Pravastatin
As of the edition of 20 October 2026, Pravastatin is a small molecule: marketed, first approved in 1991 (ES); acts on HMGCR.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2011
- Kind
- Small molecule
- Brand name
- Pravachol
- First approved
- 1 October 1991 (ES)
- Approvals on record
- 12 in 3 regions
- Holder of the most recent approval
- Laboratoires SMB; 3 holders in all
- Registered trials
- 109, 13 stopped early
- Disease areas
- Nutrition and metabolism; Urinary and reproductive; Immune system; Heart and blood vessels; Cancer; Infections
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
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Pravastatin.
See the 2 companies 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 | 14 | 9 | 1 | 2 |
| Phase 1 | 34 | 32 | 0 | 2 |
| Phase 2 | 26 | 13 | 5 | 6 |
| Phase 3 | 15 | 14 | 0 | 1 |
| Phase 4 | 20 | 15 | 0 | 2 |
| All trials | 109 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bristol Myers Squibb | Originator and Lead sponsor of trials | 1991 to now |
| Laboratoires SMB | Applicant | 2011 to now |