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Silibin
Silibin is a Small molecule drug developed by Masonic Cancer Center, University of Minnesota. It is currently in Phase 1 development. Also known as: Sil.
Silibinin is a small molecule with antioxidant effects, studied for its potential benefits in conditions such as HCV recurrence after liver transplantation, oxidative stress, and cirrhosis. It has been investigated as a treatment option in clinical trials, including a randomized, double-blind, placebo-controlled study for the treatment of HCV recurrence in liver transplanted patients.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Silibin |
|---|---|
| Also known as | Sil |
| Sponsor | Masonic Cancer Center, University of Minnesota |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Silibinin in Association With Concomitant Chemoradiotherapy and Maintenance Temozolomide in STAT3 Positive IDH Wild-type, Newly Diagnosed Glioblastoma Patients (NA)
- Effect of the Combination of Pterostilbene Cocrystal With Silybin and Nicotinamide Riboside on Exercise-Induced Oxidative Stress (NA)
- A Prospective Cohort Study on Drug-induced Liver Injury in China（DILI-P）
- Prospective Double Arm Randomized Trial: WBRT Alone and WBRT Plus Silibinin (NA)
- Plasma Exchange for Amanita Toxin-induced Acute Liver Failure
- Effect of L-ornithine-L-aspertate (LOLA) on the Gut Microbiome (PHASE4)
- Silymarin for the Prevention of Atrial Fibrillation After Cardiac Surgery (PHASE3)
- An Intervention Study of Compound Silymarin in Patients With Non-alcoholic Fatty Liver Disease (NA)
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:
- Silibin CI brief — competitive landscape report
- Silibin updates RSS · CI watch RSS
- Masonic Cancer Center, University of Minnesota portfolio CI
Frequently asked questions about Silibin
What is Silibin?
Who makes Silibin?
Is Silibin also known as anything else?
What development phase is Silibin in?
Related
- Manufacturer: Masonic Cancer Center, University of Minnesota — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Sil
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing