Canrenone Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

Multiple clinical trials evaluate this active compound and its primary formulation across Phase 1 and Phase 4 development stages, sponsored by pharmaceutical entities including CMP Development LLC and Orion Corporation Orion Pharma. Research focus areas encompass healthy volunteers as well as clinical conditions such as edema due to heart failure or cirrhosis. Recruitment status across the studies ranges from a completed Phase 1 pharmacokinetic evaluation to a Phase 4 trial currently listed as not yet recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06021860	Not yet recruiting	Edema Due to Heart Failure or Cirrhosis	CMP Development LLC	2024-06	Phase 4
NCT01083290	Completed	Healthy	Orion Corporation Orion Pharma	2010-04	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Canrenone acts as a nonselective aldosterone receptor antagonist that competitively binds to mineralocorticoid receptors, thereby inhibiting aldosterone-mediated gene transcription and sodium-potassium exchange in epithelial renal cells. This blockade reduces renal sodium and water reabsorption while conserving potassium, effectively mitigating systemic fluid overload in clinical conditions such as edema due to heart failure or cirrhosis.

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>).