Drugs / Fish oil
Fish oil
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 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 13 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00676156 Comparator | Dec 2005 → Feb 2008 | multiple sclerosis | Oregon Health and Science University | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT01594983 Comparator | Jun 2012 → Jul 2013 | — | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT01534663 Comparator | Nov 2011 → Jul 2013 | heart failure | Columbia University | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| 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 41 trial | ||||||
| Phase 4 | NCT02140788 Comparator | May 2011 → Feb 2013 | schizoaffective disorder, schizophrenia | Duke University | Terminated | No outcome recorded |
| Phase not applicable6 trials | ||||||
| — | NCT01704859 Comparator | Jun 2018 → Mar 2022 | — | Brigham and Women's Hospital | Completed | 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 |
| — | NCT01758081 Comparator | Jul 2010 → Dec 2026 expected | infectious disease | Brigham and Women's Hospital | Active not recruiting | No outcome recorded |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2014-10-27 | Otsuka Pharmaceutical Development & Commercialization, Inc. | New product for Japanese women Nature Made Fish Oil Pearl Small Pearl-shaped Capsules Concentrated With Essential Nutritional Balance of Fish Oil otsuka.co.jp ↗ |
| 2014-04-08 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces First Approval and Launch of Generic Lovaza® Capsules in the United States tevapharm.com ↗ |
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 48 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 | “vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram)” NCT01704859 ↗2“Drug: Omega-3 fatty acids (fish oil), Omacor, 1 capsule per day.” NCT04386577 ↗ “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 fatty acids (fish oil) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01758081 ↗ |
| 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 ↗ |