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 101 indications[4].[1]

Zocor is one of 1683 small molecule programs targeting Polycystic Ovary Syndrome. It is currently in Approved.

101

Indications

396

Total Trials

Active Trials

1,682

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Polycystic Ovary SyndromeApproved

SinusitisApproved

Acute PancreatitisApproved

Abnormal Circulating Lipid ConcentrationActive, not recruiting

Breast CancerCompleted

StatinsNot yet recruiting

Migraine DisorderApproved

Intestinal NeoplasmApproved

Diabetic NephropathyApproved

Combined HyperlipidemiaApproved

Polycystic Ovary SyndromeApproved

Approved

SinusitisApproved

Approved

Acute PancreatitisApproved

Approved

Abnormal Circulating Lipid ConcentrationApproved

Active, not recruiting

Breast CancerPhase 2

Completed

StatinsPhase 1

Not yet recruiting

Migraine DisorderApproved

Approved

Intestinal NeoplasmApproved

Approved

Diabetic NephropathyApproved

Approved

Combined HyperlipidemiaApproved

Approved

Showing 10 of 99 indications

Competition

Competitive Landscape

702 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Zocor

OOrganon and Co

Approved

7 2

Adenocard

Astellas

Preclinical

2 3

Lexiscan

Astellas

Preclinical

1 4

Zolymbus

AbbVie

Preclinical

1 5

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 6

Duragesic-100

CCephalon

Preclinical

2 7

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

2 8

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

1 9

Duragesic

CCephalon

Preclinical

1 10

Cortef

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 1Active, not recruiting

Neurotoxicity

NCT04514029

N/ARecruiting

Myocardial Protection

NCT01653223

Q3 2027

Recruiting

Cardiovascular Disease

NCT06858332

Q4 2027

Post-ApprovalNot yet recruiting

Alopecia Areata

NCT06399783

Clinical

Trials by Indication[1]

Statin20 trials

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

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

Bioequivalence Study of Simvastatin Tablets, 80 mg of Dr. Reddy's Under Fed Conditions

Completed·—·Phase 1·NCT01167933·44 enrolled

Bioequivalence Study of Simvastatin Tablets 80 mg of Dr. Reddy's Under Fasting Condition

Completed·—·Phase 1·NCT01167894·72 enrolled

Show 17 more trials

Anti-inflammatory Effects of Simvastatin

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

Simvastatin for mTBI

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

Evaluating Simvastatin's Potential Role in Therapy

Completed·UUniversity of Wisconsin, Madison·Phase 2·NCT00486044·103 enrolled

The DDI Study of SP2086 and Simvastatin

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

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

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

Statin Therapy Vs. Therapeutic Lifestyle Changes and Supplements

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

IIIb 6 Week Open Label Multicentre Rosuvastatin & Simvastatin

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00654446·442 enrolled

Effect of Repeated Administration of Eslicarbazepine Acetate on the Pharmacokinetics of Simvastatin in Healthy Subjects

Completed·BBial - Portela C S.A.·Phase 1·NCT00987558·30 enrolled

Intensive Statin Therapy in Patients With AMI

Unknown status·—·Phase 2·NCT01923077·140 enrolled

Safety of Simvastatin in LAM and TSC

Completed·UUniversity of Pennsylvania·Phase 1/2·NCT02061397·10 enrolled

Simvastatin Around Immediate Implant

Completed·—·Phase 2·NCT04803500·10 enrolled

Effect of Statin Use on Aldosterone Secretion

Completed·—·Phase 1·NCT02871687·103 enrolled

Simvastatin Therapy for Moderate and Severe COPD

Terminated·UUniversity of Minnesota·Phase 3·NCT01061671·885 enrolled

LDL Receptor Under Ezetimibe and Simvastatin

Completed·UUniversity of Cologne·Phase 4·NCT00317993·60 enrolled

The Effect of Multiple Doses of Epanova® on the Multiple-Dose Pharmacokinetics of Simvastatin in Healthy Normal Subjects

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01486433·52 enrolled

Effect of Gemcabene on the Pharmacokinetics of Simvastatin in Healthy Volunteers

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

Muscle Characteristics Associated With Statin Therapy

Withdrawn·SScripps Health·N/A·NCT00990834

Hypercholesterolemia9 trials

Coadministration of Ezetimibe and Simvastatin in Patients With Primary Hypercholesterolemia (P05457)

Completed·OOrganon and Co·Phase 3·NCT00653523·151 enrolled

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

Show 6 more trials

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

Combination of Telmisartan and Simvastatin in the Treatment of Hypertension and Hypercholesterolemia

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 3·NCT00316095·1,695 enrolled

Comparison of Ezetimibe Plus Simvastatin Versus Ezetimibe or Simvastatin Alone in Subjects With Primary Hypercholesterolemia (Study P03757)(COMPLETED)

Completed·OOrganon and Co·Phase 3·NCT00650819·240 enrolled

Effect of Ezetimibe Plus Simvastatin on Flow-Mediated Brachial Artery Vasoactivity in Subjects With Primary Hypercholesterolemia (Study P03336)

Terminated·OOrganon and Co·Phase 3·NCT00651391·28 enrolled

Efficacy of Lapaquistat Acetate Alone or Combined With Simvastatin in Subjects With Hypercholesterolemia

Completed· Takeda logo

Takeda·Phase 3·NCT00286481·1,362 enrolled

Ezetimibe Plus Simvastatin Versus Simvastatin Alone in African-American Subjects With Primary Hypercholesterolemia (P03377)

Completed·OOrganon and Co·Phase 4·NCT00650663·247 enrolled

Cholesterol8 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

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

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

Show 5 more trials

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

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

Crossover of Higher Dose Statins in Patients With Low High-density Lipoproteins Cholesterol (HDLc)

Unknown status·OOregon Health and Science University·Phase 4·NCT00736463·80 enrolled

SLOS: The Effect of Simvastatin in Patients Receiving Cholesterol Supplementation

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

A Study for Pre-diabetic Patients With Cholesterol Lowering Drugs

Completed·UUniversity of Chicago·Phase 2/3·NCT00831129·53 enrolled

Cholesterol and Pharmacogenetic Study

Completed·UUCSF Benioff Children's Hospital Oakland·Phase 4·NCT00451828·1,000 enrolled

Interaction6 trials

15-Day Repeated-Dose Study With SB-649868 And Its Interaction With CYP3A4 Isoenzyme In Healthy Male Subjects.

Completed· GSK logo

GSK·Phase 1·NCT00495729·36 enrolled

The Drug-drug Interaction of SP2086 and Simvastatin

Completed·JJiangsu HengRui Medicine Co., Ltd.·Phase 1·NCT02815722·16 enrolled

A Drug-Drug Interaction Study of Orforglipron (LY3502970) in Healthy Overweight and Obese Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT06186622·50 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 Study to Investigate the Interaction of GSK1292263 With Rosuvastatin and Simvastatin in Healthy Subjects

Completed· GSK logo

GSK·Phase 1·NCT01101568·28 enrolled

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

Completed· GSK logo

GSK·Phase 1·NCT01953835·37 enrolled

Efficacy and Safety6 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

Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin

Completed·KKowa Research Europe·Phase 3·NCT00309738·355 enrolled

Show 3 more trials

Comparing the Efficacy and Safety of Rosuvastatin With Atorvastatin and Simvastatin (SOLAR)

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00654173·4,444 enrolled

Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin

Completed·KKowa Research Europe·Phase 3·NCT00309777·857 enrolled

Evaluation of Efficacy and Safety of Combined Omacor (Omega-3-acid Ethyl Esters) and Simvastatin Therapy in Hypertriglyceridemic Subjects

Completed· GSK logo

GSK·Phase 3·NCT00246701·256 enrolled

109 more indications

Atorvastatin5 trials

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

A Pharmacokinetic Interaction Study Between TMC435, Atorvastatin and Simvastatin in Healthy Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT01689623·36 enrolled

Show 2 more trials

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

Completed· GSK logo

GSK·Phase 1·NCT01138072·14 enrolled

A Single-centre Open Label Study to Investigate the Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin in Healthy Male Volunteers.

Completed· GSK logo

GSK·Phase 1·NCT01299597·30 enrolled

Breast Cancer4 trials

Simvastatin and Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ or Invasive Breast Cancer

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT00354640·11 enrolled

A Prevention Trial in Subjects at High Risk for Breast Cancer

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

Simvastatin in Preventing a New Breast Cancer in Women at High Risk for a New Breast Cancer

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT00334542·50 enrolled

Show 1 more trial

Phase II Study of Simvastatin in Primary Breast Cancer; Test of Its Potential Selectivity on Basal Subtype Breast Cancer

Unknown status·NNational University Hospital, Singapore·Phase 2·NCT00807950·100 enrolled

Metastatic Colorectal Cancer4 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

A Single Arm, Phase II Study of Simvastatin Plus XELOX and Bevacizumab as First-line Chemotherapy in Metastatic Colorectal Cancer Patients

Completed·SSamsung Medical Center·Phase 2·NCT02026583·43 enrolled

Show 1 more trial

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

Unknown status·LLeiden University Medical Center·Phase 2·NCT01190462·51 enrolled

Schizophrenia4 trials

Role of Anti-Inflammatory Agents in Patients With Schizophrenia

Completed·PPakistan Institute of Living and Learning·Phase 1·NCT00929955·36 enrolled

Randomized Double Blind Placebo Control Study in Patients with Schizophrenia

Completed·PPakistan Institute of Living and Learning·Phase 2·NCT01602029·303 enrolled

Add-on Simvastatin in Schizophrenia Trial

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

Show 1 more trial

Simvastatin Addition for Patients With Recent-onset Schizophrenia

Completed·IIris Sommer·Phase 3·NCT01999309·121 enrolled

Adult Subject3 trials

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

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

Effect of SSP-004184 (SPD602) on the Pharmacokinetics of Simvastatin in Healthy Adult Subjects

Completed· Takeda logo

Takeda·Phase 1·NCT01979185·30 enrolled

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

Portal Hypertension3 trials

Simvastatin Effect on Portal Hypertension

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

Study About Simvastatin in Portal Hypertension in Compensated Cirrhosis

Unknown status·FFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau·Phase 4·NCT01282398·80 enrolled

Efficacy and Safety of Simvastatin in the Treatment of Portal Hypertension

Completed·HHospital Clinic of Barcelona·Phase 2·NCT00594191·59 enrolled

Type 2 Diabetes3 trials

Effect of Ezetimibe or Simvastatin or Both on Low Densitiy Lipoprotein -Subfractions in Patients With Type 2 Diabetes

Completed·UUniversity Hospital Freiburg·Phase 4·NCT01384058·41 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

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

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

Pneumonia2 trials

Impact of Statins on Cytokine Expression in Pneumonia

Withdrawn·TThe University of Texas Health Science Center at San Antonio·Phase 4·NCT00946166

Effect of Simvastatin on Pneumonia Prognosis in Elderly Patients

Unknown status·IIndonesia University·Phase 3·NCT01651728·200 enrolled

Safety and Efficacy2 trials

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

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

Chronic Obstructive Pulmonary Disease2 trials

Simvastatin in Chronic Obstructive Pulmonary Disease (COPD)

Unknown status·UUniversity of East Anglia·Phase 4·NCT00680641·20 enrolled

The Effect of Statins in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Completed·UUniversity of Nottingham·Phase 4·NCT01151306·70 enrolled

Myocardial Infarction2 trials

Effect of Statin Treatment on Insulin Sensitivity During Myocardial Infarction

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

Additive Effect of Ezetimibe Upon Simvastatin During Myocardial Infarction

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

Type 2 Diabetes Mellitus2 trials

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

Simvastatin and Fenofibrate vs Simvastatin Alone in Patients With Type 2 Diabetes Mellitus and Acute Coronary Syndrome

Unknown status·—·Phase 4·NCT02015988·60 enrolled

Sickle Cell Disease2 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

Multiple Sclerosis2 trials

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

Withdrawn·AAnna Tsakiri·Phase 3·NCT00429442

Multiple Sclerosis-Simvastatin Trial 2

Completed·UUniversity College, London·Phase 3·NCT03387670·964 enrolled

Concentration2 trials

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

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

To Explore The Potential For PF-04531083 To Effect The Blood Concentrations Of Simvastatin And Its Main Acid Metabolite Following Co-Administration Of Both Medications

Completed· Pfizer logo

Pfizer·Phase 1·NCT01103739·24 enrolled

COVID-192 trials

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

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

Coronavirus Response - Active Support for Hospitalised Covid-19 Patients

Withdrawn·LLondon School of Hygiene and Tropical Medicine·Phase 3·NCT04343001

Monotherapy2 trials

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

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

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

Completed·SSolvay Pharmaceuticals·Phase 3·NCT00352183·450 enrolled

Surgical2 trials

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

Completed·—·Phase 4·NCT05657015·30 enrolled

The Use of Injectable Plasma Versus the Use of Simvastatin Gel in Surgical Management of Bony Defect in Dentistry

Unknown status·—·Phase 1·NCT04824898·24 enrolled

Dyslipidemia2 trials

Efficacy of Lapaquistat Acetate and Simvastatin in Subjects With Primary Dyslipidemia.

Completed· Takeda logo

Takeda·Phase 3·NCT00256178·411 enrolled

Ezetimibe and Simvastatin in Dyslipidemia of Diabetes

Completed· Mario Negri Institute for Pharmacological Research logo

Mario Negri Institute for Pharmacological Research·Phase 2·NCT00157482·108 enrolled

Type 2 Diabetic Patients2 trials

Evaluate the Efficacy and Safety of Rosuvastatin Versus Simvastatin in Type 2 Diabetic Patients With Dyslipidemia

Completed·TTaipei Veterans General Hospital, Taiwan·Phase 4·NCT00506961·90 enrolled

Does Simvastatin Affect Insulin Sensitivity in Dyslipidemic Type 2 Diabetic Patients?

Completed·MMedical University of Vienna·N/A·NCT00704314·20 enrolled

Alzheimer's Disease2 trials

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

Cholesterol Lowering Agent to Slow Progression (CLASP) of Alzheimer's Disease Study

Completed·NNational Institute on Aging (NIA)·Phase 3·NCT00053599·400 enrolled

Aneurysm2 trials

Simvastatin in Aneurysmal Subarachnoid Haemorrhage (STASH) a Multicentre Randomised Controlled Clinical Trial

Completed·—·Phase 3·NCT00731627·803 enrolled

High-dose Simvastatin for Aneurysmal Subarachnoid Haemorrhage

Completed·—·Phase 2/3·NCT01077206·255 enrolled

Acute Coronary Syndrome2 trials

IMPROVE-IT: Examining Outcomes in Subjects With Acute Coronary Syndrome: Vytorin (Ezetimibe/Simvastatin) vs Simvastatin (P04103)

Completed·OOrganon and Co·Phase 3·NCT00202878·18,144 enrolled

Microcirculation In Acute Coronary Syndromes

Completed·HHelse Stavanger HF·Phase 4·NCT01382472·25 enrolled

Secondary Progressive Multiple Sclerosis2 trials

Investigation of Simvastatin in Secondary Progressive Multiple Sclerosis

Completed·IImperial College London·Phase 2·NCT00647348·140 enrolled

Simvastatin in Secondary Progressive Multiple Sclerosis

Completed·UUniversity College, London·Phase 2·NCT03896217·40 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

Systemic Lupus Erythematosus2 trials

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

Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus (0733-271)(TERMINATED)

Terminated·OOrganon and Co·Phase 4·NCT00739050·4 enrolled

Inflammation2 trials

Plaque Inflammation and Dysfunctional HDL in AIM-HIGH

Completed·UUniversity of Washington··NCT00880178·324 enrolled

Detection of Plaque Inflammation by Positron Emission Tomography (PET)-Effects of Simvastatin on Plaque Inflammation

Completed·KKurume University·N/A·NCT00114504·43 enrolled

Prostate Carcinoma1 trial

Study of Metformin With Simvastatin for Men With Prostate Carcinoma

Withdrawn·NNicholas Mitsiades·Phase 2·NCT01561482

Vitiligo1 trial

Clinical Trial of Simvastatin to Treat Generalized Vitiligo

Completed·JJohn Harris·Phase 2·NCT01517893·15 enrolled

Noonan syndrome1 trial

Treatment With HMG-COA Reductase Inhibitor of Growth and Bone Abnormalities in Children With Noonan Syndrome

Completed·UUniversity Hospital, Toulouse·Phase 3·NCT02713945·53 enrolled

Neurotoxicity1 trial

Neurotoxicity Prophylaxis With Intrathecal Dexamethasone and Simvastatin Post Axi-Cel

Active, not recruiting·MMasonic Cancer Center, University of Minnesota·Phase 1·NCT04514029·37 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

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

Multiple Myeloma1 trial

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

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

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

Septic Shock1 trial

Simvastatin in Patients With Septic Shock

Unknown status·MMedical University of Vienna·Phase 4·NCT00450840

Gastric Cancer1 trial

Trial of XP (Capecitabine/CDDP) Simvastatin in Advanced Gastric Cancer Patients

Completed·SSamsung Medical Center·Phase 3·NCT01099085·207 enrolled

Prospective1 trial

Simvastatin and Metformin Therapy in PCOS Women. Prospective Randomised Trial.

Unknown status·PPoznan University of Medical Sciences·N/A·NCT00396513

Pulmonary Hypertension1 trial

Simvastatin as a Treatment for Pulmonary Hypertension

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

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

Overweight1 trial

A Study to Evaluate LY3202328 in Overweight Healthy Participants and Dyslipidemia

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02714569·60 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

Cardiovascular Disease1 trial

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

Recruiting· Novartis logo

Novartis··NCT06858332·2,382 enrolled

Impaired glucose tolerance1 trial

Pioglitazone in Impaired Glucose Tolerance

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

Fatigue1 trial

The Effect of XueZhiKang on Fatigue：Comparing With Simvastatin

Completed·WWenzhou Medical University·Phase 4·NCT01686451·60 enrolled

Subarachnoid Hemorrhage1 trial

A Randomized, Double-Blind, Placebo-Controlled Trial of Simvastatin on Subarachnoid Hemorrhage-Induced Vasospasm

Completed·—·Phase 1/2·NCT00235963·104 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

Myocardial Protection1 trial

Myocardial Protection Effect of Simvastatin Undergoing Cardiac Surgery

Recruiting·SSun Yat-sen University·N/A·NCT01653223·369 enrolled

Baricitinib1 trial

A Study of Baricitinib and Simvastatin in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT01960140·40 enrolled

Chronic Kidney Disease1 trial

Efficacy and Safety Study of MCI-196 Versus Simvastatin for Dyslipidaemia in Chronic Kidney Disease (CKD) Subjects on Dialysis

Completed· Tanabe Pharma Corporation logo

Tanabe Pharma Corporation·Phase 3·NCT00858637·260 enrolled

Macroglobulinemia1 trial

Simvastatin in Waldenstrom's Macroglobulinemia

Terminated·—·Phase 2·NCT00575965·18 enrolled

Ventilator-Associated Pneumonia1 trial

STATIN-VAP STATIN-VAP - STATINs and Ventilator-Associated Pneumonia

Terminated·AAssistance Publique Hopitaux De Marseille·Phase 3·NCT01057758·300 enrolled

Atherosclerosis1 trial

Merck Carotid Atherosclerosis Trial (MK-0000-111)(COMPLETED)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT00804843·100 enrolled

Heart Failure1 trial

The Effect of Simvastatin Therapy on the Expression of Procoagulant and Inflammatory Markers in Heart Failure

Completed·UUniversity of Utah·Phase 1·NCT00769210·12 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

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

Inflammatory Response1 trial

Assessing the Role of "Statin" Therapy and Perioperative Inflammatory Response in Patients Undergoing Major Orthopedic Surgery

Completed·MMayo Clinic·Phase 4·NCT00656292·61 enrolled

Diabetic Retinopathy1 trial

Evaluating How the Treatments in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Study Affect Diabetic Retinopathy (The ACCORD Eye Study)

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 3·NCT00542178·3,472 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

Cirrhosis1 trial

Efficacy of the Combination of Simvastatin Plus Rifaximin in Patients With Decompensated Cirrhosis to Prevent ACLF Development

Completed·JJudit Pich·Phase 2/3·NCT03780673·254 enrolled

Prostatectomy1 trial

Statin Therapy Versus Placebo Prior to Prostatectomy

Completed·VVA Office of Research and Development·N/A·NCT00572468·42 enrolled

Optic Neuritis1 trial

Simvastatin Treatment of Patients With Acute Optic Neuritis

Unknown status·GGlostrup University Hospital, Copenhagen·Phase 3·NCT00261326·64 enrolled

Coronary Artery Disease1 trial

EASEGO Study: Doubling of Atorvastatin/Simvastatin or INEGY in Patients With Hypercholesterolemia and Coronary Artery Disease(CAD)(0653A-089)

Completed·OOrganon and Co·Phase 4·NCT00166530·367 enrolled

Essential Hypertension1 trial

A Study to Evaluate the Efficacy of Valsartan/Simvastatin Combinations in Patients With Both Essential Hypertension and Hypercholesterolemia

Completed· Novartis logo

Novartis·Phase 3·NCT00254475·871 enrolled

Polycystic Ovary Syndrome1 trial

Simvastatin Therapy in Women With Polycystic Ovary Syndrome.

Completed·PPoznan University of Medical Sciences·N/A·NCT00365638

Statins1 trial

The Acute Effect of Statins on Inflammatory Markers of Athersclerotic Tissue

Completed·MMayo Clinic·N/A·NCT00587717·35 enrolled

Heart Disease1 trial

Atorvastatin Versus Simvastatin In The Prevention Of Coronary Heart Disease (CHD) In Patients With Known CHD

Completed· Pfizer logo

Pfizer·Phase 4·NCT00159835·8,600 enrolled

Acute Lymphoblastic Leukemia1 trial

Effect of Simvastatin on Sepsis and Febrile Neutropenia in Patients With Acute Lymphoblastic Leukemia

Unknown status·HHospital General de Mexico·Phase 4·NCT05133310·108 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

Combination Therapy1 trial

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

Percutaneous Coronary Intervention1 trial

Effect of Acute Statin Treatment in Patients Undergoing Percutaneous Coronary Intervention

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

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

Mortality1 trial

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

Completed·—·Phase 4·NCT05230472·161 enrolled

Sepsis1 trial

Statins for the Early Treatment of Sepsis

Terminated·UUniversity of Chicago·Phase 2·NCT00528580·68 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

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

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

Colorectal Surgery1 trial

Simvastatin in Colorectal Surgery

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

Chronic Pancreatitis1 trial

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

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

Mixed Dyslipidemia1 trial

A Year 2, Safety Extension Study of the Combination of ABT-335 and Statin Therapy for Subjects With Mixed Dyslipidemia

Completed·AAbbott·Phase 3·NCT00491530·310 enrolled

Pulmonary Arterial Hypertension1 trial

A Study of Aspirin and Simvastatin in Pulmonary Arterial Hypertension

Terminated·UUniversity of Pennsylvania·Phase 2·NCT00384865·64 enrolled

Nephropathy1 trial

Ezetimibe/Simvastatin Combination in Proteinuric Nephropathy

Unknown status·AAzienda Ospedaliero Universitaria di Sassari·Phase 4·NCT00861731·30 enrolled

Critically Ill1 trial

Clinical and Economic Outcome of Simvastatin in Critically Ill Septic Patient

Completed·Ssara mostafa amin eladawy·Phase 3·NCT02067949·100 enrolled

Empagliflozin1 trial

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

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT01304329·18 enrolled

Drug Interactions1 trial

Pharmacokinetic Drug Interactions of AEGR-733 on Lipid-lowering Agents

Completed·AAegerion Pharmaceuticals, Inc.·Phase 2·NCT00359281·125 enrolled

Myopathy1 trial

Effects of Statins on Pro- and Antioxidant Status : Link With Statin-Associated Myopathy.

Completed·UUniversity Hospital, Montpellier·N/A·NCT00285181·24 enrolled

Transient Ischemic Attack1 trial

Fast Assessment of Stroke and Transient Ischemic Attack to Prevent Early Recurrence (FASTER)

Completed·UUniversity of Calgary·Phase 2/3·NCT00109382·500 enrolled

Migraine1 trial

Statin/Vitamin D & Migraine Study

Completed·RRami Burstein·Phase 2·NCT01225263·89 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

Acupuncture1 trial

Acupuncture and Moxibustion for Hyperlipemia

Unknown status·TThe First Affiliated Hospital of Hunan University of Traditional Chinese Medicine·N/A·NCT02269046·210 enrolled

Platelet Aggregation1 trial

Effect of Ezetimibe on Platelet Aggregation and LDL Tendency to Peroxidation

Completed·ZZiv Hospital·Phase 4·NCT00466401·20 enrolled

TIPS1 trial

The Indian POLYCAP Study (TIPS)

Completed·SSt. John's Research Institute·N/A·NCT00443794·2,050 enrolled

Oxidative Stress1 trial

SIMOX - Induction of Oxidative Stress

Completed·RRigshospitalet, Denmark·Phase 2·NCT02256254·40 enrolled

Monoclonal1 trial

LDL-C Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy-2

Completed· Amgen logo

Amgen·Phase 3·NCT01763866·2,067 enrolled

Pulpotomy1 trial

Simvastatin Versus MTA in Pulpotomy of Immature Permanent Molars

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

Efficacy1 trial

Comparative Efficacy Evaluation of Lipids When Treated With Niaspan & Statin or Other Lipid-Modifying Therapies-COMPELL

Completed·KKos Pharmaceuticals·Phase 4·NCT00079638·300 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

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]

Dec 23, 1991

ZOCOR

NDA NDA019766

Nov 27, 1992

ZOCOR

NDA NDA019766

Aug 9, 1993

ZOCOR

NDA NDA019766

Nov 24, 1993

ZOCOR

NDA NDA019766

Feb 22, 1994

ZOCOR

NDA NDA019766

Feb 22, 1994

ZOCOR

NDA NDA019766

Jul 28, 1994

ZOCOR

NDA NDA019766

Dec 21, 1994

ZOCOR

NDA NDA019766

Jan 23, 1995

ZOCOR

NDA NDA019766

Feb 16, 1995

ZOCOR

NDA NDA019766

Apr 19, 1995

ZOCOR

NDA NDA019766

Jun 9, 1995

ZOCOR

NDA NDA019766

Jun 30, 1995

ZOCOR

NDA NDA019766

Aug 1, 1995

ZOCOR

NDA NDA019766

Aug 1, 1995

ZOCOR

NDA NDA019766

Nov 6, 1995

ZOCOR

NDA NDA019766

Nov 22, 1996

ZOCOR

NDA NDA019766

Mar 17, 1997

ZOCOR

NDA NDA019766

May 19, 1997

ZOCOR

NDA NDA019766

May 23, 1997

ZOCOR

NDA NDA019766

Jul 18, 1997

ZOCOR

NDA NDA019766

Aug 12, 1997

ZOCOR

NDA NDA019766

Sep 9, 1997

ZOCOR

NDA NDA019766

Oct 31, 1997

ZOCOR

NDA NDA019766

Dec 2, 1997

ZOCOR

NDA NDA019766

Mar 31, 1998

ZOCOR

NDA NDA019766

Jun 29, 1998

ZOCOR

NDA NDA019766

Jul 10, 1998

ZOCOR

NDA NDA019766

Jul 10, 1998

ZOCOR

NDA NDA019766

Sep 24, 1998

ZOCOR

NDA NDA019766

Mar 22, 1999

ZOCOR

NDA NDA019766

Apr 23, 1999

ZOCOR

NDA NDA019766

Aug 5, 1999

ZOCOR

NDA NDA019766

Sep 15, 1999

ZOCOR

NDA NDA019766

Nov 22, 1999

ZOCOR

NDA NDA019766

Nov 22, 1999

ZOCOR

NDA NDA019766

Mar 15, 2000

ZOCOR

NDA NDA019766

Apr 14, 2000

ZOCOR

NDA NDA019766

Apr 27, 2000

ZOCOR

NDA NDA019766

Aug 22, 2000

ZOCOR

NDA NDA019766

Nov 7, 2000

ZOCOR

NDA NDA019766

Dec 11, 2000

ZOCOR

NDA NDA019766

Apr 10, 2001

ZOCOR

NDA NDA019766

Apr 10, 2001

ZOCOR

NDA NDA019766

Jun 4, 2001

ZOCOR

NDA NDA019766

Sep 13, 2001

ZOCOR

NDA NDA019766

Nov 14, 2001

ZOCOR

NDA NDA019766

Nov 14, 2001

ZOCOR

NDA NDA019766

Feb 22, 2002

ZOCOR

NDA NDA019766

Mar 21, 2002

ZOCOR

NDA NDA019766

Mar 21, 2002

ZOCOR

NDA NDA019766

May 6, 2002

ZOCOR

NDA NDA019766

May 6, 2002

ZOCOR

NDA NDA019766

Oct 18, 2002

ZOCOR

NDA NDA019766

Apr 16, 2003

ZOCOR

NDA NDA019766

Sep 17, 2003

ZOCOR

NDA NDA019766

Sep 17, 2003

ZOCOR

NDA NDA019766

Feb 24, 2004

ZOCOR

NDA NDA019766

Feb 24, 2004

ZOCOR

NDA NDA019766

May 17, 2005

ZOCOR

NDA NDA019766

Aug 31, 2005

ZOCOR

NDA NDA019766

Jun 1, 2007

ZOCOR

NDA NDA019766

Oct 9, 2007

SIMVASTATIN

NDA NDA021961

Nov 26, 2007

ZOCOR

NDA NDA019766

Jun 11, 2008

ZOCOR

NDA NDA019766

Mar 2, 2010

ZOCOR

NDA NDA019766

Apr 8, 2010

ZOCOR

NDA NDA019766

Nov 4, 2010

ZOCOR

NDA NDA019766

Jun 8, 2011

ZOCOR

NDA NDA019766

Jun 8, 2011

ZOCOR

NDA NDA019766

Jun 10, 2011

ZOCOR

NDA NDA019766

Oct 6, 2011

ZOCOR

NDA NDA019766

Feb 28, 2012

ZOCOR

NDA NDA019766

Oct 31, 2012

ZOCOR

NDA NDA019766

Oct 31, 2012

ZOCOR

NDA NDA019766

Nov 15, 2012

ZOCOR

NDA NDA019766

Oct 25, 2013

ZOCOR

NDA NDA019766

Feb 27, 2014

ZOCOR

NDA NDA019766

Feb 2, 2015

ZOCOR

NDA NDA019766

Mar 1, 2016

ZOCOR

NDA NDA019766

Apr 21, 2016

FLOLIPID

NDA NDA206679

Feb 28, 2018

ZOCOR

NDA NDA019766

Mar 1, 2019

ZOCOR

NDA NDA019766

Oct 4, 2019

ZOCOR

NDA NDA019766

Sep 25, 2020

ZOCOR

NDA NDA019766

Mar 7, 2022

ZOCOR

NDA NDA019766

May 31, 2022

ZOCOR

NDA NDA019766

Mar 14, 2023

ZOCOR

NDA NDA019766

Aug 9, 2023

ZOCOR

NDA NDA019766

Sources

References

[1]
ClinicalTrials.gov — 396 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 NDA019766). 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