omega-3-carboxylic acids
Trade name: epanova
Approved
May 5, 2014
Omega−3-carboxylic acids (Epanova) is a formerly marketed yet still not a Food and Drug Administration (FDA)-approved prescription medication–since taken off market by the manufacturer–used alongside a low fat and low cholesterol diet that lowers high triglyceride (fat) levels in adults with very high levels. This was the third class of fish oil-based drug, after omega−3-acid ethyl esters and ethyl eicosapentaenoic acid (Vascepa), to be approved for use as a drug. The first approval in the United States by the FDA was granted 05 May 2014. These fish oil drugs are similar to fish oil dietary supplements, but the ingredients are better controlled and have been tested in clinical trials. Specifically, Epanova contained at least 850 mg omega−3-acid ethyl esters per 1 g capsule. — Wikipedia
Clinical trial activity
14 trials · 16 clinical orgs · 2 marketing orgs
Earliest trial started Sep 1, 2002 (NCT00074542)
Timeline
2000s
- Jan 1, 2002
Earliest Phase 3 Sponsor(trial)
2010s
- Jan 1, 2010
AstraZeneca — Earliest Phase 2 Sponsor(trial)
- Jan 1, 2013
AstraZeneca — Earliest Phase 1 Sponsor(trial)
- May 5, 2014
Omthera Pharmaceuticals — Earliest FDA Approval
- May 5, 2014
AstraZeneca — Marketing Organization
- May 5, 2014
AstraZeneca — NDA Secondary Org
- May 5, 2014
Omthera Pharmaceuticals — NDA Organization
Indications
Approved for
Studied for
- Area Under Curve · Phase 1
- Atherosclerosis · Phase 3
- Cardiovascular Diseases · Phase 3
- Crohn Disease · Phase 3
- Diabetes Mellitus, Type 2 · Phase 2
- Drugs, Investigational · Phase 1
- Exocrine Pancreatic Insufficiency · Phase 2
- Fasting · Phase 1
- Healthy Volunteers · Phase 1
- Hypertriglyceridemia · Phase 3
- Pharmacokinetics · Phase 1
Mechanism of action
FFAR4 agonist
- Acyl-CoA desaturaseINHIBITOR
SCD inhibitor
- Unspecified targetOTHER
Unknown
- Unspecified targetUnknown
Unknown
Approval history
- approvedMay 5, 2014
Chemistry & pharmacology
SMILES
CC/C=C\C/C=C\C/C=C\C/C=C\C/C=C\C/C=C\CCC(=O)O.CC/C=C\C/C=C\C/C=C\C/C=C\C/C=C\CCCC(=O)O.CC/C=C\C/C=C\C/C=C\C/C=C\C/C=C\CCCCC(=O)O.CC/C=C\C/C=C\C/C=C\C/C=C\C/C=C\CCCCCC(=O)O.CC/C=C\C/C=C\C/C=C\C/C=C\CCCCCCC(=O)O.CC/C=C\C/C=C\C/C=C\CCCCCCCC(=O)O.CCCCC/C=C\C/C=C\C/C=C\C/C=C\C/C=C\CCC(=O)O.CCCCC/C=C\C/C=C\C/C=C\CCCCC(=O)O.CCCCC/C=C\C/C=C\CCCCCCCC(=O)O- Mol. weight
- 2750.26 g/mol
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Discontinued
Oral
Yes
Parenteral
No
Topical
No
Sources
- WikipediaOmega-3-carboxylic acids ↗
- NCATSF85N2YHE4E ↗
- ChEMBLCHEMBL3137327 ↗
- WikipediaOmega-3 carboxylic acids ↗
Also known as
- azd0585
- epanova
- epanova
- epanova
- long chain omega-3 and omega-6 fatty acids
- omega-3 carboxylic acid
- omega-3-carboxylic acids
- omega-3-carboxylic acids
- omega-3-carboxylic acids
- omega-3-carboxylic acids
- omega-3-carboxylic acids
- omega-3-carboxylic acids
- omega-3-carboxylic acids
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT03574142 | Phase 1 | Jun 4, 2018 | AstraZeneca, Capital Medical University |
| NCT02463071 | Phase 3 | Jun 10, 2015 | AstraZeneca, Koyokai Nakajima Hospital |
| NCT02372344 | Phase 1 | Mar 1, 2015 | AstraZeneca, Sugioka Memorial Hospital |
| NCT02370537 | Phase 2 | Mar 1, 2015 | AstraZeneca |
| NCT02359045 | Phase 1 | Feb 12, 2015 | AstraZeneca, Parexel |
| NCT02104817 | Phase 3 | Oct 30, 2014 | Adelaide Clinical Research, AstraZeneca, IQVIA, University of Rochester |
| NCT02189252 | Phase 1 | Oct 1, 2014 | AstraZeneca, Biofortis |
| NCT02209766 | Phase 1 | Aug 1, 2014 | AstraZeneca, CPC Clinical Trial Hospital |
| NCT02009865 | Phase 3 | Dec 1, 2013 | AstraZeneca |
| NCT02859129 | Phase 1 | Sep 1, 2013 | AstraZeneca, Celerion, Omthera Pharmaceuticals |
| NCT01408303 | Phase 3 | Aug 1, 2011 | AstraZeneca, Medpace, Inc., Omthera Pharmaceuticals |
| NCT01208961 | Phase 2 | Sep 1, 2010 | AstraZeneca, Radiant Research |
| NCT00613197 | Phase 3 | Jan 1, 2003 | Katholieke Universiteit Leuven, Tillotts Pharma |
| NCT00074542 | Phase 3 | Sep 1, 2002 | Tillotts Pharma |
Organizations
Research & Development (16)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| AstraZeneca | For profit | 12 | 12 | 3 | 2010 |
| Omthera Pharmaceuticals | For profit | 2 | 0 | 2 | 2011 |
| Tillotts Pharma | For profit | 2 | 2 | 1 | 2002 |
| Adelaide Clinical Research | Academic/Hospital | 1 | 0 | 1 | 2014 |
| Biofortis | For profit | 1 | 0 | 1 | 2014 |
| Capital Medical University | Academic/Hospital | 1 | 0 | 1 | 2018 |
| Celerion | For profit | 1 | 0 | 1 | 2013 |
| CPC Clinical Trial Hospital | Academic/Hospital | 1 | 0 | 1 | 2014 |
| IQVIA | For profit | 1 | 0 | 1 | 2014 |
| Katholieke Universiteit Leuven | Academic/Hospital | 1 | 0 | 1 | 2003 |
| Koyokai Nakajima Hospital | Academic/Hospital | 1 | 0 | 1 | 2015 |
| Medpace, Inc. | For profit | 1 | 0 | 1 | 2011 |
| Parexel | For profit | 1 | 0 | 1 | 2015 |
| Radiant Research | Academic/Hospital | 1 | 0 | 1 | 2010 |
| Sugioka Memorial Hospital | Academic/Hospital | 1 | 0 | 1 | 2015 |
| University of Rochester | Academic/Hospital | 1 | 0 | 1 | 2014 |
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| AstraZeneca | For profit | MKTG | May 5, 2014 |
| AstraZeneca | For profit | NDA2 | May 5, 2014 |
| Omthera Pharmaceuticals | For profit | NDA | May 5, 2014 |