Drugs / Fish oil
Fish oil
also known as
Omacor · Omega-3 fatty acids · omega-3 fish oil · Fish Oil (Containing Omega-3 Acids) · Fish oil (EPA/DHA) · Lovaza · LovazaTM (former name: Omacor) · Maxepa · +5 more
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | SMOFLIPID 20% | — | 2016-07-13 | fda.gov ↗ |
Trials 33
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT02538484 | Apr 2016 → Mar 2020 | breast cancer | The University of Texas Health Science Center at San Antonio | Completed | No outcome recorded |
| Phase 13 trials | ||||||
| Phase 1 | NCT06424860 | Nov 2025 → Dec 2026 expected | atherosclerotic cardiovascular disease, polycystic ovary syndrome | University of Alberta | Recruiting | No outcome recorded |
| Phase 1 | NCT03010917 | Mar 2017 → May 2021 | alcohol dependence | Yale University | Completed | No outcome recorded |
| Phase 1 | NCT04116203 | Jun 2016 → Nov 2020 | polycystic ovary syndrome | University of Alberta | Completed | No outcome recorded |
| Phase 29 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT06279793 | Feb 2024 → Mar 2030 expected | — | GCP-Service International West GmbH | Recruiting | No outcome recorded |
| Phase 2 | NCT04417595 | Nov 2020 → Nov 2024 | nicotine dependence | Vanderbilt University Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT03077724 | Mar 2017 → Jan 2018 | pregnancy disorder | Vanderbilt University Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT02420496 | Jun 2016 | cholestasis, liver disorder | The University of Texas Health Science Center at San Antonio | Withdrawn | No outcome recorded |
| Phase 2 | NCT01933243 | Aug 2013 → Dec 2016 | anorexia nervosa, anxiety | Andrea Bonny | Completed | No outcome recorded |
| Phase 2 | NCT01019382 | Oct 2009 → Jun 2014 | pancreatic neoplasm | University Hospitals, Leicester | Completed | No outcome recorded |
| Phase 2 | NCT00871377 | May 2008 → May 2011 | epilepsy | National Center for Complementary and Integrative Health (NCCIH) | Completed | Met primary |
| Phase 2 | NCT00351533 | Jul 2006 → Jan 2009 | acute lung injury, adult acute respiratory distress syndrome | University of Washington | Completed | Missed primary |
| Phase 2 | NCT00076518 | ? → Sep 2005 | HIV infectious disease, hypertriglyceridemia | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00336908 | Nov 2005 → Nov 2007 | — | University of Alberta | Completed | No outcome recorded |
| Phase 35 trials · 2 missed | ||||||
| Phase 3 | NCT02271230 | Aug 2014 → Dec 2019 | heart failure | Brigham and Women's Hospital | Completed | Missed primary |
| Phase 3 | NCT01565278 | Feb 2012 → Aug 2015 | parenteral nutrition-associated cholestasis | Johane Allard | Terminated | No outcome recorded |
| Phase 3 | NCT00447291 | Dec 2006 → Mar 2010 | obesity disorder | Children's Heart Center | Terminated | No outcome recorded |
| Phase 3 | NCT01211769 | Feb 2006 → Jun 2008 | alcohol dependence | Federal University of São Paulo | Completed | Missed primary |
| Phase 3 | NCT00299533 | Feb 2004 → Sep 2006 | epilepsy | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 45 trials · 1 missed | ||||||
| Phase 4 | NCT01819961 | Apr → Oct 2013 | gastric neoplasm, liver and intrahepatic bile duct neoplasm, pancreatic neoplasm | Wei Zhou | Unknown | No outcome recorded |
| Phase 4 | NCT00552084 | Nov 2007 → Apr 2014 | atrial fibrillation | Vanderbilt University | Completed | Missed primary |
| Phase 4 | NCT00232245 | Dec 2003 → Jan 2013 | atrial fibrillation | Melbourne Health | Completed | No outcome recorded |
| Phase 4 | NCT00232232 | Sep 2003 → Jul 2013 | atrial fibrillation, atrial flutter | Melbourne Health | Completed | No outcome recorded |
| Phase 4 | NCT00232219 | Jan 2003 → Nov 2013 | atrial fibrillation | Melbourne Health | Completed | No outcome recorded |
| Phase not applicable9 trials · 1 missed | ||||||
| — | NCT04965129 | Nov 2022 → May 2024 | lung cancer | Federal University of Rio de Janeiro | Unknown | No outcome recorded |
| — | NCT03697499 | Sep → Dec 2018 | cardiovascular disorder, disorder of defective peroxisome oxidative status, respiratory system disorder | Fudan University | Completed | No outcome recorded |
| — | NCT03462771 | May → Jul 2018 | muscular atrophy | Eduardo Ferriolli | Unknown | No outcome recorded |
| — | NCT03048981 | Mar → May 2017 | atherosclerosis, platelet aggregation, spontaneous | Region Skane | Completed | No outcome recorded |
| — | NCT01351805 | Jul 2010 → Nov 2018 | chronic pain syndrome, osteoarthritis, rheumatoid arthritis | Brigham and Women's Hospital | Completed | Missed primary |
| — | NCT00682318 | May 2008 → Nov 2028 expected | — | University of Pennsylvania | Active not recruiting | No outcome recorded |
| — | NCT00308295 | Apr → May 2006 | end stage renal failure | Indiana University | Completed | No outcome recorded |
| — | NCT00365742 | Apr → Jun 2006 | hyperlipidemia | Chestnut Hill Health System | Completed | No outcome recorded |
| — | NCT00371982 | Dec 2002 → Apr 2005 | type 2 diabetes mellitus | Assistance Publique - Hôpitaux de Paris | Terminated | No outcome recorded |
| Comparator or background therapy11 trials | ||||||
| Phase 1 | NCT00676156 Comparator | Dec 2005 → Feb 2008 | multiple sclerosis | Oregon Health and Science University | Completed | No outcome recorded |
| Phase 2 | NCT01594983 Comparator | Jun 2012 → Jul 2013 | — | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2/3 | NCT01534663 Comparator | Nov 2011 → Jul 2013 | heart failure | Columbia University | Completed | No outcome recorded |
| Phase 3 | NCT05613803 Comparator | Oct 2023 → Jan 2026 | asthma | Norfolk and Norwich University Hospitals NHS Foundation Trust | Completed | No outcome recorded |
| Phase 3 | NCT04386577 Comparator | Aug 2016 → Apr 2021 | — | Augusta University | Unknown | No outcome recorded |
| Phase 3 | NCT00072982 Comparator | Nov 2006 → May 2008 | rheumatoid arthritis | National Center for Complementary and Integrative Health (NCCIH) | Unknown | No outcome recorded |
| Phase 4 | NCT02140788 Comparator | May 2011 → Feb 2013 | schizoaffective disorder, schizophrenia | Duke University | Terminated | No outcome recorded |
| — | NCT01948648 Comparator | Feb 2018 → Apr 2021 | sitosterolemia | University of Manitoba | Unknown | No outcome recorded |
| — | NCT04070833 Comparator | Aug 2016 → Sep 2018 | stroke disorder | Brigham and Women's Hospital | Completed | No outcome recorded |
| — | NCT01285362 Comparator | Mar 2013 → Sep 2014 | NAFLD1 | Columbia University | Completed | No outcome recorded |
| — | NCT00914576 Comparator | Apr 2011 → Jul 2013 | — | Medical University of Vienna | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 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 ↗
LOVAZA is a prescription medication made from omega-3 fish oil indicated as an adjunct to diet, to reduce triglyceride levels in adult patients with severe (= 500 mg/dL) hypertriglyceridemia. |
All press releases naming this drug 9 releases
Evidence & citations 17 cited values
Every value below carries the sentence it was read from. 46 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | fish oil | “and Fish oil 1 gram - rich in omega 3 PUFAs; associated to a pill with 50mg of talcum powder, identical to the pill of naltrexone.” NCT01211769 ↗40“containing: Lutein 12mg, Vitamin C 300mg, Zinc 10mg, Ginko Biloba 10mg, Flavonoids 25mg, Fish oil 300mg” NCT00914576 ↗ “Fish oil 2700 mg by mouth daily for 30 days.” NCT02538484 ↗ “Fish Oil and Metformin” NCT06424860 ↗ |
| Known as | Fish Oil (Containing Omega-3 Acids) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04417595 ↗ |
| Known as | Fish oil (EPA/DHA) | “Fish oil (EPA/DHA) alone” NCT02271230 ↗ |
| Known as | Lovaza | “n-3 LCPUFA supplements (Lovaza - GlaxoSmithKline (GSK) Pharmaceuticals, provided free of charge) at a dose of 4gr/day.” NCT01285362 ↗ |
| Known as | LovazaTM (former name: Omacor) | “LovazaTM (former name: Omacor®)” NCT00682318 ↗ |
| Known as | Maxepa | “Fish oil (Maxepa)” NCT00371982 ↗ |
| Known as | n-3 fatty acids | “Fish oil (n-3 fatty acids) in drug resistant epilepsy: a randomised placebo-controlled crossover study.” PMID 25201887 ↗ Sep 2014 |
| Known as | Omacor | “Drug: Omega-3 fatty acids (fish oil), Omacor, 1 capsule per day.” NCT04386577 ↗1“Drug: Omega-3 fatty acids (fish oil) Omacor, 1 capsule per day.” NCT04070833 ↗ |
| Known as | Omega-3 | “Fish Oil; Fish Oil 1200 Mg; Omega-3” NCT04116203 ↗ |
| Known as | Omega-3 fatty acids | “Drug: Omega-3 fatty acids (fish oil), Omacor, 1 capsule per day.” NCT04386577 ↗1“Drug: Omega-3 fatty acids (fish oil) Omacor, 1 capsule per day.” NCT04070833 ↗ |
| Known as | omega-3 fish oil | “This essentially consists of a 4 hour long infusion of purified omega-3 fish oil immediately after their gemcitabine chemotherapy has finished.” NCT01019382 ↗ |
| Known as | Omegaven | “It has been used parenterally (Omegaven) in young children with short bowel syndrome and PNALD with encouraging results.” NCT01565278 ↗ |
| Known as | Super Omega-3 | “Fish oil (Super Omega-3, 4 caps/d) vs. placebo” NCT00299533 ↗ |
| Known as | Ω-3 polyunsaturated fatty acids | “recommended standard intake of 1260 mg Ω-3 polyunsaturated fatty acids (fish oil) daily - but not echinacea, ginkgo biloba, ginseng, St. John's wort, valeriana or garlic - may...” PMID 26887420 ↗ Feb 2016 |
| Action | Inhibit | “The mechanism by which EPA and DHA exert their anti-arrhythmia effect is due to inactivation of high frequency sodium and L-type calcium channels in the heart.” NCT00871377 ↗ |
| Modality | Other / unclassified | “omega-3 polyunsaturated fatty acid (PUFA) supplementation” NCT01933243 ↗ |
| Route | Other | “Liquid fish oil 7.5cc enterally every 6 hours” NCT00351533 ↗ |