Zetia, Nustendi(ezetimibe)
Ezetimibe, Lypqozet, Nexlizet, Nustendi, Roszet, Vytorin, Zetia (ezetimibe) is a small molecule pharmaceutical. Ezetimibe was first approved as Zetia on 2002-10-25. It is used to treat familial combined hyperlipidemia, hypercholesterolemia, and hyperlipoproteinemia type II in the USA. It has been approved in Europe to treat dyslipidemias and hypercholesterolemia. The pharmaceutical is active against NPC1-like intracellular cholesterol transporter 1.
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Trade Name
FDA
EMA
Ezetimibe, Zetia (discontinued: Ezetimibe)
CombinationsEzetimibe simvastatin, Lypqozet, Nexlizet, Vytorin (discontinued: Ezetimibe simvastatin, Liptruzet, Roszet)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Atorvastatin calcium
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Ezetimibe
Ezetimibe
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Simvastatin
Bempedoic acid
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Ezetimibe
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| NEXLIZET | Esperion Therapeutics | N-211617 RX | 2020-02-26 | 1 products, RLD, RS |
Ezetimibe
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Rosuvastatin calcium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ROSZET | Althera Pharmaceutical | N-213072 DISCN | 2021-03-23 | 4 products, RLD |
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Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
BEMPEDOIC ACID / EZETIMIBE, NEXLIZET, ESPERION THERAPS INC | |||
| 2025-02-21 | NCE | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Bempedoic Acid / Ezetimibe, Nexlizet, Esperion Theraps Inc | |||
| 11613511 | 2040-06-19 | DP | |
| 11760714 | 2040-06-19 | DP | |
| 10912751 | 2036-03-14 | U-3224 | |
| 11744816 | 2036-03-14 | U-3692 | |
| 7335799 | 2025-12-03 | DP | |
| Ezetimibe / Rosuvastatin Calcium, Roszet, Althera Pharms | |||
| 9763885 | 2033-05-01 | DP | U-3095 |
| 10376470 | 2033-05-01 | DP | U-3095 |
| Ezetimibe, Zetia, Organon | |||
| 7612058 | 2025-10-30 | U-1027, U-1173 | |
ATC Codes
C: Cardiovascular system drugs
— C10: Lipid modifying agents
— C10A: Lipid modifying agents, plain
— C10AX: Other lipid modifying agents in atc
— C10AX09: Ezetimibe
— C10B: Lipid modifying agents, combinations
— C10BA: Combinations of various lipid modifying agents
— C10BA02: Simvastatin and ezetimibe
— C10BA05: Atorvastatin and ezetimibe
— C10BA06: Rosuvastatin and ezetimibe
— C10BA10: Bempedoic acid and ezetimibe
— C10BA11: Pravastatin and ezetimibe
— C10BA12: Pravastatin, ezetimibe and fenofibrate
HCPCS
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Clinical
Clinical Trials
437 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 | — | 3 | — | 60 | 18 | 11 | 92 |
| Coronary disease | D003327 | — | — | — | — | 12 | 6 | 1 | 19 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | 14 | 4 | 1 | 19 |
| Coronary artery disease | D003324 | — | I25.1 | — | — | 10 | 7 | 1 | 18 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | — | 10 | 6 | 1 | 17 |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | 1 | — | 4 | 8 | — | 13 |
| Dyslipidemias | D050171 | HP_0003119 | — | — | — | — | 3 | 3 | 6 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | — | 2 | 2 | — | 4 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | — | — | 2 | 1 | — | 3 |
| Metabolic diseases | D008659 | EFO_0000589 | E88.9 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hyperlipoproteinemia type ii | D006938 | EFO_0004911 | E78.00 | — | — | 6 | — | 4 | 10 |
| Hyperlipidemias | D006949 | HP_0003077 | E78.5 | 2 | — | 7 | — | — | 9 |
| Hyperlipoproteinemias | D006951 | HP_0010980 | — | 1 | — | 5 | — | — | 6 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | — | 4 | — | — | 4 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | 4 | — | — | 4 |
| Familial combined hyperlipidemia | D006950 | EFO_0000492 | E78.49 | — | — | 4 | — | — | 4 |
| Inborn errors metabolism | D008661 | — | — | — | — | 4 | — | — | 4 |
| Inborn errors lipid metabolism | D008052 | — | — | — | — | 4 | — | — | 4 |
| Homozygous familial hypercholesterolemia | D000090542 | — | — | — | — | 1 | — | 2 | 3 |
| Hypertriglyceridemia | D015228 | EFO_0004211 | — | — | — | 3 | — | — | 3 |
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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 | Ezetimibe |
| INN | ezetimibe |
| Description | Ezetimibe is a beta-lactam that is azetidin-2-one which is substituted at 1, 3, and 4 by p-fluorophenyl, 3-(p-fluorophenyl)-3-hydroxypropyl, and 4-hydroxyphenyl groups, respectively (the 3R,3'S,4S enantiomer). It has a role as an anticholesteremic drug, an antilipemic drug and an antimetabolite. It is a member of azetidines, an organofluorine compound and a beta-lactam. |
| Classification | Small molecule |
| Drug class | antihyperlipidaemics, acyl CoA: cholesterol acyltransferase (ACAT) inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | O=C1[C@H](CC[C@H](O)c2ccc(F)cc2)[C@@H](c2ccc(O)cc2)N1c1ccc(F)cc1 |
Identifiers
| PDB | — |
| CAS-ID | 163222-33-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1138 |
| ChEBI ID | 49040 |
| PubChem CID | 150311 |
| DrugBank | DB00973 |
| UNII ID | EOR26LQQ24 (ChemIDplus, GSRS) |
Target
Agency Approved
NPC1L1
NPC1L1
Organism
Homo sapiens
Gene name
NPC1L1
Gene synonyms
NCBI Gene ID
Protein name
NPC1-like intracellular cholesterol transporter 1
Protein synonyms
Niemann-Pick C1-like protein 1, NPC1 (Niemann-Pick disease, type C1, gene)-like 1, NPC1 like 1
Uniprot ID
Mouse ortholog
Npc1l1 (237636)
NPC1-like intracellular cholesterol transporter 1 (Q6T3U4)
Alternate
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Variants
No data
Financial
Revenue by drug
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Liptruzet – Organon
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Zetia – Organon
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Zetia – Merck & Co
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Vytorin – Organon
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Vytorin – Merck & Co
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Tabular view
Estimated US medical usage
Ezetimibe
Total medical expenditures per year (USD, in millions)
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Ezetimibe
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Simvastatin
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
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Additional graphs summarizing 13,814 documents
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Safety
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Adverse Events
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27,790 adverse events reported
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