MedPath

Silibinin

Generic Name
Silibinin
Drug Type
Small Molecule
Chemical Formula
C25H22O10
CAS Number
22888-70-6
Unique Ingredient Identifier
33X338MNE4
Background

Silibinin is the major active constituent of silymarin, a standardized extract of the milk thistle seeds, containing a mixture of flavonolignans consisting of silibinin, isosilibinin, silicristin, silidianin and others. Silibinin is presented as a mixture of two diastereomers, silybin A and silybin B, which are found in an approximately equimolar ratio. Both in vitro and animal research suggest that silibinin has hepatoprotective (antihepatotoxic) properties that protect liver cells against toxins. Silibinin has also demonstrated in vitro anti-cancer effects against human prostate adenocarcinoma cells, estrogen-dependent and -independent human breast carcinoma cells, human ectocervical carcinoma cells, human colon cancer cells, and both small and nonsmall human lung carcinoma cells.

Indication

Currently being tested as a treatment of severe intoxications with hepatotoxic substances, such as death cap (Amanita phalloides) poisoning.

Associated Conditions
Acute Hepatitis, Amanita Poisoning, Cirrhosis of the Liver, Clinical Deterioration of the Liver, Fatty Liver Disease, Hepatitis, Chronic, Non Alcoholic Steatohepatitis (NASH), Nonalcoholic Fatty Liver, Recurrent Hepatitis, Severe alcoholic liver disease, Uncomplicated hepatic dysfunction

Trial of Indole-3-Carbinol and Silibinin

Phase 1
Completed
Conditions
Smoking
Interventions
First Posted Date
2018-09-27
Last Posted Date
2021-08-11
Lead Sponsor
Masonic Cancer Center, University of Minnesota
Target Recruit Count
21
Registration Number
NCT03687073
Locations
🇺🇸

Masonic Cancer Center at University of Minnesota, Minneapolis, Minnesota, United States

THISTLE - The HIV-HCV Silibinin Trial

Phase 2
Completed
Conditions
Hepatitis C
HIV
First Posted Date
2013-03-22
Last Posted Date
2015-03-05
Lead Sponsor
University of Zurich
Target Recruit Count
20
Registration Number
NCT01816490
Locations
🇨🇭

Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Zurich, Switzerland

Legalon SIL for the Treatment of HCV Recurrence in Liver Transplanted Patients

Phase 2
Terminated
Conditions
HCV Recurrence After Liver Transplantation
Interventions
Drug: Placebo
First Posted Date
2012-02-17
Last Posted Date
2012-02-17
Lead Sponsor
Rottapharm
Target Recruit Count
14
Registration Number
NCT01535092

Effect of LEGALON SIL on Hepatitis C Virus Recurrence in Stable Liver Transplanted Patients

Phase 2
Terminated
Conditions
Hepatitis C Virus Recurrence
Interventions
First Posted Date
2012-01-26
Last Posted Date
2015-03-05
Lead Sponsor
Rottapharm
Target Recruit Count
20
Registration Number
NCT01518933
Locations
🇮🇹

Azienda Ospedaliero-Universitaria Policlinico Consorziale, Bari, Italy

Intravenous Milk Thistle (Silibinin-Legalon) for Hepatic Failure Induced by Amatoxin/Amanita Mushroom Poisoning

Phase 2
Terminated
Conditions
Amanita Poisoning
Mushroom Poisoning
Amatoxin Poisoning
Liver Failure
Interventions
First Posted Date
2009-06-08
Last Posted Date
2022-04-07
Lead Sponsor
Mylan Specialty, LP
Target Recruit Count
148
Registration Number
NCT00915681
Locations
🇺🇸

Recruitment Hot Line for the United States, Somerset, New Jersey, United States

🇺🇸

Mylan Specialty LLP, Morgantown, West Virginia, United States

Intravenous Silibinin in Combination With Peg-interferon and Ribavirin in Nonresponders

Phase 2
Completed
Conditions
Hepatitis C
Interventions
First Posted Date
2008-05-26
Last Posted Date
2017-03-27
Lead Sponsor
Medical University of Vienna
Target Recruit Count
70
Registration Number
NCT00684268
Locations
🇦🇹

Medical University of Vienna, Wien, Austria

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