Overview
Pravastatin is the 6-alpha-hydroxy acid form of mevastatin. Pravastatin was firstly approved in 1991 becoming the second available statin in the United States. It was the first statin administered as the active form and not as a prodrug. This drug was developed by Sankyo Co. Ltd.; however, the first approved pravastatin product was developed by Bristol Myers Squibb and FDA approved in 1991. Pravastatin is made through a fermentation process in which mevastatin is first obtained. The manufacturing process is followed by the hydrolysis of the lactone group and the biological hydroxylation with Streptomyces carbophilus to introduce the allylic 6-alcohol group.
Indication
Pravastatin is indicated for primary prevention of coronary events hypercholesterolemic patients without clinical evidence of coronary heart disease. Its use includes the reduction of risk on myocardial infarction, undergoing myocardial revascularization procedures and cardiovascular mortality. As well, pravastatin can be used as a secondary prevention agent for cardiovascular events in patients with clinically evident coronary heart disease. This indication includes the reduction of risk of total mortality by reducing coronary death, myocardial infarction, undergoing myocardial revascularization procedures, stroke, and stroke/transient ischemic attack as well as to slow the progression of coronary atherosclerosis. The term cardiovascular events correspond to all the incidents that can produce damage to the heart muscle including the interruption of blood flow. As adjunctive therapy to diet, pravastatin is used in: In patients that do not respond adequately to diet, pravastatin is used to treat patients with primary dysbetalipoproteinemia (type III hyperlipidemia). Dyslipidemia is defined as an elevation of plasma cholesterol, triglycerides or both as well as to the presence of low levels of high-density lipoprotein. This condition represents an increased risk for the development of atherosclerosis.
Associated Conditions
- Acute Coronary Events
- Cardiovascular Outcomes
- Coronary Artery Atherosclerosis
- Death
- Dysbetalipoproteinemia
- Heterozygous Familial Hypercholesterolemia (HeFH)
- High Cholesterol
- Hyperlipidemias
- Mixed Dyslipidemias
- Myocardial Infarction
- Myocardial Revascularization
- Secondary prevention cardiovascular event
- Stroke
- Sudden Cardiac Death
- Transient Ischemic Attack
- Elevation of serum triglyceride levels
Research Report
Pravastatin (DB00175): A Comprehensive Monograph on its Pharmacology, Clinical Utility, and Comparative Profile
Executive Summary
Pravastatin is a well-established lipid-lowering agent belonging to the statin class of drugs, which function as inhibitors of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. Derived from the fungal metabolite mevastatin, pravastatin holds a unique position within its class due to a distinct pharmacological profile characterized by its hydrophilicity. This property confers a high degree of liver selectivity, concentrating its therapeutic action in the primary site of cholesterol synthesis while limiting systemic exposure. A pivotal feature of pravastatin is its minimal metabolism via the cytochrome P450 (CYP) enzyme system, which translates to a significantly lower potential for drug-drug interactions compared to many other statins.
Classified as a low-to-moderate intensity statin, pravastatin effectively reduces low-density lipoprotein cholesterol (LDL-C), total cholesterol, and triglycerides, while modestly increasing high-density lipoprotein cholesterol (HDL-C). Its clinical value is not merely defined by its lipid-modifying effects but is firmly anchored in a robust evidence base from landmark cardiovascular outcome trials, including WOS, CARE, and LIPID. These studies have unequivocally demonstrated its efficacy in both the primary and secondary prevention of major adverse cardiovascular events, such as myocardial infarction, stroke, and cardiovascular mortality.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/08/01 | Not Applicable | Not yet recruiting | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | ||
2025/04/06 | Phase 2 | Not yet recruiting | |||
2024/07/10 | Phase 2 | Recruiting | |||
2024/04/10 | Phase 4 | Completed | Pachankis, Yang I., M.D. | ||
2024/03/22 | Phase 1 | Recruiting | Children's Mercy Hospital Kansas City | ||
2023/05/10 | Phase 1 | Completed | |||
2022/09/01 | Phase 1 | Completed | |||
2021/11/15 | N/A | Completed | |||
2021/11/04 | N/A | Completed | |||
2021/01/22 | Phase 4 | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| PD-Rx Pharmaceuticals, Inc. | 43063-443 | ORAL | 20 mg in 1 1 | 2/24/2023 | |
| Bryant Ranch Prepack | 63629-9162 | ORAL | 10 mg in 1 1 | 7/26/2021 | |
| Denton Pharma, Inc. DBA Northwind Pharmaceuticals | 70934-236 | ORAL | 40 mg in 1 1 | 1/4/2021 | |
| Bryant Ranch Prepack | 63629-8904 | ORAL | 10 mg in 1 1 | 7/26/2021 | |
| Quallent | 82009-006 | ORAL | 20 mg in 1 1 | 12/5/2023 | |
| Lupin Pharmaceuticals, Inc. | 68180-485 | ORAL | 10 mg in 1 1 | 12/19/2023 | |
| DirectRX | 61919-731 | ORAL | 20 mg in 1 1 | 1/21/2020 | |
| Bryant Ranch Prepack | 63629-9164 | ORAL | 40 mg in 1 1 | 7/26/2021 | |
| Quallent | 82009-007 | ORAL | 40 mg in 1 1 | 12/5/2023 | |
| Direct_Rx | 61919-734 | ORAL | 80 mg in 1 1 | 1/15/2019 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 4/14/2011 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| PRAVAFEN HARD CAPSULES 40mg/160mg | SIN14508P | CAPSULE | 40mg | 2/21/2014 | |
| APO-PRAVASTATIN TABLET 20 mg | SIN12670P | TABLET | 20 mg | 7/22/2005 | |
| APO-PRAVASTATIN TABLET 10 mg | SIN12671P | TABLET | 10 mg | 7/22/2005 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| PMS-PRAVASTATIN TAB 20MG | N/A | N/A | N/A | 11/2/2004 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| PRALECT 10 pravastatin sodium 10mg tablet bottle | 191715 | Medicine | A | 10/24/2012 | |
| PRAVASTATIN AN pravastatin sodium 20mg tablet bottle | 191716 | Medicine | A | 10/24/2012 | |
| APX-PRAVASTATIN pravastatin sodium 20 mg tablet blister pack | 335751 | Medicine | A | 6/23/2020 | |
| AURO-PRAVASTATIN 20 pravastatin sodium 20mg tablet bottle | 191699 | Medicine | A | 10/24/2012 | |
| PRAVASTATIN AN pravastatin sodium 40mg tablet bottle | 191702 | Medicine | A | 10/24/2012 | |
| APO-PRAVASTATIN pravastatin sodium 10 mg tablets bottle | 166255 | Medicine | A | 1/11/2010 | |
| PRAVASTATIN AN pravastatin sodium 80mg tablet bottle | 191694 | Medicine | A | 10/24/2012 | |
| PRALECT 10 pravastatin sodium 10mg tablet blister pack | 191703 | Medicine | A | 10/24/2012 | |
| PRAVASTATIN SANDOZ pravastatin sodium 20 mg tablet blister pack | 152458 | Medicine | A | 10/12/2009 | |
| PRALECT 80 pravastatin sodium 80mg tablet blister pack | 191711 | Medicine | A | 10/24/2012 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| JAMP PRAVASTATIN TABLETS | 02558092 | Tablet - Oral | 20 MG | N/A | |
| BIO-PRAVASTATIN | biomed pharma | 02446278 | Tablet - Oral | 20 MG | 8/17/2016 |
| PMS-PRAVASTATIN | 02247655 | Tablet - Oral | 10 MG | 7/21/2003 | |
| PRAVASTATIN | Cobalt Pharmaceuticals Company | 02342332 | Tablet - Oral | 20 MG | N/A |
| MINT-PRAVASTATIN | mint pharmaceuticals inc | 02317451 | Tablet - Oral | 10 MG | 2/6/2009 |
| M-PRAVASTATIN | mantra pharma inc | 02467356 | Tablet - Oral | 20 MG | N/A |
| MAR-PRAVASTATIN | marcan pharmaceuticals inc | 02432064 | Tablet - Oral | 40 MG | 4/5/2018 |
| JAMP-PRAVASTATIN | 02330954 | Tablet - Oral | 10 MG | 4/1/2010 | |
| AURO-PRAVASTATIN | auro pharma inc | 02458985 | Tablet - Oral | 20 MG | 5/22/2018 |
| AVA-PRAVASTATIN | avanstra inc | 02364417 | Tablet - Oral | 10 MG | 10/11/2011 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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