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Silymarin
Silymarin, marketed by F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica, is a drug that inhibits the enzyme carbonic anhydrase 1, positioning it in a niche therapeutic area. Its key strength lies in its unique mechanism of action, which differentiates it from competitors such as glycyrrhizic acid. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | Silymarin |
|---|---|
| Also known as | LAGOSA, Milk thistle extract, Legalon, Milk Thistle, milk thistle |
| Sponsor | F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica |
| Drug class | silymarin |
| Target | Urokinase-type plasminogen activator, Carbonic anhydrase 1, Carbonic anhydrase 12 |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Common side effects
Key clinical trials
- The Efficacy and Safety of Ornithine Aspartic Acid Granules in NAFLD Against Silymarin Capsules (PHASE4)
- Clinical Evaluation of Microneedling Technique With Topical Application of Silymarin on Gingival Hyperpigmentation in Comparison With Diode Laser and Scalpel Methods. (NA)
- Milk Thistle Clinical Trial in Pediatric NAFLD (PHASE2)
- Impact of Silymarin Dosages to Decrease Drug-induced Elevated Liver Enzymes Compared to Placebo (PHASE2,PHASE3)
- Silymarin vs Hesperidin/Diosmin in Fibromyalgia (NA)
- Glucocorticoids for Acute Drug Induced Liver Injury With Hyperbilirubinemia (NA)
- Silibinin in Association With Concomitant Chemoradiotherapy and Maintenance Temozolomide in STAT3 Positive IDH Wild-type, Newly Diagnosed Glioblastoma Patients (NA)
- Study to Evaluate the Effectiveness of Legalon®
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 CI brief — competitive landscape report
- Silymarin updates RSS · CI watch RSS
- F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica portfolio CI