Zocor, Cholib(simvastatin)
Cholib, Flolipid, Juvisync, Vytorin, Zocor (simvastatin) is a small molecule pharmaceutical. Simvastatin was first approved as Zocor on 1991-12-23. It is used to treat coronary artery disease, hypercholesterolemia, hyperlipoproteinemias, and hypertriglyceridemia in the USA. It has been approved in Europe to treat dyslipidemias. The pharmaceutical is active against 3-hydroxy-3-methylglutaryl-Coenzyme A reductase.
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Commercial
Trade Name
FDA
EMA
Flolipid, Zocor (generic drugs available since 2006-12-20)
CombinationsVytorin (generic drugs available since 2006-12-20, discontinued: Juvisync)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| ezetimibe and simvastatin | ANDA | 2023-06-16 |
| flolipid | New Drug Application | 2020-10-05 |
| vytorin | New Drug Application | 2021-06-01 |
| zocor | New Drug Application | 2021-06-01 |
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
No data
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
— A10BH51: Sitagliptin and simvastatin
C: Cardiovascular system drugs
— C10: Lipid modifying agents
— C10A: Lipid modifying agents, plain
— C10AA: Hmg coa reductase inhibitors, plain lipid modifying drugs
— C10AA01: Simvastatin
— C10B: Lipid modifying agents, combinations
— C10BA: Combinations of various lipid modifying agents
— C10BA02: Simvastatin and ezetimibe
— C10BA04: Simvastatin and fenofibrate
— C10BX: Lipid modifying agents in combination with other drugs
— C10BX01: Simvastatin and acetylsalicylic acid
— C10BX04: Simvastatin, acetylsalicylic acid and ramipril
HCPCS
No data
Clinical
Clinical Trials
515 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 | 4 | 2 | 55 | 25 | 8 | 94 | |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 11 | 1 | 9 | 8 | 4 | 33 |
| Dyslipidemias | D050171 | HP_0003119 | 3 | 3 | 15 | 7 | 3 | 31 | |
| Healthy volunteers/patients | — | 25 | 1 | — | 1 | 2 | 29 | ||
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | 8 | 9 | 7 | 24 |
| Hyperlipidemias | D006949 | EFO_0003774 | E78.5 | 1 | 1 | 12 | 6 | 4 | 23 |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | 1 | — | 5 | 8 | 6 | 20 |
| Coronary disease | D003327 | — | — | 11 | 5 | 2 | 18 | ||
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | 6 | 5 | 2 | 13 |
| Inflammation | D007249 | 3 | 2 | 1 | 3 | 4 | 11 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colorectal neoplasms | D015179 | — | 5 | 1 | — | — | 6 | ||
| Peripheral arterial disease | D058729 | EFO_0004265 | 2 | 1 | 1 | — | 1 | 5 | |
| Subarachnoid hemorrhage | D013345 | EFO_0000713 | I60 | 2 | 3 | 2 | — | 1 | 5 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | 2 | — | 2 | 4 |
| Asthma | D001249 | EFO_0000270 | J45 | — | 1 | 2 | — | — | 3 |
| Relapsing-remitting multiple sclerosis | D020529 | EFO_0003929 | — | — | 3 | — | — | 3 | |
| Hyperlipoproteinemia type ii | D006938 | EFO_0004911 | E78.00 | — | — | 3 | — | — | 3 |
| Chronic progressive multiple sclerosis | D020528 | — | 2 | 1 | — | — | 3 | ||
| Esophageal and gastric varices | D004932 | EFO_0009545 | I85 | — | — | 2 | — | 1 | 3 |
| Celiac disease | D002446 | EFO_0001060 | K90.0 | 2 | 1 | 1 | — | — | 3 |
Show 26 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 9 | — | — | — | 10 |
| Prostatic neoplasms | D011471 | C61 | 1 | 2 | — | — | 2 | 5 | |
| Small cell lung carcinoma | D055752 | — | 4 | — | — | — | 4 | ||
| Multiple myeloma | D009101 | C90.0 | 2 | 2 | — | — | 1 | 4 | |
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | 2 | 2 | — | — | — | 3 |
| Depression | D003863 | F33.9 | 2 | 1 | — | — | 1 | 3 | |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | 2 | — | — | 1 | 3 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | 2 | 1 | — | — | 1 | 3 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | 3 | 3 | — | — | — | 3 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | 1 | — | — | — | 2 |
Show 31 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | C80 | 2 | — | — | — | 1 | 3 | |
| Coronary artery disease | D003324 | I25.1 | 1 | — | — | — | 2 | 3 | |
| Hiv infections | D015658 | EFO_0000764 | B20 | 2 | — | — | — | — | 2 |
| Lymphoma | D008223 | C85.9 | 1 | — | — | — | — | 1 | |
| Lipodystrophy | D008060 | E88.1 | 1 | — | — | — | — | 1 | |
| Hiv seronegativity | D018023 | 1 | — | — | — | — | 1 | ||
| Hepatitis b | D006509 | 1 | — | — | — | — | 1 | ||
| Renal cell carcinoma | D002292 | 1 | — | — | — | — | 1 | ||
| Sarcoma | D012509 | 1 | — | — | — | — | 1 | ||
| Neuroblastoma | D009447 | EFO_0000621 | 1 | — | — | — | — | 1 |
Show 20 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Congenital heart defects | D006330 | HP_0001627 | Q24.9 | — | — | — | — | 2 | 2 |
| Heart valve diseases | D006349 | EFO_0009551 | I08 | — | — | — | — | 2 | 2 |
| Chest pain | D002637 | HP_0100749 | R07.9 | — | — | — | — | 1 | 1 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | — | — | — | — | 1 | 1 |
| Prehypertension | D058246 | — | — | — | — | 1 | 1 | ||
| Cytokinesis | D048749 | — | — | — | — | 1 | 1 | ||
| Prediabetic state | D011236 | EFO_1001121 | R73.03 | — | — | — | — | 1 | 1 |
| Stable angina | D060050 | I20.8 | — | — | — | — | 1 | 1 | |
| Rheumatic heart disease | D012214 | EFO_1001161 | I09.9 | — | — | — | — | 1 | 1 |
| Aneurysm | D000783 | HP_0002617 | I72.9 | — | — | — | — | 1 | 1 |
Show 7 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | SIMVASTATIN |
| INN | simvastatin |
| Description | Simvastatin is a member of the class of hexahydronaphthalenes that is lovastatin in which the 2-methylbutyrate ester moiety has been replaced by a 2,2-dimethylbutyrate ester group. It is used as a cholesterol-lowering and anti-cardiovascular disease drug. It has a role as an EC 3.4.24.83 (anthrax lethal factor endopeptidase) inhibitor, a prodrug, an EC 1.1.1.34/EC 1.1.1.88 (hydroxymethylglutaryl-CoA reductase) inhibitor, a ferroptosis inducer and a geroprotector. It is a delta-lactone, a fatty acid ester, a statin (semi-synthetic) and a member of hexahydronaphthalenes. It is functionally related to a lovastatin. |
| Classification | Small molecule |
| Drug class | enzyme inhibitors: antihyperlipidemics (HMG-CoA inhibitors) |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CCC(C)(C)C(=O)O[C@H]1C[C@@H](C)C=C2C=C[C@H](C)[C@H](CC[C@@H]3C[C@@H](O)CC(=O)O3)[C@H]21 |
Identifiers
| PDB | — |
| CAS-ID | 79902-63-9 |
| RxCUI | 36567 |
| ChEMBL ID | CHEMBL1064 |
| ChEBI ID | 9150 |
| PubChem CID | 54454 |
| DrugBank | DB00641 |
| UNII ID | AGG2FN16EV (ChemIDplus, GSRS) |
Target
Agency Approved
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)
Alternate
No data
Variants
Clinical Variant
Identifier | Target mutation | Effect | Evaluation | Status |
|---|---|---|---|---|
| VCV000037346 | SLCO1B1, 521T>C, Val174Ala | drug response | 2022-02-15 | 1A |
Financial
Vytorin - Organon
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Vytorin - Merck Sharp & Dohme
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Zocor - Organon
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Trends
PubMed Central
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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221 adverse events reported
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