Clinical Trials

Numerous clinical trials evaluate the therapeutic potential and pharmacokinetic profile of lycopene across diverse indications, primarily focusing on oncology (prostate, breast, and metastatic colorectal cancers) and cardiovascular conditions (hypertension and vascular dysfunction), alongside periodontal disease, total motile sperm count, and skin toxicity. Sponsored by entities such as the National Cancer Institute and university medical centers, these Phase 1 through Phase 4 and nutritional interventional studies reflect varied recruitment statuses, including completed, recruiting, terminated, and withdrawn protocols.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05671562 COMPLETED
Total Motile Sperm Count
Sheffield Teaching Hospitals NHS Foundation Trust
 2023-05-03
NCT07117110 RECRUITING
Healthy
Erasmus Medical Center
 2025-07-11
NCT07120035 COMPLETED
Inflammatory Markers
East Carolina University
 2024-03-27
NCT05836909 UNKNOWN
Hypercholesterolemia
Lili Yang
 2023-05-01
NCT03783013 TERMINATED
Healthy Volunteers
USDA Beltsville Human Nutrition Research Center
 2019-01-08
NCT03167268 UNKNOWN
Colorectal Cancer Metastatic; Skin Toxicity
Ospedale San Carlo Borromeo
 2016-08-03 PHASE2
NCT03964935 UNKNOWN
Periodontal Pocket
University of Baghdad
 2018-12-01 PHASE2
NCT04652739 COMPLETED
Erosive Lichen Planus
Nourhan M.Aly
 2018-10-01 PHASE2; PHASE3
NCT03460860 COMPLETED
Skin Aging; Wrinkles
United Laboratories
 2018-03-05
NCT03820245 COMPLETED
Oxidative Stress; Atherosclerosis
Universidade Federal de Santa Maria
 2016-08-24
NCT03463967 UNKNOWN
NAFLD
Federico II University
 2016-10
NCT04446624 Completed
Breast Cancer|Depression Anxiety|Oxidative Stress
Università degli Studi del Piemonte Orientale Amedeo Avogadro
 2018-02-01 Not Applicable
NCT01102504 WITHDRAWN
Carotid Atherosclerotic Disease
Cambridge University Hospitals NHS Foundation Trust
 2015-08
NCT01733017 COMPLETED
Heart Failure
Terry Lennie
 2011-11 PHASE2
NCT03203746 COMPLETED
Chronic Periodontitis
Maie Sami tawfik
 2015-09-28 PHASE1; PHASE2
NCT01882985 COMPLETED
Adenocarcinoma of the Prostate; Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer
University of California, Irvine
 2010-12 PHASE2
NCT03492593 COMPLETED
Digestion Chambers; Stability and Metabolism of Carotenoids and Vitamin E
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
 2014-09
NCT02550483 COMPLETED
Healthy
USDA Beltsville Human Nutrition Research Center
 2015-09
NCT03608254 Completed
Vascular Health of Postmenopausal Women
University of Alabama Tuscaloosa
 2015-11-05 --
NCT01377961 WITHDRAWN
Metabolic Syndrome; Diabetes Mellitus, Non-Insulin-Dependent
The University of Texas Medical Branch, Galveston
 2010-09
NCT01949519 COMPLETED
Adenocarcinoma of the Prostate
Medical University of South Carolina
 2013-11 PHASE1
NCT02587117 COMPLETED
Oral Lichen Planus
B.P. Koirala Institute of Health Sciences
 2013-02 PHASE4
NCT00844792 COMPLETED
Cancer of the Prostate; Prostate Cancer; Prostatic Neoplasms
University Health Network, Toronto
 2008-10 PHASE2
NCT00744549 COMPLETED
Cancer of the Prostate; Prostate Cancer; Prostatic Neoplasms
University Health Network, Toronto
 2008-05 PHASE2
NCT01692340 COMPLETED
Healthy
Ohio State University Comprehensive Cancer Center
 2012-02 PHASE1; PHASE2
NCT01665742 COMPLETED
Overweight; Obesity
University College Dublin
 2012-01
NCT01667510 COMPLETED
Prehypertension
LycoRed Ltd.
 2012-08
NCT01665469 COMPLETED
Postprandial Oxidation and inflammation
LycoRed Ltd.
 2012-11
NCT02263352 COMPLETED
Positive Regulation of Oxidative Stress Process
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
 2013-01 PHASE4
NCT01321268 TERMINATED
Cellulite (Orange Peel Skin)
dsm-firmenich Switzerland AG
 2011-05
NCT00905931 UNKNOWN
Subarachnoid Hemorrhage; Aneurysm
University of Cambridge
 2010-09 PHASE2
NCT01105338 COMPLETED
Prostate Cancer
University of Bristol
 2009-08 PHASE2; PHASE3
NCT00450749 COMPLETED
Adenocarcinoma of the Prostate; Stage I Prostate Cancer; Stage II Prostate Cancer; Stage III Prostate Cancer
National Cancer Institute (NCI)
 2008-02 PHASE2
NCT01221558 COMPLETED
Healthy Men
Yonsei University
 2009-07 PHASE3
NCT00637858 TERMINATED
Hypertension
Soroka University Medical Center
 2008-10
NCT01443026 COMPLETED
Intraepithelial Prostatic Neoplasia; Prostatic Neoplasms
University of Illinois at Chicago
 2006-02 PHASE2
NCT00322114 UNKNOWN
Prostate Cancer
University of Illinois at Chicago
 2006-02
NCT02348164 COMPLETED
Bioavailability of Carotenoids
USDA, Western Human Nutrition Research Center
 2007-12
NCT00402285 COMPLETED
Prostate Cancer
University of California, San Francisco
 2003-04
NCT00450957 COMPLETED
Healthy, no Evidence of Disease; Prostate Cancer
National Cancer Institute (NCI)
 2006-10 PHASE1
NCT00068731 COMPLETED
Prostate Cancer
Alliance for Clinical Trials in Oncology
 2004-01 PHASE2
NCT00042731 COMPLETED
Prostate Cancer
H. Lee Moffitt Cancer Center and Research Institute
 2002-07
NCT00656214 COMPLETED
Lichen Planus, Oral
College of Dental Sciences, India
 2004-12 PHASE2
NCT00154843 COMPLETED
BPH
National Taiwan University Hospital
 2004-03 PHASE2
NCT00006078 COMPLETED
Prostate Cancer
University of Illinois at Chicago
 2000-06 PHASE1
NCT00172367 WITHDRAWN
Carcinoma, Transitional Cell
National Taiwan University Hospital
 2006-01 PHASE2
NCT00416390 COMPLETED
Nonmalignant Neoplasm; Prostate Cancer
University of Illinois at Chicago
NCT00093561 COMPLETED
Prostate Cancer
University of Illinois at Chicago
 2004-08 PHASE1
NCT00178113 COMPLETED
Prostatic Intraepithelial Neoplasia
University of Pittsburgh
 2003-07 PHASE1
NCT00416325 COMPLETED
Prostate Cancer
University of Illinois at Chicago
 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-02-04)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lycopene functions as a lipophilic antioxidant that quenches singlet oxygen and scavenges free radicals, thereby protecting cellular membranes from lipid peroxidation and suppressing downstream oxidative signaling cascades. This inhibition of oxidative stress and associated cellular proliferation pathways provides a mechanistic basis for its clinical investigation in prostate cancer, cardiovascular health, and inflammatory conditions.

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.