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.
Download report
Favorite
Events Timeline
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
Mock data
Subscribe for the real data
Subscribe for the real data
Commercial
Therapeutic Areas
Trade Name
FDA
EMA
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
+
Ezetimibe
Ezetimibe
+
Simvastatin
Bempedoic acid
+
Ezetimibe
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| NEXLIZET | Esperion Therapeutics | N-211617 RX | 2020-02-26 | 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
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
443 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypercholesterolemia | D006937 | HP_0003124 | — | 10 | 19 | 101 | 43 | 29 | 202 |
| Dyslipidemias | D050171 | HP_0003119 | — | 5 | 5 | 10 | 18 | 26 | 64 |
| Coronary artery disease | D003324 | — | I25.1 | 2 | 1 | 19 | 27 | 10 | 58 |
| Hyperlipidemias | D006949 | HP_0003077 | E78.5 | 4 | 4 | 22 | 10 | 10 | 49 |
| Coronary disease | D003327 | — | — | 2 | 1 | 19 | 15 | 8 | 44 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | 2 | 1 | 16 | 17 | 7 | 42 |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | 2 | — | 10 | 19 | 9 | 40 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | 2 | — | 20 | 7 | 3 | 32 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | 1 | — | 7 | 13 | 9 | 30 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | 3 | 6 | 15 | 4 | 28 |
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 | — | 4 | 9 | — | 6 | 19 |
| Homozygous familial hypercholesterolemia | D000090542 | — | — | — | 1 | 2 | — | 2 | 5 |
| 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 | HP_0001650 | — | — | — | 2 | — | — | 2 |
| Pathologic constriction | D003251 | — | — | — | — | 2 | — | — | 2 |
| Left ventricular hypertrophy | D017379 | EFO_0003896 | — | — | — | 1 | — | — | 1 |
| Hypertrophy | D006984 | EFO_0002460 | — | — | — | 1 | — | — | 1 |
Show 7 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 13 | 1 | — | — | — | 14 |
| 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 |
| 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 | HP_0001919 | 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 | — | — | — | — | — | 2 | 2 |
| Stable angina | D060050 | — | I20.89 | — | — | — | — | 2 | 2 |
| Cerebrovascular disorders | D002561 | EFO_0003763 | I60-I69 | — | — | — | — | 2 | 2 |
| Prediabetic state | D011236 | EFO_1001121 | R73.03 | — | — | — | — | 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 | — | — | — | — | — | 1 | 1 |
| Medication adherence | D055118 | EFO_0006344 | — | — | — | — | — | 1 | 1 |
Show 21 more
Epidemiology
Epidemiological information for investigational and approved indications
View more details
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
$
€
£
₣
Zetia – Organon
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Zetia – Merck & Co
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Liptruzet – Organon
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Vytorin – Organon
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Vytorin – Merck & Co
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Estimated US medical usage
Ezetimibe
Total medical expenditures per year (USD, in millions)
Mock data
Subscribe for the real data
Subscribe for the real data
Number of persons purchased
Mock data
Subscribe for the real data
Subscribe for the real data
Number of purchases
Mock data
Subscribe for the real data
Subscribe for the real data
Refill frequency
Mock data
Subscribe for the real data
Subscribe for the real data
Price per prescription (USD)
Mock data
Subscribe for the real data
Subscribe for the real data
Ezetimibe
+
Simvastatin
Total medical expenditures per year (USD, in millions)
Mock data
Subscribe for the real data
Subscribe for the real data
Number of persons purchased
Mock data
Subscribe for the real data
Subscribe for the real data
Number of purchases
Mock data
Subscribe for the real data
Subscribe for the real data
Refill frequency
Mock data
Subscribe for the real data
Subscribe for the real data
Price per prescription (USD)
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 14,100 documents
View more details
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
28,956 adverse events reported
View more details
© 2020-2024 Collaborative Drug Discovery Inc. (CDD) | Terms of Use