Zocor

(simvastatin)

ApprovedSmall molecule

Simvastatin is used to lower cholesterol and reduce the risk of heart disease and stroke by helping your body produce less cholesterol and break down cholesterol that's already in your blood.[2] Zocor is currently approved and in use across 155 indications[4].[1]

Zocor is one of 2689 small molecule programs targeting Acute Pancreatitis. It is currently in Approved.

155

Indications

393

Total Trials

Active Trials

2,688

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Acute PancreatitisApproved

Coronary Artery DiseaseActive, not recruiting

Metabolic SyndromeActive, not recruiting

HemangiomaApproved

Systemic Lupus ErythematosusActive, not recruiting

Cirrhosis of LiverApproved

Disorder of Lipid MetabolismApproved

Transient Ischemic AttackActive, not recruiting

Cardiovascular DiseaseActive, not recruiting

RigidityActive, not recruiting

Acute PancreatitisApproved

Approved

Coronary Artery DiseaseApproved

Active, not recruiting

Metabolic SyndromePreclinical

Active, not recruiting

HemangiomaApproved

Approved

Systemic Lupus ErythematosusApproved

Active, not recruiting

Cirrhosis of LiverApproved

Approved

Disorder of Lipid MetabolismApproved

Approved

Transient Ischemic AttackPhase 2/Phase 3

Active, not recruiting

Cardiovascular DiseasePhase 3

Active, not recruiting

RigidityApproved

Active, not recruiting

Showing 10 of 153 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Zocor

OOrganon and Co

Approved

9 2

Adriamycin

GGynecologic Oncology Group

Preclinical

87 3

Nolvadex

SSan Diego Pacific Oncology & Hematology Associates

Preclinical

78 4

MS Contin

Merck & Co.

Preclinical

2 5

Zolymbus

AbbVie

Preclinical

1 6

Effexor

WWyeth-Lederle Vaccines

Preclinical

2 7

Tricor

JJagotec

Preclinical

1 8

Chirocaine

PPurdue Pharma LP

Preclinical

1 9

Vfend

PPrism Pharmaceuticals

Paracetamol

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

Timeline

Expected Milestones

Q3 2026

Phase 2Recruiting

Uterine Leiomyoma

NCT03400826

Q4 2026

Phase 3Active, not recruiting

Cirrhosis

NCT03654053

Post-ApprovalRecruiting

Endometriosis

NCT05059626

Q1 2027

Phase 1Not yet recruiting

Statins

NCT07378293

Q2 2027

Phase 1Recruiting

Breast Cancer

NCT05464810

Phase 1Recruiting

Chronic Pancreatitis

NCT05771675

Clinical

Trials by Indication[1]

Statin19 trials

Effect of Local Application of Simvastatin Versus Bone Powder on Implant Bone Changes

Completed·—·Phase 1/2·NCT06016218·24 enrolled

Statin Distribution

Completed·—·Phase 1·NCT02360826·32 enrolled

Pilot Mouthwash Study of Pioglitazone and Simvastatin in Healthy Volunteers

Completed·UUniversity Hospitals Cleveland Medical Center·N/A·NCT00531882·25 enrolled

Show 16 more trials

Simvastatin for mTBI

Completed·VVA Office of Research and Development·Phase 4·NCT01952288·5 enrolled

The DDI Study of SP2086 and Simvastatin

Unknown status·JJiangsu HengRui Medicine Co., Ltd.·Phase 1·NCT02817243·24 enrolled

A Study to Investigate the Effect of MT-8554 on the Pharmacokinetics of Simvastatin and Rosuvastatin in Healthy Subjects

Completed· Tanabe Pharma Corporation logo

Tanabe Pharma Corporation·Phase 1·NCT02675309·28 enrolled

The Effect Of Simvastatin On Bone Remodeling In Socket Of Mandibular Teeth

Unknown status·HHadassah Medical Organization·N/A·NCT01085149·20 enrolled

A Study to Assess the Effects of Canagliflozin (JNJ-28431754) on the Pharmacokinetics, Pharmacodynamics, and Safety of Simvastatin in Healthy Volunteers

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 1·NCT01821027·22 enrolled

Statin Therapy Vs. Therapeutic Lifestyle Changes and Supplements

Completed·—·N/A·NCT00365742·80 enrolled

Influence of Simvastatin on Apolipoprotein B-100 (apoB-100) Secretion

Completed·UUniversity Hospital, Bonn·N/A·NCT00905541·8 enrolled

Niacin Plus Statin to Prevent Vascular Events

Terminated·AAxio Research. LLC·Phase 3·NCT00120289·3,414 enrolled

IIIb 6 Week Open Label Multicentre Rosuvastatin & Simvastatin

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00654446·442 enrolled

Muscle Characteristics Associated With Statin Therapy

Withdrawn·SScripps Health·N/A·NCT00990834

Bioequivalence Study of Simvastatin 40 mg Film-coated Tablets in Healthy Thai Volunteers

Unknown status·IInternational Bio service·Phase 1·NCT06178640·46 enrolled

Comparison of Simvastatin Versus Simvastatin/Ezetimibe on Small Dense Low -Density Lipoprotein (LDL)

Completed·UUniversity of Ioannina·Phase 4·NCT00932620·100 enrolled

Effects of Statin and Ezetimibe Association on Kinetics of Artificial Chilomicrons

Completed·UUniversity of Sao Paulo·Phase 4·NCT00481351·25 enrolled

Effect of Gemcabene on the Pharmacokinetics of Simvastatin in Healthy Volunteers

Completed·NNeuroBo Pharmaceuticals Inc.·Phase 1·NCT02587390·20 enrolled

Anti-inflammatory Effects of Simvastatin

Terminated·Pparesh Dandona·Phase 4·NCT04638400·10 enrolled

7T Magnetic Resonance Spectroscopy and Skeletal Muscle Biopsy Findings in Statin Associated Adverse Muscle Events

Terminated·UUniversity of Texas Southwestern Medical Center·Phase 4·NCT04507373·3 enrolled

Interaction6 trials

A Drug-Drug Interaction Study of Lanabecestat (LY3314814) in Healthy Participants

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT02406261·82 enrolled

A Drug-Drug Interaction Study Between GDC-0853 and Midazolam, Itraconazole, Rosuvastatin, and Simvastatin

Completed· Roche logo

Roche·Phase 1·NCT03174041·63 enrolled

Drug-Drug Interaction Study to Investigate Effects of Voclosporin on Pharmacokinetics of Simvastatin

Completed· Aurinia Pharmaceuticals logo

Aurinia Pharmaceuticals·Phase 1·NCT05306379·24 enrolled

Show 3 more trials

Drug Interaction Study of MGL-3196 With Rosuvastatin and Simvastatin

Completed· Madrigal Pharmaceuticals logo

Madrigal Pharmaceuticals·Phase 1·NCT02542969·25 enrolled

A Two-part Study to Investigate the Interaction and Pharmacokinetics of GSK2586184

Completed· GSK logo

GSK·Phase 1·NCT01953835·37 enrolled

The Interaction of Herbs and Statins

Completed·—·Phase 4·NCT05072405·38 enrolled

Cholesterol6 trials

A Pharmacodynamic Study to Evaluate the Effect of a Fixed Dose Combination Pill on Low Density Lipoprotein (LDL) Cholesterol

Terminated·FFerrer Internacional S.A.·Phase 2·NCT01004705·36 enrolled

Comparison of the Effect of Vytorin 10/80 Tablet Split Into 4 and Simvastatin 20 Milligrams on Low-density Lipoprotein (LDL) Cholesterol

Completed·—·Phase 4·NCT00762164·34 enrolled

A Research Study to Evaluate MK0653 (Ezetimibe) and Simvastatin, Given Together and Alone, on Intestinal Absorption of Cholesterol (0653-050)(COMPLETED)

Completed·OOrganon and Co·Phase 3·NCT00652301·40 enrolled

Show 3 more trials

Living With Statins - The Impact of Cholesterol Lowering Drugs on Health, Lifestyle and Well-being

Completed·UUniversity of Copenhagen·Phase 4·NCT02255682·35 enrolled

SLOS: The Effect of Simvastatin in Patients Receiving Cholesterol Supplementation

Terminated·OOregon Health and Science University·N/A·NCT01434745·1 enrolled

Ezetimibe Plus Simvastatin Versus Simvastatin in Untreated Subjects With High Cholesterol (P03435)

Completed·OOrganon and Co·Phase 4·NCT00653835·153 enrolled

Hypercholesterolemia5 trials

Follow-on Protocol of Pitavastatin Versus Simvastatin in Patients With Hypercholesterolemia or Dyslipidemia and Coronary Heart Disease Risk Factors

Completed·KKowa Research Europe·Phase 3·NCT00344175·178 enrolled

Efficacy And Safety Study Of Atorvastatin Versus Simvastatin In Type 2 Diabetic Subjects With Hypercholesterolemia

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00141141·383 enrolled

Mercury II - Compare the Efficacy and Safety of Lipid Lowering Agents Atorvastatin and Simvastatin With Rosuvastatin in High Risk Subjects With Type IIa and IIb Hypercholesterolemia

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00654407·4,875 enrolled

Show 2 more trials

Efficacy and Safety of Extended-Release Niacin/ Laropiprant/Simvastatin Tablets in Participants With Hypercholesterolemia or Mixed Dyslipidemia (MK-0524B-143)

Terminated· Merck & Co. logo

Merck & Co.·Phase 3·NCT01335997·1,139 enrolled

Ezetimibe and Simvastatin in Primary Hypercholesterolemia, Diabetes Mellitus Type 2, and Coronary Heart Disease (COMPLETED)

Completed·OOrganon and Co·Phase 3·NCT00423488·93 enrolled

Breast Cancer5 trials

A Prevention Trial in Subjects at High Risk for Breast Cancer

Completed·EEuropean Institute of Oncology·Phase 2·NCT01500577·150 enrolled

Letrozole With and Without Simvastatin for the Treatment of Stage I-III Hormone Receptor Positive, HER2 Negative Breast Cancer

Recruiting·EEmory University·Phase 1·NCT05464810·40 enrolled

Simvastatin Effect in Combination With Neoadjuvant Chemotherapy to Clinical Response and Tumor-Free Margin in Locally Advanced Breast Cancer

Completed·IIndonesia University·Phase 2·NCT04418089·60 enrolled

Show 2 more trials

The Role of Simvastatin in the Epithelial-Mesenchymal Transition Process of Breast Cancer

Recruiting·IIndonesia University·Phase 2·NCT05550415·26 enrolled

Simvastatin Plus Dual Anti-HER2 Therapy for Metastatic Breast Cancer

Active, not recruiting·BBaylor Breast Care Center·Phase 2·NCT03324425·5 enrolled

122 more indications

Cirrhosis4 trials

Remedial Mechanism of Simvastatin and Ursodeoxycholic Acid in Liver Cirrhosis: Crosstalk of Bile Secretion, Gut Microbiome, and Host Immune Response

Enrolling by invitation·—·N/A·NCT07102979·150 enrolled

Multi-Center Study of the Effects of Simvastatin on Hepatic Decompensation and Death in Subjects Presenting With High-Risk Compensated Cirrhosis

Active, not recruiting·VVA Office of Research and Development·Phase 3·NCT03654053·142 enrolled

Clinical Evaluation of Simcyp-Guided Simvastatin Dosing in Patients With Liver Cirrhosis

Completed·KKafrelsheikh University·Phase 4·NCT07459972·22 enrolled

Show 1 more trial

Simvastatin Plus Rifaximin in Decompensated Cirrhosis

Completed·JJudit Pich·Phase 2·NCT03150459·44 enrolled

Type 2 Diabetes4 trials

Nephropathy In Type 2 Diabetes and Cardio-renal Events

Completed·UUniversity of Campania Luigi Vanvitelli·Phase 4·NCT00535925·850 enrolled

A Drug-Drug Interaction Study of GK Activator (2) and Simvastatin in Patients With Type 2 Diabetes.

Completed· Roche logo

Roche·Phase 1·NCT00377442·33 enrolled

Drugs for High Blood Pressure and High Cholesterol in American Indians With Type 2 Diabetes

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 3·NCT00004266·160 enrolled

Show 1 more trial

Ezetimibe and Statins on Postprandial Lipemia in Type 2 Diabetes

Completed·FFederico II University·Phase 4·NCT00699023·13 enrolled

Sickle Cell Disease3 trials

Simvastatin (Zocor) Therapy in Sickle Cell Disease

Completed·UUCSF Benioff Children's Hospital Oakland·Phase 1/2·NCT00508027·42 enrolled

Effect of Simvastatin Treatment on Vaso-occlusive Pain in Sickle Cell Disease

Completed·UUCSF Benioff Children's Hospital Oakland·Phase 1/2·NCT01702246·24 enrolled

Central Nervous System Vascular Changes in Adult Sickle Cell Disease and the Effect of Treatment With Simvastatin

Unknown status·UUniversity of Campinas, Brazil·Phase 1/2·NCT03599609·28 enrolled

Myocardial Infarction3 trials

Simvastatin Effect on Inflammation and Endothelial Function After Myocardial Infarction

Completed·BBrasilia Heart Study Group·Phase 4·NCT00906451·58 enrolled

Additive Effect of Ezetimibe Upon Simvastatin During Myocardial Infarction

Completed·BBrasilia Heart Study Group·Phase 4·NCT00905905·40 enrolled

Effect of Statin Treatment on Insulin Sensitivity During Myocardial Infarction

Completed·BBrasilia Heart Study Group·Phase 4·NCT01205347·27 enrolled

Adult Subject3 trials

A Study To Estimate The Effect Of Repeated Dosing of PF-05175157 On The Pharmacokinetics Of A Single Dose Of Simvastatin In Healthy Adult Subjects

Completed· Pfizer logo

Pfizer·Phase 1·NCT01469468·14 enrolled

A Study To Evaluate The Safety And Tolerability Of SB-656933-AAA Following Repeated Doses In Healthy Adult Subjects

Completed· GSK logo

GSK·Phase 1·NCT00504439·36 enrolled

Drug-Drug Interaction (DDI) Study of Leramistat in Healthy Adult Subjects

Recruiting·MModern Biosciences Ltd·Phase 1·NCT06379958·48 enrolled

ART2 trials

A Multiple-dose Study of LY3031207 in Healthy Participants

Terminated· Eli Lilly logo

Eli Lilly·Phase 1·NCT01632566·39 enrolled

A Study of LY2623091 in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02300259·48 enrolled

Safety and Efficacy2 trials

Safety and Efficacy Study Comparing ABT-143 to Simvastatin in Subjects With Elevated Levels of Low Density Lipoprotein Cholesterol ("Bad Cholesterol") and Triglycerides

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00812955·474 enrolled

Evaluate Safety and Efficacy of ABT-335 in Combination With Simvastatin in Subjects With Multiple Abnormal Lipid Levels in the Blood

Completed·AAbbott·Phase 3·NCT00300456·657 enrolled

Metastatic Colorectal Cancer2 trials

Simvastatin and Panitumumab in Treating Patients With Advanced or Metastatic Colorectal Cancer

Unknown status·LLeiden University Medical Center·Phase 2·NCT01110785·46 enrolled

Trial of XELIRI/FOLFIRI + Simvastatin Followed by Simvastatin Maintenance in Metastatic Colorectal Cancer

Unknown status·SSamsung Medical Center·Phase 3·NCT01238094·258 enrolled

Multiple Myeloma2 trials

Simvastatin in Overcoming Chemotherapy Resistance in Patients With Relapsed or Refractory Multiple Myeloma

Withdrawn·WWake Forest University Health Sciences·Phase 1·NCT02971410

Efficacy and Safety of Statin on the Course of Progressive Smoldering Multiple Myeloma

Withdrawn·MMeir Medical Center·Phase 2·NCT00503763

Alzheimer's Disease2 trials

Endothelial Facilitation in Alzheimer's Disease

Completed·UUniversity of Massachusetts, Worcester·Phase 2·NCT01439555·11 enrolled

Statin Effects on Beta-Amyloid and Cerebral Perfusion in Adults at Risk for Alzheimer's Disease

Completed·UUniversity of Wisconsin, Madison·Phase 2·NCT00939822·88 enrolled

Multiple Sclerosis2 trials

A Safety Study of Combination Treatment With Avonex and Zocor in Relapsing Remitting Multiple Sclerosis

Unknown status·UUnknown Sponsor·Phase 3·NCT00242268·30 enrolled

Simvastatin as an add-on Treatment to Copaxone for the Treatment of Relapsing Multiple Sclerosis

Withdrawn·AAnna Tsakiri·Phase 3·NCT00429442

Atherosclerosis2 trials

Effect of Enhanced External Counterpulsation (EECP) on Subclinical Atherosclerosis

Completed·SSun Yat-sen University·N/A·NCT01106495·150 enrolled

Vascular Effects of Ezetimibe/Simvastatin and Simvastatin on Atherosclerosis

Completed·NNational Cheng-Kung University Hospital·Phase 4·NCT00560170·40 enrolled

Uveitis2 trials

Use of Simvastatin as a Steroid Sparing Agent for Uveitis Patients

Unknown status·UUniversity College, London·Phase 2/3·NCT02252328·50 enrolled

Simvastatin in Uveitis

Completed·FFederal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology·Phase 2·NCT04183387·50 enrolled

Chronic Periodontitis2 trials

Simvastatin Gel With Perforated Resorbable Membranes in Treatment of Intrabony Defects in Chronic Periodontitis

Completed·—·Phase 4·NCT03419429·40 enrolled

Comparative Evaluation Of 1.2% Atorvastatin and 1.2% Simvastatin Gel Local Drug Delivery And Redelivery In Chronic Periodontitis Subjects With Diabetes Mellitus: A Randomized Controlled Clinical Trial.

Completed·GGovernment Dental College and Research Institute, Bangalore·Phase 2/3·NCT03745300·120 enrolled

Cardiovascular Disease2 trials

Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia

Recruiting· Novartis logo

Novartis··NCT06858332·2,382 enrolled

A 12-week Study to Compare the Efficacy and Safety of Fixed Combinations of Fenofibrate/Simvastatin 145/20mg and Fenofibrate/Simvastatin 145/40mg Tablets Versus Fenofibrate or Simvastatin Monotherapies in Subjects With Abnormal Blood Levels of Fats (Lipids) and at High Risk of Cardiovascular Disease

Completed·AAbbott·Phase 3·NCT01674712·575 enrolled

Treatment2 trials

Treatment of HDL to Reduce the Incidence of Vascular Events HPS2-THRIVE

Completed·UUniversity of Oxford·Phase 3·NCT00461630·25,673 enrolled

Treatment of Graves´ophthalmopathy with Simvastatin (GO-S)

Recruiting·LLund University·Phase 3·NCT03131726·80 enrolled

Efficacy and Safety2 trials

12-week Open-label, Phase IIIb Comparing Efficacy and Safety of Rosuvastatin (CRESTOR™) in Combination With Ezetimibe

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00525824·1,743 enrolled

Randomized Comparative Efficacy and Safety Study of Intermittent Simvastatin and Fenofibrate in Hemodialysis

Completed·—·Phase 4·NCT02886299·60 enrolled

Chronic Pancreatitis2 trials

Simvastatin Treatment to Improve Patient-reported Outcomes in Patients With Chronic Pancreatitis

Recruiting·—·Phase 1·NCT05771675·90 enrolled

Simvastatin in Reducing Pancreatitis in Patients With Recurrent, Acute or Chronic Pancreatitis

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT02743364·8 enrolled

Schizophrenia2 trials

Cardio Risk of Acute Schizophrenia Olanzapine Duke

Withdrawn·—·Phase 4·NCT00672464

Add-on Simvastatin in Schizophrenia Trial

Terminated·NNew York State Psychiatric Institute·N/A·NCT00605995·15 enrolled

Atorvastatin2 trials

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

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00654537·5,625 enrolled

A Drug Interaction Study Between Simvastatin, Atorvastatin, Rosuvastatin, and GSK2248761 in Healthy Subjects.

Completed· GSK logo

GSK·Phase 1·NCT01138072·14 enrolled

Combination Therapy2 trials

Effect of Combination Therapy With Two Drugs (Colesevelam and Ezetimibe) in Patients With High Cholesterol

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 4·NCT00185107·45 enrolled

Effects on NF-κB Activity: High Dose Simvastatin Versus Combination Therapy With Ezetimibe

Completed·HHeidelberg University·N/A·NCT01424891·31 enrolled

Clinical Trial2 trials

A Clinical Trial Comparing Torcetrapib/Atorvastatin To Simvastatin In Subjects With High Cholesterol (A5091031).

Terminated· Pfizer logo

Pfizer·Phase 3·NCT00267280·640 enrolled

A Clinical Trial Comparing Torcetrapib/Atorvastatin To Simvastatin In Subjects With High Cholesterol.

Completed· Pfizer logo

Pfizer·Phase 3·NCT00267254·640 enrolled

Chronic Hepatitis2 trials

Simvastatin for the Treatment of Chronic Hepatitis B

Completed·—·Phase 1·NCT00994773·32 enrolled

Statins in Chronic Hepatitis C Patients Receiving Sofosbuvir/Daclatasvir Combination

Completed·—·Phase 2/3·NCT03490097·100 enrolled

Hypertensive2 trials

Antihypertensive Effect of Simvastatin in Hypertensive Patients

Unknown status·HHospital de Clinicas de Porto Alegre·Phase 4·NCT00704548·92 enrolled

Protective Effect of Zingiber Officinale L. Extract in Hypertensive Patients

Completed·JJinnah Sindh Medical University·Phase 1·NCT05682911·40 enrolled

Statins2 trials

Effects of Selected Statins on Blood Glucose Levels in Healthy Volunteers

Not yet recruiting·SShaheed Benazir Bhutto University Sheringal Dir Upper·Phase 1·NCT07378293·100 enrolled

A Study of Evacetrapib With Selected Statins in Healthy Chinese Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02156492·62 enrolled

Emotional Processing2 trials

Simvastatin and Emotional Processing (OxSTEP)

Completed·UUniversity of Oxford·N/A·NCT04973800·101 enrolled

7-day Simvastatin and Emotional Processing

Completed·UUniversity of Oxford·Phase 1/2·NCT04652089·53 enrolled

Oxidative Stress2 trials

Oxidative Stress Lowering Effect of Simvastatin and Atorvastatin.

Unknown status·AAmsterdam UMC, location VUmc·Phase 4·NCT00404599·60 enrolled

Efficacy of High and Low-Dose Simvastatin on Vascular Oxidative Stress and Neurological Outcome in Patients With AIS

Completed·TThammasat University·Phase 3·NCT03402204·64 enrolled

Heart Disease2 trials

A Trial of Inflammatory Markers, Depressive Symptoms, and Heart Disease

Terminated·NNew York State Psychiatric Institute·Phase 1·NCT00208117·7 enrolled

The Effects of Ezetimibe/Simvastatin 10/20 mg Versus Simvastatin 40 mg in High Cholesterol and Coronary Heart Disease Study (P04039AM2)(COMPLETED)

Completed·OOrganon and Co·Phase 4·NCT00423579·120 enrolled

Lung Disease1 trial

Effect of Statin Therapy on C-reactive Protein Levels in Patients With Chronic Obstructive Lung Disease (COPD)

Completed·VVA Loma Linda Health Care System·Phase 1·NCT00655993·30 enrolled

Type 2 Diabetes Mellitus1 trial

A Study of the Efficacy and Safety of MK-0431D (a Fixed-dose Combination of Sitagliptin and Simvastatin) for the Treatment of Participants With Type 2 Diabetes Mellitus (T2DM) With Inadequate Glycemic Control on Metformin Monotherapy (MK-0431D-266)

Terminated· Merck & Co. logo

Merck & Co.·Phase 3·NCT01678820·299 enrolled

Portal Hypertension1 trial

Simvastatin Effect on Portal Hypertension

Completed·UUniversidade Federal do Rio de Janeiro·Phase 3·NCT02134626·34 enrolled

Ultrasound1 trial

Evaluation Of The Portal Pressure By Doppler Ultrasound In Cirrhotic Patients Before And After Simvastatin

Completed·TTanta University·Phase 4·NCT02994485·40 enrolled

Bone Loss1 trial

Simvastatin to Prevent SCI-Induced Bone Loss

Unknown status·—·Phase 2·NCT02946424·76 enrolled

Endothelial Function1 trial

Effect of Simvastatin Withdrawal on Ocular Endothelial Function

Withdrawn·MMedical University of Vienna·Phase 4·NCT02533141

Pneumonia1 trial

Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia

Recruiting·UUMC Utrecht·Phase 3·NCT02735707·20,000 enrolled

Metabolism1 trial

Simvastatin Metabolism as a Test for CD Activity (IRB 15-007568]

Completed·EEntero Therapeutics·Phase 1·NCT03011931·40 enrolled

Vitamin D1 trial

Effect of Vitamin D Supplementation on Exercise Adaptations in Patients on Statin Therapy

Completed·PPost Graduate Institute of Medical Education and Research, Chandigarh·Phase 3·NCT02030041·33 enrolled

Peripheral Artery Disease1 trial

Effects of Nicotinic Acid Plus Simvastatin Versus Simvastatin Alone on Carotid and Femoral Intima-Media Thickness in Patients With Peripheral Artery Disease (NASCIT)

Unknown status·MMedical University of Vienna·Phase 4·NCT00712049·200 enrolled

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

Peritoneal Dialysis1 trial

Simvastatin Effect on End Stage Renal Failure Patients Treated by Peritoneal Dialysis

Unknown status·FFederal University of São Paulo·Phase 4·NCT00291863·30 enrolled

Survival1 trial

Fixed Dose Intervention Trial of New England Enhancing Survival in SMI Patients

Completed·MMclean Hospital·Phase 4·NCT02188121·227 enrolled

Pulmonary Hypertension1 trial

Simvastatin as a Treatment for Pulmonary Hypertension

Completed·IImperial College London·Phase 1/2·NCT00180713·42 enrolled

Toxicity1 trial

Detection and Prevention of Anthracycline-Related Cardiac Toxicity With Concurrent Simvastatin

Terminated·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT02096588·34 enrolled

Thrombosis1 trial

Anti-Platelet and Statin Therapy to Prevent Cancer-Associated Thrombosis

Completed·—·Phase 1·NCT02285738·17 enrolled

Midazolam1 trial

Effects of Statins on the Pharmacokinetics for Midazolam in Healthy Volunteers

Completed·HHamamatsu University·N/A·NCT00716846·11 enrolled

Platelet-rich Fibrin1 trial

Effect of Local Application of Platelet-rich Fibrin Scaffold Loaded With Simvastatin on Peri-implant Bone Changes

Completed·—·Phase 1·NCT05008068·8 enrolled

Adolescent1 trial

Effects of Ezetimibe With Simvastatin in the Therapy of Adolescents With HeFH (Study P02579)

Completed·OOrganon and Co·Phase 3·NCT00129402·248 enrolled

Biomarker1 trial

Simvastatin With or Without Ezetimibe and Atherothrombotic Biomarker Assessment

Completed·UUniversity of Maryland, Baltimore·Phase 4·NCT00819403·15 enrolled

Chemotherapy1 trial

Combined Simvastatin and Albumin Paclitaxel in Treating ES-SCLC Patients Relapsed From 1st Chemotherapy

Unknown status·SShanghai Pulmonary Hospital, Shanghai, China·Phase 2·NCT04698941·40 enrolled

Overweight1 trial

A Study to Evaluate LY3202328 in Overweight Healthy Participants and Dyslipidemia

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02714569·60 enrolled

Concentration1 trial

Study for Identifying Optimal Simvastatin Formulation for Uniform Time to Maximum Plasma Concentration

Terminated·UUniversity of Zurich·Phase 1·NCT01642862·12 enrolled

Lymphoma1 trial

Feasibility Study of Simvastatin in Hodgkin's Lymphoma Survivors

Terminated·—·N/A·NCT00746603·3 enrolled

Acute Lung Injury1 trial

Simvastatin Effect on the Incidence of Acute Lung Injury/Adult Respiratory Distress Syndrome (ALI/ARDS)

Withdrawn·UUniversity of Oklahoma·N/A·NCT01195428

Microvascular Dysfunction1 trial

Targeting Microvascular Dysfunction in Young Hypertensive Patients

Withdrawn·QQueen's University, Belfast·Phase 4·NCT01047423

COVID-191 trial

Simvastatin Nasal Rinses for the Treatment of COVID-19 Mediated Dysomsia

Withdrawn·WWashington University School of Medicine·Phase 1·NCT05542095

Monotherapy1 trial

Comparison of the Combination of Fenofibrate and 20 mg Simvastatin Versus 40 mg Simvastatin Monotherapy

Completed·SSolvay Pharmaceuticals·Phase 3·NCT00349375·1,040 enrolled

Surgical1 trial

Lepidium Sativum Extract Versus Simvastatin as an Adjunctive Local Delivery Agents to Non-Surgical Periodontal Therapy

Completed·—·Phase 4·NCT05657015·30 enrolled

Impaired glucose tolerance1 trial

Pioglitazone in Impaired Glucose Tolerance

Withdrawn·UUniversity of Leipzig·Phase 4·NCT00306826·120 enrolled

Cerebral Cavernous Malformation1 trial

Permeability MRI in Cerebral Cavernous Malformations Type 1 in New Mexico: Effects of Statins

Terminated·UUniversity of New Mexico·Phase 1·NCT01764451·12 enrolled

Bone Regeneration1 trial

Topic Simvastatin for Bone Regeneration

Recruiting·UUniversidad de Granada·Phase 1·NCT07031778·90 enrolled

Cardiovascular1 trial

Effects of Simvastatin and Ezetimibe on Cardiovascular Risk Markers in Patients With Dyslipidemia

Completed·FFundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana·N/A·NCT02304926·42 enrolled

Percutaneous Coronary Intervention1 trial

Effect of Acute Statin Treatment in Patients Undergoing Percutaneous Coronary Intervention

Terminated·MMayo Clinic·N/A·NCT00588471·57 enrolled

NAFLD1 trial

Therapeutic Effects of Compound Zhenzhu Tiaozhi Capsules in NAFLD

Unknown status·TThe First Affiliated Hospital of Guangdong Pharmaceutical University·N/A·NCT03375580·196 enrolled

Colorectal Surgery1 trial

Simvastatin in Colorectal Surgery

Completed·UUniversity of Auckland, New Zealand·Phase 3·NCT00994903·132 enrolled

Laparoscopic Sleeve Gastrectomy (LSG)1 trial

Pharmacokinetics of Simvastatin Post Laparoscopic Sleeve Gastrectomy (LSG)

Unknown status·NNational University Hospital, Singapore·Phase 4·NCT03571802·10 enrolled

Alopecia Areata1 trial

Topical Simvastatin Versus Topical Steroid in Treatment of Alopecia Areata

Not yet recruiting·—·Phase 4·NCT06399783·54 enrolled

Ischemia1 trial

Ischemia/Reperfusion Injury of Human Endothelium: Role of Glucose and Statins

Completed·UUS Department of Veterans Affairs·N/A·NCT00995670·59 enrolled

Mortality1 trial

Effect of Statin Therapy on Mortality in Patients With Ventilator Associated Pneumonia

Completed·—·Phase 4·NCT05230472·161 enrolled

Single Dose1 trial

Effect of Repeated Oral Doses of Avacopan on the Pharmacokinetics (PK) of a Single Dose of Simvastatin

Completed· Amgen logo

Amgen·Phase 1·NCT06207682·32 enrolled

Refractory1 trial

Simvastatin With Topotecan and Cyclophosphamide in Relapsed and/or Refractory Pediatric Solid and CNS Tumors

Completed·EEmory University·Phase 1·NCT02390843·13 enrolled

Rigidity1 trial

Vytorin on Carotid Intima-media Thickness and Overall Rigidity

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

Dapagliflozin1 trial

Pharmacokinetic Drug Interaction Study of Dapagliflozin and Valsartan or Simvastatin in Healthy Subjects

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT00839683·24 enrolled

Systemic Lupus Erythematosus1 trial

Efficacy and Adverse Effect of Simvastatin Compare to Rosuvastatin in Systemic Lupus Erythematosus (SLE) Patients With Corticosteroid Therapy and High Low-Density Lipoprotein (LDL) Cholesterol Level

Unknown status·RRamathibodi Hospital·Phase 4·NCT00866229·140 enrolled

Empagliflozin1 trial

Drug-drug Interaction of Empagliflozin (BI 10773) and Simvastatin

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT01304329·18 enrolled

Double-blind1 trial

Effect Of Ezetimibe Coadministration With Simvastatin In A Middle Eastern Population: A Prospective, Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial (0653-151)

Completed·OOrganon and Co·Phase 4·NCT00652444·120 enrolled

Renal insufficiency1 trial

PROMISS: Simvastatin Prevents the Contrast Induced Acute Renal Failure in Patients With Renal Insufficiency Undergoing Coronary Angiography

Completed·SSeoul National University Hospital·Phase 4·NCT00259441·320 enrolled

Kidney Transplant1 trial

The Effect of Simvastatin on Desensitization of Panel-Positive Kidney Transplant Candidates

Completed·SShiraz University of Medical Sciences·Phase 2/3·NCT00693576·82 enrolled

Cognition1 trial

Effects of Achieving Very Low LDL-Cholesterol After Treatment With Statins on Steroidogenesis and Cognition

Completed·—·Phase 4·NCT00522158

Relapse1 trial

High-dose HMG-CoA Inhibitor Simvastatin Relapsed CLL

Completed·JJohn Haslip·Phase 1·NCT00828282·3 enrolled

Pulpotomy1 trial

Simvastatin Versus MTA in Pulpotomy of Immature Permanent Molars

Unknown status·AAhmad Elheeny·Phase 1·NCT05878158·128 enrolled

Peripheral Arterial Disease1 trial

Comprehensive Magnetic Resonance of Peripheral Arterial Disease

Completed·UUniversity of Virginia·N/A·NCT00587678·85 enrolled

Mucositis1 trial

Use of Topical Subgingival Application of Simvastatin Gel in the Treatment of Peri-Implant Mucositis

Completed·AAhmed Mohamed Mahrous·Phase 2·NCT03400475·46 enrolled

Outcome1 trial

Effects of Simvastatin on Biochemical Parameters and Outcome of IVF-ICSI in Pcos Patients

Completed·TTehran University of Medical Sciences·Phase 3·NCT00575601·120 enrolled

Relapsing-Remitting Multiple Sclerosis1 trial

Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis

Completed· Biogen logo

Biogen·Phase 4·NCT00492765·380 enrolled

Chronic Rhinosinusitis1 trial

Efficacy Study of SIMVASTATIN to Treat Chronic Rhinosinusitis After Failure of Optimal Treatment

Terminated·—·Phase 2·NCT01771198·7 enrolled

Renal Protection1 trial

Study of Heart and Renal Protection

Completed·UUniversity of Oxford·Phase 4·NCT00125593·9,438 enrolled

Transplantation1 trial

Donor Simvastatin Treatment in Organ Transplantation

Completed·HHelsinki University Central Hospital·Phase 2/3·NCT01160978·84 enrolled

Mitochondria1 trial

Effects of Epicatechin on Statins for Mitochondrial Dysfunction and Impaired Exercise Capacity

Completed·UUniversity of California, San Diego·N/A·NCT02490527·19 enrolled

Cardiomyopathy1 trial

Carvedilol + Simvastatin vs. Carvedilol Alone for Cirrhosis and Cirrhotic Cardiomyopathy and Impact on Hepatic Decompensation and Survival

Recruiting·PPost Graduate Institute of Medical Education and Research, Chandigarh·N/A·NCT06431919·260 enrolled

Diabetic Retinopathy1 trial

Effect of Lipid Lowering Agents on Diabetic Retinopathy and Cardiovascular Risk of Diabetic Patients

Unknown status·AAlaa Hassan ElBaz·Phase 4·NCT04140201·80 enrolled

Rheumatoid Arthritis1 trial

Methotrexate and Statins With Methotrexate Alone in the Treatment of Rheumatoid Arthritis

Completed·KKing Edward Medical University·Phase 4·NCT04177173·100 enrolled

Sclerosing Cholangitis1 trial

Effect of Simvastatin on the Prognosis of Primary Primary Sclerosing Cholangitis (PSC)

Active, not recruiting·AAnnika Bergquist·Phase 3·NCT04133792·571 enrolled

Uterine leiomyoma1 trial

Effects of Simvastatin on Uterine Leiomyoma Size

Recruiting·JJohns Hopkins University·Phase 2·NCT03400826·60 enrolled

Drug Metabolism1 trial

KF2022#4-trial: Effects of a Beta Blocker and NSAID on CYP Mediated Drug Metabolism

Completed·HHelsinki University Central Hospital·N/A·NCT06566794·12 enrolled

Hepatopulmonary Syndrome1 trial

To Study the Safety and Efficacy of Simvastatin in Patients With Hepatopulmonary Syndrome in Cirrhosis.

Unknown status·IInstitute of Liver and Biliary Sciences, India·N/A·NCT05187715·45 enrolled

Ovarian Cancer1 trial

Statin Therapy to Reduce Progression in Women With Platinum Sensitive Ovarian Cancer

Completed·MMarc Goodman·Phase 1·NCT04457089·18 enrolled

Intracerebral Hemorrhage1 trial

Simvastatin For Intracerebral Hemorrhage Study

Terminated·JJohns Hopkins University·Phase 2·NCT00718328·1 enrolled

Morbid Obesity1 trial

Simvastatin add-on Treatment to Standard Antidepressant Therapy in Patients With Comorbid Obesity and Major Depression

Completed·—·Phase 2·NCT04301271·161 enrolled

Metformin1 trial

A Study to Evaluate the DDI of DBPR108 With Metformin,Glibenclamide,Valsartan, or Simvastatin in Healthy Subjects

Completed· CSPC ZhongQi Pharmaceutical Technology Co., Ltd. logo

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.·Phase 1·NCT04859452·56 enrolled

LDL-cholesterol1 trial

Investigating the Lowest Threshold of Vascular Benefits From LDL Cholesterol Lowering in Patients With Stable CV Disease

Unknown status·—·N/A·NCT03355027·60 enrolled

Pancreatitis1 trial

Simvastatin in the Prevention of Recurrent Pancreatitis

Terminated·EEnrique de-Madaria·Phase 3·NCT04021498·83 enrolled

Post Operative Pain1 trial

Effect of Simvastatin Versus Calcium Hydroxide Intracanal Medications on Post-operative Pain and Interleukin 6 and 8

Completed·—·N/A·NCT05525013·30 enrolled

Bone Health1 trial

Statin and Bone Health

Unknown status·TThe University of Hong Kong·Phase 4·NCT05613400·240 enrolled

Diabetes1 trial

High Potency Statins and the Risk of Diabetes

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

Treatment Resistant Depression1 trial

Simvastatin as an Augmentation Treatment for Treatment Resistant Depression: Randomized Controlled Trial.

Completed·PPakistan Institute of Living and Learning·Phase 3·NCT03435744·150 enrolled

Metabolic Syndrome1 trial

Gut Microbiomes in Patients With Metabolic Syndrome

Unknown status·—··NCT03489317·1,000 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

Chronic Kidney Disease1 trial

Lipid-lowering Therapies in Vietnamese Chronic Kidney Disease Population

Unknown status·HHue University of Medicine and Pharmacy·Phase 4·NCT03543774·30 enrolled

Biliary Tract Cancer1 trial

Adebrelimab Combined With Gemcitabine, Cisplatin, and Simvastatin for Advanced Biliary Tract Cancer

Recruiting·TTongji Hospital·Phase 1/2·NCT07392541·29 enrolled

Pancreatic Adenocarcinoma1 trial

Valproic Acid/Simvastatin Plus Gemcitabine/Nab-paclitaxel Based Regimens in Untreated Metastatic Pancreatic Adenocarcinoma Patients

Recruiting·NNational Cancer Institute, Naples·Phase 2·NCT05821556·240 enrolled

Fibrosis1 trial

Efficacy of Simvastatin in Alcoholic Liver Fibrosis

Recruiting·AAnna Cruceta·Phase 2/3·NCT04971577·90 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

Dental Implant1 trial

Effect of Locally Applied Simvastatin Gel on Dental Implant Stability and Marginal Bone Level

Completed·MMaha Zuhair·N/A·NCT07194447·42 enrolled

Effectiveness1 trial

Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine

Completed·UUniversity of Oxford·Phase 3·NCT00124072·12,064 enrolled

Cognitive impairment1 trial

Trial of Simvastatin in Amnestic Mild Cognitive Impairment (MCI) Patients

Unknown status·—·Phase 4·NCT00842920·520 enrolled

Prostate Cancer1 trial

T-reg Function Changes: a Novel Immune Regulatory Effect Underlying Benefit of Statin Use on Lethal Prostate Cancer

Recruiting·MMedical University of South Carolina·Phase 2·NCT05586360·36 enrolled

Bone Density1 trial

Salivary Bmp-2 Levels & Radiographic Measurement Of Bone Density at Extracted Tooth

Completed·PPostgraduate Medical Institute, Lahore·Phase 4·NCT05369091·24 enrolled

Endometriosis1 trial

Endometriosis and Microvascular Dysfunction; Simvastatin and Duavee

Recruiting·PPenn State University·Phase 4·NCT05059626·28 enrolled

Magnetic Resonance Imaging (MRI)1 trial

Transesophageal Magnetic Resonance Imaging (MRI) in Conjunction With Lipid Lowering Measures

Completed·JJohns Hopkins University·N/A·NCT00125060·72 enrolled

Bariatric Surgery1 trial

Impact of Bariatric Surgery on Pharmacokinetic Study of Simvastatin and Carvedilol

Unknown status·NNatalia Valadares de Moraes·Phase 4·NCT04049786·120 enrolled

Subarachnoid Hemorrhage1 trial

Use of Simvastatin for the Prevention of Vasospasm in Aneurysmal Subarachnoid Hemorrhage

Terminated·UUniversity of Illinois at Chicago·N/A·NCT00487461·25 enrolled

Unspecified3 trials

MK0524B Bioequivalence Study (0524B-070)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT00943124·220 enrolled

Ezetrol Post-Marketing Study

Completed· Merck & Co. logo

Merck & Co.·Phase 4·NCT00753883·40 enrolled

NIRS to Diagnose SAMS

Unknown status·HHartford Hospital·Phase 4·NCT03653663·40 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 23, 1991

ZOCOR

NDA NDA019766

Oct 9, 2007

SIMVASTATIN

NDA NDA021961

Apr 21, 2016

FLOLIPID

NDA NDA206679

Sources

References

[1]
ClinicalTrials.gov — 393 trial records for simvastatin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Zocor drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — simvastatin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for simvastatin. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA206679). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Zocor. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Organon and Co 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: OOrganon and Co

Patent Landscape[6]

Patent Cliff

Apr 26, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10300041Apr 26, 2027

9597289Feb 23, 2030