Icosapent ethyl
As of the edition of 20 October 2026, Icosapent ethyl is a small molecule: marketed, first approved in 2012 (US); acts on DGAT1; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2022
- Kind
- Small molecule
- Brand name
- Vascepa
- First approved
- 26 July 2012 (US)
- Approvals on record
- 6 in 3 regions
- Holder of the most recent approval
- Mochida Pharmaceutical; 3 holders in all
- Registered trials
- 27, 5 stopped early
- Disease areas
- Nutrition and metabolism; Heart and blood vessels; Mental health; Nervous system; Cancer; 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.
Companies that need a new molecule because of this drug
3 companies on route B because of this drug.
Companies on route B for this drug
In the product3 companies are on route B because of Icosapent ethyl.
See the 3 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| DGAT1 | Diacylglycerol O-acyltransferase 1 | O75907 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 1 | 0 | 0 |
| Phase 1 | 2 | 2 | 0 | 0 |
| Phase 2 | 6 | 3 | 1 | 2 |
| Phase 3 | 11 | 7 | 3 | 1 |
| Phase 4 | 7 | 3 | 1 | 2 |
| All trials | 27 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Amarin Pharma | Originator, Acquired holder and Lead sponsor of trials | 2009 to now |
| Mochida Pharmaceutical | Applicant and Lead sponsor of trials | 2020 to now |
| Recordati Industria Chimica e Farmaceutica | Applicant | 2021 to now |