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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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
458 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 | — | — | 11 | 19 | 101 | 44 | 29 | 204 |
| Dyslipidemias | D050171 | — | — | 6 | 5 | 9 | 19 | 25 | 64 |
| Coronary artery disease | D003324 | — | I25.1 | 2 | 1 | 16 | 28 | 13 | 59 |
| Hyperlipidemias | D006949 | EFO_0003774 | E78.5 | 4 | 4 | 24 | 9 | 10 | 50 |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | 2 | — | 11 | 19 | 10 | 42 |
| Coronary disease | D003327 | — | — | 2 | 1 | 18 | 13 | 8 | 41 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | 2 | 1 | 13 | 14 | 7 | 36 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | 2 | — | 18 | 7 | 3 | 30 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | 1 | — | 7 | 12 | 9 | 29 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 1 | 2 | 6 | 12 | 5 | 26 |
Show 54 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 | 7 | — | 7 | 17 |
| Homozygous familial hypercholesterolemia | D000090542 | — | — | — | 1 | 2 | — | 3 | 6 |
| Hypertriglyceridemia | D015228 | EFO_0004211 | — | — | — | 6 | — | — | 6 |
| Inborn errors lipid metabolism | D008052 | — | — | — | — | 4 | — | 1 | 5 |
| Inborn errors metabolism | D008661 | — | — | — | — | 5 | — | — | 5 |
| Essential hypertension | D000075222 | — | I10 | — | — | 3 | — | — | 3 |
| Vascular diseases | D014652 | EFO_0004264 | I77 | — | — | 1 | — | 1 | 2 |
| Aortic valve stenosis | D001024 | EFO_0000266 | — | — | — | 2 | — | — | 2 |
| Pathologic constriction | D003251 | — | — | — | — | 2 | — | — | 2 |
| Left ventricular hypertrophy | D017379 | EFO_0003896 | — | — | — | 1 | — | — | 1 |
Show 8 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 15 | 1 | — | — | — | 16 |
| Chronic hepatitis | D006521 | — | K73.9 | 1 | 2 | — | — | — | 3 |
| Chronic hepatitis d | D019701 | — | — | — | 2 | — | — | — | 2 |
| Hepatitis d | D003699 | EFO_0007304 | — | — | 2 | — | — | — | 2 |
| Prostatic neoplasms | D011471 | — | C61 | 1 | 1 | — | — | — | 2 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | — | 2 | — | — | — | 2 |
| Diabetic neuropathies | D003929 | EFO_1000783 | — | — | 1 | — | — | — | 1 |
| Polyneuropathies | D011115 | EFO_0009562 | A69.22 | — | 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 |
| Pharmacological phenomena | D000069437 | — | — | 1 | — | — | — | — | 1 |
| Endometriosis | D004715 | EFO_0001065 | N80 | 1 | — | — | — | — | 1 |
| Therapeutic equivalency | D013810 | — | — | 1 | — | — | — | — | 1 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | 1 | — | — | — | — | 1 |
| Acute kidney injury | D058186 | — | N17 | 1 | — | — | — | — | 1 |
| Alopecia areata | D000506 | EFO_0004192 | L63 | 1 | — | — | — | — | 1 |
Show 4 more
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 | — | — | — | — | — | 4 | 4 |
| Stable angina | D060050 | — | I20.89 | — | — | — | — | 2 | 2 |
| Cerebrovascular disorders | D002561 | EFO_0003763 | I60-I69 | — | — | — | — | 2 | 2 |
| Hyperlipoproteinemia type v | D006954 | Orphanet_70470 | E78.3 | — | — | — | — | 2 | 2 |
| Lactation | D007774 | — | — | — | — | — | — | 1 | 1 |
| Genetic testing | D005820 | — | — | — | — | — | — | 1 | 1 |
| Hyperlipoproteinemia type iii | D006952 | — | — | — | — | — | — | 1 | 1 |
| Arthrogryposis | D001176 | EFO_0003857 | Q74.3 | — | — | — | — | 1 | 1 |
| Medication adherence | D055118 | EFO_0006344 | — | — | — | — | — | 1 | 1 |
| Treatment adherence and compliance | D000074822 | — | — | — | — | — | — | 1 | 1 |
Show 21 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
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Variants
No data
Financial
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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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Liptruzet – Organon
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Estimated US medical usage
Ezetimibe
Total medical expenditures per year (USD, in millions)
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Ezetimibe
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Simvastatin
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Trends
PubMed Central
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Safety
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27,350 adverse events reported
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