Drugs / Epanova
Epanova
also known as
OM3-CA · omega-3 carboxylic acids · AZD0585 · free omega-3 carboxylic acids · n-3 carboxylic acids · OM3-FFA · omefas · Omega-3 carboxylic acid · +1 more
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | EPANOVA | — | 2014-05-05 | fda.gov ↗ |
Trials 13 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT03574142 | Jun 2018 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT02372344 | Mar → May 2015 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT02359045 | Feb → Jul 2015 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT02859129 | Sep → Nov 2013 | hypertriglyceridemia | AstraZeneca | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT02354976 | Sep 2015 → May 2016 | NAFLD1, hypertriglyceridemia | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT02370537 | Mar → Nov 2015 | exocrine pancreatic insufficiency, type 2 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT02279407 | Jan → Dec 2015 | NAFLD1 | AstraZeneca | Completed | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT02463071 | Jun 2015 → Mar 2017 | hypertriglyceridemia | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT02104817 | Oct 2014 → May 2020 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT02009865 | Dec 2013 → Dec 2014 | hypertriglyceridemia | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT01408303 | Aug 2011 → Jun 2012 | cardiovascular disorder, hypertriglyceridemia | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT00613197 | Jan 2003 → Aug 2006 | Crohn disease | Tillotts Pharma AG | Completed | No outcome recorded |
| Phase 3 | NCT00074542 | Sep 2002 → Jan 2005 | Crohn disease | Tillotts Pharma AG | Completed | No outcome recorded |
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02189252 Comparator | Oct 2014 → Jul 2015 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT01208961 Comparator | Sep → Nov 2010 | — | AstraZeneca | Completed | No outcome recorded |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 21 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Epanova | “Epanova® (omega-3 carboxylic acids)” NCT02370537 ↗ |
| Known as | AZD0585 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02463071 ↗ |
| Known as | free omega-3 carboxylic acids | “The aim of the EFFECT I trial (NCT02354976) was to determine the effects of free omega-3 carboxylic acids (OM-3CA) and fenofibrate on liver fat in overweight or obese...” PMID 30197273 ↗ Aug 2018 |
| Known as | n-3 carboxylic acids | “The EFFECT-II study aimed to investigate the effects of dapagliflozin and omega-3 (n-3) carboxylic acids (OM-3CA), individually or combined, on liver fat content in individuals...” PMID 29971527 ↗ Jul 2018 |
| Known as | OM3-CA | “The EFFECT-II study aimed to investigate the effects of dapagliflozin and omega-3 (n-3) carboxylic acids (OM-3CA), individually or combined, on liver fat content in individuals...” PMID 29971527 ↗ Jul 20182“The aim of the EFFECT I trial (NCT02354976) was to determine the effects of free omega-3 carboxylic acids (OM-3CA) and fenofibrate on liver fat in overweight or obese...” PMID 30197273 ↗ Aug 2018 “This study examined the effects of a mixture of highly bioavailable omega-3 carboxylic acids (OM3-CA) on nuclear magnetic resonance” PMID 26328624 ↗ Sep 2015 |
| Known as | OM3-FFA | “a novel omega-3 formulation in free fatty acid form (OM3-FFA) has as much as 4-fold greater bioavailability than ethyl ester forms” PMID 23998969 ↗ Aug 2013 |
| Known as | omefas | “Single dose of Epanova (omefas), 4x1g capsules, taken with low-fat meals” NCT01208961 ↗ |
| Known as | Omega-3 carboxylic acid | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02354976 ↗ |
| Known as | omega-3 carboxylic acids | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02370537 ↗ |
| Known as | Omega-3 Free Fatty Acids | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00074542 ↗ |
| Modality | Other / unclassified | “a carboxylic acid formulation of EPA and DHA (omega-3 CA)” PMID 33190147 ↗ Dec 2020 |
| Route | Oral | “the oral administration of omega-3 free fatty acids” PMID 18398081 ↗ Apr 2008 |