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Drug ReportsEzetimibe
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
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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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
Ezetimibe, Zetia (discontinued: Ezetimibe)
Combinations
Ezetimibe 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
Tradename
Company
Number
Date
Products
LIPTRUZETOrganonN-200153 DISCN2013-05-03
4 products, RLD
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Ezetimibe
+
Simvastatin
Tradename
Company
Number
Date
Products
VYTORINOrganonN-021687 RX2004-07-23
4 products, RLD, RS
Ezetimibe
Tradename
Company
Number
Date
Products
ZETIAOrganonN-021445 RX2002-10-25
1 products, RLD, RS
Bempedoic acid
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Ezetimibe
Tradename
Company
Number
Date
Products
NEXLIZETEsperion TherapeuticsN-211617 RX2020-02-26
1 products, RLD, RS
Ezetimibe
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Rosuvastatin calcium
Tradename
Company
Number
Date
Products
ROSZETAlthera PharmaceuticalN-213072 DISCN2021-03-23
4 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
ezetimibeANDA2025-03-24
ezetimibe and simvastatinANDA2025-03-03
lypqozetANDA2024-01-24
nexlizetNew Drug Application2024-06-05
vytorinNew Drug Application2024-11-20
zetiaNew Drug Application2024-11-04
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hypercholesterolemia—D006937—
familial combined hyperlipidemiaEFO_0000492D006950E78.49
hyperlipoproteinemia type iiEFO_0004911D006938E78.00
coronary artery disease—D003324I25.1
hypertriglyceridemiaEFO_0004211D015228—
hyperlipoproteinemias—D006951—
atherosclerosisEFO_0003914D050197I25.1
Agency Specific
FDA
EMA
Expiration
Code
BEMPEDOIC ACID / EZETIMIBE, NEXLIZET, ESPERION THERAPS INC
2025-02-21NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Bempedoic Acid / Ezetimibe, Nexlizet, Esperion Theraps Inc
116135112040-06-19DP
117607142040-06-19DP
109127512036-03-14U-3224
117448162036-03-14U-3692
73357992025-12-03DP
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
450 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypercholesterolemiaD006937—————1—1
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
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)Loading
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
RxCUI—
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
29881
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
Q9UHC9
Mouse ortholog
Npc1l1 (237636)
NPC1-like intracellular cholesterol transporter 1 (Q6T3U4)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
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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Number of persons purchased
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Ezetimibe
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Simvastatin
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 14,454 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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25,613 adverse events reported
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