Drugs / Epanova
Epanova
also known as
OM3-CA · Omega-3 carboxylic acids · free omega-3 carboxylic acids · n-3 carboxylic acids · OM3-FFA · omefas · Omega-3 carboxylic acid
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed hypertriglyceridemia 2 1 milestone | |||||
| Filed | US (FDA) | Epanova | hypertriglyceridemia 2 | — | “AstraZeneca today announced that the US Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for EpanovaTM, an investigational compound for...” astrazeneca.com ↗ “The NDA submission for Epanova was filed by Omthera Pharmaceuticals, now a wholly-owned subsidiary of AstraZeneca, as a 505(b)(1) application in July 2013.” astrazeneca.com ↗ “Regulatory filings were accepted for review for olaparib and naloxegol in Europe and for Epanova in the US.” astrazeneca.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | EPANOVA | — | 2014-05-05 | fda.gov ↗ |
Trials 10
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT03574142 | Jun 2018 | — | 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 · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT02354976 | Sep 2015 → May 2016 | NAFLD1, hypertriglyceridemia | AstraZeneca | Completed | Missed primary |
| 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 | Met primary |
| Phase 34 trials · 2 met primary · 1 missed | ||||||
| Phase 3 | NCT02104817 | Oct 2014 → May 2020 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT02009865 | Dec 2013 → Dec 2014 | hypertriglyceridemia | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT01408303 | Aug 2011 → Jun 2012 | cardiovascular disorder, hypertriglyceridemia | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT00613197 | Jan 2003 → Aug 2006 | Crohn disease | Tillotts Pharma AG | Completed | Missed primary |
| Comparator or background therapy2 trials | ||||||
| Phase 1 | NCT02189252 Comparator | Oct 2014 → Jul 2015 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT01208961 Comparator | Sep → Nov 2010 | — | AstraZeneca | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2020-01-13 | AstraZeneca | Results Update on Phase III STRENGTH trial for Epanova in mixed dyslipidaemia astrazeneca.com ↗
Independent Data Monitoring Committee has recommended to discontinue the trial as Epanova is unlikely to demonstrate a benefit to patients |
| 2014-05-06 | AstraZeneca | Regulatory US FDA approves EPANOVA for the treatment of adults with severe hypertriglyceridaemia astrazeneca.com ↗
Tuesday, 6 May 2014 AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved EPANOVA (omega-3-carboxylic acids) as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridaemia (triglyceride levels greater than or equal to 500 mg/dL). |
| 2013-09-18 | AstraZeneca | Regulatory FDA accepts new drug application for investigational compound Epanova for the treatment of severe hypertriglyceridaemia astrazeneca.com ↗ |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2020-01-13 | AstraZeneca | Update on Phase III STRENGTH trial for Epanova in mixed dyslipidaemia astrazeneca.com ↗ |
| 2014-05-06 | AstraZeneca | US FDA approves EPANOVA for the treatment of adults with severe hypertriglyceridaemia astrazeneca.com ↗ |
| 2013-09-18 | AstraZeneca | FDA accepts new drug application for investigational compound Epanova for the treatment of severe hypertriglyceridaemia astrazeneca.com ↗ |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 18 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Epanova | “Epanova® (omega-3 carboxylic acids)” NCT02370537 ↗ |
| 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 NCT02279407 ↗ |
| Modality | Other / unclassified | “a carboxylic acid formulation of EPA and DHA (omega-3 CA)” PMID 33190147 ↗ Dec 2020 |
| Route | Oral | “oral administration of omega-3 free fatty acids” PMID 18398081 ↗ Apr 2008 |