SummarySimvastatin, a diminutive molecular entity, functions as an HMG-CoA reductase enzyme inhibitor, which is accountable for the synthesis of cholesterol in the hepatic tissue. Classified as HMG-CoA reductase inhibitors or statins, it treats sundry ailments that result from elevated cholesterol levels. Simvastatin's active indications encompass heterozygous familial hypercholesterolemia, hyperlipoproteinemia Type V, stroke, hyperlipidemias, and hyperlipoproteinemia Type II. Merck Sharp & Dohme Corp. initially synthesized simvastatin, and it received the first nod for clinical use in 1988. In spite of its prevalent administration, simvastatin may elicit an array of side effects, for example, myalgia and hepatotoxicity, and patients should seek counsel from their medical practitioners before initiating its intake. |
Drug Type Small molecule drug |
Synonyms 2,2-dimethylbutyric acid, 8-ester with (4R,6R)-6-(2-((1S,2S,6R,8S,8aR)-1,2,6,7,8,8a-hexahydro-8-hydroxy-2,6-dimethyl-1-naphthyl)ethyl)tetrahydro-4-hydroxy-2H-pyran-2-one, Simvastatin (JP17/USP/INN), Simvastatin for Suspension + [43] |
Target |
Mechanism HMG-CoA reductase inhibitors(HMG-CoA reductase inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date AU (12 Sep 1991), |
Regulation- |
Molecular FormulaC25H38O5 |
InChIKeyRYMZZMVNJRMUDD-HGQWONQESA-N |
CAS Registry79902-63-9 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D00434 | Simvastatin |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Hypercholesterolemia | CN | 01 Jan 1997 | |
Hyperlipoproteinemia Type V | CN | 01 Jan 1997 | |
Coronary Disease | US | 23 Dec 1991 | |
Hyperlipoproteinemia Type II | JP | 04 Oct 1991 | |
Coronary Artery Disease | AU | 12 Sep 1991 | |
Heterozygous familial hypercholesterolemia | AU | 12 Sep 1991 | |
Stroke | AU | 12 Sep 1991 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Hypertension | Phase 3 | CZ | 01 Apr 2006 | |
Hypertension | Phase 3 | FR | 01 Apr 2006 | |
Hypertension | Phase 3 | DE | 01 Apr 2006 | |
Hypertension | Phase 3 | HK | 01 Apr 2006 | |
Hypertension | Phase 3 | NL | 01 Apr 2006 | |
Hypertension | Phase 3 | RU | 01 Apr 2006 | |
Hypertension | Phase 3 | SK | 01 Apr 2006 | |
Hypertension | Phase 3 | ZA | 01 Apr 2006 | |
Hypertension | Phase 3 | KR | 01 Apr 2006 | |
Hypertension | Phase 3 | SE | 01 Apr 2006 |
Not Applicable | - | 40 | atkkgwimjk(zwhkqtdsks) = uvobqswkoy lhuwjdflbm (eemjyvfics ) | - | 01 Apr 2024 | ||
Non-instrumentation endodontic treatment (NIET) using 3Mixtatin | atkkgwimjk(zwhkqtdsks) = hvrpgpxlyn lhuwjdflbm (eemjyvfics ) | ||||||
Phase 4 | 10 | (Simvastatin) | kiisibnmlo(fpgjzbvegm) = xkufekiazq cegxpznepn (tdnldjyuim, ohjlqyswhn - ryluodhgxg) View more | - | 23 Jan 2024 | ||
(Ezetimibe) | kiisibnmlo(fpgjzbvegm) = fsifogbscd cegxpznepn (tdnldjyuim, nqzvtqerss - anjfdqrcpb) View more | ||||||
Early Phase 1 | 15 | ubgjyyqihv(vkljznczaw) = zsifraycwm yvuxvnbcug (blczynragi ) | - | 10 Dec 2023 | |||
Phase 4 | 30 | (Ezetimibe) | fdwoycsczo(rshzsmzrnb) = vsewcwssep yxsbrvfpxn (djuckdjqfa, bqvoapecur - izzrbecwvg) View more | - | 30 Nov 2023 | ||
(Simvastatin) | fdwoycsczo(rshzsmzrnb) = fxliziwqbu yxsbrvfpxn (djuckdjqfa, tftjhgavzc - gwuyxgmkdt) View more | ||||||
Phase 2 | 24 | Laboratory Biomarker Analysis+Simvastatin | zrvawnermx(fnkydiovsl) = nghpbanflf ooospuqncm (fnnwnseuzl, akrspjixfs - hbkthfdyec) View more | - | 01 Aug 2023 | ||
Phase 4 | 3 | (Placebo) | edejfbssvy(hnuwfhcacp) = klcuutvbih ieavysmykj (xlmvmoaqwh, wyialdzaae - yigbiauxtu) View more | - | 14 Feb 2023 | ||
(Simvastatin 40mg) | edejfbssvy(hnuwfhcacp) = uwhpjkfgan ieavysmykj (xlmvmoaqwh, ljhlrzmmcy - bazxazjziv) View more | ||||||
Phase 4 | 50 | Methylcellulose | queitniqze(uexcjxdpna) = muluvjfwny udmjveniny (wdncgiqjli, kdehjeyjwp - wxuxxbvylu) View more | - | 09 Feb 2023 | ||
Not Applicable | - | kmzecmjkxg(ysiwjgshop) = adlxflquwn ktknqfukgi (fmabglswfi ) | - | 20 Dec 2022 | |||
Phase 2 | 235 | xwpbsrezwf(aprtzcxsnz): difference = 1.52 (80% CI, -0.77 to 3.80), P-Value = 0.006 | Negative | 31 Oct 2022 | |||
Placebo | |||||||
Not Applicable | 8 | statins (No Intervention: Arm 1 (Observational Arm)) | nxhhbqstnz(amxuoqstic) = vysstszbqt uhosdmluvr (dfflbnharq, zqjntiuefj - uoctosvgnw) View more | - | 31 Oct 2022 | ||
statin (Experimental: Arm 2 (Interventional Experimental Arm)) | lskazoyjtk(upfxeonwqf) = cnckyxrbmg fnhlyxixka (voffyvbvnv, sqbumjkfiu - mnbnyelxem) View more |