BV6 Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 477

Clinical Trials

A completed clinical trial associated with BV6, categorized under a phase classification of Not Applicable, evaluated the feasibility of acquiring chest lead electrocardiogram measurements via a smartwatch combined with a digital image processing algorithm. Sponsored by academic medical centers, namely the University Hospital Basel and the University of Basel, the investigation centered on electrocardiogram monitoring. Consequently, the clinical evaluation landscape for this intervention currently features a completed feasibility trial focused on diagnostic electrocardiography methods.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05425342	Completed	Electrocardiogram	University Hospital Basel Switzerland\|University of Basel	2020-12-12	Not Applicable

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

Check the BV6 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

BV6 acts as a SMAC mimetic that directly binds to cellular inhibitor of apoptosis proteins (cIAPs) and X-linked inhibitor of apoptosis protein (XIAP), triggering their autoproteolytic degradation and relieving caspase suppression to drive pro-apoptotic cell death. This pathway modulation provides therapeutic activity, while clinical assessments monitor physiological metrics such as electrocardiogram parameters to evaluate potential cardiovascular effects and treatment safety.

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>).