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 | 2025-05-22 |
| rosuvastatin calcium | ANDA | 2025-05-15 |
| 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
823 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 | — | — | — | 2 | 25 | 8 | 10 | 45 |
| Dyslipidemias | D050171 | — | — | 4 | 1 | 11 | 1 | 6 | 22 |
| Coronary artery disease | D003324 | — | I25.1 | 1 | 1 | 6 | 3 | 3 | 14 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | 1 | 6 | 3 | 3 | 13 |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | 2 | — | 4 | 5 | — | 11 |
| Coronary disease | D003327 | — | — | — | 1 | 4 | 3 | 3 | 11 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | 1 | 3 | 3 | 3 | 10 |
| Hyperlipidemias | D006949 | EFO_0003774 | E78.5 | — | 2 | 1 | 3 | 2 | 8 |
| Syndrome | D013577 | — | — | — | — | 4 | 4 | — | 8 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | 1 | — | 3 | 4 | 8 |
Show 21 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Heart failure | D006333 | EFO_0003144 | I50 | — | 1 | 3 | — | — | 4 |
| Homozygous familial hypercholesterolemia | D000090542 | — | — | — | — | 2 | — | — | 2 |
| Renal insufficiency | D051437 | — | N19 | 1 | — | 1 | — | — | 2 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | — | 1 | — | 1 | 2 |
| Pathologic constriction | D003251 | — | — | — | — | 2 | — | — | 2 |
| Hyperlipoproteinemia type iii | D006952 | — | — | — | — | 1 | — | — | 1 |
| Chronic renal insufficiency | D051436 | — | N18 | — | — | 1 | — | — | 1 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | — | 1 | — | — | 1 |
| Recurrence | D012008 | — | — | — | — | 1 | — | — | 1 |
| Thrombosis | D013927 | — | — | — | — | 1 | — | — | 1 |
Show 10 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Inflammation | D007249 | MP_0001845 | — | 1 | 1 | — | — | — | 2 |
| Wounds and injuries | D014947 | — | T14.8 | 1 | 2 | — | — | — | 2 |
| Craniocerebral trauma | D006259 | — | S00 | 1 | 2 | — | — | — | 2 |
| Proteinuria | D011507 | — | R80 | — | 2 | — | — | — | 2 |
| Traumatic brain injuries | D000070642 | — | S06 | 1 | 1 | — | — | — | 1 |
| Brain injuries | D001930 | — | S06.9 | 1 | 1 | — | — | — | 1 |
| Depression | D003863 | — | F33.9 | — | 1 | — | — | — | 1 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | — | 1 | — | — | — | 1 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | 1 | — | — | — | 1 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | — | 1 | — | — | — | 1 |
Show 2 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 10 | — | — | — | 1 | 11 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 1 | — | — | — | — | 1 |
| Arthritis | D001168 | EFO_0005856 | M05-M14 | 1 | — | — | — | — | 1 |
| Non-small-cell lung carcinoma | D002289 | — | — | 1 | — | — | — | — | 1 |
| Lung neoplasms | D008175 | — | C34.90 | 1 | — | — | — | — | 1 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | — | 1 |
| Neoplasms | D009369 | — | C80 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Vascular diseases | D014652 | EFO_0004264 | I77 | — | — | — | — | 2 | 2 |
| Peripheral arterial disease | D058729 | EFO_0004265 | — | — | — | — | — | 2 | 2 |
| Peripheral vascular diseases | D016491 | EFO_0003875 | I73.9 | — | — | — | — | 2 | 2 |
| Observation | D019370 | — | — | — | — | — | — | 1 | 1 |
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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Rosuvastatin
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Trends
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Safety
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No Black-box warning
Adverse Events
Top Adverse Reactions
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38,111 adverse events reported
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