Metolazone Clinical Trials

Size	Price	Qty
50mg	USD 97
1g	USD 670

Clinical Trials

Multiple clinical trials evaluate metolazone across cardiovascular and fluid management indications, including acute decompensated heart failure with diuretic resistance and transfusion-associated circulatory overload. Ranging in development from Early Phase 1 to those designated as Not Applicable, these studies are sponsored by academic institutions and health networks such as Cairo University and Sunnybrook Health Sciences Centre. Recruitment statuses across these records include completed and unknown.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03863626	Unknown status	Acute Decompensated Heart Failure\|Diuretics Resistance	Cairo University\|Kasr El Aini Hospital	2019-03-31	Not Applicable
NCT02802696	Completed	Transfusion-associated Circulatory Overload	Sunnybrook Health Sciences Centre\|University Health Network Toronto\|Canadian Blood Services	2016-06	Early Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Metolazone selectively inhibits the sodium-chloride symporter in the distal convoluted tubule of the nephron, thereby blocking downstream transepithelial reabsorption of sodium and chloride ions. This inhibition increases urinary excretion of water and electrolytes, reducing total blood volume to alleviate fluid congestion in clinical conditions such as acute decompensated heart failure and transfusion-associated circulatory overload.

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>).