Clinical Trials

Numerous clinical trials—ranging from Early Phase 1 to Phase 4 across completed, actively recruiting, and pending statuses—evaluate diosmin for vascular disorders, ulcerative colitis, rheumatoid arthritis, non-alcoholic steatohepatitis, and chemotherapy-induced neuropathy. Sponsored by academic institutions like Tanta University alongside pharmaceutical entities like Laboratoire Innotech International, these investigations feature Phase 2 and Phase 3 trials testing diosmin as an adjuvant for rheumatoid arthritis and within combination regimens for chemotherapy-induced neuropathy.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07745426 RECRUITING
Rheumatoid Arthritis (RA)
Tanta University
 2026-08-01 PHASE2
NCT06256575 RECRUITING
Scleroderma, Systemic; Digital Ulcer
Primus Pharmaceuticals
 2025-05-02
NCT07300735 RECRUITING
Hematologic Malignancy; Neutropenia; Bone Pain
Alexandria University
 2025-03-01
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
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
NCT06083935 UNKNOWN
Poly Cystic Ovary Syndrome
Ain Shams University
 2023-11-01 PHASE4
NCT05670457 UNKNOWN
Non-bleeding Peptic Ulcer
Tanta University
 2022-06-30 PHASE3
NCT06125002 UNKNOWN
Myalgia
Sergio Marques Borghi
 2024-01 PHASE1
NCT06333691 COMPLETED
Ovarian Hyperstimulation Syndrome
Minia University
 2022-10-01
NCT05626166 UNKNOWN
Ulcerative Colitis
Tanta University
 2022-12-15 PHASE3
NCT05750563 UNKNOWN
Haemorrhoids
Giellepi S.p.A
 2023-02-28
NCT05942547 UNKNOWN
Non Alcoholic Steatohepatitis
Tanta University
 2023-07-10 PHASE3
NCT05243706 UNKNOWN
Vinca Alkaloid Adverse Reaction
Ain Shams University
 2022-03-01 PHASE3
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
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
NCT02158000 COMPLETED
Infertility
Benha University
 2014-06
NCT04933591 COMPLETED
Varicose Veins
Pirogov Russian National Research Medical University
 2020-09-01
NCT05243238 COMPLETED
Metabolic Syndrome and Diabetic Neuropathy
Beni-Suef University
 2020-03-01
NCT04452799 UNKNOWN
Coronavirus Infection
Tanta University
 2020-07-01 EARLY_PHASE1
NCT07369635 COMPLETED
Grade II Internal Hemorrhoids With Bleeding
Hanoi Medical University
 2020-07-10 PHASE3
NCT03413618 COMPLETED
Deep Vein Thrombosis; Postthrombotic Syndrome
Pirogov Russian National Research Medical University
 2017-12-20 PHASE4
NCT03471910 COMPLETED
Venous Insufficiency
Fundação Educacional Serra dos Órgãos
 2017-06-20 PHASE4
NCT02927483 UNKNOWN
Chronic Venous Insufficiency
SunWave Pharma
 2016-11 PHASE3
NCT02616731 UNKNOWN
Menorrhagia
Ain Shams University
 2015-09 PHASE1; PHASE2
NCT02134249 COMPLETED
Infertility
Benha University
 2014-04 PHASE2; PHASE3
NCT01532882 COMPLETED
Chronic Venous Disease of Lower Limbs
Laboratoire Innotech International
 2012-01 PHASE3
NCT01477281 UNKNOWN
Chronic Venous Insufficiency; Disease
Laboratório Teuto Brasileiro S/A
 2012-02 PHASE3
NCT01110512 UNKNOWN
Venous Insufficiency
Azidus Brasil
 2010-10 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-08-04)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Diosmin acts as an agonist of the aryl hydrocarbon receptor and potentiates norepinephrine-mediated vasoconstriction in vascular smooth muscle cells, thereby increasing venous tone, enhancing lymphatic drainage, and attenuating microvascular hyperpressure and capacitance. This physiological enhancement of venous return and reduction of microvascular stasis directly supports its clinical evaluation in conditions such as chronic venous disease, varicose veins, and pelvic congestive syndrome.

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.