Triamterene Clinical Trials

Size	Price	Qty
50mg	USD 147
1g	USD 670

Clinical Trials

Multiple clinical trials evaluate triamterene for renal and cardiovascular indications, including proteinuria, hypertension, and cardiac disorders. Spanning Phase 3, Phase 4, and unspecified phases with completed or unknown recruitment statuses, these studies are sponsored by academic institutions including Georgetown University, the University of California, San Francisco, and Brigham and Women's Hospital. Representative investigations comprise a Phase 3 study on cardiovascular outcomes, a Phase 4 crossover trial in proteinuric kidney disease, and a drug repurposing analysis in hypertension.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02522650	UNKNOWN	Proteinuria	Georgetown University	2013-07	PHASE4
NCT00000525	COMPLETED	Cardiovascular Diseases; Death, Sudden, Cardiac; Heart Arrest; Heart Diseases; Hypertension	University of California, San Francisco	1986-07	PHASE3

(data from https://clinicaltrials.gov, updated on 2020-02-07)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Triamterene directly binds and blocks the epithelial sodium channel (ENaC) in a voltage-dependent manner with an IC50 of 4.5 μM, thereby preventing sodium ion reabsorption across the apical membrane of renal tubular epithelial cells. This inhibition reduces lumen-negative electrical potential and diminishes distal sodium-potassium exchange, promoting modest natriuresis that clinically contributes to blood pressure reduction and protein excretion control in conditions such as hypertension and proteinuria.

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>).