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.
Download report
Favorite
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
Mock data
Subscribe for the real data
Subscribe for the real data
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 |
Hide discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| ezetimibe and simvastatin | ANDA | 2025-05-02 |
| flolipid | New Drug Application | 2023-02-09 |
| simcor | New Drug Application | 2010-08-06 |
| simvastatin | ANDA | 2025-05-20 |
| 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
No data
Clinical
Clinical Trials
660 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypercholesterolemia | D006937 | — | — | 4 | 6 | 72 | 28 | 20 | 130 |
| Dyslipidemias | D050171 | — | — | 5 | 5 | 26 | 11 | 13 | 60 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | 1 | 16 | 12 | 14 | 43 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 12 | 1 | 10 | 9 | 6 | 38 |
| Healthy volunteers/patients | — | — | — | 31 | 1 | — | 1 | 2 | 35 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 3 | 4 | 10 | 10 | 9 | 35 |
| Coronary disease | D003327 | — | — | — | — | 15 | 13 | 5 | 33 |
| Coronary artery disease | D003324 | — | I25.1 | 1 | — | 10 | 13 | 7 | 31 |
| Hyperlipidemias | D006949 | EFO_0003774 | E78.5 | 1 | 1 | 16 | 7 | 7 | 31 |
| Hypertension | D006973 | EFO_0000537 | I10 | 2 | 4 | 8 | 12 | 5 | 30 |
Show 110 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 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 4 | 1 | — | — | 5 |
| Subarachnoid hemorrhage | D013345 | EFO_0000713 | I60 | 2 | 3 | 2 | — | 1 | 5 |
| Covid-19 | D000086382 | — | U07.1 | 1 | 1 | 2 | — | — | 4 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | 3 | 4 | 1 | — | — | 4 |
| Depression | D003863 | — | F33.9 | 2 | 1 | 1 | — | 1 | 4 |
Show 62 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 | — | 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 47 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 | — | N17 | 1 | — | — | — | 2 | 3 |
| Pulpitis | D011671 | EFO_1001139 | K04.0 | 1 | — | — | — | 2 | 3 |
| Hemangioma | D006391 | — | D18.0 | 2 | — | — | — | — | 2 |
| Stomatognathic diseases | D009057 | — | K08.9 | 2 | — | — | — | — | 2 |
| Dental pulp diseases | D003788 | EFO_0009540 | K04 | 2 | — | — | — | — | 2 |
| Lymphoma | D008223 | — | C85.9 | 1 | — | — | — | — | 1 |
| Neurotoxicity syndromes | D020258 | — | G92 | 1 | — | — | — | — | 1 |
| Lipodystrophy | D008060 | — | E88.1 | 1 | — | — | — | — | 1 |
| Hiv seronegativity | D018023 | — | — | 1 | — | — | — | — | 1 |
Show 35 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Congenital heart defects | D006330 | — | Q24.9 | — | — | — | — | 2 | 2 |
| Heart valve diseases | D006349 | EFO_0009551 | I08 | — | — | — | — | 2 | 2 |
| Aneurysm | D000783 | — | I72.9 | — | — | — | — | 2 | 2 |
| Wounds and injuries | D014947 | — | T14.8 | — | — | — | — | 2 | 2 |
| Cerebrovascular disorders | D002561 | EFO_0003763 | I60-I69 | — | — | — | — | 1 | 1 |
| Endocrine system diseases | D004700 | EFO_0001379 | E34.9 | — | — | — | — | 1 | 1 |
| Chest pain | D002637 | — | R07.9 | — | — | — | — | 1 | 1 |
| Stents | D015607 | — | — | — | — | — | — | 1 | 1 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | — | — | — | — | 1 | 1 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | — | — | — | — | 1 | 1 |
Show 22 more
Epidemiology
Epidemiological information for investigational and approved indications
View more details
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
$
€
£
â‚£
Zocor – Organon
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Vytorin – Organon
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Vytorin – Merck & Co
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Estimated US medical usage
Simvastatin
+
Ezetimibe
Total medical expenditures per year (USD, in millions)
Mock data
Subscribe for the real data
Subscribe for the real data
Number of persons purchased
Mock data
Subscribe for the real data
Subscribe for the real data
Number of purchases
Mock data
Subscribe for the real data
Subscribe for the real data
Refill frequency
Mock data
Subscribe for the real data
Subscribe for the real data
Price per prescription (USD)
Mock data
Subscribe for the real data
Subscribe for the real data
Simvastatin
+
Niacin
Total medical expenditures per year (USD, in millions)
Mock data
Subscribe for the real data
Subscribe for the real data
Number of persons purchased
Mock data
Subscribe for the real data
Subscribe for the real data
Number of purchases
Mock data
Subscribe for the real data
Subscribe for the real data
Refill frequency
Mock data
Subscribe for the real data
Subscribe for the real data
Price per prescription (USD)
Mock data
Subscribe for the real data
Subscribe for the real data
Simvastatin
Total medical expenditures per year (USD, in millions)
Mock data
Subscribe for the real data
Subscribe for the real data
Number of persons purchased
Mock data
Subscribe for the real data
Subscribe for the real data
Number of purchases
Mock data
Subscribe for the real data
Subscribe for the real data
Refill frequency
Mock data
Subscribe for the real data
Subscribe for the real data
Price per prescription (USD)
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 49,795 documents
View more details
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
55,169 adverse events reported
View more details
© 2020-2025 Collaborative Drug Discovery Inc. (CDD) | Terms of Use