Clinical Trials

Numerous clinical trials evaluate silymarin across Phase 1 through Phase 4 for diverse indications, predominantly targeting hepatic disorders such as non-alcoholic fatty liver disease, liver fibrosis, and chronic hepatitis C, alongside conditions like breast cancer and irritable bowel syndrome. Sponsored by both academic institutions and pharmaceutical companies, these studies exhibit varying recruitment statuses—ranging from active or unknown to completed Phase 2 safety and Phase 4 cardioprotection evaluations.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07410156 RECRUITING
Gingival Pigmentation; Gingival Hyperpigmentaion
Fayoum University
 2026-07-01
NCT07572552 NOT_YET_RECRUITING
Sepsis
Tanta University
 2026-05 PHASE2
NCT06922669 RECRUITING
Drug Induced Liver Injury
General Hospital of Shenyang Military Region
 2025-06-24
NCT07001150 RECRUITING
Parkinson Disease
Tanta University
 2025-05-10 PHASE2
NCT07293767 RECRUITING
Fibromyalgia (FM)
Ain Shams University
 2024-11-16
NCT06801886 ENROLLING_BY_INVITATION
Posttransplant Diabetes Mellitus; Acute Graft Rejection; Biopsy Proven Acute Rejection; Antibody Mediated Rejection of Kidney Transplant; Arterial Hypertension, Chronic Kidney Disease
University Hospital, Martin
 2020-01-07 PHASE3
NCT07058090 NOT_YET_RECRUITING
Drug Induced Liver Injury; Tuberculosis (TB)
Liaquat National Hospital & Medical College
 2025-07 PHASE1
NCT07123922 ENROLLING_BY_INVITATION
COPD (Chronic Obstructive Pulmonary Disease)
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
 2025-06-20
NCT06213857 RECRUITING
Ulcerative Colitis
Tanta University
 2025-02-01 PHASE2
NCT06376110 UNKNOWN
Acne
Austin Institute for Clinical Research
 2024-04-24
NCT06277635 UNKNOWN
Rheumatoid Arthritis; Psoriatic Arthritis; Psoriasis
Phramongkutklao College of Medicine and Hospital
 2024-02-01
NCT06724952 NOT_YET_RECRUITING
Rheumatoid Arthritis (RA)
Tanta University
 2024-12-10 PHASE4
NCT06882681 COMPLETED
Bioavailability and Pharmacokinetics
Isura
 2024-05-01
NCT05144217 COMPLETED
Drug-induced Liver Injury
Prof. Dr. Frank Behrens
 2021-06-23 PHASE2; PHASE3
NCT05631041 UNKNOWN
Metastatic Colorectal Cancer
Tanta University
 2022-12-31 PHASE3
NCT06114719 COMPLETED
Atrial Fibrillation New Onset
University of Novi Sad
 2023-01-01 PHASE3
NCT05497765 COMPLETED
Nonalcoholic Fatty Liver Disease
Guangzhou Medical University
 2022-08-01
NCT05849558 UNKNOWN
Chronic Liver Disease
MinaPharm Pharmaceuticals
 2022-02-22 PHASE4
NCT05666765 UNKNOWN
Acne Vulgaris
Tanta University
 2023-01-01 PHASE4
NCT02843451 WITHDRAWN
Body Dysmorphic Disorder
University of Chicago
 2016-10 PHASE2
NCT06425705 COMPLETED
Type 2 Diabetes Mellitus
Lahore General Hospital
 2022-02-25 PHASE2
NCT05595109 UNKNOWN
Breast Cancer; Peripheral Neuropathy; Cardiac Toxicities; Hepatic Toxicity; Cognitive Impairment
Tanta University
 2022-10-28 PHASE2; PHASE3
NCT05042245 COMPLETED
Non-alcoholic Fatty Liver Disease
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
 2019-07-23 PHASE4
NCT05626881 UNKNOWN
Melasma
Sohag University
 2022-05-01
NCT05099601 UNKNOWN
Melasma
Assiut University
 2022-05 PHASE4
NCT02337634 COMPLETED
Pathological Gambling; Gambling Disorder
University of Chicago
 2015-01 PHASE2
NCT03749070 UNKNOWN
Non-Alcoholic Fatty Liver Disease
Camila Ribeiro de Avelar
 2019-02-15
NCT04810572 COMPLETED
Insulin Resistance; Inflammatory Bowel Diseases; Overweight and Obesity; Healthy
University of Sao Paulo General Hospital
 2021-05-20
NCT05099601 Unknown status
Melasma
Assiut University
 2022-05 Phase 4
NCT04490967 UNKNOWN
Acne Vulgaris
Assiut University
 2021-04 PHASE4
NCT04816682 COMPLETED
Covid19; Liver Diseases
F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
 2021-03-17 PHASE4
NCT04394208 UNKNOWN
COVID-19; Viral Pneumonia Human Coronavirus
Cairo University
 2020-08-16 PHASE3
NCT02973295 WITHDRAWN
Non-Alcoholic Fatty Liver Disease
University Hospital Rijeka
 2019-09-20 PHASE4
NCT03982849 COMPLETED
Melasma
Islamabad Medical and Dental College
 2019-07-15 PHASE2
NCT04434404 COMPLETED
Breast Cancer
Horus University
 2018-09-10 PHASE4
NCT03216668 UNKNOWN
Liver Function Failure
Nhat Nhat Pharmaceutical Company
 2017-06-15 PHASE3
NCT03130634 COMPLETED
Metastatic Colorectal Cancer
Kaohsiung Medical University Chung-Ho Memorial Hospital
 2016-04 PHASE4
NCT04434404 Completed
Breast Cancer
Horus University
 2018-09-10 Phase 4
NCT03659058 COMPLETED
Fibrosis, Liver
Zagazig University
 2016-03-02
NCT02473913 COMPLETED
Trichotillomania; Hair Pulling Disorder
University of Chicago
 2015-03 PHASE2
NCT03174561 UNKNOWN
Irritable Bowel Syndrome
SC Fiterman Pharma SRL
 2017-05-01
NCT03216668 Unknown status
Liver Function Failure
Nhat Nhat Pharmaceutical Company
 2017-06-15 Phase 3
NCT02878863 WITHDRAWN
Hepatitis, Autoimmune
Xiaoli Fan
 2016-08 PHASE3
NCT03547895 COMPLETED
Decompensated Cirrhosis
Zagazig University
 2015-06-01
NCT02006498 COMPLETED
Non-alcoholic Fatty Liver Disease
University of Malaya
 2012-06 PHASE2
NCT01829178 COMPLETED
Upper GI Cancer; Cisplatin Adverse Reaction
Tehran University of Medical Sciences
 2013-08 PHASE2; PHASE3
NCT01436929 UNKNOWN
Tuberculosis
Seoul National University Hospital
 2011-09
NCT01800487 COMPLETED
Tuberculosis
Ramathibodi Hospital
 2012-01
NCT01018615 COMPLETED
Chronic Hepatitis C; Oxidative Stress
University of North Carolina, Chapel Hill
 2009-11 PHASE1
NCT00680407 COMPLETED
Non-alcoholic Steatohepatitis
Madaus Inc
 2008-04 PHASE2
NCT01258686 COMPLETED
Hepatitis C
Bukwang Pharmaceutical
 2010-11 PHASE3
NCT01752153 COMPLETED
Immune Abnormalities
Shiraz University of Medical Sciences
 2012-06 PHASE1
NCT02006498 Completed
Non-alcoholic Fatty Liver Disease
University of Malaya|Rottapharm
 2012-06 Phase 2
NCT00755950 TERMINATED
Acute Hepatitis A; Acute Hepatitis B; Acute Hepatitis C; Acute Hepatitis E; Acute EBV Hepatitis; Acute CMV Hepatitis
University of Maryland, Baltimore
 2008-10 PHASE2; PHASE3
NCT01003236 COMPLETED
Diabetic Nephropathy
Shiraz University of Medical Sciences
 2010-10 PHASE2
NCT00684268 COMPLETED
Hepatitis C
Medical University of Vienna
 2007-10 PHASE2
NCT00680342 COMPLETED
Chronic Hepatitis C
National Center for Complementary and Integrative Health (NCCIH)
 2008-04 PHASE2
NCT01049178 WITHDRAWN
Atopic Asthma
Vanderbilt University
 2010-09 PHASE2; PHASE3
NCT01091324 UNKNOWN
Proteinuria
National Cheng-Kung University Hospital
 2010-01 PHASE3
NCT00999349 UNKNOWN
Beta-thalassemia Major; Iron Overload
Isfahan University of Medical Sciences
 2009-03 PHASE2; PHASE3
NCT01018615 Completed
Chronic Hepatitis C|Oxidative Stress
University of North Carolina Chapel Hill|National Center for Complementary and Integrative Health (NCCIH)|National Institutes of Health (NIH)
 2009-11 Phase 1
NCT00389376 COMPLETED
Hepatitis C; Non-Alcoholic Fatty Liver Disease
National Center for Complementary and Integrative Health (NCCIH)
 2006-11 PHASE1
NCT00246363 COMPLETED
HIV Infections; Hepatitis C
Henry Sacks
 2005-01 PHASE1; PHASE2
NCT01292161 COMPLETED
Hepatitis C
Isfahan University of Medical Sciences
 2006-03 PHASE2
NCT00030030 COMPLETED
Hepatitis C, Chronic
National Center for Complementary and Integrative Health (NCCIH)
 2000-07 PHASE2
NCT00011635 COMPLETED
HIV Infection; Healthy
National Institutes of Health Clinical Center (CC)
 2001-02 PHASE1
NCT00065741 COMPLETED
HIV Seronegativity
National Center for Complementary and Integrative Health (NCCIH)
 2003-09 PHASE1
NCT00055718 COMPLETED
Drug/Agent Toxicity by Tissue/Organ; Leukemia
Herbert Irving Comprehensive Cancer Center
 2001-11 PHASE2
NCT00412763 COMPLETED
Hepatitis
University of Maryland, Baltimore
 2003-07 PHASE4

(data from https://clinicaltrials.gov, updated on 2026-02-13)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a polyphenolic flavonolignan complex, silymarin acts primarily as a direct free radical scavenger and antioxidant that inhibits lipid peroxidation and mitigates cellular oxidative damage. By suppressing downstream inflammatory cascades and preserving membrane stability, silymarin protects parenchymal cells, providing therapeutic efficacy in managing liver diseases, hepatic fibrosis, and oxidative stress-related clinical 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.