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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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Zetia (generic drugs available since 2015-06-26)
CombinationsNexlizet, Vytorin (generic drugs available since 2015-06-26, discontinued: 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
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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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| ezetimibe | ANDA | 2024-01-09 |
| ezetimibe and simvastatin | ANDA | 2024-01-16 |
| lypqozet | ANDA | 2024-01-24 |
| nexlizet | New Drug Application | 2023-12-07 |
| rosuvastatin and ezetimibe | NDA authorized generic | 2021-08-18 |
| vytorin | New Drug Application | 2022-06-01 |
| zetia | New Drug Application | 2023-07-20 |
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
No data
Clinical
Clinical Trials
423 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 | — | 8 | 14 | 93 | 41 | 23 | 179 |
| Dyslipidemias | D050171 | HP_0003119 | — | 3 | 5 | 7 | 15 | 16 | 46 |
| Hyperlipidemias | D006949 | HP_0003077 | E78.5 | 4 | 4 | 14 | 7 | 6 | 34 |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | 2 | — | 9 | 12 | 2 | 25 |
| Coronary disease | D003327 | — | — | 2 | — | 12 | 7 | 4 | 25 |
| Coronary artery disease | D003324 | — | I25.1 | — | 1 | 4 | 17 | 3 | 24 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 2 | 5 | 12 | 4 | 23 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | 1 | — | 6 | 4 | 4 | 15 |
| Hypertension | D006973 | EFO_0000537 | I10 | 2 | — | 5 | 1 | — | 8 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.810 | — | — | 2 | 5 | 1 | 8 |
Show 30 more
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 | — | 3 | 5 | — | 4 | 12 |
| Hypertriglyceridemia | D015228 | EFO_0004211 | — | — | — | 5 | — | — | 5 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | 5 | — | — | 5 |
| Inborn errors lipid metabolism | D008052 | — | — | — | — | 4 | — | — | 4 |
| Aortic valve stenosis | D001024 | HP_0001650 | — | — | — | 2 | — | — | 2 |
| Diabetic nephropathies | D003928 | EFO_0000401 | — | — | — | 1 | — | — | 1 |
| Infections | D007239 | EFO_0000544 | — | — | — | 1 | — | — | 1 |
| Inborn errors metabolism | D008661 | — | — | — | — | 1 | — | — | 1 |
| Carotid artery diseases | D002340 | EFO_0003781 | — | — | — | 1 | — | — | 1 |
| Essential hypertension | D000075222 | — | I10 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 9 | 1 | — | — | — | 10 |
| Chronic hepatitis c | D019698 | EFO_0004220 | B18.2 | 1 | 1 | — | — | — | 2 |
| Homozygous familial hypercholesterolemia | D000090542 | — | — | — | 1 | — | — | 1 | 2 |
| Chronic hepatitis d | D019701 | — | — | — | 2 | — | — | — | 2 |
| Diabetic neuropathies | D003929 | EFO_1000783 | — | — | 1 | — | — | — | 1 |
| Oxidative stress | D018384 | EFO_1001905 | — | — | 1 | — | — | — | 1 |
| Lipidoses | D008064 | — | E75.6 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pharmacokinetics | D010599 | — | — | 6 | — | — | — | — | 6 |
| Drug interactions | D004347 | — | — | 3 | — | — | — | — | 3 |
| Immunosuppression therapy | D007165 | — | — | 2 | — | — | — | — | 2 |
| Neoplasms | D009369 | — | C80 | 1 | — | — | — | 1 | 2 |
| Endometriosis | D004715 | EFO_0001065 | N80 | 1 | — | — | — | — | 1 |
| Therapeutic equivalency | D013810 | — | — | 1 | — | — | — | — | 1 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | 1 | — | — | — | — | 1 |
| Acute kidney injury | D058186 | HP_0001919 | N17 | 1 | — | — | — | — | 1 |
| Prostatic neoplasms | D011471 | — | C61 | 1 | — | — | — | — | 1 |
| Alopecia areata | D000506 | EFO_0004192 | L63 | 1 | — | — | — | — | 1 |
Show 2 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lactation | D007774 | — | — | — | — | — | — | 1 | 1 |
| Inferior wall myocardial infarction | D056989 | EFO_1000983 | — | — | — | — | — | 1 | 1 |
| Genetic testing | D005820 | — | — | — | — | — | — | 1 | 1 |
| Hyperlipoproteinemia type iii | D006952 | — | — | — | — | — | — | 1 | 1 |
| Medication adherence | D055118 | EFO_0006344 | — | — | — | — | — | 1 | 1 |
| Treatment adherence and compliance | D000074822 | — | — | — | — | — | — | 1 | 1 |
| Patient compliance | D010349 | — | — | — | — | — | — | 1 | 1 |
| Motivational interviewing | D062405 | — | — | — | — | — | — | 1 | 1 |
| Compliance | D003187 | — | — | — | — | — | — | 1 | 1 |
| Cognitive dysfunction | D060825 | HP_0001268 | G31.84 | — | — | — | — | 1 | 1 |
Show 12 more
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
No data
Variants
No data
Financial
Revenue by drug
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Zetia – Organon
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Zetia – Merck & Co
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Liptruzet – Organon
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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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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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21,548 adverse events reported
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