Clinical Trials

Multiple completed clinical trials sponsored by Mitsubishi Tanabe Pharma Corporation have evaluated the pharmacological profile of apararenone (MT-3995). Encompassing Phase 1, Phase 1/Phase 2, and Phase 2 studies, these trials were conducted in healthy volunteers and subjects with diabetic nephropathy. Key objectives included assessing safety, tolerability, pharmacokinetics, pharmacodynamics, and therapeutic effects on urine albumin-to-creatinine ratios.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02531568 Completed
Healthy
Mitsubishi Tanabe Pharma Corporation
 2015-06 Phase 1
NCT02205372 Completed
Diabetic Nephropathy
Mitsubishi Tanabe Pharma Corporation
 2014-07 Phase 1|Phase 2
NCT01889277 Completed
Diabetic Nephropathy
Mitsubishi Tanabe Pharma Corporation
 2013-07 Phase 1|Phase 2
NCT01756716 Completed
Diabetic Nephropathy
Mitsubishi Tanabe Pharma Corporation
 2012-12 Phase 2
NCT01756703 Completed
Diabetic Nephropathy
Mitsubishi Tanabe Pharma Corporation
 2012-11 Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Apararenone selectively binds to and antagonizes the nonsteroidal mineralocorticoid receptor, thereby preventing aldosterone-mediated gene transcription and blocking inflammatory and fibrotic signaling cascades. By suppressing hyperactivated mineralocorticoid signaling within renal target cells, this inhibition reduces cellular stress and pathological tissue remodeling, which supports its clinical application in attenuating kidney damage in 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>).

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Note: Technical data last updated: Sep 1, 2026.