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Drug ReportsSimvastatin
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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Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
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FDA approval date
EMA approval date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
cardiovascular diseasesD002318
nutritional and metabolic diseasesD009750
Trade Name
FDA
EMA
Flolipid, Simvastatin, Zocor (discontinued: Simvastatin, Zocor)
Combinations
Ezetimibe 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
Tradename
Company
Number
Date
Products
VYTORINOrganonN-021687 RX2004-07-23
4 products, RLD, RS
Simvastatin
Tradename
Company
Number
Date
Products
ZOCOROrganonN-019766 RX1991-12-23
4 products, RLD
FLOLIPIDTCG Fluent PharmaN-206679 RX2016-04-21
2 products, RLD, RS
Show 2 discontinued
Simvastatin
+
Sitagliptin phosphate
Tradename
Company
Number
Date
Products
JUVISYNCMerck & CoN-202343 DISCN2011-10-07
6 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
ezetimibe and simvastatinANDA2025-07-18
flolipidNew Drug Application2023-02-09
simcorNew Drug Application2010-08-06
simvastatinANDA2025-12-03
simvastatin simvastatinANDA2022-08-22
vytorinNew Drug Application2025-08-12
zocorNew Drug Application2025-03-28
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hypercholesterolemia—D006937—
coronary artery disease—D003324I25.1
hypertriglyceridemiaEFO_0004211D015228—
hyperlipoproteinemias—D006951—
familial combined hyperlipidemiaEFO_0000492D006950E78.49
hyperlipoproteinemia type iiEFO_0004911D006938E78.00
type 2 diabetes mellitusEFO_0001360D003924E11
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Simvastatin, Flolipid, Tcg Fluent Pharma
95972892030-02-23DP
103000412027-04-26DP
Simvastatin / Sitagliptin Phosphate, Juvisync, Merck Sharp Dohme
73267082026-04-11DS, DPU-1188
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
666 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cardiovascular diseasesD002318EFO_0000319I98——1——1
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———2————2
MalnutritionD044342EFO_0008572E40-E461————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameSimvastatin
INNsimvastatin
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 classenzyme inhibitors: antihyperlipidemics (HMG-CoA inhibitors)
Image (chem structure or protein)Loading
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-ID79902-63-9
RxCUI—
ChEMBL IDCHEMBL1064
ChEBI ID9150
PubChem CID54454
DrugBankDB00641
UNII IDAGG2FN16EV (ChemIDplus, GSRS)
Target
Agency Approved
HMGCR
HMGCR
Organism
Homo sapiens
Gene name
HMGCR
Gene synonyms
NCBI Gene ID
3156
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
Q8N190
Mouse ortholog
Hmgcr (15357)
3-hydroxy-3-methylglutaryl-coenzyme A reductase (Q5U4I2)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
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
Total medical expenditures per year (USD, in millions)
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Simvastatin
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 52,258 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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56,103 adverse events reported
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