Derenofylline (SLV320) Clinical Trials

Size	Price	Qty
5mg	USD 347

Clinical Trials

Derenofylline (SLV320) has been evaluated in several clinical trials sponsored by Solvay Pharmaceuticals to investigate its therapeutic potential in cardiovascular and renal conditions, including congestive heart failure, acute decompensated heart failure, and renal dysfunction. These studies predominantly comprised Phase II trials assessing cardiac hemodynamics, safety, and dose-finding parameters. While a clinical trial investigating cardiac hemodynamics reached completion, multiple clinical trials evaluating its administration were terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00744341	TERMINATED	Acute Decompensated Heart Failure; Renal Dysfunction	Solvay Pharmaceuticals	2009-02	PHASE2
NCT00744341	Terminated	Acute Decompensated Heart Failure; Renal Dysfunction	Solvay Pharmaceuticals	2009-02	Phase 2
NCT00160134	COMPLETED	Congestive Heart Failure	Solvay Pharmaceuticals	2005-01	PHASE2

(data from https://clinicaltrials.gov, updated on 2010-09-17)

Check the Derenofylline (SLV320) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Derenofylline acts as a selective adenosine A1 receptor antagonist that selectively binds the receptor to block G protein-coupled receptor activation and downstream signaling cascades. This cellular inhibition restores renal blood flow and promotes diuresis, supporting its therapeutic evaluation in clinical trials for acute decompensated heart failure, congestive heart failure, and renal dysfunction.

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>).