Rosuvastatin
Crestor, Ezallor, 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. It is known to target 3-hydroxy-3-methylglutaryl-Coenzyme A reductase.
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Commercial
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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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| crestor | New Drug Application | 2022-05-09 |
| ezallor sprinkle | New Drug Application | 2020-09-28 |
| rosuvastatin calcium | ANDA | 2023-06-20 |
| roszet | New Drug Application | 2021-09-15 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| coronary artery disease | — | D003324 | I25.1 |
| hypercholesterolemia | HP_0003124 | D006937 | — |
| hyperlipoproteinemias | — | D006951 | — |
| hypertriglyceridemia | EFO_0004211 | D015228 | — |
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
580 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 | — | 84 | — | — | 3 | — | 87 | ||
| Hypercholesterolemia | D006937 | HP_0003124 | 2 | 2 | 47 | 20 | 10 | 81 | |
| Dyslipidemias | D050171 | HP_0003119 | 7 | 4 | 27 | 12 | 4 | 54 | |
| Hyperlipidemias | D006949 | EFO_0003774 | E78.5 | 13 | 3 | 9 | 10 | 4 | 38 |
| Hypertension | D006973 | EFO_0000537 | I10 | 14 | — | 13 | 3 | 4 | 34 |
| Coronary artery disease | D003324 | I25.1 | 2 | 2 | 6 | 20 | 3 | 33 | |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | 4 | 1 | 5 | 10 | 3 | 23 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 1 | 1 | 7 | 6 | 3 | 17 |
| Acute coronary syndrome | D054058 | EFO_0005672 | 2 | — | 2 | 9 | 3 | 16 | |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | 2 | 2 | 8 | 4 | 15 |
Show 54 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 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | 1 | 1 | — | — | 4 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 2 | — | 1 | — | — | 3 |
| Covid-19 | D000086382 | U07.1 | 1 | 1 | 1 | — | — | 2 | |
| Pulmonary embolism | D011655 | EFO_0003827 | I26 | — | — | 1 | — | 1 | 2 |
| Colorectal neoplasms | D015179 | 1 | — | 1 | — | — | 2 | ||
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | 1 | 1 | — | 1 | 2 |
| Carotid stenosis | D016893 | — | — | 1 | — | 1 | 2 | ||
| Sepsis | D018805 | A41.9 | — | 1 | 1 | — | — | 2 | |
| Sars-cov-2 | D000086402 | — | — | 1 | — | — | 1 |
Show 22 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | C80 | 7 | 1 | — | — | — | 8 | |
| Hepatitis c | D006526 | B19.2 | 1 | 1 | — | — | 1 | 3 | |
| Diabetic neuropathies | D003929 | EFO_1000783 | — | 2 | — | — | — | 2 | |
| Pre-eclampsia | D011225 | EFO_0000668 | O14 | 1 | 2 | — | — | — | 2 |
| Craniocerebral trauma | D006259 | S00 | 1 | 2 | — | — | — | 2 | |
| Wounds and injuries | D014947 | T14.8 | — | 1 | — | — | — | 1 | |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | — | 1 | — | — | — | 1 |
| Oxidative stress | D018384 | EFO_1001905 | — | 1 | — | — | — | 1 | |
| Spinal cord injuries | D013119 | EFO_1001919 | — | 1 | — | — | — | 1 | |
| Osteoporosis | D010024 | EFO_0003882 | M81.0 | — | 1 | — | — | — | 1 |
Show 15 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pharmacokinetics | D010599 | 3 | — | — | — | — | 3 | ||
| Non-small-cell lung carcinoma | D002289 | 2 | — | — | — | — | 2 | ||
| Malaria | D008288 | EFO_0001068 | B54 | 2 | — | — | — | — | 2 |
| Melanoma | D008545 | 1 | — | — | — | — | 1 | ||
| Balloon angioplasty coronary | D015906 | EFO_0003951 | 1 | — | — | — | — | 1 | |
| Hereditary angioedemas | D054179 | EFO_0004131 | 1 | — | — | — | — | 1 | |
| Squamous cell neoplasms | D018307 | 1 | — | — | — | — | 1 | ||
| Food-drug interactions | D018565 | 1 | — | — | — | — | 1 | ||
| Bacterial skin diseases | D017192 | 1 | — | — | — | — | 1 | ||
| Parkinson disease | D010300 | EFO_0002508 | G20 | 1 | — | — | — | — | 1 |
Show 17 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Percutaneous coronary intervention | D062645 | — | — | — | — | 2 | 2 | ||
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | — | — | — | — | 2 | 2 |
| Coronary occlusion | D054059 | I21 | — | — | — | — | 1 | 1 | |
| Drug-eluting stents | D054855 | — | — | — | — | 1 | 1 | ||
| Cerebrovascular disorders | D002561 | EFO_0003763 | I60-I69 | — | — | — | — | 1 | 1 |
| Intracranial arterial diseases | D020765 | EFO_1000990 | — | — | — | — | 1 | 1 | |
| Behcet syndrome | D001528 | EFO_0003780 | M35.2 | — | — | — | — | 1 | 1 |
| Arteriosclerosis | D001161 | EFO_0009086 | I70 | — | — | — | — | 1 | 1 |
| Ankylosing spondylitis | D013167 | EFO_0003898 | M45 | — | — | — | — | 1 | 1 |
| Human influenza | D007251 | EFO_0007328 | J11.1 | — | — | — | — | 1 | 1 |
Show 1 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 | 301542 |
| ChEMBL ID | CHEMBL1496 |
| ChEBI ID | 38545 |
| PubChem CID | 446157 |
| DrugBank | DB01098 |
| UNII ID | 413KH5ZJ73 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
HMGCR
HMGCR
Organism
Homo sapiens
Gene name
HMGCR
Gene synonyms
NCBI Gene ID
Protein name
3-hydroxy-3-methylglutaryl-Coenzyme A reductase
Protein synonyms
3-hydroxy-3-methylglutaryl CoA reductase (NADPH), HMG-CoA reductase, hydroxymethylglutaryl-CoA reductase
Uniprot ID
Mouse ortholog
Hmgcr (15357)
3-hydroxy-3-methylglutaryl-coenzyme A reductase (Q5U4I2)
Variants
Clinical Variant
Identifier | Target mutation | Effect | Evaluation | Status |
|---|---|---|---|---|
| VCV000037346 | SLCO1B1, 521T>C, Val174Ala | drug response | 2022-02-15 | 1A |
| VCV000030389 | ABCG2, 421C>A, Gln141Lys | drug response | 2021-03-24 | 2A |
Financial
Crestor - AstraZeneca
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Trends
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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120,349 adverse events reported
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