Gemfibrozil
As of the edition of 20 October 2026, Gemfibrozil is a small molecule: marketed, first approved in 1982 (US); acts on PPARA; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1991
- Kind
- Small molecule
- Brand name
- Lopid
- First approved
- 1 January 1982 (US)
- Approvals on record
- 5 in 3 regions
- Holder of the most recent approval
- Pfizer
- Registered trials
- 32, 3 stopped early
- Disease areas
- Nutrition and metabolism; Nervous system; Mental health; Heart and blood vessels; Chemically induced; Hormones
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
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Gemfibrozil.
See the 1 company 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 | 1 | 1 | 0 | 0 |
| Phase 1 | 24 | 23 | 0 | 0 |
| Phase 2 | 5 | 3 | 1 | 1 |
| Phase 3 | 1 | 0 | 0 | 1 |
| Phase 4 | 1 | 0 | 0 | 1 |
| All trials | 32 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Applicant, Earlier holder and Lead sponsor of trials | 2009 to now |