Rosuvastatin
Crestor, Rosuvastatin, Roszet (rosuvastatin) is a small molecule pharmaceutical. Rosuvastatin was first approved as Crestor on 2003-08-12. It is used to treat coronary artery disease, hypercholesterolemia, hyperlipoproteinemias, and hypertriglyceridemia in the USA.
Download report
Favorite
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
Mock data
Subscribe for the real data
Subscribe for the real data
Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| cardiovascular diseases | D002318 |
| nutritional and metabolic diseases | D009750 |
Trade Name
FDA
EMA
Crestor, Rosuvastatin (discontinued: Ezallor, Rosuvastatin)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Rosuvastatin calcium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| CRESTOR | AstraZeneca | N-021366 RX | 2003-08-12 | 4 products, RLD, RS |
Show 1 discontinued
Ezetimibe
+
Rosuvastatin calcium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ROSZET | Althera Pharmaceutical | N-213072 DISCN | 2021-03-23 | 4 products, RLD |
Hide discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| crestor | New Drug Application | 2024-07-31 |
| ezallor sprinkle | New Drug Application | 2024-12-10 |
| rosuvastatin | ANDA | 2025-03-20 |
| rosuvastatin calcium | ANDA | 2025-03-17 |
| rosuvastatin rosuvastatin calcium | ANDA | 2025-01-17 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ROSUVASTATIN CALCIUM, CRESTOR, IPR | |||
| 2023-05-27 | ODE-118 | ||
ATC Codes
A: Alimentary tract and metabolism drugs
— A10: Drugs used in diabetes
— A10B: Blood glucose lowering drugs, excl. insulins
— A10BH: Dipeptidyl peptidase 4 (dpp-4) inhibitors for blood glucose lowering
— A10BH52: Gemigliptin and rosuvastatin
C: Cardiovascular system drugs
— C10: Lipid modifying agents
— C10A: Lipid modifying agents, plain
— C10AA: Hmg coa reductase inhibitors, plain lipid modifying drugs
— C10AA07: Rosuvastatin
— C10B: Lipid modifying agents, combinations
— C10BA: Combinations of various lipid modifying agents
— C10BA06: Rosuvastatin and ezetimibe
— C10BA07: Rosuvastatin and omega-3 fatty acids
— C10BA09: Rosuvastatin and fenofibrate
— C10BX: Lipid modifying agents in combination with other drugs
— C10BX05: Rosuvastatin and acetylsalicylic acid
— C10BX07: Rosuvastatin, amlodipine and lisinopril
— C10BX09: Rosuvastatin and amlodipine
— C10BX10: Rosuvastatin and valsartan
— C10BX13: Rosuvastatin, perindopril and indapamide
— C10BX14: Rosuvastatin, amlodipine and perindopril
— C10BX16: Rosuvastatin and fimasartan
— C10BX17: Rosuvastatin and ramipril
HCPCS
No data
Clinical
Clinical Trials
809 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypercholesterolemia | D006937 | — | — | 3 | 8 | 67 | 26 | 26 | 130 |
| Healthy volunteers/patients | — | — | — | 116 | — | — | 3 | 3 | 122 |
| Dyslipidemias | D050171 | — | — | 15 | 8 | 34 | 23 | 20 | 99 |
| Coronary artery disease | D003324 | — | I25.1 | 4 | 8 | 14 | 35 | 18 | 76 |
| Hyperlipidemias | D006949 | EFO_0003774 | E78.5 | 18 | 3 | 11 | 15 | 11 | 57 |
| Hypertension | D006973 | EFO_0000537 | I10 | 17 | 1 | 20 | 9 | 10 | 56 |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | 6 | 3 | 9 | 25 | 11 | 53 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | 2 | 6 | 13 | 22 | 12 | 52 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 10 | 3 | 8 | 17 | 13 | 50 |
| Coronary disease | D003327 | — | — | 1 | 6 | 11 | 18 | 10 | 44 |
Show 98 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Arthritis | D001168 | EFO_0005856 | M05-M14 | 2 | 2 | 1 | — | 2 | 6 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 2 | 2 | 1 | — | 1 | 5 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 4 | — | 1 | — | — | 5 |
| Essential hypertension | D000075222 | — | I10 | — | — | 4 | — | — | 4 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | 1 | 1 | — | — | 4 |
| Homozygous familial hypercholesterolemia | D000090542 | — | — | — | — | 3 | — | — | 3 |
| Carotid stenosis | D016893 | — | — | — | — | 2 | — | 1 | 3 |
| Renal insufficiency | D051437 | — | N19 | 2 | — | 1 | — | — | 3 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | 2 | 1 | — | 1 | 3 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | 2 | 1 | — | 1 | 3 |
Show 47 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 11 | 2 | — | — | — | 12 |
| Hepatitis c | D006526 | — | B19.2 | 2 | 3 | — | — | 1 | 6 |
| Hepatitis | D006505 | — | K75.9 | 1 | 3 | — | — | 1 | 5 |
| Percutaneous coronary intervention | D062645 | — | — | 1 | 1 | — | — | 3 | 4 |
| Hepatitis a | D006506 | EFO_0007305 | B15 | — | 3 | — | — | 1 | 4 |
| Carcinoma | D002277 | — | C80.0 | 1 | 2 | — | — | — | 3 |
| Infections | D007239 | EFO_0000544 | — | 1 | 2 | — | — | — | 3 |
| Fibrosis | D005355 | — | — | 1 | 1 | — | — | 1 | 3 |
| Diabetic neuropathies | D003929 | EFO_1000783 | — | — | 2 | — | — | — | 2 |
| Polyneuropathies | D011115 | EFO_0009562 | A69.22 | — | 2 | — | — | — | 2 |
Show 42 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Overweight | D050177 | — | E66.3 | 5 | — | — | — | — | 5 |
| Pharmacokinetics | D010599 | — | — | 4 | — | — | — | — | 4 |
| Non-small-cell lung carcinoma | D002289 | — | — | 4 | — | — | — | — | 4 |
| Lung neoplasms | D008175 | — | C34.90 | 2 | — | — | — | — | 2 |
| Crohn disease | D003424 | EFO_0000384 | K50 | 2 | — | — | — | — | 2 |
| Malaria | D008288 | EFO_0001068 | B54 | 2 | — | — | — | — | 2 |
| Alcoholic fatty liver | D005235 | — | K70.0 | 2 | — | — | — | — | 2 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | 2 | — | — | — | — | 2 |
| Melanoma | D008545 | — | — | 1 | — | — | — | — | 1 |
| Blood platelet disorders | D001791 | — | — | 1 | — | — | — | — | 1 |
Show 37 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Peripheral arterial disease | D058729 | EFO_0004265 | — | — | — | — | — | 4 | 4 |
| Muscular diseases | D009135 | EFO_0002970 | G72.9 | — | — | — | — | 3 | 3 |
| Peripheral vascular diseases | D016491 | EFO_0003875 | I73.9 | — | — | — | — | 2 | 2 |
| Computed tomography angiography | D000072226 | — | — | — | — | — | — | 2 | 2 |
| Coronary occlusion | D054059 | — | I21 | — | — | — | — | 1 | 1 |
| Drug-eluting stents | D054855 | — | — | — | — | — | — | 1 | 1 |
| Endovascular procedures | D057510 | — | — | — | — | — | — | 1 | 1 |
| Thoracic injuries | D013898 | — | S20-S29 | — | — | — | — | 1 | 1 |
| Genetic testing | D005820 | — | — | — | — | — | — | 1 | 1 |
| Arthrogryposis | D001176 | EFO_0003857 | Q74.3 | — | — | — | — | 1 | 1 |
Show 20 more
Epidemiology
Epidemiological information for investigational and approved indications
View more details
Drug
General
| Drug common name | Rosuvastatin |
| INN | rosuvastatin |
| Description | Rosuvastatin is a dihydroxy monocarboxylic acid that is (6E)-7-{4-(4-fluorophenyl)-2-[methyl(methylsulfonyl)amino]-6-(propan-2-yl)pyrimidin-5-yl} hept-6-enoic acid carrying two hydroxy substituents at positions 3 and 5 (the 3R,5S-diastereomer). It has a role as an antilipemic drug, an anti-inflammatory agent, a CETP inhibitor, a cardioprotective agent, a xenobiotic and an environmental contaminant. It is a member of pyrimidines, a sulfonamide, a dihydroxy monocarboxylic acid, a statin (synthetic) and a member of monofluorobenzenes. It is functionally related to a hept-6-enoic acid. It is a conjugate acid of a rosuvastatin(1-). ... More |
| Classification | Small molecule |
| Drug class | enzyme inhibitors: antihyperlipidemics (HMG-CoA inhibitors) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC(C)c1nc(N(C)S(C)(=O)=O)nc(-c2ccc(F)cc2)c1/C=C/[C@@H](O)C[C@@H](O)CC(=O)O |
Identifiers
| PDB | — |
| CAS-ID | 287714-41-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1496 |
| ChEBI ID | 38545 |
| PubChem CID | 446157 |
| DrugBank | DB01098 |
| UNII ID | 413KH5ZJ73 (ChemIDplus, GSRS) |
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Crestor – AstraZeneca
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Estimated US medical usage
Rosuvastatin
Total medical expenditures per year (USD, in millions)
Mock data
Subscribe for the real data
Subscribe for the real data
Number of persons purchased
Mock data
Subscribe for the real data
Subscribe for the real data
Number of purchases
Mock data
Subscribe for the real data
Subscribe for the real data
Refill frequency
Mock data
Subscribe for the real data
Subscribe for the real data
Price per prescription (USD)
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 23,029 documents
View more details
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
36,720 adverse events reported
View more details
© 2020-2025 Collaborative Drug Discovery Inc. (CDD) | Terms of Use