pravastatin
Trade name: pravachol
Approved
Oct 31, 1991
Pravastatin (marketed as Pravachol or Selektine) is a member of the drug class of statins, used in combination with diet, exercise, and weight loss for lowering cholesterol and preventing cardiovascular disease. Pravastatin acts as a lipoprotein-lowering drug through two pathways. In the major pathway, pravastatin inhibits the function of hydroxymethylglutaryl-CoA (HMG-CoA) reductase. As a reversible competitive inhibitor, pravastatin sterically hinders the action of HMG-CoA reductase by occupying the active site of the enzyme. Taking place primarily in the liver, this enzyme is responsible for the conversion of HMG-CoA to mevalonate in the rate-limiting step of the biosynthetic pathway for cholesterol. Pravastatin also inhibits the synthesis of very-low-density lipoproteins, which are the precursor to low-density lipoproteins (LDL). These reductions increase the number of cellular LDL receptors, thus LDL uptake increases, removing it from the bloodstream. Pravastatin is primarily used for the treatment of dyslipidemia and the prevention of cardiovascular disease. It is recommended to be used only after other measures, such as diet, exercise, and weight reduction, have not improved cholesterol levels. The evidence for the use of pravastatin is generally weaker than for other statins. The antihypertensive and lipid-lowering treatment to prevent heart attack trial (ALLHAT), failed to demonstrate a difference in all-cause mortality or nonfatal myocardial infarction/fatal coronary heart disease rates between patients receiving pravastatin 40 mg daily (a common starting dose) and those receiving usual care. Pravastatin is generally well tolerated; adverse reactions have usually been mild and transient. In 4-month-long placebo-controlled trials, 1.7% of Pravastatin-treated patients and 1.2% of placebo-treated patients were discontinued from treatment because of adverse experiences attributed to study drug therapy; this difference was not statistically significant. — NCATS
Clinical trial activity
157 trials · 166 clinical orgs · 24 marketing orgs
Earliest trial started Dec 1, 1986 (NCT00000461)
Timeline
1980s
- Jan 1, 1986
Earliest Phase 2 Sponsor(trial)
1990s
- Oct 31, 1991
Bristol-Myers Squibb — Earliest FDA Approval
- Oct 31, 1991
Bristol-Myers Squibb — NDA Organization
- Jan 1, 1992
Earliest Phase 3 Sponsor(trial)
- Jan 1, 1998
Earliest Phase 1 Sponsor(trial)
2000s
- Sep 30, 2003
Ranbaxy — Marketing Organization
- Apr 24, 2006
Teva — Marketing Organization
- Oct 23, 2006
Apotex — Marketing Organization
- Oct 23, 2006
Apnar Pharma — Marketing Organization
- Oct 23, 2006
Cipla — Marketing Organization
- Oct 23, 2006
Dr. Reddy's Laboratories — Marketing Organization
- Oct 23, 2006
Mylan — Marketing Organization
- Oct 23, 2006
Sandoz — Marketing Organization
- Oct 23, 2006
Watson Pharmaceuticals — Marketing Organization
- Oct 23, 2006
Novartis — Marketing Organization
- Oct 23, 2006
PHARMOBEDIENT — Marketing Organization
- Nov 21, 2006
Pliva — Marketing Organization
- Nov 21, 2006
Barr Laboratories — Marketing Organization
- May 11, 2007
Glenmark Pharmaceuticals — Marketing Organization
- Jan 8, 2008
Lupin — Marketing Organization
- Feb 11, 2008
Senores Pharms — Marketing Organization
- Apr 30, 2008
Zydus Discovery DMCC — Marketing Organization
2010s
- Nov 17, 2016
Accord Research — Marketing Organization
- Feb 2, 2017
Aurobindo Pharma — Marketing Organization
- Apr 13, 2018
Chartwell Pharmaceuticals — Marketing Organization
- Apr 13, 2018
Appco Pharma — Marketing Organization
- Apr 13, 2018
Biocon Limited — Marketing Organization
- Nov 23, 2018
Zhejiang Hisun Pharmaceutical Co. Ltd. — Marketing Organization
Indications
Approved for
Studied for
- Acute Coronary Syndrome · Phase 4
- Acute Kidney Injury · Phase 1
- Aging · Phase 4
- Albinism, Oculocutaneous · Phase 1/Phase 2
- Albuminuria · Phase 3
- Alzheimer Disease · Phase 4
- Angina Pectoris · Phase 4
- Arterial Occlusive Diseases · Phase 3
- Arthritis, Rheumatoid · Phase 1
- Atherosclerosis · Phase 4
- Breast Neoplasms · Phase 2
- Carcinoma, Hepatocellular · Phase 3
- Cardiovascular Diseases · Phase 4
- Coronary Artery Disease · Phase 4
- Coronary Disease · Phase 4
- Diabetes Mellitus · Phase 4
- Diabetes Mellitus, Type 2 · Phase 4
- Drug Interactions · Phase 1
- Dyslipidemias · Phase 4
- Endothelial Cells · Phase 1
- Esophageal Neoplasms · Phase 4
- Fetal Growth Retardation · Phase 2
- Fibrosis · Phase 2
- Fontan Procedure · Phase 1
- Healthy Volunteers · Phase 1
- Heart Diseases · Phase 3
- Heart Failure · Phase 4
- Hematopoietic Stem Cell Transplantation · Phase 1
- Hermanski-Pudlak Syndrome · Phase 1/Phase 2
- HIV · Phase 4
- HIV Infections · Phase 4
- HIV Seronegativity · Phase 1
- Hyperglycemia · Phase 4
- Hyperlipidemias · Phase 4
- Hyperlipoproteinemias · Phase 3
- Hyperlipoproteinemia Type III · Phase 3
- Hypertension · Phase 4
- Hypertension, Pregnancy-Induced · Phase 3
- Ischemic Attack, Transient · Phase 4
- Ischemic Stroke · Phase 4
- Kidney Diseases · Phase 3
- Kidney Failure, Chronic · Phase 3
- Leukemia · Phase 2
- Leukemia, Monocytic, Acute · Phase 1/Phase 2
- Leukemia, Myeloid, Acute · Phase 1/Phase 2
- Leukemia, Myelomonocytic, Acute · Phase 1/Phase 2
- Lipid Metabolism · Phase 4
- Lipodystrophy · Phase 4
- Liver Cirrhosis · Phase 2
- Liver Neoplasms · Phase 3
- Lung Neoplasms · Phase 3
- Lupus Erythematosus, Systemic · Phase 2
- Lymphedema · Phase 2
- Lymphoma · Phase 2
- Metabolic Diseases · Phase 4
- Metabolic Syndrome · Phase 2
- Metabolism · Phase 4
- Mucocutaneous Lymph Node Syndrome · Phase 2
- Multiple Sclerosis, Relapsing-Remitting · Phase 3
- Musculoskeletal Diseases · Phase 2
- Myocardial Infarction · Phase 4
- Myocardial Ischemia · Phase 4
- Nephrotic Syndrome · Phase 1
- Obstetric Labor Complications · Phase 3
- Osteoporosis, Postmenopausal · Phase 4
- Pediatrics · Phase 2
- Peripheral Arterial Disease · Phase 4
- Pharmacokinetics · Phase 4
- Pharmacology · Phase 4
- Placental Insufficiency · Phase 2
- Platelet Storage Pool Deficiency · Phase 1/Phase 2
- Pneumonia, Ventilator-Associated · Early Phase 1
- Polycystic Kidney, Autosomal Dominant · Phase 4
- Prediabetic State · Phase 4
- Pre-Eclampsia · Phase 3
- Progeria · Phase 2
- Psychotic Disorders · Phase 4
- Pulmonary Fibrosis · Phase 1/Phase 2
- Renal Insufficiency, Chronic · Phase 4
- Sarcoma · Phase 2
- Schizophrenia · Phase 4
- Sports Medicine · Phase 1
- Stomach Neoplasms · Phase 4
- Therapeutic Equivalency · Phase 1
- Tuberculosis · Phase 2
- Tuberculosis, Pulmonary · Phase 2
- Vascular Diseases · Phase 3
Mechanism of action
- HMG-CoA reductaseINHIBITOR
HMGCR inhibitor
Combination products
pravigard pac (copackaged)
with acetylsalicylic acid
Approval history
- approvedOct 31, 1991
Chemistry & pharmacology
SMILES
CC[C@H](C)C(=O)O[C@H]1C[C@H](O)C=C2C=C[C@H](C)[C@H](CC[C@@H](O)C[C@@H](O)CC(=O)O)[C@H]21- Mol. weight
- 424.53 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
- ChEMBLCHEMBL1144 ↗
- WikipediaPravastatin ↗
- NCATSKXO2KT9N0G ↗
- ChEMBLCHEMBL690 ↗
Also known as
- (+)-(3r,5r)-3,5-dihydroxy-7-[(1s,2s,6s,8s,8ar)-6-hydroxy-2-methyl-8-{[(s)-2-methylbutyryl]oxy}-1,2,6,7,8,8a-hexahydro-1-naphthyl]heptanoic acid
- (+)-(3r,5r)-3,5-dihydroxy-7-[(1s,2s,6s,8s,8ar)-6-hydroxy-2-methyl-8-{[(s)-2-methylbutyryl]oxy}-1,2,6,7,8,8a-hexahydro-1-naphthyl]heptanoic acid
- cs-514
- cs-514
- dehypotin
- elisor
- elisor
- eptastatin
- eptastatin sodium
- eptastatin sodium
- fenofibrate / pravastatin
- hgp0816
- lipemol
- lipemol
- liplat
- liplat
- lipostat
- lipostat
- mevalothin
- pravachol
- pravachol
- pravachol
- pravachol
- pravachol
- pravastatin
- pravastatin
- pravastatin
- pravastatin
- pravastatin
- pravastatin
- pravastatin
- pravastatin
- pravastatin
- pravastatin
- pravastatina
- pravastatina
- pravastatin acid
- pravastatin acid
- pravastatin acid
- pravastatine
- pravastatine
- pravastatin sodium
- pravastatin sodium
- pravastatin sodium
- pravastatin sodium
- pravastatinum
- pravastatinum
- sq-31000
- sq-31000
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07217938 | Phase 2 | Dec 1, 2025 | Peter MacCallum Cancer Centre |
| NCT07098975 | Phase 2 | Sep 30, 2025 | Universidad Autonoma de Barcelona, University of Barcelona |
| NCT06912763 | Phase 2 | Aug 8, 2025 | University of Texas at Houston |
| NCT06856772 | Phase 4 | Feb 28, 2025 | University of Copenhagen |
| NCT06785727 | Phase 4 | Feb 1, 2025 | University of Amsterdam |
| NCT06494111 | Phase 2 | Nov 29, 2024 | University of Texas at Houston |
| NCT06324396 | Phase 1 | Mar 1, 2024 | Indiana University, University of Kansas |
| NCT05852769 | Phase 1 | May 31, 2023 | Bristol-Myers Squibb |
| NCT05524246 | Phase 1 | Nov 30, 2022 | University of Cincinnati |
| NCT04719481 | Phase 4 | Nov 30, 2021 | Peking University |
| NCT04608344 | Phase 1 | Nov 4, 2020 | Galapagos NV, Gilead Sciences |
| NCT04356209 | Phase 2 | Jun 30, 2020 | University of Montpellier |
| NCT04425902 | Phase 1 | Jun 16, 2020 | ViiV Healthcare |
| NCT04190433 | Phase 2 | Jan 1, 2020 | Mayo Clinic |
| NCT04092751 | Phase 1 | Oct 22, 2019 | Clinical Network Services, Scynexis, Inc. |
| NCT03944512 | Phase 3 | Jun 30, 2019 | George Washington University, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), University of Texas, Galveston |
| NCT03882177 | Phase 2 | Jun 15, 2019 | Johns Hopkins University, National Institute of Allergy and Infectious Diseases (NIAID), University of the Witwatersrand |
| NCT03456102 | Phase 2 | Feb 1, 2019 | Johns Hopkins University |
| NCT04284657 | Phase 2 | Jan 30, 2019 | University of Southern California |
| NCT03510715 | Phase 3 | Sep 3, 2018 | Regeneron, Sanofi |
Organizations
Research & Development (166)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Yonsei University | Academic/Hospital | 8 | 7 | 3 | 2009 |
| National Heart, Lung, and Blood Institute (NHLBI) | Government | 7 | 3 | 3 | 1986 |
| Bristol-Myers Squibb | For profit | 6 | 4 | 3 | 2000 |
| Harvard University | Academic/Hospital | 6 | 5 | 3 | 1986 |
| Merck | For profit | 6 | 2 | 3 | 2005 |
| National Institute of Allergy and Infectious Diseases (NIAID) | Government | 6 | 5 | 3 | 1999 |
| Hanmi Pharmaceutical | For profit | 5 | 5 | 2 | 2014 |
| Regeneron | For profit | 5 | 0 | 1 | 2012 |
| Sanofi | For profit | 5 | 5 | 1 | 2012 |
| AstraZeneca | For profit | 4 | 4 | 3 | 2001 |
| National Cancer Institute (NCI) | Government | 4 | 0 | 2 | 2009 |
| Teva | For profit | 4 | 4 | 1 | 2000 |
| University of Washington | Academic/Hospital | 4 | 4 | 4 | 2002 |
| Daiichi Sankyo | For profit | 3 | 1 | 1 | 1994 |
| Kowa | For profit | 3 | 3 | 2 | 2005 |
| National Institutes of Health (NIH) | Government | 3 | 1 | 3 | 2002 |
| Pharma Medica | For profit | 3 | 0 | 1 | 2000 |
| University of Colorado, Denver | Academic/Hospital | 3 | 3 | 2 | 2006 |
| AAIPharma | For profit | 2 | 0 | 1 | 2002 |
| American Heart Association | Academic/Hospital | 2 | 0 | 2 | 2009 |
Marketing (30)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Accord Research | For profit | MKTG | Nov 17, 2016 |
| Apnar Pharma | For profit | MKTG | Oct 23, 2006 |
| Apotex | For profit | SYN | Oct 23, 2006 |
| Apotex | For profit | MKTG | Oct 23, 2006 |
| Appco Pharma | For profit | MKTG | Apr 13, 2018 |
| Aurobindo Pharma | For profit | MKTG | Feb 2, 2017 |
| Aurobindo Pharma | For profit | SYN | Feb 2, 2017 |
| Aurobindo Pharma | For profit | SYN | Apr 24, 2006 |
| Barr Laboratories | For profit | MKTG | Nov 21, 2006 |
| Biocon Limited | For profit | MKTG | Apr 13, 2018 |
| Bristol-Myers Squibb | For profit | NDA | Oct 31, 1991 |
| Chartwell Pharmaceuticals | For profit | MKTG | Apr 13, 2018 |
| Cipla | For profit | MKTG | Oct 23, 2006 |
| Dr. Reddy's Laboratories | For profit | MKTG | Oct 23, 2006 |
| Glenmark Pharmaceuticals | For profit | MKTG | May 11, 2007 |
| Glenmark Pharmaceuticals | For profit | SYN | May 11, 2007 |
| Lupin | For profit | MKTG | Jan 8, 2008 |
| Mylan | For profit | MKTG | Oct 23, 2006 |
| Mylan | For profit | SYN | May 27, 2010 |
| Novartis | For profit | MKTG | Oct 23, 2006 |
| PHARMOBEDIENT | For profit | MKTG | Oct 23, 2006 |
| Pliva | For profit | MKTG | Nov 21, 2006 |
| Ranbaxy | For profit | MKTG | Sep 30, 2003 |
| Sandoz | For profit | MKTG | Oct 23, 2006 |
| Senores Pharms | For profit | MKTG | Feb 11, 2008 |
| Teva | For profit | MKTG | Apr 24, 2006 |
| Teva | For profit | SYN | Jan 15, 2008 |
| Watson Pharmaceuticals | For profit | MKTG | Oct 23, 2006 |
| Zhejiang Hisun Pharmaceutical Co. Ltd. | For profit | MKTG | Nov 23, 2018 |
| Zydus Discovery DMCC | For profit | MKTG | Apr 30, 2008 |