Zetia, Nustendi(ezetimibe)
Liptruzet, 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
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
+
Ezetimibe
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| LIPTRUZET | Organon | N-200153 DISCN | 2013-05-03 | 4 products, RLD |
Hide discontinued
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
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ZETIA | Organon | N-021445 RX | 2002-10-25 | 1 products, RLD, RS |
Ezetimibe
+
Rosuvastatin calcium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ROSZET | Althera Pharmaceutical | N-213072 DISCN | 2021-03-23 | 4 products, RLD |
Hide discontinued
Ezetimibe
+
Simvastatin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| VYTORIN | Organon | N-021687 RX | 2004-07-23 | 4 products, RLD, RS |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| familial combined hyperlipidemia | EFO_0000492 | D006950 | E78.49 |
| hypercholesterolemia | HP_0003124 | D006937 | — |
| hyperlipoproteinemia type ii | EFO_0004911 | D006938 | E78.00 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
BEMPEDOIC ACID / EZETIMIBE, NEXLIZET, ESPERION THERAPS INC | |||
| 2025-02-21 | NCE | ||
| 2023-02-26 | NP | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Bempedoic Acid / Ezetimibe, Nexlizet, Esperion Theraps Inc | |||
| 11613511 | 2040-06-19 | DP | |
| 10912751 | 2036-03-14 | U-3224 | |
| 7335799 | 2025-12-03 | DP | |
| 8497301 | 2023-12-23 | U-2746 | |
| 9000041 | 2023-12-23 | U-2746 | |
| 9624152 | 2023-12-23 | U-2749 | |
| 10118881 | 2023-12-23 | U-2746 | |
| 10941095 | 2023-12-23 | U-2746 | |
| 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
330 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 | 12 | 83 | 39 | 15 | 157 | |
| Hyperlipidemias | D006949 | EFO_0003774 | E78.5 | 3 | 4 | 14 | 6 | 4 | 30 |
| Dyslipidemias | D050171 | HP_0003119 | 2 | 4 | 6 | 9 | 7 | 28 | |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | 2 | — | 7 | 12 | 2 | 23 |
| Coronary disease | D003327 | 2 | — | 11 | 6 | 3 | 22 | ||
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 2 | 5 | 7 | 3 | 17 |
| Coronary artery disease | D003324 | I25.1 | — | 1 | 3 | 12 | 1 | 16 | |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | 1 | — | 2 | 4 | 3 | 10 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.81 | — | — | 2 | 4 | 1 | 7 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | — | 3 | 2 | 1 | 6 |
Show 26 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 | — | 2 | 4 | — | 3 | 9 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | 5 | — | — | 5 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | 4 | — | — | 4 |
| Inborn errors lipid metabolism | D008052 | — | — | 4 | — | — | 4 | ||
| Hypertriglyceridemia | D015228 | EFO_0004211 | — | — | 3 | — | — | 3 | |
| Diabetic nephropathies | D003928 | EFO_0000401 | — | — | 1 | — | — | 1 | |
| Infections | D007239 | EFO_0000544 | — | — | 1 | — | — | 1 | |
| Inborn errors metabolism | D008661 | — | — | 1 | — | — | 1 | ||
| Aortic valve stenosis | D001024 | EFO_0000266 | Q25.1 | — | — | 1 | — | — | 1 |
| Carotid artery diseases | D002340 | EFO_0003781 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 7 | 1 | — | — | — | 8 | ||
| Chronic hepatitis c | D019698 | EFO_0004220 | B18.2 | 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 | 4 | — | — | — | — | 4 | ||
| Drug interactions | D004347 | 3 | — | — | — | — | 3 | ||
| Immunosuppression therapy | D007165 | 2 | — | — | — | — | 2 | ||
| Therapeutic equivalency | D013810 | 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 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Inferior wall myocardial infarction | D056989 | EFO_1000983 | — | — | — | — | 1 | 1 | |
| Cerebrovascular disorders | D002561 | EFO_0003763 | I60-I69 | — | — | — | — | 1 | 1 |
| Prediabetic state | D011236 | EFO_1001121 | R73.03 | — | — | — | — | 1 | 1 |
| Heart disease risk factors | D000082742 | — | — | — | — | 1 | 1 | ||
| Acalculous cholecystitis | D042101 | EFO_1000790 | — | — | — | — | 1 | 1 | |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | — | — | — | 1 | 1 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 1 | 1 |
| Stable angina | D060050 | I20.8 | — | — | — | — | 1 | 1 | |
| Vascular diseases | D014652 | EFO_0004264 | I77 | — | — | — | — | 1 | 1 |
| Covid-19 | D000086382 | U07.1 | — | — | — | — | 1 | 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 | 341248 |
| 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
Clinical Variant
No data
Financial
Zetia - Organon
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Zetia - Merck Sharp & Dohme
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Vytorin - Organon
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Vytorin - Merck Sharp & Dohme
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Trends
PubMed Central
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Safety
Black-box Warning
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Adverse Events
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3,288 adverse events reported
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