Last reviewed · How we verify
Silymarin (Silybum marianum)
Silymarin is a flavonolignan mixture that protects liver cells by acting as an antioxidant and anti-inflammatory agent, stabilizing cell membranes and inhibiting toxin uptake.
Silymarin is a flavonolignan mixture that protects liver cells by acting as an antioxidant and anti-inflammatory agent, stabilizing cell membranes and inhibiting toxin uptake. Used for Liver disease and hepatotoxicity (including drug-induced liver injury), Cirrhosis support, Hepatitis C (adjunctive).
At a glance
| Generic name | Silymarin (Silybum marianum) |
|---|---|
| Sponsor | University of Maryland, Baltimore |
| Drug class | Herbal extract / Antioxidant |
| Modality | Small molecule |
| Therapeutic area | Hepatology / Gastroenterology |
| Phase | FDA-approved |
Mechanism of action
Silymarin, the active component of milk thistle (Silybum marianum), exerts hepatoprotective effects primarily through free radical scavenging and lipid peroxidation inhibition. It also modulates inflammatory pathways and may enhance liver cell regeneration. The mechanism involves stabilization of hepatocyte membranes and competitive inhibition of toxin binding to liver cells.
Approved indications
- Liver disease and hepatotoxicity (including drug-induced liver injury)
- Cirrhosis support
- Hepatitis C (adjunctive)
Common side effects
- Gastrointestinal upset
- Allergic reactions (rare)
- Headache
Key clinical trials
- Milk Thistle Clinical Trial in Pediatric NAFLD (PHASE2)
- Silymarin Bioavailability Study (NA)
- Beneficial Effect of Silymarin in Ulcerative Colitis (PHASE2)
- Milk Thistle in Pathological Gambling (PHASE2)
- Impact of Silymarin Adjunct Therapy on Proteinuria in Type 2 Diabetic Patients on RAS Inhibitors (PHASE2)
- Effect of Silymarin Against Methotrexate-induced Liver Injury in Rheumatic Diseases (NA)
- Nutraceutical Composition Containing Natural Products Derivatives on the Modulation of the Endocrine Neuroimmune Axis (NA)
- Exercise, Milk Thistle, and Lactobacillus to Influence Plasma Bilirubin (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Silymarin (Silybum marianum) CI brief — competitive landscape report
- Silymarin (Silybum marianum) updates RSS · CI watch RSS
- University of Maryland, Baltimore portfolio CI