Clinical Trials

Multiple clinical trials investigate this agent and related procedural interventions across conditions including severe aortic stenosis, aortic valve stenosis, femoral vascular closure during endovascular procedures, and multiple myeloma. Spanning Phase 2 trials alongside non-phased observational and procedural studies, these efforts are sponsored by academic medical centers, health research institutes, and commercial entities. Across the dataset, recruitment statuses encompass both active recruiting cohorts and completed clinical evaluations.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06173115 Recruiting
Severe Aortic Stenosis
Second Affiliated Hospital School of Medicine Zhejiang University
2023-10-20 Not Applicable
NCT05335525 Recruiting
Vascular Closure|Endovascular Procedure|Hemostasis|Peripheral Vascular Disease|Femoral Artery
Terumo Europe N.V.|Terumo Medical Corporation
2022-09-30 --
NCT04656951 Recruiting
Multiple Myeloma
University of Cologne|Janssen-Cilag G.m.b.H
2021-06-01 Phase 2
NCT04459208 Completed
Aortic Valve Stenosis
Helios Health Institute GmbH
2020-06-26 Not Applicable

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

Check the 4-Vinylcyclohexene diepoxide (VCD) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

4-Vinylcyclohexene diepoxide acts as an alkylating agent that targets primordial and primary ovarian follicles, disrupting downstream steroidogenic enzyme pathways and inducing selective apoptotic depletion of pre-antral oocytes. This focal ovotoxicity results in premature loss of ovarian function and systemic estrogen reduction, establishing its relevance as a pharmacological model for menopausal induction as well as for evaluating therapeutic outcomes in clinical conditions such as multiple myeloma and aortic vascular disorders.

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>).

Note: Technical data last updated: Sep 1, 2026.