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Simvastatin + Lovaza
Simvastatin + Lovaza is a Statin + Omega-3 fatty acid combination Small molecule drug developed by GlaxoSmithKline. It is currently in Phase 3 development for Dyslipidemia with elevated triglycerides and LDL cholesterol, Cardiovascular risk reduction in patients requiring both statin and triglyceride-lowering therapy.
Simvastatin lowers LDL cholesterol by inhibiting HMG-CoA reductase, while Lovaza (omega-3 fatty acids) reduces triglycerides through multiple pathways including reduced hepatic VLDL production.
Simvastatin is a small molecule statin used to treat conditions such as hypertriglyceridemia, diabetes mellitus type 2, and dyslipidemias. Lovaza, also known as ethyl icosapentate (AMR101), is a small molecule omega-3 fatty acid used to treat hypertriglyceridemia, often in combination with statins like simvastatin.
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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. -
Big-pharma sponsor
+3.0pp
GlaxoSmithKline is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 | Simvastatin + Lovaza |
|---|---|
| Sponsor | GlaxoSmithKline |
| Drug class | Statin + Omega-3 fatty acid combination |
| Target | HMG-CoA reductase (simvastatin); VLDL synthesis and triglyceride metabolism (Lovaza) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
This combination targets two distinct lipid pathways: simvastatin blocks the rate-limiting enzyme in cholesterol synthesis to reduce LDL-C levels, while Lovaza provides high-dose omega-3 polyunsaturated fatty acids (EPA and DHA) that suppress triglyceride synthesis and increase triglyceride clearance. Together, they address multiple dyslipidemia components in cardiovascular disease.
Approved indications
- Dyslipidemia with elevated triglycerides and LDL cholesterol
- Cardiovascular risk reduction in patients requiring both statin and triglyceride-lowering therapy
Common side effects
- Muscle pain or myalgia
- Elevated liver enzymes
- Gastrointestinal upset
- Fishy aftertaste or eructation
Key clinical trials
- An Open-label Extension to Assess the Continued Efficacy of Omacor Plus Simvastatin (PHASE4)
- Women With Chest Pain and Normal Coronary Arteries Study (NA)
- Effect of AMR101 (Ethyl Icosapentate) on Triglyceride (Tg) Levels in Patients on Statins With High Tg Levels (≥ 200 and < 500 mg/dL) (PHASE3)
- Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride (Tg) Levels ≥ 500 and ≤ 2000 mg/dL (PHASE3)
- A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High-Risk Patients With Hypertriglyceridemia and on Statin (PHASE3)
- Open-Label Extension of a Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lovaza® and Simvastatin Therapy in Hypertriglyceridemic Subjects (PHASE3)
- Evaluation of Efficacy and Safety of Combined Omacor (Omega-3-acid Ethyl Esters) and Simvastatin Therapy in Hypertriglyceridemic Subjects (PHASE3)
- Efficacy and Safety of Prescription Omega-3 Fatty Acid Added to Stable Statin Therapy in Patients With Type 2 Diabetes and Hypertriglyceridemia (PHASE4)
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:
- Simvastatin + Lovaza CI brief — competitive landscape report
- Simvastatin + Lovaza updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about Simvastatin + Lovaza
What is Simvastatin + Lovaza?
How does Simvastatin + Lovaza work?
What is Simvastatin + Lovaza used for?
Who makes Simvastatin + Lovaza?
What drug class is Simvastatin + Lovaza in?
What development phase is Simvastatin + Lovaza in?
What are the side effects of Simvastatin + Lovaza?
What does Simvastatin + Lovaza target?
Related
- Drug class: All Statin + Omega-3 fatty acid combination drugs
- Target: All drugs targeting HMG-CoA reductase (simvastatin); VLDL synthesis and triglyceride metabolism (Lovaza)
- Manufacturer: GlaxoSmithKline — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Dyslipidemia with elevated triglycerides and LDL cholesterol
- Indication: Drugs for Cardiovascular risk reduction in patients requiring both statin and triglyceride-lowering therapy
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing