Phenprocoumon Clinical Trials

Size	Price	Qty
5mg	USD 97
25mg	USD 257

Clinical Trials

Multiple completed clinical trials have evaluated phenprocoumon across diverse therapeutic indications and phases. A Phase 3 trial, sponsored by the Atrial Fibrillation Network, Bristol-Myers Squibb, and Pfizer, evaluated oral anticoagulation regimens in patients with atrial fibrillation and end-stage kidney disease. Additionally, a Phase 1 study sponsored by Hoffmann-La Roche assessed pharmacokinetic interactions involving phenprocoumon in patients with malignant melanoma neoplasms.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02933697	Completed	Atrial Fibrillation\|End-stage Kidney Disease	Atrial Fibrillation Network\|Bristol-Myers Squibb\|Pfizer	2017-06-20	Phase 3
NCT01849666	Completed	Malignant Melanoma Neoplasms	Hoffmann-La Roche	2013-09	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Phenprocoumon acts as a vitamin K reductase antagonist that blocks the reduction of vitamin K, thereby preventing the essential post-translational gamma-carboxylation and activation of clotting factors II, VII, IX, and X. This inhibition disrupts the coagulation cascade to attenuate thrombin generation and blood clot formation, establishing its clinical utility in mitigating thromboembolic complications in conditions such as atrial fibrillation.

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>).