Ethacrynic Acid Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 247

Clinical Trials

Multiple clinical trials have been completed to evaluate ethacrynic acid across indications, including non-muscle invasive bladder cancer, glaucoma, and fluid overload. Early-stage Phase 1 and Phase 1/2 trials sponsored by academic medical centers and individual investigators focused on drug elimination and delivery techniques. Additionally, a Phase 3 clinical trial conducted by the Bambino Gesù Hospital and Research Institute evaluated continuous ethacrynic acid infusion in pediatric patients with fluid overload.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02852564	COMPLETED	Bladder Cancer	Eugene Lee, MD	2016-08	PHASE1
NCT02852564	Completed	Bladder Cancer	Eugene Lee MD\|University of Kansas Medical Center	2016-08	Phase 1
NCT02051946	COMPLETED	Glaucoma	Molly Walsh	2014-05	PHASE1; PHASE2
NCT01628731	COMPLETED	Fluid Overload	Bambino Gesù Hospital and Research Institute	2012-10	PHASE3

(data from https://clinicaltrials.gov, updated on 2017-08-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ethacrynic acid binds and inhibits the sodium-potassium-chloride cotransporter (NKCC2) in the thick ascending limb of Henle's loop, which blocks luminal electrolyte reabsorption and disrupts the corticomedullary osmotic gradient. This impairment prevents renal water reabsorption to induce profound diuresis and natriuresis, providing clinical efficacy against fluid overload while informing targeted investigative approaches in conditions like glaucoma and non-muscle invasive bladder cancer.

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>).