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.
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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 |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| crestor | New Drug Application | 2024-07-31 |
| ezallor sprinkle | New Drug Application | 2025-03-11 |
| rosuvastatin | ANDA | 2025-09-25 |
| rosuvastatin calcium | ANDA | 2025-10-01 |
| 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
837 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 126 | — | — | 3 | 3 | 132 |
| Hypercholesterolemia | D006937 | — | — | 6 | 8 | 65 | 26 | 26 | 131 |
| Dyslipidemias | D050171 | — | — | 17 | 10 | 34 | 27 | 24 | 110 |
| Coronary artery disease | D003324 | — | I25.1 | 2 | 4 | 9 | 35 | 17 | 66 |
| Hyperlipidemias | D006949 | EFO_0003774 | E78.5 | 19 | 6 | 15 | 13 | 12 | 64 |
| Hypertension | D006973 | EFO_0000537 | I10 | 18 | — | 17 | 12 | 10 | 57 |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | 6 | 5 | 7 | 21 | 9 | 47 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 10 | 4 | 3 | 17 | 10 | 43 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | 2 | 3 | 7 | 17 | 12 | 40 |
| Coronary disease | D003327 | — | — | — | 3 | 8 | 12 | 9 | 31 |
Show 93 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 2 | 2 | 1 | — | 1 | 5 |
| Essential hypertension | D000075222 | — | I10 | — | — | 4 | — | — | 4 |
| Renal insufficiency | D051437 | — | N19 | 2 | — | 1 | — | 1 | 4 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | 1 | 1 | — | — | 4 |
| Covid-19 | D000086382 | — | U07.1 | 2 | 1 | 1 | — | — | 3 |
| Homozygous familial hypercholesterolemia | D000090542 | — | — | — | — | 3 | — | — | 3 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | 2 | 1 | — | 1 | 3 |
| Fibrosis | D005355 | — | — | 1 | 2 | 1 | — | — | 3 |
| Aortic valve stenosis | D001024 | EFO_0000266 | — | — | — | 2 | — | 1 | 3 |
| Unstable angina | D000789 | EFO_1000985 | I20.0 | — | 1 | 1 | — | — | 2 |
Show 39 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 |
| Percutaneous coronary intervention | D062645 | — | — | 1 | 1 | — | — | 3 | 4 |
| Diabetic neuropathies | D003929 | EFO_1000783 | — | — | 2 | — | — | — | 2 |
| Osteoporosis | D010024 | EFO_0003882 | M81.0 | 1 | 1 | — | — | — | 2 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | — | 2 | — | — | — | 2 |
| Pre-eclampsia | D011225 | EFO_0000668 | O14 | 1 | 2 | — | — | — | 2 |
| Inferior wall myocardial infarction | D056989 | EFO_1000983 | — | — | 1 | — | — | 1 | 2 |
| Ototoxicity | D000081015 | — | — | 1 | 2 | — | — | — | 2 |
| Orthomyxoviridae infections | D009976 | EFO_0007411 | — | — | 1 | — | — | 1 | 2 |
Show 34 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Overweight | D050177 | — | E66.3 | 7 | — | — | — | — | 7 |
| Pharmacokinetics | D010599 | — | — | 4 | — | — | — | — | 4 |
| Non-small-cell lung carcinoma | D002289 | — | — | 4 | — | — | — | — | 4 |
| Respiratory syncytial virus infections | D018357 | EFO_1001413 | — | 2 | — | — | — | — | 2 |
| Disease | D004194 | EFO_0000408 | R69 | 1 | — | — | — | 1 | 2 |
| Crohn disease | D003424 | EFO_0000384 | K50 | 2 | — | — | — | — | 2 |
| Metabolic diseases | D008659 | EFO_0000589 | E88.9 | 1 | — | — | — | 1 | 2 |
| Malaria | D008288 | EFO_0001068 | B54 | 2 | — | — | — | — | 2 |
| Alcoholic fatty liver | D005235 | — | K70.0 | 2 | — | — | — | — | 2 |
| Melanoma | D008545 | — | — | 1 | — | — | — | — | 1 |
Show 48 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 | — | — | — | — | — | 3 | 3 |
| Vascular diseases | D014652 | EFO_0004264 | I77 | — | — | — | — | 3 | 3 |
| Muscular diseases | D009135 | EFO_0002970 | G72.9 | — | — | — | — | 3 | 3 |
| Peripheral vascular diseases | D016491 | EFO_0003875 | I73.9 | — | — | — | — | 2 | 2 |
| Coronary occlusion | D054059 | — | I21 | — | — | — | — | 1 | 1 |
| Drug-eluting stents | D054855 | — | — | — | — | — | — | 1 | 1 |
| Endovascular procedures | D057510 | — | — | — | — | — | — | 1 | 1 |
| Contusions | D003288 | — | T14.8 | — | — | — | — | 1 | 1 |
| Genetic testing | D005820 | — | — | — | — | — | — | 1 | 1 |
| Arthrogryposis | D001176 | EFO_0003857 | Q74.3 | — | — | — | — | 1 | 1 |
Show 18 more
Epidemiology
Epidemiological information for investigational and approved indications
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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-). |
| 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
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Variants
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Crestor – AstraZeneca
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Estimated US medical usage
Rosuvastatin
Total medical expenditures per year (USD, in millions)
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Trends
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Safety
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Adverse Events
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39,424 adverse events reported
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