Clinical Trials

Numerous clinical trials evaluate hesperidin as a monotherapy or within botanical fixed-dose combinations across diverse conditions, including vascular diseases, metabolic syndrome, hypertension, chemotherapy-induced toxicities, neuroprotective effects, and endothelial function. Spanning Early Phase 1 through Phase 4 alongside non-interventional protocols, these studies incorporate active, recruiting, completed, and withdrawn statuses. Sponsored by both academic medical centers and pharmaceutical organizations, this research reflects broad clinical interest in hesperidin's therapeutic efficacy.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07750223 RECRUITING
Cognitive Dysfunction; Overweight and Obesity
Min Hou
 2026-02-01
NCT07300735 RECRUITING
Hematologic Malignancy; Neutropenia; Bone Pain
Alexandria University
 2025-03-01
NCT07452562 RECRUITING
Multiple Sclerosis
Swansea University
 2026-01-07
NCT07598214 RECRUITING
Cancer Patients
Beni-Suef University
 2025-02-03 PHASE4
NCT06367166 ACTIVE_NOT_RECRUITING
Varicose Veins of Lower Limb; Varix; Vascular Diseases; Leg Edema
Ryazan State Medical University
 2023-04-01
NCT07588828 COMPLETED
Post-operative Seroma Formation; Breast Cancer Surgery
Ittefaq Hospital trust
 2024-10-01 PHASE4
NCT07185386 COMPLETED
Prodromal to Chronic Venous Disease
Ekalab S.r.l.
 2025-05-28
NCT07293767 RECRUITING
Fibromyalgia (FM)
Ain Shams University
 2024-11-16
NCT06672952 RECRUITING
Exercise Performance; Exercise Recovery; Cognitive Function; Nitric Oxide; Blood Flow; Endurance Exercise
Lindenwood University
 2025-04-15
NCT06811220 NOT_YET_RECRUITING
Breast Cancer
Alexandria University
 2025-01-27 PHASE3
NCT06546111 RECRUITING
Helicobacter Pylori Infection
Sadat City University
 2024-10-01 PHASE1; PHASE2
NCT05756179 RECRUITING
Rheumatoid Arthritis
Alexandria University
 2023-07-18 PHASE3
NCT06579482 COMPLETED
Chronic Venous Insufficiency
Fundação Educacional Serra dos Órgãos
 2024-11-06 PHASE4
NCT06584799 RECRUITING
Pelvic Venous Disorders
Pirogov Russian National Research Medical University
 2024-12 PHASE3
NCT06352099 COMPLETED
Cognitive Impairment; Old Age; Debility
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
 2024-05-02
NCT06402032 COMPLETED
Pulp Exposure, Dental; Dental Pulp Capping
Cairo University
 2022-09-01
NCT05243706 UNKNOWN
Vinca Alkaloid Adverse Reaction
Ain Shams University
 2022-03-01 PHASE3
NCT04731987 COMPLETED
Metabolic Syndrome; Vascular Compliance; Predisposition to Cardiovascular Disease
University Hospital, Clermont-Ferrand
 2021-02-24
NCT04316390 COMPLETED
Higher Uric Acid Concentrations (>5,5 mg/dl); Healthy
University of Kiel
 2022-07-15
NCT04360889 COMPLETED
Lower Extremity Lymphedema
Ryazan State Medical University
 2019-09-01 PHASE4
NCT04358497 UNKNOWN
Pelvic Congestive Syndrome; Pelvic Varices; Venous Disease
Hospital de Clínicas Dr. Manuel Quintela
 2020-10-01 PHASE4
NCT06249620 COMPLETED
Healthy
Industrial Farmacéutica Cantabria, S.A.
 2022-04-19
NCT05243706 Unknown status
Vinca Alkaloid Adverse Reaction
Ain Shams University
 2022-03-01 Phase 3
NCT05158192 COMPLETED
Bioequivalence
Laboratorios Andromaco S.A.
 2021-11-04 PHASE1
NCT04933591 COMPLETED
Varicose Veins
Pirogov Russian National Research Medical University
 2020-09-01
NCT04715932 COMPLETED
Covid19; Anosmia; Fever; Cough; Shortness of Breath; Sore Throat; Nausea; Vomiting; Headache; Muscle Weakness; Pain, Muscle; Pain, Chest; Pain, Joint; Pain, Abdominal; Pain; Irritable Mood; Confusion
Montreal Heart Institute
 2021-02-18 PHASE2
NCT05243238 COMPLETED
Metabolic Syndrome and Diabetic Neuropathy
Beni-Suef University
 2020-03-01
NCT04452799 UNKNOWN
Coronavirus Infection
Tanta University
 2020-07-01 EARLY_PHASE1
NCT04234100 COMPLETED
Blood Pressure; Hypertension
Technological Centre of Nutrition and Health, Spain
 2020-02-24
NCT03984916 COMPLETED
Biological Availability
Technological Centre of Nutrition and Health, Spain
 2019-06-13
NCT04234100 Completed
Blood Pressure|Hypertension
Technological Centre of Nutrition and Health Spain
 2020-02-24 Not Applicable
NCT03734835 UNKNOWN
Metabolic Syndrome
National Nutrition and Food Technology Institute
 2018-04-01
NCT03734510 UNKNOWN
Non Alcoholic Steatohepatitis
National Nutrition and Food Technology Institute
 2018-03-01
NCT04597983 COMPLETED
Power; Metabolic Disturbance; Change, Body Weight; Changes Fatty; Muscle Loss; Oxidative Stress; Inflammatory Response; Oxygen Deficiency; Acid-Base Imbalance; Electrolyte Disturbance
Francisco Javier Martínez Noguera
 2018-09-22
NCT03734874 UNKNOWN
Metabolic Syndrome
National Nutrition and Food Technology Institute
 2018-06-01
NCT03737422 COMPLETED
PreDiabetes
National Nutrition and Food Technology Institute
 2018-01-01
NCT03522896 COMPLETED
Effect of Food on Postprandial Hyperglycemia
University of Leeds
 2017-09-30
NCT02907320 WITHDRAWN
Venous Disease Classification (CEAP): C2 or C3
Pierre Fabre Medicament
 2016-12 PHASE2
NCT03471910 COMPLETED
Venous Insufficiency
Fundação Educacional Serra dos Órgãos
 2017-06-20 PHASE4
NCT03377153 UNKNOWN
Non Alcoholic Steatohepatitis
National Nutrition and Food Technology Institute
 2017-06-01
NCT03377140 UNKNOWN
Non Alcoholic Steatohepatitis
National Nutrition and Food Technology Institute
 2017-06-01
NCT03372109 COMPLETED
Body Weight Changes
Supplement Formulators, Inc.
 2017-11-14
NCT02479568 COMPLETED
Cardiovascular Risk Factors
Technological Centre of Nutrition and Health, Spain
 2016-01-12 PHASE3
NCT02927483 UNKNOWN
Chronic Venous Insufficiency
SunWave Pharma
 2016-11 PHASE3
NCT01773486 WITHDRAWN
Obesity; Insulin Resistance
University of Maryland, Baltimore
 2015-06 PHASE2
NCT02610491 COMPLETED
Metabolic Syndrome; Obesity
Maastricht University Medical Center
 2015-02 PHASE2
NCT02380144 Unknown status
Healthy
University of Hohenheim
 2014-01 Not Applicable
NCT01881204 COMPLETED
Osteoporosis, Postmenopausal
Purdue University
 2011-04
NCT01477281 UNKNOWN
Chronic Venous Insufficiency; Disease
Laboratório Teuto Brasileiro S/A
 2012-02 PHASE3
NCT00545116 COMPLETED
Osteopenia; Osteoporosis
Société des Produits Nestlé (SPN)
 2007-10 PHASE2
NCT01110512 UNKNOWN
Venous Insufficiency
Azidus Brasil
 2010-10 PHASE3
NCT00914251 UNKNOWN
Endothelial Dysfunction; Metabolic Syndrome
University of Rome Tor Vergata
 2008-11 PHASE2
NCT00914251 Unknown status
Endothelial Dysfunction|Metabolic Syndrome
University of Rome Tor Vergata
 2008-11 Phase 2
NCT00330096 COMPLETED
Osteoporosis, Osteopenia
Société des Produits Nestlé (SPN)
 2006-03 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-08-06)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a flavanone glycoside, hesperidin scavenges reactive oxygen species and modulates signaling through opioid and adenosine receptors, thereby suppressing pro-inflammatory cascades and reducing endothelial cellular injury. This cytoprotective and anti-inflammatory activity restores vascular tone and capillary permeability, underlying its therapeutic relevance in managing clinical trial conditions such as venous disease, hypertension, and metabolic endothelial dysfunction.

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.