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, Ezallor (generic drugs available since 2016-04-29)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ezetimibe
+
Rosuvastatin calcium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ROSZET | Althera Pharmaceutical | N-213072 DISCN | 2021-03-23 | 4 products, RLD |
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Rosuvastatin calcium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| CRESTOR | IPR Pharmaceutical | N-021366 RX | 2003-08-12 | 4 products, RLD, RS |
| EZALLOR SPRINKLE | Sun Pharmaceutical Industries | N-208647 RX | 2018-12-18 | 4 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| crestor | New Drug Application | 2024-07-31 |
| ezallor sprinkle | New Drug Application | 2023-08-16 |
| rosuvastatin | ANDA | 2024-10-01 |
| rosuvastatin calcium | ANDA | 2024-10-03 |
| rosuvastatin rosuvastatin calcium | ANDA | 2023-06-27 |
Indications
FDA
EMA
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
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Clinical
Clinical Trials
783 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypercholesterolemia | D006937 | HP_0003124 | — | 3 | 8 | 66 | 26 | 25 | 128 |
| Healthy volunteers/patients | — | — | — | 114 | — | — | 3 | 3 | 120 |
| Dyslipidemias | D050171 | HP_0003119 | — | 14 | 7 | 32 | 23 | 19 | 95 |
| Coronary artery disease | D003324 | — | I25.1 | 4 | 8 | 14 | 34 | 15 | 72 |
| Hyperlipidemias | D006949 | HP_0003077 | E78.5 | 18 | 3 | 11 | 15 | 11 | 57 |
| Hypertension | D006973 | EFO_0000537 | I10 | 17 | 1 | 19 | 9 | 10 | 55 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | 2 | 6 | 13 | 21 | 12 | 51 |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | 6 | 3 | 9 | 22 | 11 | 50 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | 10 | 3 | 7 | 16 | 13 | 48 |
| Coronary disease | D003327 | — | — | 1 | 6 | 11 | 18 | 10 | 44 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Arthritis | D001168 | HP_0001369 | 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 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | 1 | 1 | — | — | 4 |
| Essential hypertension | D000075222 | — | I10 | — | — | 3 | — | — | 3 |
| Homozygous familial hypercholesterolemia | D000090542 | — | — | — | — | 3 | — | — | 3 |
| Carotid stenosis | D016893 | — | — | — | — | 2 | — | 1 | 3 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 2 | — | 1 | — | — | 3 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | 2 | 1 | — | 1 | 3 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | 2 | 1 | — | 1 | 3 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 10 | 2 | — | — | — | 11 |
| Hepatitis c | D006526 | — | B19.2 | 2 | 3 | — | — | 1 | 6 |
| Hepatitis | D006505 | HP_0012115 | 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 |
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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 | HP_0100526 | 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 |
| Melanoma | D008545 | — | — | 1 | — | — | — | — | 1 |
| Blood platelet disorders | D001791 | — | — | 1 | — | — | — | — | 1 |
| Balloon angioplasty coronary | D015906 | EFO_0003951 | — | 1 | — | — | — | — | 1 |
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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 | HP_0003198 | 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 |
| Thoracic injuries | D013898 | — | S20-S29 | — | — | — | — | 1 | 1 |
| Genetic testing | D005820 | — | — | — | — | — | — | 1 | 1 |
| Arthrogryposis | D001176 | EFO_0003857 | — | — | — | — | — | 1 | 1 |
| Medication adherence | D055118 | EFO_0006344 | — | — | — | — | — | 1 | 1 |
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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) |
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Crestor – AstraZeneca
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Estimated US medical usage
Rosuvastatin
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Safety
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69,334 adverse events reported
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