Pitavastatin
As of the edition of 20 October 2026, Pitavastatin is a small molecule: marketed, first approved in 2009 (US); acts on HMGCR; no US protection of its own is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2021
- Kind
- Small molecule
- Brand name
- Livalo
- First approved
- 3 August 2009 (US)
- Approvals on record
- 16 in 5 regions
- Holder of the most recent approval
- Kowa; 6 holders in all
- Registered trials
- 71, 4 stopped early
- Disease areas
- Nutrition and metabolism; Heart and blood vessels; Cancer; Urinary and reproductive; Pregnancy and women's health; Hormones
US protection
No US protection of its own is listed.
The FDA registers list no drug-substance patent or exclusivity of its own that counts for this drug.
Medicure holds a later exclusivity on its own new formulation or combination product, ending 2031; it does not protect the original 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 Pitavastatin.
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 | 9 | 4 | 2 | 1 |
| Phase 1 | 19 | 14 | 5 | 0 |
| Phase 2 | 1 | 0 | 1 | 0 |
| Phase 3 | 19 | 15 | 0 | 2 |
| Phase 4 | 23 | 15 | 1 | 1 |
| All trials | 71 |