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)
Mechanism and Biochemical Profile
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>).
- 4-Vinylcyclohexene diepoxide (VCD) Solubility in DMSO
- 4-Vinylcyclohexene diepoxide (VCD) Stock Solution
- 4-Vinylcyclohexene diepoxide (VCD) Storage
- 4-Vinylcyclohexene diepoxide (VCD) Stability
- 4-Vinylcyclohexene diepoxide (VCD) Molecular Weight
- 4-Vinylcyclohexene diepoxide (VCD) SMILES
- 4-Vinylcyclohexene diepoxide (VCD) CAS Number
- 4-Vinylcyclohexene diepoxide (VCD) Chemical Structure (2D and 3D)
- 4-Vinylcyclohexene diepoxide (VCD) SDS|MSDS