Fish oil
As of the edition of 20 October 2026, Fish oil is a drug: marketed, first approved in 2012 (CA).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2016
- Kind
- Unknown
- Brand name
- Smoflipid 20%
- First approved
- 20 November 2012 (CA)
- Approvals on record
- 5 in 2 regions
- Holder of the most recent approval
- Fresenius Kabi; 2 holders in all
- Registered trials
- 62, 5 stopped early
- Disease areas
- Cancer; Mental health; Nervous system; Heart and blood vessels; Skin and connective tissue; Urinary and reproductive
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 | 20 | 11 | 3 | 2 |
| Phase 1 | 7 | 5 | 2 | 0 |
| Phase 2 | 16 | 10 | 2 | 1 |
| Phase 3 | 13 | 9 | 2 | 2 |
| Phase 4 | 6 | 6 | 0 | 0 |
| All trials | 62 |