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ezetimibe/simvastatin 10/40
ezetimibe/simvastatin 10/40 is a Combination lipid-lowering agent (ezetimibe + statin) Small molecule drug developed by Organon and Co. It is currently in Phase 3 development for Hypercholesterolemia and mixed dyslipidemia, Cardiovascular risk reduction in patients requiring LDL-C lowering. Also known as: Vytorin.
Ezetimibe/simvastatin reduces blood cholesterol by blocking intestinal cholesterol absorption (ezetimibe) and inhibiting hepatic cholesterol synthesis (simvastatin).
Ezetimibe/simvastatin reduces blood cholesterol by blocking intestinal cholesterol absorption (ezetimibe) and inhibiting hepatic cholesterol synthesis (simvastatin). Used for Hypercholesterolemia and mixed dyslipidemia, Cardiovascular risk reduction in patients requiring LDL-C lowering.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Cardiovascular Phase 3 risk
-2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | ezetimibe/simvastatin 10/40 |
|---|---|
| Also known as | Vytorin |
| Sponsor | Organon and Co |
| Drug class | Combination lipid-lowering agent (ezetimibe + statin) |
| Target | NPC1L1 transporter (ezetimibe); HMG-CoA reductase (simvastatin) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
Ezetimibe selectively inhibits the Niemann-Pick C1-like 1 (NPC1L1) transporter in the intestinal brush border, reducing dietary and biliary cholesterol absorption. Simvastatin is an HMG-CoA reductase inhibitor that decreases cholesterol synthesis in the liver. Together, this combination provides complementary mechanisms to lower LDL cholesterol and triglycerides while raising HDL cholesterol.
Approved indications
- Hypercholesterolemia and mixed dyslipidemia
- Cardiovascular risk reduction in patients requiring LDL-C lowering
Common side effects
- Myalgia
- Elevated liver transaminases
- Headache
- Abdominal pain
- Diarrhea
- Rhabdomyolysis
Key clinical trials
- EASEGO Study: Doubling of Atorvastatin/Simvastatin or INEGY in Patients With Hypercholesterolemia and Coronary Artery Disease(CAD)(0653A-089) (PHASE4)
- IMPROVE-IT: Examining Outcomes in Subjects With Acute Coronary Syndrome: Vytorin (Ezetimibe/Simvastatin) vs Simvastatin (P04103) (PHASE3)
- Vytorin (10/20 Or 10/40) Compared to Atorvastatin (10 mg or 20 mg) in Patients With Coronary Artery Disease (0653A-126)(COMPLETED) (PHASE4)
- The Effects of Ezetimibe/Simvastatin 10/20 mg Versus Simvastatin 40 mg in High Cholesterol and Coronary Heart Disease Study (P04039AM2)(COMPLETED) (PHASE4)
- A Study to Assess the Cholesterol Lowering Effect of Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Elderly Patients With High Cholesterol at High or Moderately High Risk for Coronary Heart Disease (0653A-128) (PHASE3)
- Ezetimibe/Simvastatin in Patients With Metabolic Syndrome (0653A-107)(COMPLETED) (PHASE3)
- Ezetimibe/Simvastatin (10 mg/40 mg) vs. the Doubling of Atorvastatin in High Risk Participants (MK-0653A-134 AM1)(COMPLETED) (PHASE3)
- A Study to Determine the Number of Patients Who Reach Optimal Cholesterol Levels on Each of Three Different Treatments (0653A-121) (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:
- ezetimibe/simvastatin 10/40 CI brief — competitive landscape report
- ezetimibe/simvastatin 10/40 updates RSS · CI watch RSS
- Organon and Co portfolio CI
Frequently asked questions about ezetimibe/simvastatin 10/40
What is ezetimibe/simvastatin 10/40?
How does ezetimibe/simvastatin 10/40 work?
What is ezetimibe/simvastatin 10/40 used for?
Who makes ezetimibe/simvastatin 10/40?
Is ezetimibe/simvastatin 10/40 also known as anything else?
What drug class is ezetimibe/simvastatin 10/40 in?
What development phase is ezetimibe/simvastatin 10/40 in?
What are the side effects of ezetimibe/simvastatin 10/40?
What does ezetimibe/simvastatin 10/40 target?
Related
- Drug class: All Combination lipid-lowering agent (ezetimibe + statin) drugs
- Target: All drugs targeting NPC1L1 transporter (ezetimibe); HMG-CoA reductase (simvastatin)
- Manufacturer: Organon and Co — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Hypercholesterolemia and mixed dyslipidemia
- Indication: Drugs for Cardiovascular risk reduction in patients requiring LDL-C lowering
- Also known as: Vytorin
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing