Clinical Trials

Numerous clinical trials evaluate the therapeutic and physiological effects of (-)-epicatechin across Phase 1 through Phase 3 designs, alongside observational and bioavailability studies. Investigated conditions include Becker muscular dystrophy, pulmonary arterial hypertension, acute radiation dermatitis with skin fibrosis, endothelial dysfunction, pre-diabetes, and mobility disability in older adults. Supported by academic, medical, and corporate entities—including the University of California, Davis, Mars Inc., and Quadram Institute Bioscience—these trials encompass completed, active, recruiting, withdrawn, and enrolling-by-invitation recruitment statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07161726 RECRUITING
Mobility Disability
University of Alabama at Birmingham
 2026-04-21 PHASE1; PHASE2
NCT07149506 ENROLLING_BY_INVITATION
Radiation Dermatitis Acute; Radiation Dermatitis; Fibrosis; Skin
CARLOS FRANCISCO SAAVEDRA GARCIA
 2025-09-01 PHASE3
NCT06631820 RECRUITING
Chronic Kidney Disease(CKD); Myosteatosis; Mitochondrial Dysfunction; Muscle Function; Muscle Mass
Karolinska Institutet
 2025-01-17
NCT06086145 Recruiting
Adults
University of California Davis|Mars Inc.
 2023-11-02 --
NCT05113498 COMPLETED
Diet Modification
University Ghent
 2021-11-01
NCT04386304 COMPLETED
Becker Muscular Dystrophy
Epirium Bio Inc.
 2020-07-13 PHASE1
NCT02490527 COMPLETED
Statin Intolerance
University of California, San Diego
 2015-06
NCT02660112 COMPLETED
Friedreich's Ataxia
Ralitza Gavrilova
 2016-09 PHASE2
NCT01856868 COMPLETED
Becker Muscular Dystrophy
Craig McDonald, MD
 2013-05 PHASE1; PHASE2
NCT03382067 COMPLETED
Test Anxiety
Prof. Dominique de Quervain, MD
 2017-12-04
NCT03214133 COMPLETED
Collagen Synthesis
University of California, Davis
 2017-05-23
NCT02964377 COMPLETED
Duchenne Muscular Dystrophy
Craig McDonald, MD
 2016-11 PHASE1; PHASE2
NCT03236662 COMPLETED
Becker Muscular Dystrophy
Craig McDonald, MD
 2016-11 PHASE2
NCT03194620 COMPLETED
Healthy
University of California, Davis
 2016-08
NCT02898571 UNKNOWN
The Impact of Vitamin c and Epicatechin Upon Antioxidant Capactity
Newcastle University
 2016-07
NCT02013856 COMPLETED
Blood Pressure
Quadram Institute Bioscience
 2014-07
NCT02656212 COMPLETED
Pre-diabetes
Veterans Medical Research Foundation
 2015-09 PHASE1
NCT02292342 COMPLETED
Vasodilation
University of Reading
 2014-05 EARLY_PHASE1
NCT02330276 COMPLETED
Pre-diabetes
Veterans Medical Research Foundation
 2014-09 PHASE1
NCT02408289 COMPLETED
Obesity
Brooklyn College of the City University of New York
 2015-03
NCT02068040 COMPLETED
Heart Failure
University of California, San Diego
 2014-01
NCT01671514 COMPLETED
Heart Failure; Type 2 Diabetes
University of California, San Diego
 2012-07
NCT02221791 COMPLETED
Endothelial Dysfunction; Bioavailability
Wageningen University
 2014-06
NCT01880866 WITHDRAWN
Pulmonary Arterial Hypertension
University of California, San Francisco
 2013-07 PHASE1
NCT01585519 COMPLETED
Cardiovascular Disease
Queen's University, Belfast
 2012-04
NCT01690676 COMPLETED
Borderline Hypertension
Danisco
 2012-08 PHASE2
NCT01691404 COMPLETED
Hypertension; Endothelial Dysfunction
Wageningen University
 2012-09
NCT01097226 COMPLETED
Healthy
Quadram Institute Bioscience
 2010-04
NCT01969994 COMPLETED
ADME
The Institutes for Pharmaceutical Discovery, LLC
 2009-12

(data from https://clinicaltrials.gov, updated on 2026-05-08)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a bioactive dietary flavanol, (-)-epicatechin scavenges reactive oxygen species and stimulates endothelial nitric oxide synthase signaling, suppressing oxidative stress pathways and preserving mitochondrial respiration. This cellular antioxidant and bioenergetic enhancement improves vascular endothelial reactivity and muscle performance, providing therapeutic rationale for clinical trials targeting endothelial dysfunction, Becker muscular dystrophy, and impaired mobility.

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.