rosuvastatin
Trade name: crestor
Small moleculeapproved
Approved
Aug 12, 2003
CRESTOR (rosuvastatin calcium) is an inhibitor of HMG-CoA reductase. It has been widely launched for the treatment of patients with dyslipidaemia and has also been approved in the US and EU to slow the progression of atherosclerosis. — NCATS
Clinical trial activity
717 trials · 408 clinical orgs · 37 marketing orgs
Phase 1
278
Phase 2
213
Phase 3
174
Phase 4
174
Earliest trial started Aug 1, 1999 (NCT00654303)
Timeline
1990s
- Jan 1, 1999
AstraZeneca — Earliest Phase 3 Sponsor(trial)
2000s
- Jan 1, 2003
Earliest Phase 1 Sponsor(trial)
- Aug 12, 2003
Earliest FDA Approval
- Aug 12, 2003
Amneal Pharmaceuticals — NDA Secondary Org
- Aug 12, 2003
AstraZeneca — Marketing Organization
- Jan 1, 2004
Earliest Phase 2 Sponsor(trial)
2010s
- Feb 12, 2016
Watson Pharmaceuticals — NDA Secondary Org
- Feb 12, 2016
Allergan PLC (2015) — NDA Secondary Org
- Apr 29, 2016
Allergan PLC (2015) — Marketing Organization
- Jul 19, 2016
Strides Pharma Science — Marketing Organization
- Jul 19, 2016
Sun Pharmaceuticals — NDA Secondary Org
- Jul 19, 2016
Sun Pharmaceuticals — Marketing Organization
- Jul 19, 2016
Chartwell Pharmaceuticals — Marketing Organization
- Jul 19, 2016
Allied Pharmaceutical Services — Marketing Organization
- Jul 19, 2016
Apotex — Marketing Organization
- Jul 19, 2016
Aurobindo Pharma — Marketing Organization
- Jul 19, 2016
Glenmark Pharmaceuticals — Marketing Organization
- Jul 19, 2016
Mylan — Marketing Organization
- Jul 19, 2016
Sandoz — Marketing Organization
- Jul 19, 2016
Teva — Marketing Organization
- Jul 19, 2016
Novartis — Marketing Organization
- Oct 31, 2016
Renata — Marketing Organization
- Oct 31, 2016
Accord Research — Marketing Organization
- Oct 31, 2016
Biocon Limited — Marketing Organization
- Oct 31, 2016
Changzhou Jinyuan Pharmaceutical Manufacturing Co., Ltd. — Marketing Organization
- Oct 31, 2016
Hetero Labs Ltd — Marketing Organization
- Oct 31, 2016
Jubilant Innovation Ltd. — Marketing Organization
- Oct 31, 2016
Torrent Pharmaceuticals Limited — Marketing Organization
- Nov 23, 2016
Cadila Healthcare — Marketing Organization
- Mar 21, 2017
Alkem Labs Ltd — Marketing Organization
- Jul 31, 2017
Lupin — Marketing Organization
- Nov 22, 2017
MSN Laboratories — Marketing Organization
- Oct 16, 2018
Amneal Pharmaceuticals — Marketing Organization
- Mar 1, 2019
Jingxin — Marketing Organization
- Mar 1, 2019
Zydus Discovery DMCC — Marketing Organization
- Apr 9, 2019
Umedica Labs Pvt Ltd — Marketing Organization
- Apr 24, 2019
Sciegen Pharmaceticals — Marketing Organization
- May 7, 2019
Shandong Lanjin Pharmaceuticals Co.,Ltd — Marketing Organization
- Nov 4, 2019
Zhejiang Yongtai — Marketing Organization
2020s
- Apr 1, 2020
Sunshine Lake Pharma Co., Ltd. — Marketing Organization
- Aug 12, 2020
Inventia Hlthcare — Marketing Organization
- Mar 23, 2021
Althera Pharms — NDA Secondary Org
- Nov 6, 2024
Macleods Pharmaceuticals, Ltd — Marketing Organization
- May 16, 2025
Mankind Pharma — Marketing Organization
Indications
Approved for
Studied for
- 22q11 Deletion Syndrome · Phase 4
- Acute Coronary Syndrome · Phase 4
- Acute Lung Injury · Phase 3
- Aged · Phase 1
- Anemia · Phase 1
- Anemia, Sickle Cell · Phase 1
- Angina Pectoris · Phase 4
- Angioedemas, Hereditary · Phase 1
- Angioplasty · Phase 4
- Angioplasty, Balloon, Coronary · Phase 1
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis · Phase 3
- Aortic Valve Stenosis · Phase 3
- Arteriovenous Fistula · Phase 2
- Arthritis, Psoriatic · Phase 4
- Arthritis, Rheumatoid · Phase 2/Phase 3
- Asthma · Phase 1
- Atherosclerosis · Phase 4
- Atrial Fibrillation · Phase 4
- Autoimmune Diseases · Phase 1
- Blood Platelet Disorders · Phase 2
- Blood Platelets · Phase 1
- Blood Pressure · Phase 2/Phase 3
- Breast Neoplasms · Phase 4
- Burns · Phase 2
- Carcinoma, Non-Small-Cell Lung · Phase 1
- Carcinoma, Squamous Cell · Phase 1
- Cardiomyopathy, Dilated · Phase 3
- Cardiovascular Diseases · Phase 4
- Carotid Artery Diseases · Phase 4
- Carotid Stenosis · Phase 4
- Cerebral Hemorrhage · Phase 2
- Cerebral Infarction · Phase 4
- Cholangitis, Sclerosing · Early Phase 1
- Chronic Periodontitis · Phase 4
- Clonal Hematopoiesis · Phase 2
- Cognitive Dysfunction · Phase 3
- Colitis, Ulcerative · Phase 2/Phase 3
- Colorectal Neoplasms · Phase 3
- Coronary Artery Disease · Phase 4
- Coronary Disease · Phase 4
- COVID-19 · Phase 1
- Craniocerebral Trauma · Phase 2
- C-Reactive Protein · Phase 3
- Critical Illness · Phase 2
- Crohn Disease · Early Phase 1
- Cytochrome P-450 CYP2C19 · Phase 1
- Dehydration · Phase 4
- Depression · Phase 2
- Depressive Disorder · Phase 3
- Diabetes Mellitus · Phase 4
- Diabetes Mellitus, Type 2 · Phase 4
- Diabetic Neuropathies · Phase 2
- Diagnostic Self Evaluation · Phase 1
- Drug Interactions · Phase 4
- Drug-Related Side Effects and Adverse Reactions · Phase 4
- Drugs, Investigational · Phase 4
- Dual Anti-Platelet Therapy · Phase 2
- Dyslipidemias · Phase 4
- Endocrine System Diseases · Phase 4
- Endometrial Hyperplasia · Phase 2/Phase 3
- Endometrial Neoplasms · Phase 2
- Endomyocardial Fibrosis · Phase 4
- Endothelial Cells · Phase 4
- Endotoxemia · Phase 1
- Erb-b2 Receptor Tyrosine Kinases · Phase 1
- Esophageal and Gastric Varices · Phase 2/Phase 3
- Essential Hypertension · Phase 3
- Fibrosis · Phase 2/Phase 3
- Friedreich Ataxia · Early Phase 1
- Furcation Defects · Phase 4
- General Surgery · Phase 3
- Glaucoma · Phase 4
- Glomerular Filtration Rate · Phase 2/Phase 3
- Health · Phase 1
- Healthy Volunteers · Phase 4
- Heart · Phase 4
- Heart Disease Risk Factors · Phase 4
- Heart Diseases · Phase 4
- Heart Failure · Phase 4
- Heart Failure, Diastolic · Phase 4
- Heart Failure, Systolic · Phase 4
- Hepacivirus · Phase 1
- Hepatitis B · Phase 2
- Hepatitis B, Chronic · Phase 1
- Hepatitis C · Phase 2
- Hepatitis C, Chronic · Phase 2
- Hip Fractures · Phase 3
- HIV · Phase 4
- HIV Infections · Phase 4
- HIV Seropositivity · Early Phase 1
- Homozygous Familial Hypercholesterolemia · Phase 3
- Hydroxymethylglutaryl-CoA Reductase Inhibitors · Phase 4
- Hypercholesterolemia · Phase 4
- Hyperglycemia · Phase 4
- Hyperlipidemias · Phase 4
- Hyperlipoproteinemia Type II · Phase 4
- Hyperlipoproteinemia Type III · Phase 3
- Hyperlipoproteinemia Type IV · Phase 4
- Hyperlipoproteinemia Type V · Phase 4
- Hypertension · Phase 4
- Hypertension, Portal · Phase 2/Phase 3
- Hypertriglyceridemia · Phase 4
- Immunosuppression Therapy · Phase 1
- Infarction, Anterior Cerebral Artery · Phase 4
- Inflammation · Phase 1
- Inflammatory Bowel Diseases · Early Phase 1
- Influenza A Virus, H1N1 Subtype · Phase 2
- Insulin Resistance · Phase 4
- Intestinal Absorption · Phase 1
- Intracranial Arterial Diseases · Phase 4
- Intracranial Arteriosclerosis · Phase 4
- Ischemia · Phase 4
- Ischemic Attack, Transient · Phase 4
- Ischemic Stroke · Phase 4
- Kidney Diseases · Phase 4
- Kidney Failure, Chronic · Phase 2
- Kidney Transplantation · Phase 4
- Leukemia, Myeloid, Acute · Phase 1
- Lipids · Phase 2/Phase 3
- Lipoproteins · Phase 4
- Liver Cirrhosis · Phase 2
- Liver Cirrhosis, Alcoholic · Phase 2
- Liver Cirrhosis, Biliary · Phase 2
- Lupus Erythematosus, Systemic · Phase 4
- Major Depressive Disorder · Phase 3
- Malaria · Phase 1
- Melanoma · Phase 1
- Metabolic Diseases · Phase 1
- Metabolic Syndrome · Phase 4
- Metabolism · Phase 4
- Molecular Imaging · Phase 4
- Mutation · Phase 1
- Myelodysplastic Syndromes · Phase 2
- Myocardial Infarction · Phase 4
- Myocardial Ischemia · Phase 3
- Myocardial Stunning · Phase 4
- Myocardium · Phase 3
- Neoplasms · Phase 2
- Non-alcoholic Fatty Liver Disease · Phase 4
- Nutritional and Metabolic Diseases · Phase 4
- Obesity · Phase 1
- Obesity, Abdominal · Phase 3
- Osteoporosis · Phase 2
- Ovarian Neoplasms · Phase 2
- Overweight · Phase 1
- Oxidative Stress · Phase 2
- Parkinson Disease · Phase 1
- Percutaneous Coronary Intervention · Phase 4
- Periodontitis · Phase 4
- Peripheral Arterial Disease · Phase 4
- Pharmacokinetics · Phase 4
- Postthrombotic Syndrome · Phase 3
- Precancerous Conditions · Phase 3
- Pre-Eclampsia · Phase 2
- Primary Prevention · Phase 4
- Prostatic Neoplasms · Phase 1
- Prostatic Neoplasms, Castration-Resistant · Phase 1
- Proteinuria · Phase 4
- Psoriasis · Phase 4
- Pulmonary Disease, Chronic Obstructive · Phase 2
- Pulmonary Embolism · Phase 3
- Rectal Neoplasms · Phase 2
- Renal Artery Obstruction · Phase 2/Phase 3
- Renal Insufficiency · Phase 3
- Renal Insufficiency, Chronic · Phase 4
- Reperfusion Injury · Phase 4
- Respiratory Syncytial Virus Infections · Phase 1
- Rosuvastatin Calcium · Phase 4
- SARS-CoV-2 · Phase 3
- Scleroderma, Systemic · Phase 3
- Sedentary Behavior · Phase 4
- Sepsis · Phase 3
- Sexual Dysfunction, Physiological · Phase 4
- Skin Diseases, Bacterial · Phase 1
- Spinal Cord Injuries · Phase 2
- Sports Medicine · Phase 4
- ST Elevation Myocardial Infarction · Phase 4
- Stents · Phase 2/Phase 3
- Stroke · Phase 4
- Telomere · Phase 4
- Telomere Shortening · Phase 4
- Therapeutic Equivalency · Phase 1
- Thromboembolism · Phase 4
- Thrombosis · Phase 4
- Tomography · Phase 3
- Toxicity Tests · Phase 3
- Tuberculosis, Pulmonary · Phase 2
- Upper Extremity Deep Vein Thrombosis · Phase 1/Phase 2
- Vasomotor System · Phase 1
- Venous Cutdown · Phase 4
- Venous Thromboembolism · Phase 4
- Venous Thrombosis · Phase 4
- Ventricular Dysfunction, Left · Phase 1
- Volunteers · Phase 1
- Weight Gain · Phase 3
- Wounds and Injuries · Phase 2
Mechanism of action
- HMG-CoA reductaseINHIBITOR
HMGCR inhibitor
Combination products
roszet
with ezetimibe
Also known as ezerosu
Approval history
- approvedAug 12, 2003
Chemistry & pharmacology
Loading structure…
SMILES
CC(C)c1nc(N(C)S(C)(=O)=O)nc(-c2ccc(F)cc2)c1/C=C/[C@@H](O)C[C@@H](O)CC(=O)O- Mol. weight
- 481.55 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL1496 ↗
- WikipediaRosuvastatin ↗
- NCATS413KH5ZJ73 ↗
- ChEMBLCHEMBL1744447 ↗
Also known as
- (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-(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
- (3r,5s,6e)-7-{4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl}-3,5-dihydroxyhept-6-enoic acid
- 7-(4-(4-fluorophenyl)-6-isopropyl-2-(n-methyl-n-methanesulfonylaminopyrimidin)-5-yl)-3,5-dihydroxy-6-heptenoic acid
- abt-143
- crestor
- crestor
- crestor
- crestor
- crestor
- dp-r207
- dwj1276
- hcp1306
- rosuvastatin
- rosuvastatin
- rosuvastatin
- rosuvastatin
- rosuvastatin
- rosuvastatin
- rosuvastatin
- rosuvastatin
- rosuvastatin calcium
- rosuvastatin calcium
- rosuvastatin calcium
- rosuvastatin calcium
- rosuvastatin calcium
- rosuvastatin zinc
- rosuvastatin zinc
- s 4522
- s-4522
- s-4522
- s-4522
- yh16410
- yhr1703
- yhr1704
- zd4522
- zd-4522
- zd-4522
- zd-4522 (calcium salt)
- zd-4522 (calcium salt)
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07232069 | Phase 3 | Apr 1, 2026 | Duke University, Harvard University, Johns Hopkins University, National Heart, Lung, and Blood Institute (NHLBI), University of North Carolina at Chapel Hill |
| NCT07303816 | Phase 4 | Apr 1, 2026 | Harvard University, National Heart, Lung, and Blood Institute (NHLBI) |
| NCT07255820 | Phase 4 | Jan 1, 2026 | Bahria University |
| NCT07309042 | Phase 1 | Dec 31, 2025 | Beijing Inno Medicine Co., Ltd. |
| NCT07269756 | Phase 1 | Dec 31, 2025 | Suzhou Suncadia Biopharmaceuticals Co., Ltd. |
| NCT07300280 | Phase 1 | Dec 29, 2025 | Merck |
| NCT07297693 | Phase 1 | Dec 19, 2025 | Hanmi Pharmaceutical |
| NCT07267221 | Phase 1 | Dec 1, 2025 | Daewoong Pharmaceutical Co. LTD. |
| NCT07254221 | Phase 4 | Nov 22, 2025 | Shiraz University |
| NCT07222098 | Phase 1 | Nov 18, 2025 | Merck |
| NCT07128888 | Phase 1 | Nov 17, 2025 | Gan and Lee Pharmaceuticals, USA |
| NCT07223671 | Phase 1 | Nov 12, 2025 | Bristol-Myers Squibb |
| NCT07216482 | Phase 3 | Nov 11, 2025 | Merck |
| NCT07239414 | Phase 3 | Nov 10, 2025 | Sheikh Zayed Medical College |
| NCT07215260 | Phase 1 | Nov 5, 2025 | Boehringer Ingelheim |
| NCT07260851 | Phase 1 | Nov 5, 2025 | Daewoong Pharmaceutical Co. LTD. |
| NCT07158398 | Phase 1 | Oct 31, 2025 | Deciphera Pharmaceuticals LLC |
| NCT07218900 | Phase 2 | Oct 24, 2025 | AstraZeneca |
| NCT07235748 | Phase 1 | Oct 7, 2025 | Servier |
| NCT07201545 | Phase 1 | Oct 7, 2025 | Daiichi Sankyo |
Showing 20 of 717 trials
Page 1 / 36
Organizations
Research & Development (408)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| AstraZeneca | For profit | 109 | 84 | 4 | 1999 |
| Yonsei University | Academic/Hospital | 26 | 18 | 4 | 2007 |
| Yuhan Pharmaceutical Company | For profit | 25 | 24 | 3 | 2011 |
| Seoul National University | Academic/Hospital | 20 | 8 | 3 | 2010 |
| Merck | For profit | 19 | 17 | 4 | 2003 |
| Daewoong Pharmaceutical Co. LTD. | For profit | 17 | 15 | 3 | 2011 |
| Hanmi Pharmaceutical | For profit | 17 | 16 | 3 | 2013 |
| Sanofi | For profit | 15 | 12 | 2 | 2012 |
| Sungkyunkwan University | Academic/Hospital | 15 | 4 | 3 | 2011 |
| Capital Medical University | Academic/Hospital | 14 | 8 | 3 | 2010 |
| Regeneron | For profit | 14 | 3 | 2 | 2012 |
| Boehringer Ingelheim | For profit | 13 | 12 | 2 | 2007 |
| Eli Lilly | For profit | 12 | 10 | 3 | 2010 |
| Bristol-Myers Squibb | For profit | 11 | 10 | 1 | 2014 |
| Pfizer | For profit | 11 | 10 | 1 | 2019 |
| GlaxoSmithKline | For profit | 10 | 10 | 1 | 2009 |
| Government Dental College and Research Institute, Bangalore | Academic/Hospital | 10 | 10 | 2 | 2013 |
| Jeil Pharmaceutical Co., Ltd. | For profit | 9 | 9 | 2 | 2014 |
| Korea University | Academic/Hospital | 9 | 3 | 3 | 2014 |
| Peking University | Academic/Hospital | 9 | 5 | 4 | 2011 |
408 organizations
Page 1 / 21
Marketing (51)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Accord Research | For profit | MKTG | Oct 31, 2016 |
| Alkem Labs Ltd | For profit | MKTG | Mar 21, 2017 |
| Allergan PLC (2015) | For profit | NDA2 | Feb 12, 2016 |
| Allergan PLC (2015) | For profit | MKTG | Apr 29, 2016 |
| Allied Pharmaceutical Services | For profit | MKTG | Jul 19, 2016 |
| Althera Pharms | For profit | NDA2 | Mar 23, 2021 |
| Amneal Pharmaceuticals | For profit | NDA2 | Aug 12, 2003 |
| Amneal Pharmaceuticals | For profit | MKTG | Oct 16, 2018 |
| Apotex | For profit | SYN | Jul 19, 2016 |
| Apotex | For profit | MKTG | Jul 19, 2016 |
| AstraZeneca | For profit | NDA | — |
| AstraZeneca | For profit | MKTG | Aug 12, 2003 |
| Aurobindo Pharma | For profit | MKTG | Jul 19, 2016 |
| Biocon Limited | For profit | MKTG | Oct 31, 2016 |
| Biocon Limited | For profit | SYN | Oct 31, 2016 |
| Cadila Healthcare | For profit | MKTG | Nov 23, 2016 |
| Changzhou Jinyuan Pharmaceutical Manufacturing Co., Ltd. | For profit | MKTG | Oct 31, 2016 |
| Chartwell Pharmaceuticals | For profit | MKTG | Jul 19, 2016 |
| Glenmark Pharmaceuticals | For profit | MKTG | Jul 19, 2016 |
| Glenmark Pharmaceuticals | For profit | SYN | Jul 19, 2016 |
| Hetero Labs Ltd | For profit | MKTG | Oct 31, 2016 |
| Inventia Hlthcare | For profit | SYN | Feb 5, 2021 |
| Inventia Hlthcare | For profit | MKTG | Aug 12, 2020 |
| Jingxin | For profit | MKTG | Mar 1, 2019 |
| Jubilant Innovation Ltd. | For profit | MKTG | Oct 31, 2016 |
| Lupin | For profit | MKTG | Jul 31, 2017 |
| Lupin | For profit | SYN | Jul 31, 2017 |
| MSN Laboratories | For profit | SYN | Nov 22, 2017 |
| MSN Laboratories | For profit | MKTG | Nov 22, 2017 |
| Macleods Pharmaceuticals, Ltd | For profit | MKTG | Nov 6, 2024 |
| Mankind Pharma | For profit | MKTG | May 16, 2025 |
| Mylan | For profit | MKTG | Jul 19, 2016 |
| Mylan | For profit | SYN | Jul 19, 2016 |
| Novartis | For profit | MKTG | Jul 19, 2016 |
| Renata | For profit | MKTG | Oct 31, 2016 |
| Sandoz | For profit | SYN | Jul 19, 2016 |
| Sandoz | For profit | MKTG | Jul 19, 2016 |
| Sciegen Pharmaceticals | For profit | MKTG | Apr 24, 2019 |
| Shandong Lanjin Pharmaceuticals Co.,Ltd | For profit | MKTG | May 7, 2019 |
| Strides Pharma Science | For profit | MKTG | Jul 19, 2016 |
| Sun Pharmaceuticals | For profit | NDA2 | Jul 19, 2016 |
| Sun Pharmaceuticals | For profit | MKTG | Jul 19, 2016 |
| Sunshine Lake Pharma Co., Ltd. | For profit | MKTG | Apr 1, 2020 |
| Sunshine Lake Pharma Co., Ltd. | For profit | SYN | Apr 1, 2020 |
| Teva | For profit | MKTG | Jul 19, 2016 |
| Torrent Pharmaceuticals Limited | For profit | MKTG | Oct 31, 2016 |
| Umedica Labs Pvt Ltd | For profit | MKTG | Apr 9, 2019 |
| Umedica Labs Pvt Ltd | For profit | SYN | Apr 9, 2019 |
| Watson Pharmaceuticals | For profit | NDA2 | Feb 12, 2016 |
| Zhejiang Yongtai | For profit | MKTG | Nov 4, 2019 |
| Zydus Discovery DMCC | For profit | MKTG | Mar 1, 2019 |