like and interleukin-1 receptors. By suppressing downstream pro-inflammatory NF-κB and MAPK activation along with cytokine production, this targeted inhibition blunts systemic inflammatory responses, directly supporting its clinical evaluation in autoimmune and hyper-inflammatory conditions such as rheumatoid arthritis and COVID-19 pneumonia.

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>).