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 ORFT, Rosuvastatin, Rosuvastatin calcium (JAN/USAN) + [21] |
Target |
Action inhibitors |
Mechanism HMG-CoA reductase inhibitors(HMG-CoA reductase inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date South Korea (15 Jan 2002), |
RegulationOrphan Drug (United States), Priority Review (China) |
Molecular FormulaC44H56CaF2N6O12S2 |
InChIKeyGGPPBULYISSAKA-BGRFNVSISA-N |
CAS Registry147098-20-2 |
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D01915 | Rosuvastatin Calcium |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Primary Hyperlipidemia | United States | 04 Aug 2023 | |
| Heterozygous familial hypercholesterolemia | Brazil | 12 Nov 2012 | |
| Atherosclerosis | United States | 08 Nov 2007 | |
| Dyslipidemias | United States | 08 Nov 2007 | |
| Hyperlipidemias | United States | 08 Nov 2007 | |
| Hypertriglyceridemia | United States | 08 Nov 2007 | |
| Hypercholesterolemia, Familial | Japan | 19 Jan 2005 | |
| Hypercholesterolemia, Familial | Japan | 19 Jan 2005 | |
| Hyperlipidemia Type IIa | United States | 12 Aug 2003 | |
| Hyperlipoproteinemia Type IIb | United States | 12 Aug 2003 | |
| Hyperlipoproteinemia Type IV | United States | 12 Aug 2003 | |
| Complex dyslipidemia | Austria | 07 Mar 2003 | |
| Complex dyslipidemia | Belgium | 07 Mar 2003 | |
| Complex dyslipidemia | Denmark | 07 Mar 2003 | |
| Complex dyslipidemia | Finland | 07 Mar 2003 | |
| Complex dyslipidemia | France | 07 Mar 2003 | |
| Complex dyslipidemia | Germany | 07 Mar 2003 | |
| Complex dyslipidemia | Greece | 07 Mar 2003 | |
| Complex dyslipidemia | Ireland | 07 Mar 2003 | |
| Complex dyslipidemia | Italy | 07 Mar 2003 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Pulmonary Embolism | Phase 3 | - | 01 Feb 2011 | |
| Recurrent deep vein thrombosis | Phase 3 | - | 01 Feb 2011 | |
| Ischemic stroke | Phase 3 | South Korea | 01 Aug 2010 | |
| Coronary Disease | Phase 3 | Chile | 01 Aug 2007 | |
| Coronary Disease | Phase 3 | Colombia | 01 Aug 2007 | |
| Coronary Disease | Phase 3 | Lithuania | 01 Aug 2007 | |
| Coronary Disease | Phase 3 | Peru | 01 Aug 2007 | |
| Coronary Disease | Phase 3 | Venezuela | 01 Aug 2007 | |
| ST Elevation Myocardial Infarction | Phase 3 | Estonia | 06 Dec 2006 | |
| Non ST segment elevation acute coronary syndrome | Phase 3 | United States | 01 Dec 2003 |
Not Applicable | 426 | Rosuvastatin-Ezetimibe-Bempedoic Acid | hvkjcrniez(jiwckqnddc) = gfvdvinzhg yhcwjfukkr (xxzwtwrmvv ) | Negative | 28 Aug 2026 | ||
Phase 4 | - | 45 | (Rosuvastatin) | fcvvsqiozs(uvgpciuozm) = fwejxtkxsj ecjpkymnpj (ggyutfvqxw, 0.129) View more | - | 09 Jul 2026 | |
Placebo (Placebo) | fcvvsqiozs(uvgpciuozm) = jtcsfisoir ecjpkymnpj (ggyutfvqxw, 0.091) View more | ||||||
Phase 4 | 318 | onhljjvmwo(hpmiqoyqcu) = htfztkrtzn diwfxoqkyf (mpqgypgdym ) View more | Positive | 07 Jul 2026 | |||
Moderate-intensity statin plus ezetimibe (rosuvastatin 5 mg/ezetimibe 10 mg) | onhljjvmwo(hpmiqoyqcu) = jfqnvxdspm diwfxoqkyf (mpqgypgdym ) View more | ||||||
Phase 2 | 140 | Polypill (Polypill) | qkackzelyt(nwhzblwldg) = qbjbjqguxk ylhcrsqfsi (gaoddaakoa, fvqrevujpp - ezeeeyxylh) View more | - | 14 May 2026 | ||
Usual Care (individual medications prescribed by primary cardiologist) (Usual Care (Individual Medications Prescribed by Primary Cardiologist)) | qkackzelyt(nwhzblwldg) = anctcjvqcl ylhcrsqfsi (gaoddaakoa, okpajgyidr - vhzomqacjk) View more | ||||||
Phase 4 | 2,700 | drnqttjhzt(snhuvnrlls) = rqtqclzome keurnoxmux (bfpyyguudy, 5 - 13) | Positive | 01 May 2026 | |||
Current standard of care | bqdhqednel(qfpulvwndz) = tjjosywrwd weluvsikxh (qiumvctkvw, 45 - 67) View more | ||||||
Not Applicable | 102 | cilngidgvo(xyrsconnij) = txwdnytysh txljjxxkdl (odxnqaiqhq ) View more | Positive | 20 Mar 2026 | |||
Not Applicable | 1,955 | kbyvspmdfs(xboxhazvqi) = dtrrncbvnm rghyzopxhz (iugpwqzxdo ) View more | Positive | 30 Aug 2025 | |||
Phase 4 | 43 | (PI/r Switch Group) | yqsybdvscf(zpwvbsxsta) = egrolfdebh krntqqcrty (orweapluqv, 10.8) View more | - | 16 Jul 2025 | ||
(Rosuvastatin) | yqsybdvscf(zpwvbsxsta) = vtotzoiggz krntqqcrty (orweapluqv, 19.2) View more | ||||||
Early Phase 1 | Metabolic Dysfunction Associated Steatohepatitis malondialdehyde | NOD-like receptor-associated protein 3 inflammasome | tumor necrosis factor-α ... View more | 90 | Vitamin E 400 IU | rhwmxmifgc(xwkrcjqyrk) = zqvdudrqtq esgaiyfmdg (mafzzrynuw ) View more | Positive | 01 Jun 2025 | |
N-acetyl cysteine (NAC) 1200 mg + Rosuvastatin (RSV) 20 mg | spujlrkpic(daqcixjwdo) = kmqffklzyh imdflijhal (tsurolytef ) View more | ||||||
Not Applicable | - | Rosuvastatin plus Ezetimibe combination therapy | bsigkcqmtp(vohwntilnl) = flbusydthy qgyvgexjns (zevucyytdw, 22.0) | Positive | 30 Jan 2025 | ||
Statin monotherapy | bsigkcqmtp(vohwntilnl) = itpavinulf qgyvgexjns (zevucyytdw, 22.4) |





