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Simvastatine
Simvastatine is a Small molecule drug developed by Tel-Aviv Sourasky Medical Center. It is currently in Phase 1 development.
Simvastatin is a medication that has been studied as an intracanal treatment for endodontic conditions such as Endodontically Retard Teeth and Periapical Radiolucency. It has also been investigated for its potential effects on Schizophrenia, Schizoaffective Disorder, and Breast Cancer Stage IV, although the primary focus of these studies is unclear.
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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 | Simvastatine |
|---|---|
| Sponsor | Tel-Aviv Sourasky Medical Center |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Drug Repurposing in Thyroid Carcinoma: a Feasibility Trial (PHASE1)
- Simvastatin in Preventing Liver Cancer in Patients With Liver Cirrhosis (PHASE2)
- Adebrelimab Combined With Gemcitabine, Cisplatin, and Simvastatin for Advanced Biliary Tract Cancer (PHASE1, PHASE2)
- Intensive Cholesterol-Lowering and CD8+ T Cells in Prostate Cancer (PHASE2)
- Clinical Evaluation of Simcyp-Guided Simvastatin Dosing in Patients With Liver Cirrhosis (PHASE4)
- Triple Antibiotic Paste vs Simvastatin for Lesion Sterilization and Tissue Repair in Primary Molars. (PHASE2)
- KF2022#4-trial: Effects of a Beta Blocker and NSAID on CYP Mediated Drug Metabolism (NA)
- T-reg Function Changes: a Novel Immune Regulatory Effect Underlying Benefit of Statin Use on Lethal Prostate Cancer (PHASE2)
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:
- Simvastatine CI brief — competitive landscape report
- Simvastatine updates RSS · CI watch RSS
- Tel-Aviv Sourasky Medical Center portfolio CI
Frequently asked questions about Simvastatine
What is Simvastatine?
Who makes Simvastatine?
What development phase is Simvastatine in?
Related
- Manufacturer: Tel-Aviv Sourasky Medical Center — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing