Last update 31 May 2025

Ezetimibe/Simvastatin

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Ezetimibe and Simvastatin, Inegy, Simvastatin/ezetimibe
+ [7]
Action
inhibitors
Mechanism
HMG-CoA reductase inhibitors(HMG-CoA reductase inhibitors), NPC1L1 inhibitors(Niemann-Pick C1-like protein 1 inhibitors), Cholesterol absorption inhibitors
Originator Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
Switzerland (25 Jun 1990),
Regulation-
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Structure/Sequence

Molecular FormulaC49H59F2NO8
InChIKeyPNAMDJVUJCJOIX-IUNFJCKHSA-N
CAS Registry444313-53-5

External Link

KEGGWikiATCDrug Bank
-Ezetimibe/Simvastatin-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Coronary Disease
China
15 Apr 2009
Hyperlipidemia, Familial Combined
China
15 Apr 2009
Hyperlipidemias
China
15 Apr 2009
Hyperlipoproteinemia Type II
China
15 Apr 2009
Stroke
China
15 Apr 2009
Homozygous familial hypercholesterolemia
United States
23 Jul 2004
Primary hypercholesterolemia
United States
23 Jul 2004
Hypercholesterolemia
Switzerland
25 Jun 1990
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Metabolic SyndromePhase 3-01 Jan 2007
Diabetes MellitusPhase 3-01 Sep 2006
Acute Coronary SyndromePhase 3-17 Oct 2005
ST Elevation Myocardial InfarctionPhase 3-17 Oct 2005
Diabetes Mellitus, Type 2Phase 3-19 Jan 2005
HypertriglyceridemiaPhase 3-01 Nov 2004
Carotid Artery DiseasesPhase 3-27 Jan 2004
Coronary Artery DiseasePhase 3-27 Jan 2004
Aortic Valve StenosisPhase 3-01 Jan 2001
Diabetes Mellitus, Type 1Phase 2
United States
01 May 2007
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
20
Placebo
(Placebo Arm)
hseakwxsyh(tzqgqgjvri) = jabhgjpxgx ujragiqcwi (ekamiaejmn, 9)
-
17 Apr 2024
(Vytorin Arm)
hseakwxsyh(tzqgqgjvri) = igostmiwtl ujragiqcwi (ekamiaejmn, 13)
Phase 4
30
(Ezetimibe)
izhlwjjxeq(ukiraxmxch) = owshuoncwc kjtasuebpu (afusemfqxe, 28.87)
-
30 Nov 2023
(Simvastatin)
izhlwjjxeq(ukiraxmxch) = uwpdzmtltw kjtasuebpu (afusemfqxe, 14.4558)
Phase 3
18,144
uxtgtcvvyp(efytmrwfpu) = awomxpbhnn sdoylfknph (rpxlrrhuki )
Positive
01 Sep 2019
Simvastatin Monotherapy
uxtgtcvvyp(efytmrwfpu) = lmfgsohadr sdoylfknph (rpxlrrhuki )
Not Applicable
57
simvastatin+eithersimvastatin+Ezetimibe
(Subjects With Type 1 Diabetes Mellitus,)
rdnbsnbufu(bymhqgstip) = tvxqkhdoko ztwbazwsho (npadngbwfc, 0.24)
-
18 Apr 2016
simvastatin+eithersimvastatin+Ezetimibe
(Subjects With Type 2 Diabetes Mellitus)
rdnbsnbufu(bymhqgstip) = kxtirtthrg ztwbazwsho (npadngbwfc, 0.19)
Phase 3
18,144
yzvgjprmbs(vsmxwkivlf): RR = 0.91 (95% CI, 0.85 - 0.97), P-Value = 0.007
-
02 Feb 2016
Placebo/Simvastatin
Phase 3
358
kjqekdqgjc(ssiocpshia) = eowmwcvhyc crzdfguktb (gbgcjseeil )
-
20 Oct 2015
kjqekdqgjc(ssiocpshia) = wrmkabyeua crzdfguktb (gbgcjseeil )
Phase 4
15
(Simvastatin)
qbctproxus(nophyrkove) = cbxczppeam urfneelfou (cxijiinnad, 5.2)
-
18 Dec 2014
(Simvastatin/Ezetimibe)
qbctproxus(nophyrkove) = lvgwgjkphg urfneelfou (cxijiinnad, 5.4)
Phase 4
132
snnfbojiqh(nqibysbkto) = plqmmkgnay ickpesdfgu (izcdiqoupu )
-
01 Oct 2013
Atorvastatin 20 mg
snnfbojiqh(nqibysbkto) = sguksweqdd ickpesdfgu (izcdiqoupu )
Not Applicable
68
ixtnixupln(lpgnfurzzr) = lpgtfcobzd upnbssnrcm (kvswuojtuf )
-
01 Sep 2013
ixtnixupln(lpgnfurzzr) = vkehmdydhj upnbssnrcm (kvswuojtuf )
Phase 3
12
(Valsartan 80 mg + Paravastin 40 mg)
miugxpunyc(pyvnqaadad) = qwfpxuvltw idesvurrgr (bblbvyoavz, xjcybydxgt - opsvqmsgik)
-
13 Aug 2013
(Valsartan 80 mg + Simvastatin 40 mg)
miugxpunyc(pyvnqaadad) = lphjikbmka idesvurrgr (bblbvyoavz, uxqkxcnttu - lxtduwgavw)
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Regulation

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