Clinical Trials

Several non-interventional clinical trials evaluate diagnostic and management parameters across vascular, surgical, and musculoskeletal settings, including pulmonary embolism, deep vein thrombosis, mammaplasty, active sacroiliitis in ankylosing spondylitis, and knee synovitis or osteoarthritis. Classified under unspecified or not applicable trial phases, these studies are primarily managed by hospital networks and academic institutions. Recruitment statuses across these investigations comprise both completed protocols and trials with unknown statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05413317 Completed
Pulmonary Embolism
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
 2022-03-04 --
NCT05300139 Completed
Deep Vein Thrombosis
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
 2021-11-29 --
NCT05687006 Completed
Mammaplasty
St. Anne''s University Hospital Brno Czech Republic|Masaryk University
 2021-01-01 Not Applicable
NCT04329182 Unknown status
Active Sacroiliitis in Ankylosing Spondylitis
Assiut University
 2020-05 --
NCT03167333 Unknown status
Synovitis of Knee|Osteoarthritis Knee
Taipei Veterans General Hospital Taiwan
 2020-03-01 Not Applicable

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

Check the 1-Cyclohexyl-3-dodecyl urea product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

1-Cyclohexyl-3-dodecyl urea selectively binds to and inhibits soluble epoxide hydrolase (sEH), thereby preventing the enzymatic degradation of anti-inflammatory epoxyeicosatrienoic acids (EETs) and increasing their endogenous cellular concentrations. By suppressing downstream pro-inflammatory signaling and preserving vascular endothelial integrity, this action targets pathophysiological pathways relevant to investigated conditions such as deep vein thrombosis, pulmonary embolism, and knee 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>).

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