Belnacasan (VX-765) Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 470

Clinical Trials

Multiple Phase II clinical trials have evaluated Belnacasan (VX-765) across diverse indications, including epilepsy, treatment-resistant partial epilepsy, COVID-19, and chronic plaque psoriasis. Sponsored by pharmaceutical entities such as Vertex Pharmaceuticals Incorporated alongside healthcare research centers like MedStar Health, these studies are officially recorded as either completed or terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05164120	COMPLETED	COVID-19	MedStar Health	2021-12-14	PHASE2
NCT01501383	TERMINATED	Epilepsy	Vertex Pharmaceuticals Incorporated	2011-12	PHASE2
NCT01501383	Terminated	Epilepsy	Vertex Pharmaceuticals Incorporated	2011-12	Phase 2
NCT01048255	COMPLETED	Partial Epilepsy	Vertex Pharmaceuticals Incorporated	2010-01	PHASE2
NCT00205465	COMPLETED	Psoriasis	Vertex Pharmaceuticals Incorporated	2004-12	PHASE2

(data from https://clinicaltrials.gov, updated on 2024-09-19)

Check the Belnacasan (VX-765) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Belnacasan (VX-765) selectively and irreversibly binds to interleukin-1β converting enzyme (caspase-1), preventing the proteolytic cleavage and maturation of pro-inflammatory cytokines such as IL-1β and IL-18 to suppress neuroinflammatory and peripheral inflammatory cascades. By attenuating inflammatory mediator release and neuronal hyperexcitability, this targeted caspase-1 inhibition provides a therapeutic rationale for managing inflammatory and seizure disorders such as psoriasis, COVID-19, and partial epilepsy.

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>).