Rosuvastatin
As of the edition of 20 October 2026, Rosuvastatin is a small molecule: marketed, first approved in 2003 (CA); acts on HMGCR.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2022
- Kind
- Small molecule
- Brand name
- Crestor
- First approved
- 18 February 2003 (CA)
- Approvals on record
- 26 in 7 regions
- Holder of the most recent approval
- Sanofi; 10 holders in all
- Registered trials
- 541, 36 stopped early
- Disease areas
- Nutrition and metabolism; Heart and blood vessels; Hormones; Urinary and reproductive; Nervous system; 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
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 Rosuvastatin.
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 |
|---|---|---|
| HMGCR | 3-hydroxy-3-methylglutaryl-coenzyme A reductase | P04035 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 49 | 21 | 13 | 4 |
| Phase 1 | 236 | 203 | 18 | 7 |
| Phase 2 | 41 | 22 | 5 | 5 |
| Phase 3 | 109 | 84 | 12 | 8 |
| Phase 4 | 106 | 57 | 9 | 12 |
| All trials | 541 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| AstraZeneca | Applicant and Lead sponsor of trials | 1999 to now |
| Sanofi | Later holder and Lead sponsor of trials | 2015 to now |
| Merck & Co. | Applicant and Lead sponsor of trials | 2015 to now |
| Aché Laboratórios Farmacêuticos | Applicant | 2019 to now |
| Libbs Farmacêutica LTDA | Later holder | 2019 to now |
| SUN Pharmaceutical Industries | Acquired holder | 2022 to now |