Phenindione Clinical Trials

Size	Price	Qty
50mg	USD 97
1g	USD 670

Clinical Trials

A completed Phase 3 clinical trial sponsored by an academic investigator at Ain Shams University evaluated the therapeutic application of phenindione for anticoagulation management during pregnancy. The study investigated low-dose oral anticoagulant protocols aimed at mitigating maternal thromboembolic risks in pregnant patients fitted with mechanical heart valve prostheses. Consequently, the clinical evaluation of phenindione remains highly specialized, focusing specifically on high-risk cardiovascular indications in obstetric populations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01758640	Completed	Anticoagulation in Pregnancy	Yasser Elnahas\|Ain Shams University	2010-02	Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Phenindione acts as a Vitamin K antagonist that competitively inhibits Vitamin K epoxide reductase, thereby blocking the cyclic reduction of vitamin K and preventing the functional activation of clotting factors II, VII, IX, and X. This disruption of the coagulation cascade inhibits thrombin formation and clot propagation, providing essential antithrombotic efficacy relevant to managing anticoagulation and preventing thromboembolic events in pregnant patients with mechanical heart valve prostheses.

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>).