Pravachol

(Pravastatin)

ApprovedSmall molecule

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Pravastatin is used to lower cholesterol and reduce the risk of heart disease and stroke by helping your body produce less cholesterol and clear it from your bloodstream more effectively.[2] Pravachol is currently approved and in use across 52 indications[4].[1]

Pravachol is one of 1101 small molecule programs targeting Coronary Artery Disease. It is currently in Approved.

Indications

107

Total Trials

Active Trials

1,100

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Coronary Artery DiseaseActive, not recruiting

Metabolic SyndromeActive, not recruiting

Disorder of Lipid MetabolismApproved

Cardiovascular DiseaseActive, not recruiting

Endothelial DysfunctionActive, not recruiting

RigidityActive, not recruiting

Left Ventricular HypertrophyActive, not recruiting

DysphagiaActive, not recruiting

HyperlipidemiaApproved

StrokeActive, not recruiting

Coronary Artery DiseasePreclinical

Active, not recruiting

Metabolic SyndromePreclinical

Active, not recruiting

Disorder of Lipid MetabolismApproved

Approved

Cardiovascular DiseaseApproved

Active, not recruiting

Endothelial DysfunctionPreclinical

Active, not recruiting

RigidityApproved

Active, not recruiting

Left Ventricular HypertrophyPhase 3

Active, not recruiting

DysphagiaPhase 2

Active, not recruiting

HyperlipidemiaApproved

Approved

StrokePhase 3

Active, not recruiting

Showing 10 of 51 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Pravachol

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Tykerb

80 3

Cymbalta

Alnylam Pharmaceuticals

Preclinical

3 4

Zinecard

CChildren's Oncology Group

Preclinical

2 5

Acupan

YYonsei University

Preclinical

1 6

Avastin

Roche

Preclinical

4 7

Nubain

AAultman Health Foundation

Preclinical

1 8

Paracetamol

GSK

Preclinical

1 9

Zoladex

Luye Pharma Group Ltd.

Preclinical

8 10

Neoadjuvant Therapy

SSun Yat-sen University

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2028

Phase 2Recruiting

Placental Insufficiency

NCT07098975

Q4 2028

Phase 2Recruiting

Dysphagia

NCT07217938

Q1 2031

Phase 2Recruiting

Fibrosis

NCT04356209

Phase 2Recruiting

Lymphedema

NCT06494111

Q1 2033

Phase 2Recruiting

Fibrosis

NCT06912763

Clinical

Trials by Indication[1]

Statin16 trials

Statin Distribution

Completed·—·Phase 1·NCT02360826·32 enrolled

Effect of GDC-0810 on the Pharmacokinetics of Pravastatin in Healthy Female Subjects of Non-Childbearing Potential

Completed· Roche logo

Roche·Phase 1·NCT02621957·15 enrolled

Comparison of the Combination of Fenofibrate and Simvastatin Versus Pravastatin

Completed·SSolvay Pharmaceuticals·Phase 3·NCT00362206·423 enrolled

Show 13 more trials

The Influence of Raltegravir on Pravastatin Pharmacokinetics(GRAPPA)

Completed·RRadboud University Medical Center·Phase 1·NCT00665717·24 enrolled

Pharmacodynamics, Preliminary Pharmacokinetics and Tolerability of BIBB 515 BS or Pravastatin in Hyperlipemic Healthy Male Subjects

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02266485·60 enrolled

Statin Therapy in Patients With Early Stage ADPKD

Active, not recruiting·UUniversity of Colorado, Denver·Phase 4·NCT03273413·150 enrolled

Statin Adjunctive Therapy for TB

Completed·JJohns Hopkins University·Phase 2·NCT03456102·16 enrolled

A 12-Week Study Comparing Pitavastatin 4 mg vs. Pravastatin 40 mg in HIV-Infected Subjects

Completed·KKowa Research Institute, Inc.·Phase 4·NCT01301066·252 enrolled

A Study Comparing the Mechanisms of Action of Lifibrol and Pravastatin

Completed·UUniversity Hospital, Bonn·Phase 3·NCT01057654·18 enrolled

Fed, Bioequivalence Study of Pravastatin Sodium 80 mg Tablets Versus Pravachol® 80 mg Tablets In Subjects

Completed· Mylan Pharmaceuticals Inc logo

Mylan Pharmaceuticals Inc·Phase 1·NCT00648544·44 enrolled

Effect of Statin Use on Aldosterone Secretion

Completed·—·Phase 1·NCT02871687·103 enrolled

Pravastatin for Hyperlipidaemia in HIV.

Completed·KKirby Institute·Phase 4·NCT00227500·40 enrolled

Rosuvastatin Versus Pravastatin in HIV Patients Treated With Boosted Protease Inhibitors (PI) (ANRS126)

Completed·FFrench National Agency for Research on AIDS and Viral Hepatitis·Phase 4·NCT00117494·86 enrolled

Pravastatin Sodium 40 mg Tablets Food Challenge Study

Completed· Teva logo

Teva·Phase 1·NCT00834847·24 enrolled

Fasting Bioequivalence Study of Pravastatin Sodium 80 mg Tablets Versus Pravachol® 80 mg Tablets In Normal Healthy Subjects

Completed· Mylan Pharmaceuticals Inc logo

Mylan Pharmaceuticals Inc·Phase 1·NCT00650221·43 enrolled

Pravastatin and Protease Inhibitors in HIV-Infected Patients

Completed·UUniversity Hospital, Bordeaux·Phase 2·NCT00221754·21 enrolled

Interaction6 trials

A Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 in Healthy Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT05852769·18 enrolled

Genetic Predictors of Variability in the Drug-drug Interaction Between Darunavir/Ritonavir and Pravastatin

Completed·UUniversity of Colorado, Denver·Phase 4·NCT00630734·32 enrolled

Cilostazol-Simvastatin Drug Interaction Study

Unknown status·—·Phase 1·NCT02431013·20 enrolled

Show 3 more trials

A Study of the PK Interaction of CXA-10 With Pravastatin and Vytorin® in Healthy Males

Completed·CComplexa, Inc.·Phase 1·NCT02547402·10 enrolled

A Drug-Drug Interaction Study Between AZD1981 and Pravastatin to Study the Effect of AZD1981 on the Kinetics of Pravastatin

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01254461·30 enrolled

Evaluation of Pharmacokinetic Interaction Between GSK3640254 and Caffeine, Metoprolol, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin in Healthy Adults

Completed· GSK logo

GSK·Phase 1·NCT04425902·20 enrolled

Efficacy and Safety3 trials

Study to Compare the Efficacy and Safety of Pitavastatin and Pravastatin in Elderly Patients

Completed·KKowa Research Europe·Phase 3·NCT00257686·962 enrolled

Evaluation of the Efficacy and Safety of Rosuvastatin 5 mg Versus Pravastatin 40 mg and Atorvastatin 10 mg in Type IIa and IIb Hypercholesterolaemic Patients

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT00631189·668 enrolled

Efficacy and Safety Study of Sorafenib Plus Pravastatin to Treat Advanced Hepatocarcinoma

Completed·—·Phase 2·NCT01418729·216 enrolled

Atorvastatin3 trials

This Study Uses Ultrasound to Determine Whether Atorvastatin or Pravastatin Effects the Progression of Coronary Plaque.

Completed· Pfizer logo

Pfizer·Phase 4·NCT00380939·600 enrolled

STELLAR-Rosuvastatin vs. Atorvastatin, Pravastatin, Simvastatin Across Dose Ranges

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00654537·5,625 enrolled

Drug-Drug Interaction Study of Vadadustat With Rosuvastatin, Sulfasalazine, Pravastatin, Atorvastatin and Simvastatin

Completed·AAkebia Therapeutics·Phase 1·NCT03801733·134 enrolled

Preeclampsia3 trials

Pravastatin to Prevent Preeclampsia

Terminated·TThe George Washington University Biostatistics Center·Phase 3·NCT03944512·102 enrolled

Indonesia Pravastatin to Prevent Preeclampsia Study

Unknown status·UUniversitas Airlangga·Phase 2·NCT03648970·280 enrolled

Pravastatin for Prevention of Preeclampsia

Completed·TThe University of Texas Medical Branch, Galveston·Phase 1·NCT01717586·48 enrolled

66 more indications

Acute Coronary Syndrome3 trials

High Intensity Lipid Lowering Following Acute Coronary Syndromes for Persons Living With HIV

Completed·MMatthew Feinstein·Phase 2·NCT02841774·10 enrolled

Yokohama Assessment of Fluvastatin, Pravastatin, Pitavastatin and Atorvastatin in Acute Coronary Syndrome (Yokohama-ACS)

Completed·YYokohama City University Medical Center·Phase 4·NCT00549926·200 enrolled

Early Effects of Intensive Lipid Lowering Treatment With Ezetimibe/ Simvastatin (Vytorin®) Assessed by Virtual Histology-Intravascular Ultrasound (VH-IVUS) and Optical Coherence Tomography (OCT) on Plaque Characteristics in Patients With Acute Coronary Syndrome

Completed·YYonsei University·Phase 4·NCT01857843·160 enrolled

Fibrosis3 trials

Curative Efficacy of Pravastatine in Patients Presented Delayed Cutaneous and Subcutaneous Radio-induced Fibrosis

Completed·GGustave Roussy, Cancer Campus, Grand Paris·Phase 2·NCT01268202·61 enrolled

Improving Theempowerment in Patients With Severe Breast Fibrosis Radio-induced Treated by Pravastatin : Benefit of e-PROs (Electronic " Patient Reported Outcome ") on Breast-related Quality of Life

Recruiting·IInstitut du Cancer de Montpellier - Val d'Aurelle·Phase 2·NCT04356209·105 enrolled

Reversing External-beam Radiotherapy-associated Fibrosis Syndrome: an Interventional Bayesian Adaptive Randomized-controlled Orphan Drug Platform Trial for Orodental Sequelae (Reverse-fibrose)

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT06912763·250 enrolled

Endothelial Dysfunction2 trials

Endothelial Dysfunction as a Risk Factor in HIV Study

Completed·NNational Institutes of Health Clinical Center (CC)·Phase 1·NCT00039663·75 enrolled

Effect of Pravastatin on Endothelial Dysfunction Following a Single High Fat Meal

Unknown status·NNational Center for Research Resources (NCRR)·N/A·NCT00005117

Atherosclerosis2 trials

Prevention of Atherosclerosis and Heart Disease in Patients With Systemic Lupus Erythematosis (SLE)

Completed·—·Phase 2·NCT00054938·150 enrolled

Harvard Atherosclerosis Reversibility Project (HARP)

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 2·NCT00000461

Cholesterol2 trials

A Study to Assess the Effect of RO4607381 in Patients With Relatively Low Levels of High Density Lipoprotein-Cholesterol (HDL-C)

Completed· Roche logo

Roche·Phase 2·NCT00697203·292 enrolled

Safety of Red Yeast Rice for High Cholesterol in Individuals With Statin Intolerance

Completed·UUniversity of Pennsylvania·Phase 2·NCT00639223·43 enrolled

Autosomal Dominant Polycystic Kidney Disease2 trials

Effect of Statin Therapy on Disease Progression in Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Completed·UUniversity of Colorado, Denver·Phase 3·NCT00456365·110 enrolled

Pravastatin and Alkali Therapy in Patients With Autosomal Dominant Polycystic Kidney Disease

Completed·UUniversity of Southern California·Phase 2·NCT04284657·1 enrolled

Tics2 trials

Pharmacodynamics, Preliminary Pharmacokinetics and Tolerability of BIBB 1464 (Tablet) in Hyperlipemic Healthy Male Subjects

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02229773·100 enrolled

Repeated Dose Study for the Investigation of Heritability of and Genetic Influences on Drug Pharmacokinetics

Completed·IInstitut fuer anwendungsorientierte Forschung und klinische Studien GmbH·Phase 1·NCT01845194·117 enrolled

Coronary Artery Disease2 trials

Serial EValuation of multiplE Coronary Artery Diseases by an Optical Coherence Tomography; Assessment of the Changes of de Novo Lesions and Comparisons of Neointimal Coverage Between Xience Prime® Versus Cypher SelectTM Stents; SEVEN-Xience Study

Completed·YYonsei University·Phase 4·NCT01856374·60 enrolled

A Trial Comparing the Effect of Pravastatin and Rosuvastatin on Atherosclerosis Progression Measured by Carotid Intima Media Thickness in Patients With Coronary Artery Disease After Biolimus Eluting Stent (Nobori®) Implantation: CPR IMT

Completed·YYonsei University·N/A·NCT01872845·671 enrolled

Peritoneal Dialysis1 trial

Single Dose Pravastatin Pharmacokinetics in Pediatric Peritoneal Dialysis Patients

Terminated·—·Phase 1·NCT00571194·7 enrolled

Endometriosis1 trial

Statins: A New Therapeutic Option for Treatment of Patients With Endometriosis

Withdrawn·—·N/A·NCT02079974

Lymphedema1 trial

Systemic Therapy of Open-label Prophylactic Pravastatin or Pentoxifylline/Tocopherol Prevention of Lymphedema Advancing to Eventual Fibrosis: an Interventional Registry-embedded Bayesian Randomized Trial for Radiation Sequelae (STOP4-LATE-FIBROSE)

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT06494111·295 enrolled

Acute Myocardial Infarction1 trial

Pravastatin for Acute Myocardial Infarction With Minimally to Mildly Increased Levels of Serum Cholesterol Study

Unknown status·OOsaka Acute Coronary Insufficiency Study Group·Phase 4·NCT00688922·400 enrolled

Combined hyperlipidemia1 trial

A Study to Evaluate Daily Pravastatin, Fenofibrate or Pravafen in the Treatment of Combined Hyperlipidemia

Completed· Shionogi logo

Shionogi·Phase 3·NCT00459745·481 enrolled

Progeria1 trial

A Study of Zoledronic Acid, Pravastatin, and Lonafarnib for Patients With Progeria

Completed·—·Phase 2·NCT00879034·5 enrolled

Kidney Transplant1 trial

Prevention of Kidney Transplant Rejection

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00005010

Homozygous Familial Hypercholesterolemia1 trial

An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Homozygous Familial Hypercholesterolemia

Completed· Sanofi logo

Sanofi·Phase 3·NCT03510715·18 enrolled

Liver Disease1 trial

Pravastatin Efficacy and Safety Trial in Hypercholesterolemic Patients With Chronic Liver Disease

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 4·NCT00529178·232 enrolled

Injury1 trial

Pravastatin as a Prophylactic to Reduce Endothelial Injury in Pediatric Patients With Elevated Body Mass Index

Completed·—·Phase 1·NCT05524246·25 enrolled

Schizoaffective Disorder1 trial

Improving Symptoms of Schizophrenia and Schizoaffective Disorder by Supplementing Medications With Pravastatin

Completed·UUniversity of Pittsburgh·Phase 4·NCT00177580·72 enrolled

Prevention1 trial

Prevention of Renal and Vascular Endstage Disease Intervention Trial

Completed·UUniversity Medical Center Groningen·Phase 3·NCT03073018·864 enrolled

Dyslipidemia1 trial

Longitudinal Study of Multi-Analyte Profile for Dyslipidemia

Unknown status·MMaiHealth Inc·N/A·NCT01441908·40 enrolled

Lip1 trial

Type III Dysbetalipoproteinemia

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00214604·30 enrolled

Trial1 trial

Arterial Disease Multifactorial Intervention Trial (ADMIT)

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 3·NCT00000539

Relapsing-Remitting Multiple Sclerosis1 trial

Safety and Efficacy of Pravastatin in Relapsing-remitting Multiple Sclerosis

Completed·NNantes University Hospital·Phase 3·NCT00200655·40 enrolled

Rigidity1 trial

Vytorin on Carotid Intima-media Thickness and Overall Rigidity

Completed·HHospital Universitario 12 de Octubre·Phase 4·NCT00738296·90 enrolled

Heart Failure1 trial

South Korean Pitavastatin Heart Failure Study

Completed·JJW Pharmaceutical·Phase 4·NCT00701285·70 enrolled

Cardiomyopathy1 trial

Autophagy Activation for the Alleviation of Cardiomyopathy Symptoms After Anthracycline Treatment, ATACAR Trial

Withdrawn·MMayo Clinic·Phase 2·NCT04190433

Hermansky-Pudlak syndrome1 trial

Pilot Study of a Multi-Drug Regimen for Severe Pulmonary Fibrosis in Hermansky-Pudlak Syndrome

Terminated·NNational Human Genome Research Institute (NHGRI)·Phase 1/2·NCT00467831·3 enrolled

Drug Interactions1 trial

Study to Evaluate Organic Anion Transporting Polypeptide (OATP) Transporter-Mediated Drug-Drug Interactions Between Filgotinib and Statins as Probe Drugs in Healthy Participants

Completed· Gilead logo

Gilead·Phase 1·NCT04608344·27 enrolled

Fasting Conditions1 trial

Pravastatin 80 mg Tablets Dosed in Healthy Subjects Under Non-Fasting Conditions

Completed· Teva logo

Teva·Phase 1·NCT00829309·16 enrolled

Acute Myeloid Leukemia1 trial

Pravastatin, Idarubicin, and Cytarabine in Treating Patients With Acute Myeloid Leukemia

Completed·FFred Hutchinson Cancer Center·Phase 1·NCT00107523

Schizophrenia1 trial

Effects of Pravastatin on Cholesterol, Inflammation and Cognition in Schizophrenia

Completed·MMassachusetts General Hospital·Phase 4·NCT01082588·60 enrolled

Hepatocellular Carcinoma1 trial

Palliative Treatment of Hepatocellular Carcinoma in Patient With CHILD B Cirrhosis

Completed·UUniversity Hospital, Bordeaux·Phase 2·NCT01357486·160 enrolled

Homeostasis1 trial

The Statins on Glucose Homeostasis in Subjects With Impaired Fasting Glucose

Unknown status·TTaipei Veterans General Hospital, Taiwan·Phase 4·NCT01816997·160 enrolled

Stroke1 trial

Japan Statin Treatment Against Recurrent Stroke (J-STARS)

Completed·TTranslational Research Center for Medical Innovation, Kobe, Hyogo, Japan·Phase 3·NCT00221104·1,578 enrolled

Cardiovascular Prevention1 trial

Cardiovascular Prevention for Persons With HIV

Completed·HHennepin Healthcare Research Institute·N/A·NCT00982189·37 enrolled

Drug Metabolism1 trial

Open Label Study for the Functional Characterization of Drug Metabolism and Transport

Completed·MMatthias Schwab·Phase 1·NCT01788254·144 enrolled

Oxidative Stress1 trial

Effect of Statins on Oxidative Stress and Endothelial Progenitor Cells

Completed·EEmory University·Phase 2·NCT00166036·36 enrolled

Hyperlipidemia1 trial

Prevail-Us: A Study Of Pitavastatin 4 mg Vs. Pravastatin 40 mg In Patients With Primary Hyperlipidemia Or Mixed Dyslipidemia

Completed·KKowa Research Institute, Inc.·Phase 4·NCT01256476·328 enrolled

Left Ventricular Hypertrophy1 trial

Left Ventricular Hypertrophy Reduction With Statins in Hypertensives Patients (MK0653A-168)

Terminated·FFundación Lindavista del Corazón AC·Phase 3·NCT00738972·12 enrolled

ART1 trial

A Study of Evacetrapib in Japanese and Non-Japanese Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT01958489·24 enrolled

Pneumonia1 trial

Pravastatin and Ventilatory Associated Pneumonia

Completed·UUniversity of Thessaly·Phase 1·NCT00702130·152 enrolled

Diabetes1 trial

High Potency Statins and the Risk of Diabetes

Completed·CCanadian Network for Observational Drug Effect Studies, CNODES··NCT02518503·136,966 enrolled

PreDiabetes1 trial

Effect of Pravastatin in the Subjects With Prediabetes or Early Diabetes

Completed·SSamsung Medical Center·Phase 4·NCT02754739·44 enrolled

Esophageal Cancer1 trial

Study to Evaluate the Efficacy of Pravastatin on Survival and Recurrence of Advanced Gastroesophageal Cancer

Unknown status·—·Phase 4·NCT01038154·146 enrolled

Tuberculosis1 trial

StAT-TB (Statin Adjunctive Therapy for TB): A Phase 2b Dose-finding Study of Pravastatin in Adults With Tuberculosis

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT03882177·16 enrolled

Type 2 Diabetes1 trial

An Observational Study Investigating the Effectiveness of Pravastatin on Renal Function in Korean Dyslipidemic Patients With Type 2 Diabetes

Completed· Daiichi Sankyo logo

Daiichi Sankyo··NCT05107063·2,972 enrolled

Monotherapy1 trial

Coadministration of Ezetimibe With Fenofibrate Versus Pravastatin Monotherapy for the Treatment of Hyperlipidaemia in HIV-infected Patients

Unknown status·OOspedale di Circolo - Fondazione Macchi·Phase 4·NCT00843661·60 enrolled

Methotrexate1 trial

Effects of Concomitant Administration of BMS-986195 on Methotrexate, Caffeine, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT03131973·26 enrolled

Familial Hypercholesterolemia1 trial

An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia

Completed· Sanofi logo

Sanofi·Phase 3·NCT03510884·153 enrolled

Chronic Kidney Disease1 trial

Effect of Pravastatin on Erythrocyte Membrane Fatty Acid Contents in Patients With Chronic Kidney Disease

Completed·—·Phase 4·NCT02992548·62 enrolled

Renal insufficiency1 trial

Anti-Oxidant Therapy In Chronic Renal Insufficiency (ATIC) Study

Terminated·AAmsterdam UMC, location VUmc·Phase 4·NCT00384618·100 enrolled

Leukemia1 trial

Monitoring and Treatment of Relapsed Leukemia Following Allogeneic Hematopoietic Stem Cell Transplantation in Children

Terminated·RReuven Schore·Phase 1·NCT02484261·10 enrolled

Nephrotic Syndrome1 trial

Lipid Lowering Agents to Limit Lipid Oxidation and Activation of Clotting System in Nephrotic Syndrome

Completed·UUniversity of North Carolina, Chapel Hill·Phase 1·NCT01845428·7 enrolled

Unknown status·UUniversity of Virginia·N/A·NCT00599625·40 enrolled

Acute Kidney Injury1 trial

High Potency Statins and Acute Kidney Injury

Completed·CCanadian Network for Observational Drug Effect Studies, CNODES··NCT02518516·2,067,639 enrolled

Major Adverse Cardiac Events1 trial

Primary Prevention of Major Adverse Cardiac Events (MACE) With Standard and Intensive Statin Treatment in Patients With Diabetes: Survival and Cardiovascular Event Assessments

Terminated·PPositive Trial Group·N/A·NCT01173939·10,000 enrolled

Placental Insufficiency1 trial

Statin Intervention for Severe Early-Onset Placental Insufficiency. (STATIN-PRE Trial)

Recruiting·FFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau·Phase 2·NCT07098975·154 enrolled

Aspirin1 trial

Aspirin Mono Therapy 12-months After Drug-eluting Stents Implantation

Unknown status·YYonsei University·Phase 4·NCT01557075·2,000 enrolled

Dysphagia1 trial

Novel Treatment of Radiation Associated Dysphagia With Statins

Recruiting·PPeter MacCallum Cancer Centre, Australia·Phase 2·NCT07217938·48 enrolled

Optical Coherence Tomography1 trial

COmparison and Modification in Neointimal Pattern Assessed by Optical Coherence Tomography With High Versus Moderate Efficacy Statin Treatment After Drug Eluting Stent Implantation: COMPASS Trial

Completed·YYonsei University·N/A·NCT02155530·30 enrolled

Medication1 trial

Effects of Statin Medications on Mental Processes, Behavior, and Serotonin Levels

Completed·UUniversity of California, San Diego·Phase 4·NCT00330980·1,000 enrolled

Heart Transplantation1 trial

Statin InTensity to Prevent Coronary Artery Vasculopathy After Heart Transplantation

Withdrawn·MMontefiore Medical Center·N/A·NCT05251129

Unspecified1 trial

Do HMG CoA Reductase Inhibitors Affect Abeta Levels?

Completed·SSeattle Institute for Biomedical and Clinical Research·Phase 4·NCT00303277·35 enrolled

Regulatory

FDA Approval Timeline[5]

Oct 31, 1991

PRAVACHOL

NDA NDA019898

Sources

References

[1]
ClinicalTrials.gov — 107 trial records for Pravastatin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Pravachol drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Pravastatin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Pravastatin. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA019898). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Karuna Therapeutics, Inc., a Bristol Myers Squibb company company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: HMG-Coa Reductase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Pravachol

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2028

Q4 2028

Q1 2031

Q1 2033

Trials by Indication[1]

Statin16 trials

Interaction6 trials

Efficacy and Safety3 trials

Atorvastatin3 trials

Preeclampsia3 trials

Acute Coronary Syndrome3 trials

Fibrosis3 trials

Endothelial Dysfunction2 trials

Atherosclerosis2 trials

Cholesterol2 trials

Autosomal Dominant Polycystic Kidney Disease2 trials

Tics2 trials

Coronary Artery Disease2 trials

Peritoneal Dialysis1 trial

Endometriosis1 trial

Lymphedema1 trial

Acute Myocardial Infarction1 trial

Combined hyperlipidemia1 trial

Progeria1 trial

Kidney Transplant1 trial

Homozygous Familial Hypercholesterolemia1 trial

Liver Disease1 trial

Injury1 trial

Schizoaffective Disorder1 trial

Prevention1 trial

Dyslipidemia1 trial

Lip1 trial

Trial1 trial

Relapsing-Remitting Multiple Sclerosis1 trial

Rigidity1 trial

Heart Failure1 trial

Cardiomyopathy1 trial

Hermansky-Pudlak syndrome1 trial

Drug Interactions1 trial

Fasting Conditions1 trial

Acute Myeloid Leukemia1 trial

Schizophrenia1 trial

Hepatocellular Carcinoma1 trial

Homeostasis1 trial

Stroke1 trial

Cardiovascular Prevention1 trial

Drug Metabolism1 trial

Oxidative Stress1 trial

Hyperlipidemia1 trial

Left Ventricular Hypertrophy1 trial

ART1 trial

Pneumonia1 trial

Diabetes1 trial

PreDiabetes1 trial

Esophageal Cancer1 trial

Tuberculosis1 trial

Type 2 Diabetes1 trial

Monotherapy1 trial

Methotrexate1 trial

Familial Hypercholesterolemia1 trial

Chronic Kidney Disease1 trial

Renal insufficiency1 trial

Leukemia1 trial

Nephrotic Syndrome1 trial

Kawasaki Disease1 trial

Heart Attack1 trial

Crohn's Disease1 trial

Acute Kidney Injury1 trial

Major Adverse Cardiac Events1 trial

Placental Insufficiency1 trial

Aspirin1 trial

Dysphagia1 trial

Optical Coherence Tomography1 trial

Medication1 trial

Heart Transplantation1 trial

Unspecified1 trial