Drugs / Lovaza
Lovaza
also known as
omega-3-acid ethyl esters · Omacor · P-OM3 · fish oil · omega-3-acid ethyl ester · TAK-085 · Lovaza (omega-3-acid ethyl esters) · OM-3 EE · +1 more
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | LOVAZA | — | 2009-09-16 | fda.gov ↗ |
| Approved | US (FDA) | LOVAZA | — | 2004-11-10 | fda.gov ↗ |
Trials 55
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 04 trials | ||||||
| Phase 0 | NCT04308889 | Jul 2018 → Feb 2022 | dermatitis | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 0 | NCT01823991 | Jul 2014 → Apr 2017 | breast cancer | H. Lee Moffitt Cancer Center and Research Institute | Completed | No outcome recorded |
| Phase 0 | NCT01784042 | Mar 2013 → Mar 2017 | breast cancer | Milton S. Hershey Medical Center | Withdrawn | No outcome recorded Stop: Business |
| Phase 0 | NCT00688961 | Jun → Aug 2007 | — | Sanford Research | Completed | No outcome recorded |
| Phase 13 trials | ||||||
| Phase 1 | NCT03438955 | Feb → Jul 2018 | hypertriglyceridemia | DongKoo Bio & Pharma | Unknown | No outcome recorded |
| Phase 1 | NCT01929070 | Feb → Mar 2013 | — | Hanmi Pharmaceutical Company Limited | Completed | No outcome recorded |
| Phase 1 | NCT00694746 | Jun 2008 → Mar 2014 | NAFLD1 | Boston University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/214 trials · 1 met primary | ||||||
| Phase 1/2 | NCT03169777 | Aug 2018 → Jan 2019 | colorectal cancer | ImmunityBio, Inc. | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT03169738 | Feb 2018 → Jan 2019 | non-small cell lung carcinoma | ImmunityBio, Inc. | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT03387098 | Dec 2017 → Sep 2018 | malignant pancreatic neoplasm | ImmunityBio, Inc. | Terminated | No outcome recorded |
| Phase 1/2 | NCT03197571 | Dec 2017 → Jan 2019 | urothelial carcinoma | ImmunityBio, Inc. | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT03197584 | Dec 2017 → Feb 2019 | ovarian carcinoma | ImmunityBio, Inc. | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT03175666 | Dec 2017 → Jan 2019 | triple-negative breast carcinoma | ImmunityBio, Inc. | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT03167164 | Dec 2017 → Jan 2019 | cutaneous neuroendocrine carcinoma | ImmunityBio, Inc. | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT03169790 | Dec 2017 → Jan 2019 | non-Hodgkin lymphoma | ImmunityBio, Inc. | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT03169764 | Dec 2017 → Jan 2019 | head and neck squamous cell carcinoma | ImmunityBio, Inc. | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT03329248 | Nov 2017 → Aug 2018 | malignant pancreatic neoplasm | ImmunityBio, Inc. | Terminated | No outcome recorded |
| Phase 1/2 | NCT01191177 | Jan 2011 → Jan 2012 | liver disorder, short bowel syndrome | Boston Children's Hospital | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT01155336 | Jun 2010 → May 2011 | myocardial infarction | University of Rochester | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT00959842 | Sep 2009 → Feb 2010 | hypertriglyceridemia | Sanford Research | Completed | No outcome recorded |
| Phase 1/2 | NCT00771914 | Nov 2008 → Jan 2009 | — | University of Rochester | Completed | Met primary |
| Phase 27 trials · 2 missed | ||||||
| Phase 2 | NCT06195306 | Jul 2025 → Jan 2027 expected | ductal breast carcinoma in situ, lobular breast carcinoma in situ | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT02370537 | Mar → Nov 2015 | exocrine pancreatic insufficiency, type 2 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT01252290 | Nov 2010 → May 2013 | breast cancer | Carol Fabian, MD | Completed | No outcome recorded |
| Phase 2 | NCT01252277 | Nov 2010 → Apr 2013 | breast cancer | Carol Fabian, MD | Completed | No outcome recorded |
| Phase 2 | NCT00805870 | Mar → Dec 2009 | myositis disease | Western Michigan University | Completed | Missed primary |
| Phase 2 | NCT00672633 | Apr 2008 → Dec 2011 | hypertriglyceridemia | Boston Children's Hospital | Terminated | Missed primary Stop: Enrollment |
| Phase 2 | NCT00517972 | — | depressive disorder | University of Arizona | Withdrawn | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT05281562 | Feb → Mar 2023 | diabetes mellitus, diabetic neuropathy, ulcer of lower limbs | Prisma Health-Midlands | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2/3 | NCT00915902 | Jul 2009 → Sep 2012 | hypertriglyceridemia | Babu Balagopal | Completed | No outcome recorded |
| Phase 36 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT03018041 | Sep 2017 → Mar 2024 | — | Joe Chan | Completed | No outcome recorded |
| Phase 3 | NCT04756180 | Oct 2016 → Apr 2019 | hypertriglyceridemia | Abbott | Completed | No outcome recorded |
| Phase 3 | NCT00435045 | Feb → Oct 2007 | hypertriglyceridemia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00402363 | Nov 2006 → Jan 2010 | atrial fibrillation | GlaxoSmithKline | Completed | Missed primary |
| Phase 3 | NCT00903409 | Nov 2005 → Jun 2008 | hypertriglyceridemia | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT00246701 | Nov 2005 → Jun 2006 | hypertriglyceridemia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 414 trials · 2 met primary · 1 missed | ||||||
| Phase 4 | NCT02839902 | Dec 2016 → Aug 2017 | hyperlipidemia | Takeda | Completed | Mixed |
| Phase 4 | NCT02824432 | Aug 2016 → Aug 2017 | hyperlipidemia | Takeda | Completed | No outcome recorded |
| Phase 4 | NCT02010359 | Jun 2014 → Jun 2017 | obesity disorder | University of Pennsylvania | Completed | No outcome recorded |
| Phase 4 | NCT01180764 | Aug 2010 → Aug 2012 | hypertriglyceridemia | University of Utah | Withdrawn | No outcome recorded |
| Phase 4 | NCT01041521 | Jan 2010 → Aug 2014 | HIV infectious disease, hypertriglyceridemia | Tufts University | Completed | No outcome recorded |
| Phase 4 | NCT00833976 | Jul 2009 → Mar 2013 | bipolar disorder, hyperlipoproteinemia, hypertriglyceridemia, schizoaffective disorder +1 | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00437099 | Feb 2009 → Feb 2011 | borderline personality disorder | Hospital Universitari Vall d'Hebron Research Institute | Unknown | No outcome recorded |
| Phase 4 | NCT00286234 | Oct 2007 → Aug 2008 | hypertriglyceridemia, metabolic syndrome X | University of South Dakota | Completed | No outcome recorded |
| Phase 4 | NCT00678743 | Aug 2007 → Aug 2009 | hyperlipidemia | Provident Clinical Research | Completed | Met primary |
| Phase 4 | NCT00598910 | Aug 2007 → Sep 2008 | hypertriglyceridemia | Solvay Pharmaceuticals | Terminated | Met primary Stop: Enrollment |
| Phase 4 | NCT00328536 | Apr 2007 → Nov 2008 | atherosclerosis, type 2 diabetes mellitus | Ruhr University of Bochum | Completed | No outcome recorded |
| Phase 4 | NCT00891293 | Mar 2006 → May 2008 | hypertriglyceridemia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT00246636 | Oct 2005 → Feb 2007 | hypertriglyceridemia | GlaxoSmithKline | Completed | Missed primary |
| Phase 4 | NCT00257283 | Nov 2002 → Jun 2005 | chronic renal failure syndrome | Pronova BioPharma | Completed | No outcome recorded |
| Phase not applicable4 trials | ||||||
| — | NCT01048502 | Jan 2010 → May 2011 | cardiovascular disorder | University of Pennsylvania | Completed | No outcome recorded |
| — | NCT00723398 | Mar 2009 → Apr 2015 | breast cancer | Milton S. Hershey Medical Center | Completed | No outcome recorded |
| — | NCT01157780 | Oct 2008 → Jun 2014 | parenteral nutrition-associated cholestasis | University of Tennessee | Unknown | No outcome recorded |
| — | NCT00577590 | Oct 2003 → Aug 2012 | type 2 diabetes mellitus | Washington University School of Medicine | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT00841451 | — | atrial fibrillation | St. Luke's-Roosevelt Hospital Center | No longer available | No outcome recorded |
| Comparator or background therapy23 trials | ||||||
| Phase 1 | NCT02189252 Comparator | Oct 2014 → Jul 2015 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT01431690 Comparator | Aug → Oct 2011 | hypertriglyceridemia | AstraZeneca | Completed | No outcome recorded |
| Phase 1/2 | NCT03167177 Background | Dec 2017 → Jan 2019 | melanoma | ImmunityBio, Inc. | Withdrawn | No outcome recorded |
| Phase 2 | NCT03598309 Comparator | Jun 2019 → May 2025 overdue | lung cancer | H. Lee Moffitt Cancer Center and Research Institute | Active not recruiting | No outcome recorded |
| Phase 2 | NCT01208961 Comparator | Sep → Nov 2010 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT01001767 Comparator | Apr 2009 → Mar 2010 | HIV infectious disease, heart disorder | University Hospitals Cleveland Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT00515541 Comparator | Sep 2007 → Jun 2009 | cardiovascular disorder, hemorrhagic disease | Invitrox | Completed | No outcome recorded |
| Phase 2 | NCT00845845 Comparator | Mar 2006 → Oct 2010 | metabolic dysfunction-associated steatohepatitis | University of Illinois at Chicago | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT01725646 Comparator | Jul 2011 → Jul 2013 | hypertriglyceridemia | Excelsior | Completed | No outcome recorded |
| Phase 3 | NCT01367145 Comparator | Jan 2011 → Nov 2013 | peripheral arterial disease | Medical University of Vienna | Completed | No outcome recorded |
| Phase 3 | NCT01277237 Comparator | Sep 2010 → Aug 2012 | NAFLD1 | University of Edinburgh | Completed | No outcome recorded |
| Phase 3 | NCT00944229 Comparator | Jan 2010 → Mar 2014 | congestive heart failure | Columbia University | Terminated | No outcome recorded |
| Phase 4 | NCT01046604 Comparator | Jan 2010 → Oct 2013 | inflammation of heart layer, mitochondrial disease, mitral valve insufficiency | East Carolina University | Unknown | No outcome recorded |
| Phase 4 | NCT00760513 Comparator | Nov 2009 → Nov 2013 | NAFLD1 | University Hospital Southampton NHS Foundation Trust | Completed | No outcome recorded |
| Phase 4 | NCT00941642 Comparator | Sep 2009 → Sep 2012 | NAFLD1 | Huntington Medical Research Institutes | Unknown | No outcome recorded |
| Phase 4 | NCT00934219 Comparator | Jul 2009 → Jul 2012 | hypertriglyceridemia | Jewish Hospital, Cincinnati, Ohio | Unknown | No outcome recorded |
| Phase 4 | NCT00828178 Comparator | Feb 2009 → Feb 2011 | systemic lupus erythematosus | Michelle Petri M.D.,MPH | Completed | No outcome recorded |
| Phase 4 | NCT00795717 Comparator | Jul 2008 → Oct 2010 | HIV infectious disease, cardiovascular disorder | Tufts University | Completed | No outcome recorded |
| — | NCT01107964 Comparator | Jul 2010 → Aug 2014 | dry eye syndrome | Milton S. Hershey Medical Center | Completed | No outcome recorded |
| — | NCT00743197 Comparator | May 2008 → May 2010 | intermediate coronary syndrome | Northwestern University | Terminated | No outcome recorded |
| — | NCT01002118 Comparator | Jan 2008 → Feb 2011 | cardiovascular disorder | University of Iowa | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT00569686 Comparator | Sep 2007 → Dec 2009 | peripheral arterial disease | University of Virginia | Withdrawn | No outcome recorded |
| — | NCT00454493 Comparator | Aug 2006 → Oct 2008 | coronary artery disorder | Olive View-UCLA Education & Research Institute | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2019-06-15 | Zydus Lifesciences Limited | Regulatory USFDA for Omega-3-Acid Ethyl Esters Capsules zyduslife.com ↗
Zydus’ Nesher Pharmaceuticals, a subsidiary of Zydus Pharmaceuticals USA has received the final approval from the USFDA to market Omega-3-Acid Ethyl Esters Capsules USP (US RLD – Lovaza Capsules), 1 gram. |
| 2014-04-08 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces First Approval and Launch of Generic Lovaza® Capsules in the United States tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) announces the approval of the generic equivalent to Lovaza® (Omega-3-Acid Ethyl Esters Capsules, USP), in the United States. |
| 2010-11-14 | GlaxoSmithKline | Results New study findings show no benefit of prescription omega-3 fatty acids in prevention of recurrent symptomatic atrial fibrillation in affected patients gsk.com ↗
The study showed no benefit in reducing the recurrence of symptomatic AF in patient groups treated with high-dose, prescription omega-3 fatty acids and placebo. |
All press releases naming this drug 7 releases
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 84 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Lovaza | “Patients with confirmed symptomatic paroxysmal or persistent AF (5:1 ratio) will be randomized to receive either 4 g/d P-OM3 (Lovaza; GlaxoSmithKline, Research Triangle Park,...” PMID 19619690 ↗ Aug 200947“The study drug, Omega-3-acid ethyl esters (Lovaza) was given to patients PO daily as two, 1 g capsules taken twice daily during the duration of their 8-week treatment period.” NCT00915902 ↗ “Prescription omega-3-acid ethyl ester (P-OM3; Lovaza) therapy is indicated for treating very high triglyceride levels (>or= 500 mg/dL) at a dose of 4 g/day.” PMID 19820283 ↗ Sep 2009 “Open-label Antara (fenofibrate) + open-label Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]” NCT00891293 ↗ “oral omega-3-acid ethyl esters (Lovaza, GlaxoSmithKline, Research Triangle Park, NC)” NCT01107964 ↗ “Lovaza (Omega-3 acid ethyl esters)” NCT01180764 ↗ “Lovaza (omega-3-acid ethyl esters)” NCT00805870 ↗ “Lovaza (omega-3-acid ethyl esters)” NCT00246701 ↗ “LOVAZA (Omega-3)” NCT00944229 ↗ |
| Known as | fish oil | “Lovaza® is the brand name for prescription strength fish oil pills.” NCT01048502 ↗ |
| Known as | Lovaza (omega-3-acid ethyl esters) | “Lovaza (omega-3-acid ethyl esters)” NCT01784042 ↗ |
| Known as | OM-3 EE | “a prescription OM-3 EE (Lovaza(®), GlaxoSmithKline, Research Triangle Park, NC).” PMID 23312053 ↗ Jan 2012 |
| Known as | Omacor | “The aim of this investigator initated study is to examine the effect of OMACOR (Omega-3-acid ethyl ester 90) on the incidence of cardiovascular events and mortality in patients...” NCT00257283 ↗21“The investigators will conduct a randomized clinical trial to evaluate the efficacy of Lovaza (formerly known as Omacor) in reducing triglyceride levels in youth ages 10-19...” NCT00672633 ↗ “The purpose of OM5/LOV111859 was to evaluate efficacy and safety of Omacor (omega-3-acid ethyl esters) as add-on therapy to Antara (fenofibrate) and diet for the treatment of...” NCT00246636 ↗ “The purpose of this study is to evaluate efficacy and safety of Omacor (omega-3-acid ethyl esters) in patients with recurrent, symptomatic atrial fibrillation.” NCT00402363 ↗ “Open-label Antara (fenofibrate) + open-label Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor]” NCT00891293 ↗ “Open-label Simvastatin + Lovaza® (omega-3-acid ethyl esters) \[formerly known as Omacor\]” NCT00903409 ↗ “Coadministration of Crestor 5mg 4tab and Omacor capsupe 1g 4cap in the fasting state” NCT01929070 ↗ “Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] plus atorvastatin” NCT00435045 ↗ “Combined Omacor (Omega-3-acid Ethyl Esters)” NCT00246701 ↗ “Omacor® (omega-3-acid ethyl esters)” NCT02370537 ↗ |
| Known as | Omega-3 | “LOVAZA (Omega-3)” NCT00944229 ↗ |
| Known as | omega-3-acid ethyl ester | “Lovaza (omega-3-acid ethyl ester)” NCT01191177 ↗ |
| Known as | omega-3-acid ethyl esters | “The purpose of OM5/LOV111859 was to evaluate efficacy and safety of Omacor (omega-3-acid ethyl esters) as add-on therapy to Antara (fenofibrate) and diet for the treatment of...” NCT00246636 ↗29“Each 1-gram capsule of LOVAZA (omega-3-acid ethyl esters) contains at least 900 mg of the ethyl esters of omega-3 fatty acids.” NCT00944229 ↗ “Single dose of Lovaza (omega-3-acid ethyl esters), 4x1g capsules, taken with low-fat meals” NCT01208961 ↗ “Prescription Lovaza (omega-3-acid ethyl esters) from GlaxoSmithKline at 4 grams day” NCT02010359 ↗ “Lovaza (omega-3-acid ethyl esters) [formerly known as Omacor] plus atorvastatin” NCT00435045 ↗ “Omega-3-acid ethyl esters (Lovaza) 3 gram once a day for 12 weeks” NCT00828178 ↗ “Simvastatin + Lovaza® (omega-3-acid ethyl esters)” NCT00903409 ↗ “Omega-3-acid ethyl esters (TAK-085) capsule” NCT02839902 ↗ “Omacor (omega-3-acid ethyl esters)” NCT00517972 ↗ “Omacor (omega-3-acid ethyl esters)” NCT00454493 ↗ “Lovaza (omega-3-acid ethyl esters)” NCT00246701 ↗ |
| Known as | P-OM3 | “Patients with confirmed symptomatic paroxysmal or persistent AF (5:1 ratio) will be randomized to receive either 4 g/d P-OM3 (Lovaza; GlaxoSmithKline, Research Triangle Park,...” PMID 19619690 ↗ Aug 20093“Prescription omega-3-acid ethyl ester (P-OM3; Lovaza) therapy is indicated for treating very high triglyceride levels (>or= 500 mg/dL) at a dose of 4 g/day.” PMID 19820283 ↗ Sep 2009 “Prescription omega-3 acid ethyl esters (P-OM3) and extended release niacin (ERN) both have beneficial effects on plasma lipids and lipoproteins.” PMID 25932792 ↗ Apr 2015 “prescription omega-3 acid ethyl ester (P-OM3) therapy” PMID 20451686 ↗ Mar 2010 |
| Known as | TAK-085 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02824432 ↗ |
| Action | Inhibit | “Lovaza but not Raloxifene-reduced SCD-16 and SCD-18” PMID 28145413 ↗ Feb 2017 |
| Modality | Small molecule | “Since Omacor contains in high-dose purified n-3 fatty acids eicosapentaenoic and docosahexaenoic acid (EPA and DHA)” NCT00328536 ↗ |
| Route | Oral | “When Lovaza® is ingested (an omega n3 fatty acid)” NCT00515541 ↗ |