Zocor, Cholib(simvastatin)
Cholib, Flolipid, Juvisync, Simvastatin, 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
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| cardiovascular diseases | D002318 |
| nutritional and metabolic diseases | D009750 |
Trade Name
FDA
EMA
Flolipid, Simvastatin, Zocor (discontinued: Simvastatin, Zocor)
CombinationsEzetimibe simvastatin, Vytorin (discontinued: Ezetimibe simvastatin, Juvisync)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ezetimibe
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Simvastatin
Simvastatin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ZOCOR | Organon | N-019766 RX | 1991-12-23 | 4 products, RLD |
| FLOLIPID | TCG Fluent Pharma | N-206679 RX | 2016-04-21 | 2 products, RLD, RS |
Show 2 discontinued
Simvastatin
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Sitagliptin phosphate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| JUVISYNC | Merck & Co | N-202343 DISCN | 2011-10-07 | 6 products, RLD |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| ezetimibe and simvastatin | ANDA | 2025-03-03 |
| flolipid | New Drug Application | 2023-02-09 |
| simcor | New Drug Application | 2010-08-06 |
| simvastatin | ANDA | 2025-03-18 |
| simvastatin simvastatin | ANDA | 2022-08-22 |
| vytorin | New Drug Application | 2024-11-20 |
| zocor | New Drug Application | 2025-03-28 |
Indications
FDA
EMA
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
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Clinical
Clinical Trials
658 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 | — | — | 1 | — | 31 | 12 | 5 | 49 |
| Coronary disease | D003327 | — | — | — | — | 7 | 4 | 1 | 12 |
| Coronary artery disease | D003324 | — | I25.1 | — | — | 5 | 4 | 1 | 10 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | — | 5 | 4 | 1 | 10 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | 6 | 2 | 1 | 9 |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | — | 2 | 5 | — | 7 |
| Dyslipidemias | D050171 | — | — | — | — | — | 2 | 1 | 3 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | 2 | 1 | — | 3 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | — | — | 2 | 1 | — | 3 |
| Systemic lupus erythematosus | D008180 | EFO_0002690 | M32 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hyperlipidemias | D006949 | EFO_0003774 | E78.5 | 1 | — | 4 | — | — | 5 |
| Hyperlipoproteinemia type ii | D006938 | EFO_0004911 | E78.00 | — | — | 3 | — | 1 | 4 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | — | 4 | — | — | 4 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | 4 | — | — | 4 |
| Acute coronary syndrome | D054058 | EFO_0005672 | — | — | — | 2 | — | — | 2 |
| Syndrome | D013577 | — | — | — | — | 2 | — | — | 2 |
| Homozygous familial hypercholesterolemia | D000090542 | — | — | — | — | 1 | — | 1 | 2 |
| Hyperlipoproteinemias | D006951 | — | — | — | — | 2 | — | — | 2 |
| Familial combined hyperlipidemia | D006950 | EFO_0000492 | E78.49 | — | — | 2 | — | — | 2 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | — | 1 | — | — | 1 |
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Indications Phases 2
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Indications Phases 1
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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 | — |
| 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
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Variants
No data
Financial
Revenue by drug
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Vytorin – Organon
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Vytorin – Merck & Co
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Zocor – Organon
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Tabular view
Estimated US medical usage
Simvastatin
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Ezetimibe
Total medical expenditures per year (USD, in millions)
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Simvastatin
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Niacin
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Simvastatin
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 49,228 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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55,169 adverse events reported
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