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
+
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
+
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 | 2024-10-28 |
| flolipid | New Drug Application | 2023-02-09 |
| simcor | New Drug Application | 2010-08-06 |
| simvastatin | ANDA | 2024-10-15 |
| simvastatin simvastatin | ANDA | 2022-08-22 |
| vytorin | New Drug Application | 2024-03-28 |
| zocor | New Drug Application | 2023-08-09 |
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
No data
Clinical
Clinical Trials
653 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 | 6 | 72 | 28 | 20 | 130 |
| Dyslipidemias | D050171 | HP_0003119 | — | 5 | 5 | 26 | 11 | 14 | 61 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | 1 | 16 | 11 | 13 | 41 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 12 | 1 | 10 | 9 | 6 | 38 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | 3 | 4 | 10 | 10 | 9 | 35 |
| Healthy volunteers/patients | — | — | — | 30 | 1 | — | 1 | 2 | 34 |
| Coronary disease | D003327 | — | — | — | — | 15 | 14 | 5 | 34 |
| Coronary artery disease | D003324 | — | I25.1 | 1 | — | 10 | 13 | 7 | 31 |
| Hyperlipidemias | D006949 | HP_0003077 | E78.5 | 1 | 1 | 16 | 7 | 7 | 31 |
| Hypertension | D006973 | EFO_0000537 | I10 | 2 | 4 | 8 | 12 | 5 | 30 |
Show 109 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 10 | 1 | — | — | 12 |
| Hyperlipoproteinemia type ii | D006938 | EFO_0004911 | E78.00 | — | — | 9 | — | 1 | 10 |
| Neoplasms | D009369 | — | C80 | 5 | 1 | 1 | — | 3 | 9 |
| Hemorrhage | D006470 | MP_0001914 | R58 | 2 | 4 | 3 | — | 1 | 7 |
| Colorectal neoplasms | D015179 | — | — | — | 5 | 1 | — | — | 6 |
| Ischemia | D007511 | EFO_0000556 | — | — | 2 | 4 | — | 1 | 5 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 4 | 1 | — | — | 5 |
| Subarachnoid hemorrhage | D013345 | EFO_0000713 | I60 | 2 | 3 | 2 | — | 1 | 5 |
| Covid-19 | D000086382 | — | — | 1 | 1 | 2 | — | — | 4 |
| Ischemic stroke | D000083242 | — | — | — | 1 | 3 | — | 1 | 4 |
Show 64 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prostatic neoplasms | D011471 | — | C61 | 1 | 3 | — | — | 2 | 6 |
| Multiple myeloma | D009101 | — | C90.0 | 2 | 4 | — | — | 1 | 6 |
| Plasma cell neoplasms | D054219 | — | — | 2 | 4 | — | — | 1 | 6 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | — | 5 | — | — | — | 5 |
| Small cell lung carcinoma | D055752 | — | — | — | 4 | — | — | — | 4 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 2 | 3 | — | — | — | 4 |
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | 2 | 2 | — | — | — | 3 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | 2 | — | — | 1 | 3 |
| Cardiomyopathies | D009202 | EFO_0000318 | I42 | — | 2 | — | — | 1 | 3 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | 2 | 1 | — | — | 1 | 3 |
Show 48 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv infections | D015658 | EFO_0000764 | B20 | 3 | — | — | — | — | 3 |
| Acute kidney injury | D058186 | HP_0001919 | N17 | 1 | — | — | — | 2 | 3 |
| Hemangioma | D006391 | — | D18.0 | 2 | — | — | — | — | 2 |
| Lymphoma | D008223 | — | C85.9 | 1 | — | — | — | — | 1 |
| Neurotoxicity syndromes | D020258 | — | G92 | 1 | — | — | — | — | 1 |
| Lipodystrophy | D008060 | HP_0009125 | E88.1 | 1 | — | — | — | — | 1 |
| Hiv seronegativity | D018023 | — | — | 1 | — | — | — | — | 1 |
| Hepatitis b | D006509 | — | — | 1 | — | — | — | — | 1 |
| Chronic hepatitis b | D019694 | EFO_0004239 | B18.1 | 1 | — | — | — | — | 1 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 1 | — | — | — | — | 1 |
Show 34 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 |
| Aneurysm | D000783 | HP_0002617 | I72.9 | — | — | — | — | 2 | 2 |
| Wounds and injuries | D014947 | — | T14.8 | — | — | — | — | 2 | 2 |
| Pulpitis | D011671 | EFO_1001139 | K04.0 | — | — | — | — | 2 | 2 |
| Cerebrovascular disorders | D002561 | EFO_0003763 | I60-I69 | — | — | — | — | 1 | 1 |
| Endocrine system diseases | D004700 | EFO_0001379 | E34.9 | — | — | — | — | 1 | 1 |
| Chest pain | D002637 | HP_0100749 | R07.9 | — | — | — | — | 1 | 1 |
| Stents | D015607 | — | — | — | — | — | — | 1 | 1 |
| Liver diseases | D008107 | HP_0002910 | K70-K77 | — | — | — | — | 1 | 1 |
Show 21 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 | — |
| 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
No data
Financial
Revenue by drug
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Zocor – Organon
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Vytorin – Organon
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Vytorin – Merck & Co
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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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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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57,426 adverse events reported
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