Omega-3-acid ethyl esters
As of the edition of 20 October 2026, Omega-3-acid ethyl esters is a small molecule: marketed, first approved in 2004 (US); no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2012
- Kind
- Small molecule
- Brand name
- Lovaza
- First approved
- 10 November 2004 (US)
- Approvals on record
- 3 in 2 regions
- Holder of the most recent approval
- Osmotica Pharmaceutical; 3 holders in all
- Registered trials
- 74, 23 stopped early
- Disease areas
- Nutrition and metabolism; Cancer; Heart and blood vessels; Skin and connective tissue; Hormones; Digestive system
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 11 | 8 | 0 | 0 |
| Phase 1 | 6 | 3 | 0 | 2 |
| Phase 2 | 26 | 7 | 1 | 17 |
| Phase 3 | 13 | 12 | 0 | 1 |
| Phase 4 | 18 | 13 | 0 | 3 |
| All trials | 74 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Takeda | Applicant and Lead sponsor of trials | 2009 to now |
| Trygg Pharma | Later holder | 2014 to now |
| Osmotica Pharmaceutical | Acquired holder | 2021 to now |
| Waylis Therapeutics | Acquired holder | 2025 to now |