Decernotinib (VX-509) Clinical Trials

Size	Price	Qty
2mg	USD 147
5mg	USD 197

Clinical Trials

Decernotinib (VX-509) has undergone multiple completed clinical trials sponsored exclusively by Vertex Pharmaceuticals Incorporated, spanning Phase 1 through Phase 2/3 evaluations. These studies primarily investigated dose-ranging efficacy, safety, and long-term therapeutic outcomes in adult patients with active rheumatoid arthritis. Additionally, Phase 1 trials in healthy volunteers evaluated single- and multiple-dose pharmacokinetics as well as drug interaction profiles with corticosteroids.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01590459	COMPLETED	Rheumatoid Arthritis	Vertex Pharmaceuticals Incorporated	2012-04	PHASE2
NCT01830985	COMPLETED	Rheumatoid Arthritis	Vertex Pharmaceuticals Incorporated	2013-04	PHASE2; PHASE3
NCT01754935	COMPLETED	Rheumatoid Arthritis	Vertex Pharmaceuticals Incorporated	2013-01	PHASE2
NCT01886209	COMPLETED	Drug Interactions	Vertex Pharmaceuticals Incorporated	2013-06	PHASE1
NCT01886209	Completed	Drug Interactions	Vertex Pharmaceuticals Incorporated	2013-06	Phase 1
NCT01830985	Completed	Rheumatoid Arthritis	Vertex Pharmaceuticals Incorporated	2013-04	Phase 2\|Phase 3
NCT01754935	Completed	Rheumatoid Arthritis	Vertex Pharmaceuticals Incorporated	2013-01	Phase 2
NCT01052194	COMPLETED	Rheumatoid Arthritis	Vertex Pharmaceuticals Incorporated	2010-02	PHASE2
NCT01052194	Completed	Rheumatoid Arthritis	Vertex Pharmaceuticals Incorporated	2010-02	Phase 2
NCT00789126	COMPLETED	Healthy	Vertex Pharmaceuticals Incorporated	2008-10	PHASE1

(data from https://clinicaltrials.gov, updated on 2015-11-20)

Check the Decernotinib (VX-509) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Decernotinib selectively binds to Janus kinase 3 (JAK3) with a Ki of 2.5 nM, blocking downstream STAT protein phosphorylation and suppressing pro-inflammatory cytokine signaling in immune cells. This inhibition halts lymphocyte-mediated autoimmune responses, thereby mitigating systemic inflammation and tissue damage in rheumatoid arthritis.

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>).