Esaxerenone (CS-3150) Clinical Trials

Size	Price	Qty
1mg	USD 147
5mg	USD 357

Clinical Trials

Multiple clinical trials, primarily sponsored by industry sponsor Daiichi Sankyo, have evaluated Esaxerenone (CS-3150) across Phase 1, Phase 2, and Phase 3 clinical development, with recruitment status listed as completed across all protocols. Focusing on cardiovascular and renal indications, these studies assessed the therapeutic efficacy and safety of the drug both as monotherapy and in combination regimens. Key conditions evaluated include essential hypertension, severe hypertension, primary aldosteronism, hypertension with moderate renal impairment, and diabetic nephropathy.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02885662	COMPLETED	Primary Aldosteronism	Daiichi Sankyo Co., Ltd.	2016-09
NCT02890173	COMPLETED	Essential Hypertension	Daiichi Sankyo Co., Ltd.	2016-09	PHASE3
NCT02722265	COMPLETED	Essential Hypertension	Daiichi Sankyo Co., Ltd.	2016-03	PHASE3
NCT02807987	COMPLETED	Hypertension With Moderate Renal Impairment	Daiichi Sankyo Co., Ltd.	2016-06	PHASE3
NCT02848170	COMPLETED	Essential Hypertension	Daiichi Sankyo Co., Ltd.	2016-08
NCT02807974	COMPLETED	Hypertension	Daiichi Sankyo Co., Ltd.	2016-06	PHASE3
NCT02808026	COMPLETED	Severe Hypertension	Daiichi Sankyo Co., Ltd.	2016-06	PHASE3
NCT02345057	COMPLETED	Diabetic Nephropathy	Daiichi Sankyo	2015-01	PHASE2
NCT04019652	COMPLETED	Hypertension; Mineralocorticoid Receptor Antagonist	Daiichi Sankyo	2015-11-19	PHASE1
NCT02448628	COMPLETED	Hypertension	Daiichi Sankyo	2015-05	PHASE2
NCT02345044	COMPLETED	Essential Hypertension	Daiichi Sankyo	2015-01	PHASE2

(data from https://clinicaltrials.gov, updated on 2018-12-21)

Check the Esaxerenone (CS-3150) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Esaxerenone selectively binds to the mineralocorticoid receptor and potently inhibits aldosterone binding with an IC50 value of 9.4 nM, thereby blocking downstream receptor activation and mineralocorticoid-mediated gene expression. This inhibition suppresses aldosterone-driven renal sodium reabsorption and cellular oxidative stress, which provides therapeutic utility in reducing albuminuria progression and managing hypertension, primary aldosteronism, and diabetic nephropathy.

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>).