Icosapent
As of the edition of 20 October 2026, Icosapent is a small molecule: marketed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed
- Kind
- Small molecule
- Brand name
- Ácidos Omega
- Approvals on record
- 3 in 3 regions
- Holder of the most recent approval
- Sanum-Kehlbeck Gmbh & Co.Kg; 3 holders in all
- Registered trials
- 16, 1 stopped early
- Disease areas
- Cancer; Mental health; Nutrition and metabolism; Blood and lymph; Heart and blood vessels; Digestive system
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 1 | 0 | 0 |
| Phase 1 | 2 | 1 | 1 | 0 |
| Phase 2 | 4 | 2 | 0 | 1 |
| Phase 3 | 7 | 6 | 0 | 0 |
| Phase 4 | 2 | 1 | 0 | 0 |
| All trials | 16 |
Who ran its trials
| Company | Role | Years |
|---|---|---|
| Mochida Pharmaceutical | Lead sponsor of trials | 2018 to now |