Fenofibrate
As of the edition of 20 October 2026, Fenofibrate is a small molecule: marketed, first approved in 1986 (ES); acts on PPARA.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2013
- Kind
- Small molecule
- Brand name
- Lipidil
- First approved
- 1 January 1986 (ES)
- Approvals on record
- 27 in 6 regions
- Holder of the most recent approval
- Lupin; 12 holders in all
- Registered trials
- 124, 15 stopped early
- Disease areas
- Nutrition and metabolism; Hormones; Heart and blood vessels; Digestive system; Inherited and neonatal; 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.
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 Fenofibrate.
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 |
|---|---|---|
| PPARA | Peroxisome proliferator-activated receptor alpha | Q07869 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 33 | 20 | 2 | 5 |
| Phase 1 | 12 | 9 | 2 | 1 |
| Phase 2 | 22 | 12 | 4 | 5 |
| Phase 3 | 36 | 18 | 9 | 3 |
| Phase 4 | 21 | 14 | 0 | 1 |
| All trials | 124 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Abbott | Applicant, Earlier holder and Lead sponsor of trials | 1993 to now |
| SkyePharma | Later holder | 2005 to now |
| Cipher Pharmaceuticals | Later holder | 2006 to now |
| ASKA Pharmaceutical | Applicant | 2011 to now |
| Laboratoires SMB | Applicant | 2011 to now |
| AbbVie | Acquired holder | 2012 to now |
| Viatris | Acquired holder | 2013 to now |
| Bausch Health | Acquired holder | 2019 to now |
| Lupin | Acquired holder | 2020 to now |
| Jagotec | Acquired holder | 2026 to now |