Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4 and unassigned protocols evaluate silibinin in hepatic disorders, oncology, and toxicology. These studies encompass conditions such as chronic liver disease, advanced hepatocellular carcinoma, prostate cancer, amatoxin poisoning, hepatitis C recurrence, and acute myeloid leukemia. Sponsored by diverse academic medical centers, foundations, and pharmaceutical entities—including Columbia University, Medica Sur Clinic & Foundation, and Fujian Medical University Union Hospital—trial statuses vary from completed or terminated to actively recruiting, particularly for combination chemotherapy regimens.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06964815 RECRUITING
Glioblastoma; IDH Wild-type and STAT3-positive Glioblastoma
Istituto Oncologico Veneto IRCCS
 2025-11-12
NCT07561892 RECRUITING
Acute Myeloid Leukemia; Newly Diagnosed; Chemotherapy Effect
Fujian Medical University Union Hospital
 2022-04-01 PHASE4
NCT05689619 RECRUITING
Brain Metastases, Adult; Non Small Cell Lung Cancer; Breast Cancer
A.O.U. Città della Salute e della Scienza
 2023-09-01
NCT05793489 ACTIVE_NOT_RECRUITING
Brain Metastases, Adult
Istituto Clinico Humanitas
 2023-03-06
NCT05497765 COMPLETED
Nonalcoholic Fatty Liver Disease
Guangzhou Medical University
 2022-08-01
NCT05069298 UNKNOWN
Overweight and Obesity; Hypercholesterolemia; Hypertriglyceridemia
Universidad Católica San Antonio de Murcia
 2023-01-12
NCT03687073 COMPLETED
Smoking
Masonic Cancer Center, University of Minnesota
 2018-11-29 PHASE1
NCT00915681 TERMINATED
Amatoxin Poisoning; Amanita Poisoning; Mushroom Poisoning; Liver Failure
Mylan Specialty, LP
 2009-11-10 PHASE2
NCT03440164 Completed
Liver Diseases|Chronic Liver Disease
Medica Sur Clinic & Foundation
 2016-11-11 --
NCT01871662 WITHDRAWN
Hepatitis C, Chronic
Rottapharm
 2013-08 PHASE2; PHASE3
NCT01816490 COMPLETED
HIV; Hepatitis C
University of Zurich
 2013-04 PHASE2
NCT01518933 TERMINATED
Hepatitis C Virus Recurrence
Rottapharm
 2011-08 PHASE2
NCT01535092 TERMINATED
HCV Recurrence After Liver Transplantation
Rottapharm
 2010-09 PHASE2
NCT00684268 COMPLETED
Hepatitis C
Medical University of Vienna
 2007-10 PHASE2
NCT01129570 Completed
Advanced Hepatocellular Carcinoma
Abby Siegel|Lotte & John Hecht Memorial Foundation|Columbia University
 2010-02 Phase 1
NCT00487721 Completed
Prostate Cancer
University of Colorado Denver|Sir Mortimer B. Davis - Jewish General Hospital
 2006-08 Phase 2
NCT00181662 Completed
Healthy
Massachusetts General Hospital
 2005-08 Not Applicable

(data from https://clinicaltrials.gov, updated on 2025-12-02)

Check the Silibinin (NSC 651520) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Silibinin directly inhibits P-glycoprotein-mediated efflux transport and cytochrome P450 enzymatic activity, thereby blocking xenobiotic clearance pathways and increasing intracellular drug accumulation. This modulation of drug transport and hepatic metabolism reduces therapeutic resistance and cellular injury, underlying its clinical application in chronic liver disease, hepatocellular carcinoma, and combination chemotherapy protocols.

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.