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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
Therapeutic Areas
Therapeutic Area
MeSH
hereditary congenital and neonatal diseases and abnormalitiesD009358
nutritional and metabolic diseasesD009750
Trade Name
FDA
EMA
Zetia (generic drugs available since 2015-06-26)
Combinations
Nexlizet, 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
LIPTRUZETOrganonN-200153 DISCN2013-05-03
4 products, RLD
Hide discontinued
Bempedoic acid
+
Ezetimibe
Tradename
Company
Number
Date
Products
NEXLIZETEsperion TherapeuticsN-211617 RX2020-02-26
1 products, RLD, RS
Ezetimibe
Tradename
Company
Number
Date
Products
ZETIAOrganonN-021445 RX2002-10-25
1 products, RLD, RS
Ezetimibe
+
Rosuvastatin calcium
Tradename
Company
Number
Date
Products
ROSZETAlthera PharmaceuticalN-213072 DISCN2021-03-23
4 products, RLD
Hide discontinued
Ezetimibe
+
Simvastatin
Tradename
Company
Number
Date
Products
VYTORINOrganonN-021687 RX2004-07-23
4 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
ezetimibeANDA2023-06-20
lypqozetANDA2021-01-14
nexlizetNew Drug Application2021-09-24
roszetNew Drug Application2021-09-15
vytorinNew Drug Application2021-06-01
zetiaNew Drug Application2021-06-01
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
familial combined hyperlipidemiaEFO_0000492D006950E78.49
hypercholesterolemiaHP_0003124D006937
hyperlipoproteinemia type iiEFO_0004911D006938E78.00
Agency Specific
FDA
EMA
Expiration
Code
BEMPEDOIC ACID / EZETIMIBE, NEXLIZET, ESPERION THERAPS INC
2025-02-21NCE
2023-02-26NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Bempedoic Acid / Ezetimibe, Nexlizet, Esperion Theraps Inc
116135112040-06-19DP
109127512036-03-14U-3224
73357992025-12-03DP
84973012023-12-23U-2746
90000412023-12-23U-2746
96241522023-12-23U-2749
101188812023-12-23U-2746
109410952023-12-23U-2746
Ezetimibe / Rosuvastatin Calcium, Roszet, Althera Pharms
97638852033-05-01DPU-3095
103764702033-05-01DPU-3095
Ezetimibe, Zetia, Organon
76120582025-10-30U-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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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypercholesterolemiaD006937HP_0003124812833915157
HyperlipidemiasD006949EFO_0003774E78.534146430
DyslipidemiasD050171HP_00031192469728
AtherosclerosisD050197EFO_0003914I25.12712223
Coronary diseaseD0033272116322
Type 2 diabetes mellitusD003924EFO_0001360E11257317
Coronary artery diseaseD003324I25.11312116
Cardiovascular diseasesD002318EFO_0000319I98124310
Metabolic syndromeD024821EFO_0000195E88.812417
Diabetes mellitusD003920EFO_0000400E08-E133216
Show 26 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hyperlipoproteinemia type iiD006938EFO_0004911E78.002439
HypertensionD006973EFO_0000537I1055
Heart diseasesD006331EFO_0003777I51.944
Inborn errors lipid metabolismD00805244
HypertriglyceridemiaD015228EFO_000421133
Diabetic nephropathiesD003928EFO_000040111
InfectionsD007239EFO_000054411
Inborn errors metabolismD00866111
Aortic valve stenosisD001024EFO_0000266Q25.111
Carotid artery diseasesD002340EFO_000378111
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients718
Chronic hepatitis cD019698EFO_0004220B18.2112
Chronic hepatitis dD01970122
Diabetic neuropathiesD003929EFO_100078311
Oxidative stressD018384EFO_100190511
LipidosesD008064E75.611
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PharmacokineticsD01059944
Drug interactionsD00434733
Immunosuppression therapyD00716522
Therapeutic equivalencyD01381011
Acute kidney injuryD058186HP_0001919N1711
Prostatic neoplasmsD011471C6111
Alopecia areataD000506EFO_0004192L6311
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Inferior wall myocardial infarctionD056989EFO_100098311
Cerebrovascular disordersD002561EFO_0003763I60-I6911
Prediabetic stateD011236EFO_1001121R73.0311
Heart disease risk factorsD00008274211
Acalculous cholecystitisD042101EFO_100079011
Alzheimer diseaseD000544EFO_0000249F0311
ObesityD009765EFO_0001073E66.911
Stable anginaD060050I20.811
Vascular diseasesD014652EFO_0004264I7711
Covid-19D000086382U07.111
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameEZETIMIBE
INNezetimibe
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 classantihyperlipidaemics, 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-ID163222-33-1
RxCUI341248
ChEMBL IDCHEMBL1138
ChEBI ID49040
PubChem CID150311
DrugBankDB00973
UNII IDEOR26LQQ24 (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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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 11,171 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,288 adverse events reported
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