Drugs / Omegaven
Omegaven
also known as
fish oil · fish oil infusion · FOLE · omega-3 fatty acids · Omega-3 fish oil emulsion · Omega-3 fish oil lipid emulsion · OMEGAVEN 10% · Ω3-FAs
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | OMEGAVEN | — | 2018-07-27 | fda.gov ↗ |
Trials 47 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 5 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT04647604 Comparator | Jun 2020 → Jan 2021 | COVID-19 | Karolinska University Hospital | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT01884948 Comparator | Jul 2013 → Mar 2016 | — | University of Zurich | Unknown | No outcome recorded |
| Phase 3 | NCT01175330 Comparator | Aug 2010 → Dec 2012 | atrial fibrillation, ischemic disease | Meshalkin Research Institute of Pathology of Circulation | Terminated | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT02231203 Comparator | Oct 2014 → Jun 2016 | colon carcinoma | Medical Center Alkmaar | Completed | No outcome recorded |
| Phase 4 | NCT02349594 Comparator | Jan 2014 → May 2015 | Crohn disease | Radboud University Medical Center | Completed | No outcome recorded |
Press releases naming this drug 1 release
| 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 ↗ |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 53 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Omegaven | “In a published article (Gura, Duggan et al. 2006) reporting 2 cases in depth and in a subsequent paper (Gura, Lee et al. 2008) reporting 18 patients with established PNALD who...” NCT03072667 ↗52“In the omega-3 group, the lipid content of TPN was replaced partially by omega-3 fatty acids (Omegaven®, Fresenius-Kabi) up to 0.2 g/kg BW per day.” NCT00929461 ↗ “10% n-3 fatty acid (Omegaven, Fresenius-Kabi, Germany)” PMID 27614675 ↗ Aug 2016 “started on Omegaven®” NCT01425567 ↗ |
| Known as | fish oil | “The purpose of the study is to investigate if intravenous fish oil, commercially available as Omegaven, safely and effectively reverses parenteral nutrition associated...” NCT00969332 ↗ |
| Known as | fish oil infusion | “This is an expanded access protocol for use of intravenous fish oil infusion, Omegaven, in infants and children with parenteral nutrition associated liver disease (PNALD) to...” NCT02929303 ↗ |
| Known as | FOLE | “The experimental group will receive FOLE (Omegaven®, Fresenius Kabi AG, Bad Homburg v.d.h., Germany), a 10% lipid solution.” NCT02512718 ↗ |
| Known as | omega-3 fatty acids | “A randomized, double-blind study of the effects of omega-3 fatty acids (Omegaven) on outcome after major liver resection” NCT01884948 ↗ |
| Known as | Omega-3 fish oil emulsion | “Omega-3 fish oil emulsion (Omegaven)” NCT01175330 ↗ |
| Known as | Omega-3 fish oil lipid emulsion | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01194063 ↗ |
| Known as | OMEGAVEN 10% | “OMEGAVEN 10%® will be used as the sole lipid supplement at a dose of 0.5 to 1.0 g/kg/Infusion with a maximum dose per infusion of 40 grams, in view of formulation constraints...” NCT01284049 ↗ |
| Known as | Ω3-FAs | “2 single intravenous infusions of Omegaven® (Ω3-FAs) vs. placebo” PMID 31626819 ↗ Oct 2019 |
| Modality | Other / unclassified | “fish-oil preparation (Omegaven)” NCT00412256 ↗ |
| Route | Other | “parenterally applied fat emulsions” NCT00412256 ↗ |