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Simvastin
Simvastin is a Small molecule drug developed by US Department of Veterans Affairs. It is currently in Phase 1 development.
Simvastatin is a medication used to treat conditions such as high cholesterol, low-density lipoprotein (LDL) cholesterol, and hypercholesterolemia. It is also studied for its potential effects on chronic nephropathy, prediabetes, and inflammation, although the evidence for these uses is not as well established.
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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 | Simvastin |
|---|---|
| Sponsor | US Department of Veterans Affairs |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Systematic Management of High Cholesterol Utilizing Computer Monitoring (NA)
- Effect of Simvastatin and Ezetimibe on Lipid and Inflammation (NA)
- Ezetimibe/Simvastatin Combination in Proteinuric Nephropathy (PHASE4)
- Comparison of Efficacy and Safety of Ezetimibe or Statin Monotherapy to Co-Administration of Both (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:
- Simvastin CI brief — competitive landscape report
- Simvastin updates RSS · CI watch RSS
- US Department of Veterans Affairs portfolio CI
Frequently asked questions about Simvastin
What is Simvastin?
Who makes Simvastin?
What development phase is Simvastin in?
Related
- Manufacturer: US Department of Veterans Affairs — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing