Clinical Trials

Numerous clinical trials spanning Early Phase 1 through Phase 4 have evaluated simvastatin acid across diverse indications, with recruitment statuses ranging from active and completed to withdrawn or terminated. Supported by both industrial sponsors and academic institutions, research has investigated the compound's pharmacokinetic profiles and drug-drug interactions in healthy subjects and patients with conditions including type 2 diabetes mellitus, chronic pain, non-segmental vitiligo, renal tubular acidosis, and lung cancer.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06209359 RECRUITING
Heart Failure; Diuretic Resistance
Yale University
 2024-07-24 PHASE1
NCT06637826 ACTIVE_NOT_RECRUITING
Healthy
National Natural Science Foundation of China
 2024-10-01 EARLY_PHASE1
NCT05639907 RECRUITING
Inflammation Caused by the Placement of a Temporary Anchorage Device
University of Colorado, Denver
 2022-11-11
NCT07722351 COMPLETED
Skin Aging; Hyperpigmentation
Medical University of Silesia
 2025-10-29
NCT05247567 TERMINATED
Quaternary Ammonium; Hypersensitivity
Assistance Publique - Hôpitaux de Paris
 2022-10-27
NCT04742660 COMPLETED
Postoperative Nausea
Konkuk University Medical Center
 2021-05-11
NCT05868798 COMPLETED
Sleep Deprivation; Military Activity; Sleep; Cognitive Change; Military Combat Stress Reaction
Jan Malecek
 2020-10-01 PHASE1
NCT04721964 COMPLETED
Iron Deficiency Anemia; Gastro Intestinal Bleeding; Iron-deficiency
Swiss Federal Institute of Technology
 2021-02-25
NCT01783873 TERMINATED
Occupational Asthma
University Hospital, Strasbourg, France
 2012-09
NCT03247400 COMPLETED
Non-segmental Vitiligo
Nicolaus Copernicus University
 2016-12-01 PHASE1; PHASE2
NCT04127513 COMPLETED
Xerosis Cutis
Indonesia University
 2017-04-01 PHASE3
NCT03105869 COMPLETED
Prostate Cancer
Poitiers University Hospital
 2014-12-16
NCT02561858 COMPLETED
Uric Acid Stones
Centre Hospitalier Universitaire de Nice
 2015-10-14
NCT02525458 COMPLETED
Oral Health
Frank Tay, BDSc (Hons), PhD
 2015-07 PHASE2
NCT01579370 COMPLETED
Multidrug Resistant Organisms; Healthcare Associated Infections
Duke University
 2012-04
NCT00166166 TERMINATED
Hyperlipidemia
Emory University
 2002-07 PHASE2
NCT01440478 COMPLETED
Healthy Subjects
Eli Lilly and Company
 2011-09 PHASE1
NCT00946933 COMPLETED
Healthy
Queen's University
 2009-11
NCT01103739 COMPLETED
Chronic Pain
Pfizer
 2010-03 PHASE1
NCT01111123 COMPLETED
Plaque Psoriasis
Icahn School of Medicine at Mount Sinai
 2009-01 PHASE4
NCT05642689 COMPLETED
Healthy
Société des Produits Nestlé (SPN)
 2009-11
NCT00924430 COMPLETED
Type 2 Diabetes Mellitus
Solvay Pharmaceuticals
 2009-06 PHASE1
NCT00560495 WITHDRAWN
Lung Cancer
Roswell Park Cancer Institute
 2007-05 PHASE1
NCT00586131 COMPLETED
End-stage Renal Disease
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
 2003-09 PHASE4
NCT00098514 COMPLETED
Unspecified Adult Solid Tumor, Protocol Specific
Dana-Farber Cancer Institute
 2003-12 PHASE1
NCT02183623 COMPLETED
Healthy
Boehringer Ingelheim
 2005-09 PHASE1
NCT02187536 COMPLETED
Healthy
Boehringer Ingelheim
 2000-04 PHASE1
NCT00514670 COMPLETED
Respiratory Infections; Gastrointestinal Diseases
Boston Children's Hospital
 2006-03

(data from https://clinicaltrials.gov, updated on 2026-05-22)

Check the Simvastatin acid (ammonium) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Simvastatin acid ammonium acts as a potent inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A reductase (HMGCR), which blocks the rate-limiting conversion of HMG-CoA to mevalonate and subsequently decreases indoxyl sulfate-induced reactive oxygen species production in human cardiomyocytes. This modulation of mevalonate pathway signaling and oxidative stress provides the pharmacological basis for its lipid-lowering and cardioprotective actions, directly supporting its clinical evaluation in type 2 diabetes mellitus and pharmacokinetic research.

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.