Clinical Trials

Numerous clinical trials spanning Early Phase 1 through Phase 4 have evaluated MitoQ (mitoquinone) mesylate across a broad spectrum of conditions, including ulcerative colitis, sickle cell disease, non-alcoholic fatty liver disease, chronic hepatitis C, chronic kidney disease, and schizophrenia. Sponsored by diverse academic and corporate entities such as the University of Edinburgh and Antipodean Pharmaceuticals Inc., these studies encompass various recruitment statuses, ranging from active recruiting and not yet recruiting to completed and terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07228208 NOT_YET_RECRUITING
Type 2 Diabetes (T2DM); Endothelial Dysfunction
Medical College of Wisconsin
 2026-09-01
NCT03586414 ACTIVE_NOT_RECRUITING
Diastolic Dysfunction
University of Colorado, Denver
 2021-08-01
NCT06424756 RECRUITING
Healthy
University of Georgia
 2024-07-01 PHASE2
NCT07406243 NOT_YET_RECRUITING
Aging; Postmenopause
Colorado State University
 2026-04
NCT05373043 RECRUITING
Long-COVID
VA Office of Research and Development
 2022-11-01
NCT07229261 RECRUITING
Preeclampsia; Pregnancy
Medical College of Wisconsin
 2026-03-18
NCT06027554 RECRUITING
Frailty; Mild Cognitive Impairment; Aging
UConn Health
 2024-10-07 PHASE2
NCT06191965 RECRUITING
Schizophrenia and Related Disorders; Mitochondrial Alteration; Cognitive Impairment
Mclean Hospital
 2024-06-01 PHASE2; PHASE3
NCT06930638 RECRUITING
Stroke
Medical College of Wisconsin
 2025-07-22 PHASE2
NCT05539625 WITHDRAWN
Ulcerative Colitis
University of Edinburgh
 2025-09-01 PHASE2
NCT06409949 RECRUITING
Peripheral Arterial Disease
University of Nebraska
 2023-06-01
NCT02966665 RECRUITING
Chronic Obstructive Pulmonary Disease; Pulmonary Artery Hypertension; Heart Failure; Hypertension
Russell Richardson
 2008-09 PHASE1
NCT07244809 RECRUITING
Adverse Childhood Experience; Endothelial Function (FMD); Endothelial Injury; Mitochondrial Function; Oxidative Stress; Psychosocial Influence on Cardiovascular Disease
University of Iowa
 2025-10-13
NCT05886816 RECRUITING
SARS-CoV Infection; COVID-19
University of Texas Southwestern Medical Center
 2024-03-01 PHASE2
NCT07142096 RECRUITING
Breast Cancer
Université Catholique de Louvain
 2025-07-20
NCT06351683 TERMINATED
Lower Urinary Tract Symptoms; Overactive Bladder Syndrome
Iman Al-Naggar, PhD
 2024-04-03 PHASE2
NCT04276740 ACTIVE_NOT_RECRUITING
Ulcerative Colitis Flare
University of Edinburgh
 2022-05-31 PHASE2
NCT04851288 COMPLETED
Aging
University of Colorado, Boulder
 2021-04-02 PHASE2
NCT06784531 COMPLETED
Cold Exposure
United States Army Research Institute of Environmental Medicine
 2024-09-16
NCT05561556 COMPLETED
Cardiovascular Diseases; Hypertension; Racism; Vascular Diseases
Auburn University
 2022-12-06
NCT04334135 UNKNOWN
Racial Disparities; Blood Pressure; Cardiovascular Risk Factor; Renal Function
Auburn University
 2020-10-02
NCT06429059 COMPLETED
Amyotrophic Lateral Sclerosis ALS
Duke University
 2024-06-12 PHASE2
NCT04267926 COMPLETED
Multiple Sclerosis; Fatigue
VA Office of Research and Development
 2020-04-01 PHASE1; PHASE2
NCT05686967 ACTIVE_NOT_RECRUITING
Aging; Menopause
University of Colorado, Denver
 2023-01-16 EARLY_PHASE1
NCT05605548 TERMINATED
Chronic Obstructive Pulmonary Disease
Virginia Commonwealth University
 2023-02-16 EARLY_PHASE1
NCT05410873 COMPLETED
Dilated Cardiomyopathy
Imperial College London
 2022-07-26 PHASE2
NCT04026711 COMPLETED
Asthma; Obesity
University of Vermont
 2020-01-01 PHASE1
NCT05381454 COMPLETED
Respiratory Viral Infection; Antiviral Treatment; COVID-19
University of California, Los Angeles
 2022-04-28 PHASE1; PHASE2
NCT06069245 COMPLETED
Healthy
Ball State University
 2022-09-14
NCT05872139 COMPLETED
Aging; Endothelial Dysfunction; Cardiovascular Function; Arterial Stiffness
Ball State University
 2022-09-23
NCT05146843 UNKNOWN
Breast Neoplasms
D'Or Institute for Research and Education
 2022-06-02
NCT03960073 COMPLETED
Renal Insufficiency, Chronic; Heart Failure With Preserved Ejection Fraction
Virginia Commonwealth University
 2019-07-31
NCT04109820 COMPLETED
Sickle Cell Disease
University of Pittsburgh
 2020-03-10
NCT05539625 Not yet recruiting
Ulcerative Colitis
University of Edinburgh|The Jon Moulton Charity Trust|MitoQ
 2022-09 Phase 2
NCT03514875 WITHDRAWN
Alzheimer Disease, Early Onset; Mild Cognitive Impairment
University of Nebraska
 2019-11-11
NCT03506633 COMPLETED
Peripheral Arterial Disease; Peripheral Artery Disease
University of Nebraska
 2018-09-05
NCT04558190 COMPLETED
Insulin Resistance
University of Copenhagen
 2020-09-02
NCT04098510 UNKNOWN
Healthy
University of Copenhagen
 2019-09-08
NCT04109820 Recruiting
Sickle Cell Disease
University of Pittsburgh
 2020-03-01 Not Applicable
NCT04098510 Unknown status
Healthy
University of Copenhagen
 2019-09-08 Not Applicable
NCT02364648 UNKNOWN
Chronic Kidney Disease
University of Delaware
 2017-07-01 PHASE4
NCT03166800 TERMINATED
Multiple Sclerosis; Fatigue
Oregon Health and Science University
 2018-09-15 PHASE1; PHASE2
NCT02597023 COMPLETED
Aging
University of Colorado, Boulder
 2015-09
NCT01167088 TERMINATED
Non-alcoholic Fatty Liver Disease
Antipodean Pharmaceuticals, Inc.
 2010-11 PHASE2
NCT01167088 Terminated
Non-alcoholic Fatty Liver Disease
Antipodean Pharmaceuticals Inc.
 2010-11 Phase 2
NCT00433108 Completed
Chronic Hepatitis C
Antipodean Pharmaceuticals Inc.
 2007-03 Phase 2
NCT00329056 COMPLETED
Parkinson's Disease
Antipodean Pharmaceuticals, Inc.
 2006-05 PHASE2
NCT00433108 COMPLETED
Chronic Hepatitis C
Antipodean Pharmaceuticals, Inc.
 2007-03 PHASE2

(data from https://clinicaltrials.gov, updated on 2025-11-14)

Check the MitoQ (Mitoquinone) Mesylate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

MitoQ mesylate is a triphenylphosphonium-conjugated antioxidant that selectively accumulates within the inner mitochondrial membrane to scavenge hydrogen peroxide and block intracellular reactive oxygen species generation. By suppressing mitochondrial oxidative damage and inhibiting lipid peroxidation, MitoQ preserves cellular bioenergetics, which underpins its therapeutic rationale across clinical trials investigating inflammatory, renal, and vascular conditions such as ulcerative colitis and chronic kidney disease.

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>).

Jump to

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