VX-150 Clinical Trials

Size	Price	Qty
5mg	USD 337
25mg	USD 970

Clinical Trials

Multiple clinical trials sponsored by Vertex Pharmaceuticals Incorporated have evaluated the efficacy and safety of the selective sodium channel inhibitor VX-150 in managing acute pain and knee osteoarthritis. These completed, industry-sponsored studies progressed through Phase 2 development, incorporating Phase 2a and Phase 2b designs. Together, they provide key clinical data regarding pain attenuation in subjects following surgical procedures or suffering from chronic joint conditions.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03764072	Completed	Acute Pain	Vertex Pharmaceuticals Incorporated	2018-12-12	Phase 2
NCT03206749	Completed	Acute Pain	Vertex Pharmaceuticals Incorporated	2017-06-29	Phase 2
NCT02660424	Completed	Osteoarthritis	Vertex Pharmaceuticals Incorporated	2015-12	Phase 2

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

Check the VX-150 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

VX-150 functions as an orally bioavailable prodrug that rapidly converts into an active moiety to selectively inhibit the voltage-gated sodium channel NaV1.8, thereby blocking inward sodium currents and halting action potential generation in primary sensory nociceptors. This attenuation of neuronal hyperexcitability suppresses peripheral pain signal transmission, providing the pharmacological rationale for its clinical evaluation in treating acute pain and osteoarthritis.

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>).