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Pravastatin

Generic Name
Pravastatin
Brand Names
Pravafenix
Drug Type
Small Molecule
Chemical Formula
C23H36O7
CAS Number
81093-37-0
Unique Ingredient Identifier
KXO2KT9N0G

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.

Background

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

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/04/06
Phase 2
Not yet recruiting
2024/07/10
Phase 2
Not yet 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
Active, not recruiting
2021/11/04
N/A
Completed
2021/01/22
Phase 4
UNKNOWN
2020/11/23
Phase 4
Completed

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
Pravastatin Sodium Capsules
国药准字H20080673
化学药品
胶囊剂
9/8/2023
Pravastatin Sodium Capsules
国药准字H20080674
化学药品
胶囊剂
6/14/2023
Pravastatin Sodium Tablets
国药准字H20253858
化学药品
片剂
4/8/2025
Pravastatin Sodium Tablets
国药准字H20040100
化学药品
片剂
12/17/2019
Pravastatin Sodium Tablets
国药准字H20050736
化学药品
片剂
7/8/2020
Pravastatin Sodium Tablets
国药准字H20253951
化学药品
片剂
4/15/2025
Pravastatin Sodium Tablets
国药准字H20253952
化学药品
片剂
4/15/2025
Pravastatin Sodium Tablets
国药准字H20234727
化学药品
片剂
12/29/2023
Pravastatin Sodium Tablets
国药准字H20050150
化学药品
片剂
5/22/2020
Pravastatin Sodium Tablets
国药准字H20234726
化学药品
片剂
12/29/2023

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
PMS-PRAVASTATIN TAB 20MG
N/A
trenton-boma ltd
N/A
N/A
11/2/2004
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