LOVAZA (omega-3-acid ethyl esters)
Lovaza is a combination of omega-3 fatty acids used to lower very high triglyceride levels in adults. It helps patients with severe hypertriglyceridemia, specifically those with levels at or above 500 mg/dL, alongside a specialized lipid-lowering diet. This medication is typically prescribed after attempts to control lipids through exercise, weight loss, and the management of contributing medical conditions like diabetes or hypothyroidism.
How LOVAZA Works
This medication works by reducing the synthesis of triglycerides in the liver, as its primary components are poor substrates for the enzymes responsible for creating these fats. It may also increase the breakdown of fats in the blood and enhance the liver's ability to oxidize fatty acids.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2004-11-10
- Routes
- ORAL
- Dosage Forms
- CAPSULE
LOVAZA Approval History
What LOVAZA Treats
1 indicationsLOVAZA is approved for 1 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypertriglyceridemia
LOVAZA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to LOVAZA
3 of 16FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
25 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06195306 | NCI-2023-10830 NCI-2023-10830, UMICC 2024.076 | Ph 2 | recruiting | Low Dose Tamoxifen With or Without Omega-3 Fatty Acids for Breast Cancer Risk Reduction |
| NCT03169790 | QUILT-3.052 | Ph 1, Ph 2 | withdrawn | QUILT-3.052: NANT Non-Hodgkin Lymphoma (NHL) Vaccine: Combination Immunotherapy in Subjects With Relapsed CD20-positive NHL |
| NCT03169764 | QUILT-3.047 | Ph 1, Ph 2 | withdrawn | QUILT-3.047: NANT Head and Neck Squamous Cell Carcinoma (HNSCC) Vaccine: Combination Immunotherapy in Subjects With HNSCC Who Have Progressed on or After Chemotherapy and PD-1/PD-L1 Therapy |
| NCT03175666 | QUILT-3.049 | Ph 1, Ph 2 | withdrawn | QUILT-3.049: NANT Triple Negative Breast Cancer (TNBC) Vaccine: Combination Immunotherapy in Subjects With TNBC Who Have Progressed on or After Anthracycline-based Chemotherapy |
| NCT03167164 | QUILT-3.045 | Ph 1, Ph 2 | withdrawn | QUILT-3.045: NANT Merkel Cell Carcinoma (MCC) Vaccine: Combination Immunotherapy in Subjects With MCC Who Have Progressed on or After PD-L1 Therapy |
| NCT03169777 | QUILT-3.050 | Ph 1, Ph 2 | withdrawn | QUILT-3.050: NANT Colorectal Cancer (CRC) Vaccine: Combination Immunotherapy in Subjects With Recurrent or Metastatic CRC |
| NCT03167177 | QUILT-3.046 | Ph 1, Ph 2 | withdrawn | QUILT-3.046: NANT Melanoma Vaccine: Combination Immunotherapy in Subjects With Melanoma Who Have Progressed On or After Chemotherapy and PD-1/PD-L1 Therapy |
| NCT03169738 | QUILT-3.044 | Ph 1, Ph 2 | withdrawn | QUILT-3.044: NANT Non-small Cell Lung Cancer (NSCLC) Vaccine: Combination Immunotherapy in Subjects With NSCLC Who Have Progressed After Treatment With PD-1/PD-L1 Inhibitors |
| NCT03197571 | QUILT-3.048 | Ph 1, Ph 2 | withdrawn | QUILT-3.048: NANT Urothelial Cancer Vaccine: Combination Immunotherapy in Subjects With Urothelial Cancer Who Have Progressed on or After Chemotherapy and PD-1/PD-L1 Therapy |
| NCT05281562 results posted | 1876718 | Ph 2, Ph 3 | terminated | Immunonutrition for Diabetic Foot Ulcers |
| NCT03329248 results posted | QUILT-3.060 | Ph 1, Ph 2 | terminated | QUILT-3.060: NANT Pancreatic Cancer Vaccine: Molecularly Informed Integrated Immunotherapy in Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy |
| NCT03387098 results posted | QUILT-3.070 | Ph 1, Ph 2 | terminated | QUILT-3.070:Pancreatic Cancer Vaccine: Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy |
| NCT00915902 results posted | GIDDING | Ph 2, Ph 3 | completed | Fish Oil Study for High Triglyceride Levels in Children |
| NCT00959842 ELLF results posted | LVZ 112860 GSK - LVZ 112860 | Ph 1, Ph 2 | completed | Effects of Lovaza on Lipoprotein Composition and Function in Mild Hypertriglyceridemia |
| NCT01041521 HOST results posted | LVZ112667 1R01HL096585-01A1 | Ph 4 | completed | The Impact of Omega Three Fatty Acids on Vascular Function in HIV |
| NCT00795717 HALO results posted | LVZ111888 011293-GSK Contract Reference# | Ph 4 | completed | Human Immunodeficiency Virus (HIV), Arterial Dysfunction, Lipids, Lovaza (HALO) Trial |
| NCT02010359 FAIR results posted | 1K23DK095913-01A1 1K23DK095913-01A1 | Ph 4 | completed | Fish Oils and Adipose Inflammation Reduction |
| NCT00791089 results posted | LVZ111900 | Ph 4 | terminated | Effects of Fish Oil on Post Ablation Arrhythmias |
| NCT00833976 results posted | 2008-P-002219 | Ph 4 | completed | Omega-3 Fatty Acids (Lovaza) for Second Generation Antipsychotic-Associated Hypertriglyceridemia |
| NCT02189252 ECLIPSEIV results posted | D5880C00003 OM-EPA-013 | Ph 1 | completed | An Open-Label Crossover Study to Compare the Relative Bioavailability, Efficacy and Safety of Epanova® and Lovaza® in Men and Women With a History of Pancreatitis |
| NCT00694746 | IIT40 | Ph 1 | terminated | Study of Fish Oil to Reduce ALT Levels in Adolescents |
| NCT01431690 | OM-EPA-006 | Ph 1 | completed | Interaction of Epanova on Warfarin Pharmacokinetic and Anticoagulant Activity and Comparison of the Effects of Epanova and Lovaza on Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) After Low-fat Meals |
| NCT01001767 results posted | AIDS 10-08-24 | Ph 2 | completed | Pilot Placebo Controlled Study With Lovaza in Cardiovascular Disease |
| NCT00672633 results posted | 08010028 | Ph 2 | terminated | Trial of Lovaza in Adolescents With Mild to Moderately Elevated Triglycerides |
| NCT00771914 results posted | Study Protocol 112421 | Ph 1, Ph 2 | completed | The Effects of Omega-3 Fatty Acids on Aspirin Resistance |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LOVAZA FDA Label Details
Indications & Usage
FDA Label (PDF)LOVAZA is indicated for the treatment of Hypertriglyceridemia.
Track LOVAZA with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment