Drugs / Silymarin
last change May 2026 re-read 2 minutes ago

Silymarin

also known as Silibinin · Legalon · milk thistle · Silybin · silibin · iSIL · ivSIL · Legalon Sil · +4 more

Traditional medicine (herbal / TCM) targets STAT3, TNF via inhibition

Developed for
chronic hepatitis C virus infection · hepatitis C virus infection · HIV infectious disease · NAFLD1 · acne · diabetic kidney disease · disorder of defective peroxisome oxidative status · drug-induced liver injury
+37 more · hyperpigmentation of the skin · acute transplant rejection · allergic asthma · atrial fibrillation · beta-thalassemia major · colorectal cancer · COVID-19 · diabetes mellitus · end stage renal failure · essential hypertension · fibromyalgia · hepatitis · hepatocellular carcinoma · hypertensive nephropathy · immunodeficiency disease · infectious disease with sepsis · liver disorder · liver failure · metabolic dysfunction-associated steatohepatitis · mycotoxicosis · prostate cancer · proteinuria · trichotillomania · type 2 diabetes mellitus · ulcerative colitis · viral pneumonia · chemotherapy-induced toxicity · cisplatin toxicity · cognitive impairment with or without cerebellar ataxia · depressive disorder · fibrotic liver disease · Parkinson disease · pathological gambling · peripheral neuropathy · psoriasis · psoriatic arthritis · rheumatoid arthritis
Investigated by
National Center for Complementary and Integrative Health (NCCIH) · Rottapharm · Shiraz University of Medical Sciences · Tanta University · Assiut University · Beth Israel Deaconess Medical Center
+45 more · Isfahan University of Medical Sciences · Madaus Inc · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Thomas Jefferson University · University of North Carolina, Chapel Hill · University of Pennsylvania · University of Pittsburgh · Abby Siegel · Ain Shams University · Azienda Ospedaliera Universitaria Policlinico · Belupo · Bionorica SE · Brooke Army Medical Center · Bukwang Pharmaceutical · Cairo University · Henry Sacks · Islamabad Medical and Dental College · Kaohsiung Medical University Chung-Ho Memorial Hospital · Lahore General Hospital · Liaquat National Hospital & Medical College · Lotte & John Hecht Memorial Foundation · Masonic Cancer Center, University of Minnesota · Medical University of Vienna · MinaPharm Pharmaceuticals · Mylan Specialty, LP · National Institute of Nursing Research (NINR) · National Institutes of Health (NIH) · National Institutes of Health Clinical Center (CC) · Office of Dietary Supplements (ODS) · Prof. Dr. Frank Behrens · Seoul National University Hospital · Sir Mortimer B. Davis - Jewish General Hospital · University Hospital Rijeka · University Hospital, Martin · University Magna Graecia · University of Chicago · University of Colorado, Denver · University of Malaya · University of Maryland, Baltimore · University of North Carolina · University of Novi Sad · University of Rijeka · University of Zurich · VA Office of Research and Development · Vanderbilt University

Trials 45 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 18 trials
Phase 1 NCT07058090 Jul → Dec 2025 overdue drug-induced liver injury, tuberculosis Liaquat National Hospital & Medical College Not yet recruiting No outcome recorded
Phase 1 NCT03687073 Nov 2018 → May 2021 Masonic Cancer Center, University of Minnesota Completed No outcome recorded
Phase 1 NCT01752153 Jun → Sep 2012 immunodeficiency disease Shiraz University of Medical Sciences Completed No outcome recorded
Phase 1 NCT01129570 Feb 2010 → Jun 2013 hepatocellular carcinoma Abby Siegel Completed No outcome recorded
Phase 1 NCT01018615 Nov 2009 → Apr 2013 chronic hepatitis C virus infection, disorder of defective peroxisome oxidative status University of North Carolina, Chapel Hill Completed No outcome recorded
Phase 1 NCT00389376 Nov 2006 → Jan 2008 NAFLD1, hepatitis C virus infection National Center for Complementary and Integrative Health (NCCIH) Completed No outcome recorded
Phase 1 NCT00065741 Sep 2003 → Mar 2006 National Center for Complementary and Integrative Health (NCCIH) Completed No outcome recorded
Phase 1 NCT00011635 Feb → Jun 2001 HIV infectious disease National Institutes of Health Clinical Center (CC) Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT00246363 Jan 2005 → Dec 2007 HIV infectious disease, chronic hepatitis C virus infection Henry Sacks Completed No outcome recorded
Phase 219 trials
Phase 2 NCT07572552 May 2026 → Apr 2027 expected infectious disease with sepsis Tanta University Not yet recruiting No outcome recorded
Phase 2 NCT06213857 Feb → May 2025 overdue ulcerative colitis Tanta University Recruiting No outcome recorded
Phase 2 NCT06425705 Feb 2022 → Jul 2023 type 2 diabetes mellitus Lahore General Hospital Completed No outcome recorded
Phase 2 NCT03982849 Jul → Dec 2019 hyperpigmentation of the skin Islamabad Medical and Dental College Completed No outcome recorded
Phase 2 NCT02473913 Mar 2015 → Jun 2018 trichotillomania University of Chicago Completed No outcome recorded
Phase 2 NCT01816490 Apr 2013 → Apr 2014 HIV infectious disease, chronic hepatitis C virus infection University of Zurich Completed No outcome recorded
Phase 2 NCT02006498 Jun 2012 → Dec 2015 NAFLD1 University of Malaya Completed No outcome recorded
Phase 2 NCT01518933 Aug 2011 → Apr 2012 hepatitis C virus infection Rottapharm Terminated No outcome recorded
Phase 2 NCT01265563 Jan 2011 → Feb 2015 diabetic kidney disease, disorder of defective peroxisome oxidative status, proteinuria VA Office of Research and Development Completed No outcome recorded
Phase 2 NCT01003236 Oct 2010 → Oct 2011 diabetic kidney disease Shiraz University of Medical Sciences Completed No outcome recorded
Phase 2/33 trials
Phase 2/3 NCT05144217 Jun 2021 → Dec 2024 drug-induced liver injury Prof. Dr. Frank Behrens Completed No outcome recorded
Phase 2/3 NCT01049178 Sep 2010 allergic asthma Vanderbilt University Withdrawn No outcome recorded
Phase 2/3 NCT00999349 Mar → Dec 2009 beta-thalassemia major, disorder of iron metabolism and transport Isfahan University of Medical Sciences Unknown No outcome recorded
Phase 34 trials
Phase 3 NCT06114719 Jan 2023 → Sep 2024 atrial fibrillation University of Novi Sad Completed No outcome recorded
Phase 3 NCT04394208 Aug 2020 → Jan 2021 COVID-19, viral pneumonia Cairo University Unknown No outcome recorded
Phase 3 NCT06801886 Jan 2020 → Dec 2025 overdue acute transplant rejection, diabetes mellitus, hypertensive nephropathy University Hospital, Martin Enrolling by invitation No outcome recorded
Phase 3 NCT01258686 Nov 2010 → Nov 2012 chronic hepatitis C virus infection Bukwang Pharmaceutical Completed No outcome recorded
Phase 48 trials
Phase 4 NCT05666765 Jan → Nov 2023 acne Tanta University Unknown No outcome recorded
Phase 4 NCT05099601 May → Dec 2022 hyperpigmentation of the skin Assiut University Unknown No outcome recorded
Phase 4 NCT05849558 Feb 2022 → Dec 2023 liver disorder MinaPharm Pharmaceuticals Unknown No outcome recorded
Phase 4 NCT04490967 Apr → Dec 2021 acne Assiut University Unknown No outcome recorded
Phase 4 NCT02973295 Sep 2019 → Dec 2020 NAFLD1 University Hospital Rijeka Withdrawn No outcome recorded
Phase 4 NCT03130634 Apr 2016 → Jun 2019 colorectal cancer Kaohsiung Medical University Chung-Ho Memorial Hospital Completed No outcome recorded
Phase 4 NCT03538327 Oct 2013 → Apr 2014 essential hypertension University Magna Graecia Completed No outcome recorded
Phase 4 NCT00412763 Jul 2003 → Oct 2005 hepatitis University of Maryland, Baltimore Completed No outcome recorded
Phase not applicable2 trials
NCT07293767 Nov 2024 → Jan 2026 overdue fibromyalgia Ain Shams University Recruiting No outcome recorded
NCT01436929 Sep 2011 → Oct 2013 tuberculosis Seoul National University Hospital Unknown No outcome recorded
Also used as a comparator or background therapy in 21 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT05523648 Background Jan 2020 → Dec 2021 NAFLD1, chronic hepatitis B virus infection Sichuan Leshan Traditional Chinese Medicine Hospital Completed No outcome recorded
Phase 22 trials
Phase 2 NCT07001150 Comparator May 2025 → May 2026 overdue Parkinson disease Tanta University Recruiting No outcome recorded
Phase 2 NCT02337634 Comparator Jan 2015 → Dec 2022 pathological gambling University of Chicago Completed No outcome recorded
Phase 2/32 trials
Phase 2/3 NCT05595109 Comparator Oct 2022 → Apr 2023 breast cancer, chemotherapy-induced toxicity, cognitive impairment with or without cerebellar ataxia, peripheral neuropathy Tanta University Unknown No outcome recorded
Phase 2/3 NCT01829178 Comparator Aug 2013 → Sep 2014 cisplatin toxicity, gastroesophageal adenocarcinoma Tehran University of Medical Sciences Completed No outcome recorded
Phase 36 trials
Phase 3 NCT05631041 Comparator Dec 2022 → Nov 2024 colorectal cancer Tanta University Unknown No outcome recorded
Phase 3 NCT03216668 Comparator Jun 2017 → Jun 2019 liver failure Nhat Nhat Pharmaceutical Company Unknown No outcome recorded
Phase 3 NCT02878863 Background Aug 2016 → Mar 2017 autoimmune hepatitis Xiaoli Fan Withdrawn No outcome recorded
Phase 3 NCT01935817 Comparator Jun 2010 → Dec 2012 fibrotic liver disease University of Catania Completed No outcome recorded
Phase 3 NCT01957319 Comparator Feb 2010 → Jul 2013 depressive disorder University of Catania Completed No outcome recorded
Phase 44 trials
Phase 4 NCT06724952 Comparator Dec 2024 → Mar 2025 overdue rheumatoid arthritis Tanta University Not yet recruiting No outcome recorded
Phase 4 NCT04816682 Comparator Mar → Jun 2021 COVID-19, liver disorder F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica Completed No outcome recorded
Phase 4 NCT05042245 Comparator Jul 2019 → Dec 2022 NAFLD1 Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Completed No outcome recorded
Phase 4 NCT02347319 Comparator Apr 2012 → May 2013 liver disorder PharmaKing Completed No outcome recorded
Phase not applicable6 trials
NCT06922669 Background Jun 2025 → Mar 2027 expected drug-induced liver injury General Hospital of Shenyang Military Region Recruiting No outcome recorded
NCT06277635 Comparator Feb 2024 → Apr 2025 psoriasis, psoriatic arthritis Phramongkutklao College of Medicine and Hospital Unknown No outcome recorded
NCT05626881 Comparator May → Dec 2022 hyperpigmentation of the skin Sohag University Unknown No outcome recorded
NCT03659058 Comparator Mar 2016 → Aug 2018 fibrotic liver disease Zagazig University Completed No outcome recorded
NCT03547895 Comparator Jun 2015 → May 2016 cirrhosis of liver Zagazig University Completed No outcome recorded

Evidence & citations 17 cited values

Every value below carries the sentence it was read from. 70 sources stand behind the page.

FieldValueCited text
Known as Silymarin “The control group was treated with silymarin glucosamine tablets (Jiangsu Zhongxing Pharmaceutical Co., Ltd.; National medicine permission number: H32026233; Production batch:...” NCT05523648
51

Silymarin is a complex mixture of 6 major flavonolignans and other minor polyphenolic compounds derived from the milk thistle plant Silybum marianum; it has shown antioxidant,...” PMID 28419855 Apr 2017

Silymarin (milk thistle), an extract obtained from Silybum marianum seeds containing a complex of flavonolignans with a potent intracellular antioxidant property.” NCT06213857

“Patients were randomly assigned to 2 equal groups to receive three 140-mg tablets of silymarin or 3 tablets of placebo daily for 3 months.” PMID 22770926 Jul 2012

Silymarin or Milk Thistle may therefore offer promise for the treatment of individuals with trichotillomania.” NCT02473913

Silymarin,a mixture of three isomeric flavonolignans, is isolated from milk thistle (Silybum marianum) seeds” NCT01001845

“In this clinical study silymarin will be administered in different dosages and compared to placebo” NCT05144217

Silymarin (derived from milk thistle) has antioxidant properties.” PMID 38478366 Mar 2024

Silymarin 420 mg in 3 divided dose plus standard chemotherapy” NCT01829178

Silymarin was manufactured with concentration of 1.4%” NCT05626881

“Ursoplus® capsules (UDCA 250mg & Silymarin 140mg)” NCT05849558

NCT07293767

NCT06724952

NCT00030030

NCT06277635

NCT00412763

NCT02973295

NCT01049178

NCT06801886

NCT03130634

NCT06922669

NCT00999349

NCT01436929

NCT00680407

NCT07572552

NCT03659058

NCT01292161

NCT01258686

NCT04816682

NCT07058090

NCT05042245

NCT01018615

NCT06425705

NCT03547895

NCT05099601

NCT05595109

NCT05631041

NCT00680342

NCT02878863

NCT01091324

NCT00065741

NCT00011635

NCT04490967

NCT06114719

NCT00246363

NCT04394208

NCT01800487

NCT01752153

NCT00389376

NCT03982849

NCT07001150

NCT05666765

Known as iSIL “Intravenous Silibinin (iSIL)” NCT01816490
Known as ivSIL “Intravenous silibinin (ivSIL) is a potent antiviral agent against HCV.” PMID 22155914 2011
Known as Legalon “Silymarin (Legalon)” NCT01752153
4

“Silymarin (LEGALON)” NCT00999349

“Silymarin (LEGALON)” NCT07293767

NCT02347319

NCT03216668

Known as Legalon Sil “First, 16 patients received 10 mg/kg/day SIL IV (Legalon Sil; Madaus, Köln, Germany) for 7 days.” PMID 18771667 Aug 2008
Known as milk thistle “vitamin K (Phytomenadione) 10 mg+ furosemide and spironolactone (Lasilactone) 50 mg + milk thistle (Silymarin) 140 mg + Albumin infusion” NCT03547895
4

“Silymarin or Milk Thistle may therefore offer promise for the treatment of individuals with gambling disorder.” NCT02337634

“Silymarin or Milk Thistle may therefore offer promise for the treatment of individuals with trichotillomania.” NCT02473913

“Silymarin (milk thistle)” NCT00011635

“Silymarin (milk thistle)” NCT00246363

Known as Realsil “it was also recommended to take silybin coniugated to vitamin E and phosphatidylcholine that shows higher intestinal absorption and bioavailability (Indena, IBI-Lorenzini spa...” NCT03538327
Known as SIL “Oral Silibinin (SIL) is widely used for treatment of hepatitis C, but its efficacy is unclear.” PMID 18771667 Aug 2008
Known as silibin ClinicalTrials.gov intervention name — accepted as the source's own label NCT01265563
1

NCT03687073

Known as Silibinin “The control group was treated with silibinin meglumine tablets and tenofovir, while the treatment group was treated with Ganshuang granules combined with silybin meglumine...” PMID 36588741 Dec 2022
7

Silibinin is a polyphenolic flavonolignan derived from milk thistle (Silybum marianium) with anti-oxidant properties.” PMID 20127732 Jun 2010

NCT01816490

NCT03687073

NCT00915681

NCT01518933

NCT00684268

NCT01535092

Known as Silybin ClinicalTrials.gov intervention name — accepted as the source's own label NCT03538327
3

NCT01957319

NCT01129570

NCT01935817

Known as Silymarin capsule “Drug: Silymarin capsuleNCT05042245
Known as Silymarin capsules Silymarin capsules in the active comparator arm.” NCT05042245
Action Inhibit “In vitro silibinin (SIL) inhibits viral replication, possibly by inhibiting HCV RNA polymerase.” PMID 22155914 2011
Modality Traditional medicine (herbal / TCM) “Silymarin (Milk thistle) is a commonly used dietary supplement in HIV-infected patients for treatment of hepatitis or as a hepato-protectant.” NCT00011635
Route Oral “given concurrently via the oral route” NCT00065741
Target TNF “Silibinin is able to inhibit Tumor necrosis factor-alpha (TNF-α).” NCT01518933