Last update 04 Nov 2024

Rosuvastatin Calcium

Overview

Basic Info

SummaryRosuvastatin, a drug sold under the trade names of Ezallor and Crestor, is a small molecule that functions as an inhibitor of HMG-CoA reductase, an enzyme responsible for cholesterol synthesis in the liver. By inhibiting the production of cholesterol, rosuvastatin helps to reduce the level of cholesterol and triglycerides in the bloodstream. This drug is primarily used to treat hypercholesterolemia, hyperlipidemias, and heart failure. Although it is available in several countries, including the US, China, Japan, and the Netherlands, it has been granted Priority Review and Orphan Drug status by the FDA. Ongoing research is evaluating the effectiveness of rosuvastatin in treating other conditions, and its active indication is expanding. Nevertheless, rosuvastatin may cause side effects, and patients should be closely monitored during treatment to avoid adverse effects.
Drug Type
Small molecule drug
Synonyms
(3R,5S,6E)-7-(4-(4-fluorophenyl)-6-(1-methylethyl)-2-(ethyl(methylsulfonyl)amino)-5-pyrimidinyl)-3,5-dihydroxy-6-heptenoic acid, (3R,5S,6E)-7-{4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl}-3,5-dihydroxyhept-6-enoic acid, Rosuvastatin
+ [18]
Mechanism
HMG-CoA reductase inhibitors(HMG-CoA reductase inhibitors)
Originator Organization
Drug Highest PhaseApproved
RegulationOrphan Drug (US), Priority Review (CN)
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Structure

Molecular FormulaC44H56CaF2N6O12S2
InChIKeyGGPPBULYISSAKA-BGRFNVSISA-N
CAS Registry147098-20-2

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Heterozygous familial hypercholesterolemia
US
04 Aug 2023
Primary Hyperlipidemia
US
04 Aug 2023
Hypertriglyceridemia
US
18 Dec 2018
Atherosclerosis
US
08 Nov 2007
Hypercholesterolemia
JP
19 Jan 2005
Hypercholesterolemia
JP
19 Jan 2005
Hyperlipoproteinemia Type II
JP
19 Jan 2005
Hyperlipoproteinemia Type II
JP
19 Jan 2005
Hyperlipidemia Type IIa
US
12 Aug 2003
Hyperlipoproteinemia Type IIb
US
12 Aug 2003
Hyperlipoproteinemia Type IV
US
12 Aug 2003
Primary hypercholesterolemia
US
12 Aug 2003
Homozygous familial hypercholesterolemia
NL
06 Nov 2002
Hyperlipoproteinemia Type III
NL
06 Nov 2002
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Acute Coronary SyndromePhase 3
US
01 Dec 2003
Acute Coronary SyndromePhase 3
CR
01 Dec 2003
Acute Coronary SyndromePhase 3
SV
01 Dec 2003
Acute Coronary SyndromePhase 3
MA
01 Dec 2003
Acute Coronary SyndromePhase 3
PA
01 Dec 2003
Chronic systolic heart failurePhase 3
BE
01 Sep 2003
Chronic systolic heart failurePhase 3
BG
01 Sep 2003
Chronic systolic heart failurePhase 3
CZ
01 Sep 2003
Chronic systolic heart failurePhase 3
DK
01 Sep 2003
Chronic systolic heart failurePhase 3
FI
01 Sep 2003
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
1,196
lzcegiepbr(urdoadgzha) = qkylemdpwx lyazputkqy (vyaqmeelyj, irxykliivl - axphzchlnw)
-
30 Oct 2024
Phase 1
12
(Period 1: Rosuvastatin 10 mg)
hzraidfsmq(juotwiuuie) = zgowwucgon fqoggudpgc (uxmeigijwt, viyrlyuyqb - ggmkentnfd)
-
28 Oct 2024
Rosuvastatin+Nirmatrelvir+Ritonavir
(Period 2: Rosuvastatin 10 mg + Nirmatrelvir 300 mg/ Ritonavir 100 mg)
hzraidfsmq(juotwiuuie) = bbtzbdpgkh fqoggudpgc (uxmeigijwt, iwonhcvjsc - fyfydaveqx)
Phase 4
79
Cardiac Magnetic Resonance Image (MRI)+Atorvastatin+Rosuvastatin
zbhtbosyeu(lejdxfdslq) = vwgqxacars gtckjvlxrs (maogcwyreu, jdbcgjyogz - xhfkkbdbpn)
-
09 Oct 2024
Phase 2
-
Rosuvastatin 20mg
lxhhotksgv(vumvczpxlk) = kcvegkcyry pvrleshwsi (uyhmqrzsge )
Positive
12 Sep 2024
lxhhotksgv(vumvczpxlk) = xboiorpdpi pvrleshwsi (uyhmqrzsge )
Not Applicable
-
jirhsjuwgz(sxyqfxmvpf) = cpzgvxufkt kyhwaffoqs (vfwhdgpptk )
-
11 Oct 2023
FDA
ManualManual
Not Applicable
82
Placebo
yxurgmduma(vvzpuupssr) = ubnasyxhqe gpzglocowx (mjhvbpumkb )
Positive
04 Aug 2023
yxurgmduma(vvzpuupssr) = igxrncjxrc gpzglocowx (mjhvbpumkb )
Not Applicable
984
htgvmgsikr(nlvskbkkbu) = xkxmyewqjv hyvgqermaq (zzgvdvcduq )
Positive
04 Aug 2023
Placebo
htgvmgsikr(nlvskbkkbu) = lajxzlkbhw hyvgqermaq (zzgvdvcduq )
Not Applicable
17,802
zqjpwxqdvy(wcognkihxq) = tdrijkxyfq kxtadwmgmf (oamxvvqxli )
Positive
04 Aug 2023
Placebo
zqjpwxqdvy(wcognkihxq) = pzowswlqsh kxtadwmgmf (oamxvvqxli )
FDA
ManualManual
Not Applicable
-
bjqwcsaagl(qyztlgbuxn) = uyviukmqii wmfthtixdr (dccitdungn, -49 to to46)
Positive
04 Aug 2023
bjqwcsaagl(qyztlgbuxn) = fnpwmbjazz wmfthtixdr (dccitdungn, -40 to to36)
Not Applicable
530
utivmiauzq(gklpzqtkez) = jivetatlbb dvtprxvlww (kvjjrwnhse )
Positive
01 May 2023
utivmiauzq(gklpzqtkez) = ojgbmyqcxa dvtprxvlww (kvjjrwnhse )
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