Fluvastatin
As of the edition of 20 October 2026, Fluvastatin is a small molecule: marketed, first approved in 1993 (US); acts on HMGCR; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2002
- Kind
- Small molecule
- Brand name
- Lescol
- First approved
- 31 December 1993 (US)
- Approvals on record
- 5 in 3 regions
- Holder of the most recent approval
- Ethyx Pharmaceuticals; 4 holders in all
- Registered trials
- 42, 3 stopped early
- Disease areas
- Nutrition and metabolism; Heart and blood vessels; Urinary and reproductive; Cancer; Pregnancy and women's health; 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
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 Fluvastatin.
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 |
|---|---|---|
| HMGCR | 3-hydroxy-3-methylglutaryl-coenzyme A reductase | P04035 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 7 | 5 | 2 | 0 |
| Phase 1 | 3 | 2 | 0 | 1 |
| Phase 2 | 7 | 5 | 0 | 1 |
| Phase 3 | 7 | 6 | 0 | 1 |
| Phase 4 | 18 | 15 | 0 | 0 |
| All trials | 42 |