VX-702 Clinical Trials

Size	Price	Qty
10mg	USD 147
1g	USD 1,990

Clinical Trials

Multiple clinical trials have evaluated the small-molecule inhibitor VX-702 exclusively for the treatment of moderate to severe active rheumatoid arthritis. Sponsored by Vertex Pharmaceuticals Incorporated, these completed Phase II studies were randomized, double-blind, and placebo-controlled evaluations assessing the drug's safety and anti-inflammatory efficacy as monotherapy or concomitantly with methotrexate. Overall, this trial portfolio highlights targeted clinical investigation into mitigating inflammatory autoimmune responses.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00395577	Completed	Rheumatoid Arthritis	Vertex Pharmaceuticals Incorporated	2006-11	Phase 2
NCT00205478	COMPLETED	Rheumatoid Arthritis	Vertex Pharmaceuticals Incorporated	2005-06	PHASE2
NCT00395577	COMPLETED	Rheumatoid Arthritis	Vertex Pharmaceuticals Incorporated	2006-11	PHASE2

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

Check the VX-702 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

VX-702 acts as a highly selective inhibitor of p38α mitogen-activated protein kinase (MAPK), blocking p38α-mediated signaling cascades to suppress the gene transcription and downstream production of key pro-inflammatory cytokines, including TNF-α, IL-1, and IL-6. By blunting the synthesis of these inflammatory mediators, the compound inhibits immune cell activation and systemic tissue inflammation, offering clinical relevance for the treatment of inflammatory autoimmune conditions such as 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>).