Drugs / Simvastatin
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Simvastatin

Small molecule targets ABCB1, HMGCR, PTEN via inhibition / activation

Developed for
hyperlipidemia · type 2 diabetes mellitus · hyperlipoproteinemia · atherosclerosis · cirrhosis of liver · hypertensive disorder · cardiovascular disorder · coronary artery disorder
+172 more · breast cancer · hyperlipidemia, combined, 2 · Alzheimer disease · colorectal cancer · portal hypertension · metabolic syndrome X · plasma cell myeloma · diabetes mellitus · infectious disease with sepsis · obesity disorder · rheumatoid arthritis · schizophrenia · sickle cell disease · small cell lung carcinoma · stroke disorder · acute coronary syndrome · chronic obstructive pulmonary disease · COVID-19 · cystic fibrosis · familial hypercholesterolemia · hypertriglyceridemia · ischemic stroke · low density lipoprotein cholesterol, mild elevation of · major depressive disorder · malignant pancreatic neoplasm · myocardial infarction · peripheral arterial disease · prostate cancer · schizoaffective disorder · statin toxicity · systemic lupus erythematosus · transient ischemic attack · alopecia areata · asthma · biliary tract cancer · bipolar disorder · bone disorder · chronic kidney disease · congenital heart disease · dental pulp necrosis · depressive disorder · diabetic kidney disease · diastolic heart failure · dilated cardiomyopathy · esophageal varices · essential hypertension · female breast carcinoma · heart valve disorder · intracranial vasospasm · invasive breast carcinoma · multiple sclerosis · non-small cell lung carcinoma · pneumonia · polycystic ovary syndrome · pulmonary hypertension · recurrent acute pancreatitis · subarachnoid hemorrhage · type 1 diabetes mellitus · uveitis · acquired aneurysmal subarachnoid hemorrhage · acute pancreatitis · acute respiratory distress syndrome · aortic valve stenosis · astrocytoma, IDH-mutant, grade 4 · atherosclerotic cardiovascular disease · autoinflammatory syndrome · breast carcinoma · carotid artery disorder · cerebrovascular disorder · choroideremia · chronic hepatitis C virus infection · chronic lymphocytic leukemia/small lymphocytic lymphoma · chronic pancreatitis · chronic periodontitis · chronic renal failure syndrome · cirrhotic cardiomyopathy · clear cell sarcoma · cognitive impairment with or without cerebellar ataxia · dental pulp disorder · disease of orbital part of eye adnexa · end stage renal failure · endometriosis · erectile dysfunction · esophageal varices with bleeding · Ewing sarcoma · exposure, dental pulp · famililal cerebral cavernous malformations · female infertility · fibrotic liver disease · gastric cancer · gastroesophageal adenocarcinoma · gastroesophageal cancer · generalized vitiligo · germ cell tumor · glioblastoma · glucose metabolism disease · heart disorder · heart failure · hepatitis B virus infection · hepatoblastoma · hepatocellular carcinoma · homozygous familial hypercholesterolemia · hormone receptor-positive breast cancer · infiltrating bladder urothelial carcinoma · intestinal neoplasm · intracerebral hemorrhage · kidney failure · lung cancer · lymphangioleiomyomatosis · metastatic malignant neoplasm in the brain · metastatic neoplasm · migraine disorder · mucositis · myocardial ischemia · neuroblastoma · Noonan syndrome · olfactory nerve disorder · osteoporosis · osteosarcoma · ovarian cancer · pachyonychia congenita · pancreatic adenocarcinoma · paroxysmal atrial fibrillation · periapical periodontitis · periodontal disorder · periodontitis, aggressive · platinum-induced ototoxicity · prediabetes syndrome · primary aldosteronism · primary sclerosing cholangitis · prostate carcinoma · pulpitis · rectum adenocarcinoma · relapsing-remitting multiple sclerosis · renal cell carcinoma · retinoblastoma · rhabdoid tumor · rhabdomyosarcoma · schizophreniform disorder · sinusitis · skin hemangioma · Smith-Lemli-Opitz syndrome · smoldering plasma cell myeloma · tooth disorder · traumatic brain injury · triple-negative breast carcinoma · tuberous sclerosis · uterine corpus leiomyoma · Waldenstrom macroglobulinemia · Wilms tumor · xanthoma · acute lung injury · acute myocardial infarction · adult acute respiratory distress syndrome · bone resorption disease · critical illness polyneuropathy · diabetic polyneuropathy · diabetic retinopathy · disease of bone structure · disease related to transplantation · disorder of defective peroxisome oxidative status · hypertriglyceridemia 2 · intermediate coronary syndrome · NAFLD1 · optic neuritis · Parkinson disease · periodontitis · pneumonia caused by pseudomonas aeruginosa infection · pulmonary arterial hypertension · pulmonary emphysema · secondary progressive multiple sclerosis · vitiligo
Investigated by
Organon and Co · Merck Sharp & Dohme LLC · AstraZeneca · Eli Lilly and Company · Samsung Medical Center · GlaxoSmithKline
+351 more · Pfizer · National Cancer Institute (NCI) · Boehringer Ingelheim · National Heart, Lung, and Blood Institute (NHLBI) · National Institutes of Health (NIH) · UMC Utrecht · Ain Shams University · Cairo University · Cedars-Sinai Medical Center · Kos Pharmaceuticals · National Cancer Center, Korea · National University Hospital, Singapore · Novartis · Schering-Plough · Solvay Pharmaceuticals · Abbott · Brasilia Heart Study Group · Canadian Institutes of Health Research (CIHR) · Duke University · Imperial College London · Instituto de Salud Carlos III · Johns Hopkins University · Medical University of Vienna · National Institute on Aging (NIA) · Peking Union Medical College Hospital · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Sun Yat-sen University · UCSF Benioff Children's Hospital Oakland · University of Oxford · University of Washington · American Heart Association · Amsterdam UMC, location VUmc · Biogen · Chang Gung Memorial Hospital · Charite University, Berlin, Germany · Chinese Academy of Sciences · Columbia University · Emory University · FISABIO Foundation · Ferrer Internacional S.A. · Hanmi Pharmaceutical Company Limited · Hoffmann-La Roche · Imperial College Healthcare NHS Trust · Indonesia University · Institute of Liver and Biliary Sciences, India · James Graham Brown Cancer Center · Jiangsu HengRui Medicine Co., Ltd. · Judit Pich · Khyber Medical University Peshawar · Leiden University Medical Center · Mahidol University · Medical Research Council · National Cancer Institute, Naples · National Institute of Allergy and Infectious Diseases (NIAID) · National Taiwan University Hospital · Northern California Institute of Research and Education · Poznan University of Medical Sciences · Ramathibodi Hospital · Royal College of Surgeons, Ireland · Sant Pau Research Institute · Seoul National University Hospital · Shaheed Benazir Bhutto University Sheringal Dir Upper · Shanghai Pulmonary Hospital, Shanghai, China · Stanford University · Stanley Medical Research Institute · Tongji Hospital · Universitas Indonesia · University of Calgary · University of California, Davis · University of California, Los Angeles · University of Louisville · University of Pennsylvania · University of Sao Paulo · University of Texas Southwestern Medical Center · all 357 on the full record

Regulatory milestones approvals, filings & regulatory actions · 14 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed chronic kidney disease 1 milestone
Filed US (FDA) VYTORIN chronic kidney disease 2011-07-29

“Supplemental New Drug Applications (sNDAs) for the cholesterol-lowering medicines VYTORIN (ezetimibe/simvastatin) and ZETIA (ezetimibe) have been accepted for standard review...” merck.com ↗

Approved Indication not stated 3 milestones
Approved EU (EMA) Cholib — 2013-08-26 europa.eu ↗
Label expansions (11) US (FDA) ZOCOR — 1995-06-30 – 2003-04-16 fda.gov ↗
Approved US (FDA) ZOCOR — 1991-12-23 fda.gov ↗

Trials 385 · started per year

today
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EU approved 2013
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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 014 trials
Phase 0 NCT06273111 Nov 2026 → Mar 2028 expected skin hemangioma Joyce Teng Not yet recruiting No outcome recorded
Phase 0 NCT07031778 Jan 2025 overdue bone disorder University of Granada Recruiting No outcome recorded
Phase 0 NCT05771675 Oct 2024 → Dec 2026 expected chronic pancreatitis, recurrent acute pancreatitis Cedars-Sinai Medical Center Recruiting No outcome recorded
Phase 0 NCT05878158 Apr 2023 → Jan 2024 exposure, dental pulp Ahmad Elheeny Unknown No outcome recorded
Phase 0 NCT05464810 Sep 2022 → Apr 2027 expected female breast carcinoma, hormone receptor-positive breast cancer, invasive breast carcinoma Emory University Recruiting No outcome recorded
Phase 0 NCT04457089 Jan 2021 → Nov 2024 ovarian cancer Marc Goodman Completed No outcome recorded
Phase 0 NCT04514029 Aug 2020 → Nov 2023 overdue lymphoma Masonic Cancer Center, University of Minnesota Active not recruiting No outcome recorded
Phase 0 NCT02971410 Apr 2017 → Nov 2021 plasma cell myeloma Wake Forest University Health Sciences Withdrawn No outcome recorded
Phase 0 NCT03011931 Mar 2016 → Jan 2019 celiac disease Entero Therapeutics Completed No outcome recorded
Phase 0 NCT02534376 Sep 2015 → Feb 2019 prostate cancer Cedars-Sinai Medical Center Completed No outcome recorded
Phase 175 trials · 1 missed
Phase 1 NCT07389304 Mar → Dec 2026 expected — Shaheed Benazir Bhutto University Sheringal Dir Upper Not yet recruiting No outcome recorded
Phase 1 NCT07378293 Mar → Dec 2026 expected diabetes mellitus Shaheed Benazir Bhutto University Sheringal Dir Upper Not yet recruiting No outcome recorded
Phase 1 NCT06925490 Jun 2025 → Sep 2026 overdue pulpitis Cairo University Not yet recruiting No outcome recorded
Phase 1 NCT06948747 May → Oct 2025 — AstraZeneca Completed No outcome recorded
Phase 1 NCT06478940 Aug 2024 → Aug 2025 dental pulp disorder Cairo University Unknown No outcome recorded
Phase 1 NCT06186622 Jan → Jul 2024 obesity disorder Eli Lilly and Company Completed No outcome recorded
Phase 1 NCT05542095 May 2023 COVID-19, olfactory nerve disorder Washington University School of Medicine Withdrawn No outcome recorded
Phase 1 NCT05580250 Nov → Dec 2022 — Eli Lilly and Company Withdrawn No outcome recorded Stop: Business
Phase 1 NCT06207682 Jun → Aug 2022 — Amgen Completed No outcome recorded
Phase 1 NCT05306379 Jan → Apr 2022 — Aurinia Pharmaceuticals Inc. Completed No outcome recorded
Phase 1/214 trials · 2 met primary
Phase 1/2 NCT07392541 Jan 2026 → Jan 2028 expected biliary tract cancer Tongji Hospital Recruiting No outcome recorded
Phase 1/2 NCT06553157 Sep 2024 → Jul 2025 cancer, platinum-induced ototoxicity Minia University Completed No outcome recorded
Phase 1/2 NCT06030622 Apr → Dec 2024 malignant pancreatic neoplasm State University of New York - Downstate Medical Center Unknown No outcome recorded
Phase 1/2 NCT04652089 Dec 2020 → Sep 2021 depressive disorder University of Oxford Completed No outcome recorded
Phase 1/2 NCT03599609 Mar 2018 → Jan 2020 sickle cell disease, stroke disorder University of Campinas, Brazil Unknown No outcome recorded
Phase 1/2 NCT02061397 Mar 2014 → Dec 2019 lymphangioleiomyomatosis, tuberous sclerosis University of Pennsylvania Completed No outcome recorded
Phase 1/2 NCT01654562 Dec 2012 → Jul 2013 choroideremia University of Alberta Terminated No outcome recorded Stop: Enrollment
Phase 1/2 NCT01702246 Feb 2012 → May 2015 sickle cell disease UCSF Benioff Children's Hospital Oakland Completed Met primary
Phase 1/2 NCT01092572 May 2010 autoinflammatory syndrome, cystic fibrosis University of British Columbia Withdrawn No outcome recorded Stop: Business
Phase 1/2 NCT00795288 Aug 2008 → Feb 2013 subarachnoid hemorrhage Washington University School of Medicine Completed No outcome recorded
Phase 270 trials · 3 met primary · 7 missed
Phase 2 NCT07625930 Jan 2027 → Apr 2029 expected gastroesophageal adenocarcinoma McGill University Health Centre/Research Institute of the McGill University Health Centre Not yet recruiting No outcome recorded
Phase 2 NCT07831369 Sep 2026 → Sep 2027 expected astrocytoma, IDH-mutant, grade 4, glioblastoma Inova Health Care Services Recruiting No outcome recorded
Phase 2 NCT07662785 Aug 2026 → Aug 2027 expected xanthoma Klira Skin Not yet recruiting No outcome recorded
Phase 2 NCT07213557 Mar 2026 → Sep 2027 expected gastroesophageal cancer National Cancer Institute, Naples Recruiting No outcome recorded
Phase 2 NCT07307989 Aug 2025 → Jul 2029 expected hyperlipidemia, ischemic stroke Chang Gung Memorial Hospital Recruiting No outcome recorded
Phase 2 NCT07003815 Jun 2025 → Dec 2026 expected biliary tract cancer Tongji Hospital Not yet recruiting No outcome recorded
Phase 2 NCT06437574 Jul 2024 → Feb 2028 expected prostate cancer Cedars-Sinai Medical Center Recruiting No outcome recorded
Phase 2 NCT07264842 Jun 2024 → Apr 2026 overdue dental pulp necrosis Dow University of Health Sciences Recruiting No outcome recorded
Phase 2 NCT05586360 Mar 2024 → Mar 2027 expected prostate cancer Medical University of South Carolina Recruiting No outcome recorded
Phase 2 NCT05821556 Jun 2023 → Aug 2026 overdue pancreatic adenocarcinoma National Cancer Institute, Naples Recruiting No outcome recorded
Phase 2/39 trials · 2 missed
Phase 2/3 NCT04971577 Feb 2022 → Mar 2027 expected alcohol abuse, fibrotic liver disease Anna Cruceta Recruiting No outcome recorded
Phase 2/3 NCT04301336 Nov 2019 → Nov 2020 sickle cell disease Beni-Suef University Completed No outcome recorded
Phase 2/3 NCT03780673 Jan 2019 → Dec 2022 cirrhosis of liver Judit Pich Completed Missed primary
Phase 2/3 NCT03490097 Dec 2017 → May 2018 chronic hepatitis C virus infection, metabolic syndrome X Ain Shams University Completed No outcome recorded
Phase 2/3 NCT02252328 Sep 2015 → Aug 2018 uveitis University College, London Unknown No outcome recorded
Phase 2/3 NCT01338324 Apr 2010 → Jun 2011 celiac disease All India Institute of Medical Sciences Completed No outcome recorded
Phase 2/3 NCT00676897 Feb 2008 → Dec 2010 infectious disease with sepsis Beth Israel Deaconess Medical Center Completed No outcome recorded
Phase 2/3 NCT00693576 Apr 2007 → May 2008 — Shiraz University of Medical Sciences Completed No outcome recorded
Phase 2/3 NCT00109382 May 2003 → Feb 2007 transient ischemic attack University of Calgary Completed Missed primary
Phase 386 trials · 14 met primary · 4 missed
Phase 3 NCT05963568 Apr 2026 → Jan 2029 expected stroke disorder Northern California Institute of Research and Education Recruiting No outcome recorded
Phase 3 NCT03654053 Oct 2020 → Dec 2026 expected cirrhosis of liver VA Office of Research and Development Active not recruiting No outcome recorded
Phase 3 NCT04133792 Oct 2020 → Mar 2028 expected primary sclerosing cholangitis Annika Bergquist Active not recruiting No outcome recorded
Phase 3 NCT04343001 Oct 2020 → Apr 2021 COVID-19 London School of Hygiene and Tropical Medicine Withdrawn No outcome recorded
Phase 3 NCT03971019 Mar 2019 → May 2024 female breast carcinoma Peking Union Medical College Hospital Unknown No outcome recorded
Phase 3 NCT03435744 Jan 2019 → Jun 2021 major depressive disorder Pakistan Institute of Living and Learning Completed Missed primary
Phase 3 NCT03131726 Jan 2018 → Jan 2027 expected disease of orbital part of eye adnexa Lund University Recruiting No outcome recorded
Phase 3 NCT04021498 Sep 2017 → Mar 2025 recurrent acute pancreatitis Enrique de-Madaria Terminated Missed primary Stop: Enrollment
Phase 3 NCT02850081 Jun 2017 → Mar 2020 carotid stenosis, stroke disorder Columbia University Terminated No outcome recorded Stop: Enrollment
Phase 3 NCT02713945 Jan 2017 → Mar 2023 Noonan syndrome University Hospital, Toulouse Completed No outcome recorded
Phase 471 trials · 6 met primary · 8 missed
Phase 4 NCT06856772 Feb 2025 → Mar 2028 expected atherosclerotic cardiovascular disease Tor Biering-Sørensen Not yet recruiting No outcome recorded
Phase 4 NCT06785727 Feb 2025 → Dec 2028 expected transient ischemic attack Prof. dr. Nathalie van der Velde Not yet recruiting No outcome recorded
Phase 4 NCT06399783 Oct 2024 → Oct 2027 expected alopecia areata Assiut University Not yet recruiting No outcome recorded
Phase 4 NCT06523465 Sep 2024 → Dec 2025 overdue hypertensive disorder, primary aldosteronism Third Military Medical University Recruiting No outcome recorded
Phase 4 NCT07459972 Mar 2024 → Mar 2025 cirrhosis of liver, portal hypertension Kafrelsheikh University Completed No outcome recorded
Phase 4 NCT05059626 Dec 2023 → Dec 2025 overdue endometriosis Penn State University Recruiting No outcome recorded
Phase 4 NCT05658692 Oct 2022 → Oct 2023 acute respiratory distress syndrome Second Affiliated Hospital, School of Medicine, Zhejiang University Unknown No outcome recorded
Phase 4 NCT05613400 Apr 2022 → Dec 2024 type 2 diabetes mellitus The University of Hong Kong Unknown No outcome recorded
Phase 4 NCT05133310 Nov 2021 → Dec 2022 acute lymphoblastic leukemia, infectious disease with sepsis Hospital General de Mexico Unknown No outcome recorded
Phase 4 NCT05369091 Dec 2020 → Oct 2021 bone disorder Postgraduate Medical Institute, Lahore Completed No outcome recorded
Phase not applicable46 trials · 2 met primary · 4 missed
— NCT07704918 Dec 2026 → Dec 2027 expected melanoma University of Colorado, Denver Not yet recruiting No outcome recorded
— NCT07102979 Sep → Dec 2025 overdue cirrhosis of liver Chang Gung Memorial Hospital Enrolling by invitation No outcome recorded
— NCT06431919 Jun 2025 → Jan 2028 expected acute kidney injury, cirrhosis of liver, cirrhotic cardiomyopathy, diastolic heart failure Post Graduate Institute of Medical Education and Research, Chandigarh Recruiting No outcome recorded
— NCT07692620 Jun 2025 → May 2026 tooth disorder Maruwan Ali Alteer Completed No outcome recorded
— NCT05677945 Mar 2023 → Mar 2024 dental pulp necrosis Cairo University Unknown No outcome recorded
— NCT05525013 Oct 2022 → Jun 2024 periapical periodontitis Cairo University Completed No outcome recorded
— NCT05187715 Feb 2022 → Oct 2023 cirrhosis of liver Institute of Liver and Biliary Sciences, India Unknown No outcome recorded
— NCT04973800 Jul 2021 → Feb 2023 depressive disorder University of Oxford Completed No outcome recorded
— NCT07823751 Apr 2021 → Apr 2023 breast carcinoma Universitas Indonesia Completed No outcome recorded
— NCT04575090 Mar 2016 → Feb 2017 statin toxicity University of Texas Southwestern Medical Center Completed No outcome recorded
Comparator or background therapy201 trials
Phase 0 NCT05682911 Comparator Jan → Jun 2018 — Jinnah Sindh Medical University Completed No outcome recorded
Phase 0 NCT00720577 Comparator Dec 2005 → Jul 2007 peripheral arterial disease Medtronic Endovascular Completed No outcome recorded
Phase 1 NCT06379958 Comparator Apr → Sep 2024 overdue — Modern Biosciences Ltd Recruiting No outcome recorded
Phase 1 NCT04178980 Comparator Jan 2020 → Jan 2022 statin toxicity Assiut University Unknown No outcome recorded
Phase 1 NCT02871687 Comparator Apr 2016 → Mar 2021 — Brigham and Women's Hospital Completed No outcome recorded
Show all 201 trials opens the full record — a long page

News releases announcing trial results or a regulatory action · 13

DateIssuerRelease
2016-02-15 Merck Sharp & Dohme LLC Regulatory Merck Receives Complete Response Letter from the U.S. FDA for ZETIA® (ezetimibe) and VYTORIN® (ezetimibe and simvastatin) merck.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter regarding Merck’s Supplemental New Drug Applications for ZETIA® and VYTORIN® for the reduction of the risk of cardiovascular events (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina, or need for revascularization) in patients with coronary heart disease.
2015-09-01 Merck Sharp & Dohme LLC Results New Analyses from the IMPROVE-IT Study with VYTORIN® (ezetimibe and simvastatin) merck.com ↗
Merck (NYSE:MRK), known as MSD in the United States and Canada, today announced results from new analyses from the IMPROVE-IT study.
2015-06-03 Merck Sharp & Dohme LLC Results Results from Investigational IMPROVE-IT Study of VYTORIN® (ezetimibe and simvastatin) Published in the New England Journal of Medicine merck.com ↗
Merck (NYSE: MRK ), known as MSD outside the United States and Canada, today announced that the New England Journal of Medicine published the results of the IMPROVE-IT trial, an investigational study comparing treatment with VYTORIN ® (ezetimibe and simvastatin) to treatment with simvastatin alone in more than 18,000 patients presenting with acute coronary syndromes.
2015-03-16 Merck Sharp & Dohme LLC Results New Analysis from Investigational IMPROVE-IT Study Shows VYTORIN® (ezetimibe/simvastatin) Reduced Total (Initial and Recurrent) Cardiovascular Events More than Simvastatin Alone in Patients Presenting with Acute Coronary Syndromes merck.com ↗
VYTORIN reduced total events by 9% vs. simvastatin alone (incidence-rate ratio [IRR] 0.91, 95% CI 0.85-0.97, p=0.007).
2014-11-17 Merck Sharp & Dohme LLC Results VYTORIN® (ezetimibe/simvastatin) Significantly Reduced Cardiovascular Events More than Simvastatin Alone in Patients Presenting with Acute Coronary Syndromes in the Investigational IMPROVE-IT Study merck.com ↗
In IMPROVE-IT, at seven years, 32.7 percent of patients taking VYTORIN experienced a primary endpoint event compared to 34.7 percent of patients taking simvastatin alone (hazard ratio of 0.936, p=0.016).
2012-01-25 Merck Sharp & Dohme LLC Regulatory New FDA Approved Labeling For VYTORIN® (Ezetimibe/Simvastatin) Includes Results From the Study of Heart and Renal Protection (SHARP) in Patients With Moderate to Severe Chronic Kidney Disease merck.com ↗
2011-11-02 Merck Sharp & Dohme LLC Regulatory FDA Advisory Committee Unanimously Recommends Approval of Merck’s VYTORIN® (ezetimibe/simvastatin) for Use in Patients with Pre-Dialysis Chronic Kidney Disease merck.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) unanimously voted to recommend approval of Merck’s VYTORIN® (ezetimibe/simvastatin) for use in patients with pre-dialysis chronic kidney disease.
2011-10-07 Merck Sharp & Dohme LLC Regulatory FDA Approves Merck’s JUVISYNC™ (sitagliptin and simvastatin) Tablets, a Once-Daily Therapy for Patients with Type 2 Diabetes Who Need to Lower Blood Sugar and Cholesterol, Known Risk Factors for Cardiovascular Disease merck.com ↗
The FDA approved JUVISYNC based upon clinical bioequivalence studies in healthy subjects that demonstrated administration of JUVISYNC is equivalent to co-administration of corresponding doses of the two individual medications, sitagliptin and simvastatin, as separate tablets.
2006-12-21 Perrigo Company Regulatory Perrigo Company Announces FDA Approval For Simvastatin Tablets perrigo.com ↗
The Perrigo Company (NASDAQ: PRGO)(TASE: PRGO) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market Simvastatin Tablets, USP, 5 mg, 10 mg, 20 mg, 40 mg and 80 mg.
2006-06-25 Teva Branded Pharmaceutical Products R&D, Inc. Regulatory Teva Receives First U.S. Approval of Generic Zocor® Tablets; Product to be Shipped Immediately tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Merck's Zocor® (Simvastatin) Tablets, 5 mg, 10 mg, 20 mg, and 40 mg.
2006-05-25 Teva Branded Pharmaceutical Products R&D, Inc. Regulatory Teva Announces Tentative Approval of Simvastatin Tablets; Provides Update on 180-Day Exclusivity tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration ("FDA") has granted tentative approval for the Company's Ivax Abbreviated New Drug Application ("ANDA") for Simvastatin Tablets USP, 5 mg, 10 mg, 20 mg, 40 mg and 80 mg.
2006-01-01 Teva Branded Pharmaceutical Products R&D, Inc. Regulatory Teva Announces Tentative Approval of Simvastatin Tablets tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U. S. Food and Drug Administration has granted tentative approval for the Company's ANDA for Simvastatin Tablets USP, 5 mg, 10 mg, 20 mg, 40 mg and 80 mg.

All press releases naming this drug 21 releases

DateIssuerRelease

Evidence & citations 28 cited values

Every value below carries the sentence it was read from. 590 sources stand behind the page.

FieldValueCited text
Known as simvastatin “The purpose of this study is to determine whether administration of lapaquistat acetate co-administered with atorvastatin, rosuvastatin or simvastatin (stable statin therapy)...” NCT00249899 ↗
581

“The purpose of this study is to determine the safety, tolerability and efficacy of a combination therapy interferon beta-1a(Avonex) plus simvastatin (Zocor) vs. interferon...” NCT00146068 ↗

“Cardiovascular Fixed Dose Combination Pill: A Pharmacodynamic Interaction Study to Evaluate the Effect of a Fixed Dose Combination of Acetylsalicylic Acid, Simvastatin and...” NCT01005290 ↗

“One of ARBs(Valsartan, Olmesartan, Candesartan, Telmisartan, Fimasartan, Losartan and Irbesartan) and one of statins(Rosuvastatin, Atorvastatin, Pitavastatin, Simvastatin,...” NCT04061824 ↗

“Usual dosage for atorvastatin 10-80 mg/tab once daily by mouth; simvastatin 20-80 mg/tab once daily by mouth; pravastatin 10-80 mg/tab once daily by mouth; rosuvastatin 5-20...” NCT00850460 ↗

“Patients remained on ongoing statin therapy (not study provided) of either Atorvastatin 10mg or 20mg; Simvastatin 5mg, 10mg or 20mg; Rosuvastatin 5mg or 10mg; or Pravastatin...” NCT02072161 ↗

“Version 1 contains aspirin 75mg, simvastatin 40mg, Lisinopril 10mg and Atenolol 50mg; Version 2 contains aspirin 75mg, simvastatin 40mg, Lisinopril 10mg and Hydrochlorothiazide 12.5mg.” NCT01326676 ↗

“Version 1 contains aspirin 75mg, simvastatin 40mg, Lisinopril 10mg and Atenolol 50mg; Version 2 contains aspirin 75mg, simvastatin 40mg, Lisinopril 10mg and Hydrochlorothiazide 12.5mg.” NCT01057537 ↗

“Vytorin is a drug combination (Ezetimibe and Simvastatin) that targets the two primary sources of cholesterol, absorption in the gut and synthesis in the liver.” NCT06437574 ↗

“Statin (pravastatin, simvastatin, fluvastatin, atorvastatin, pitavastatin, rosuvastatin) at stable dose with or without other LMT as clinically indicated.” NCT02107898 ↗

“Additionally, Cohorts 1 and 3 will include an assessment of potential drug-drug interaction with simvastatin to examine CYP3A4 inhibition by GSK2647544.” NCT01978327 ↗

Show 571 more sources

Known as Brand name: Simvastatin Normon, 40 mg “Brand name: Simvastatin Normon, 40 mg” NCT04021498 ↗
Known as C10AA01 ChEMBL registry synonym — accepted as the source's own label CHEMBL1064 ↗
Known as Flolipid ChEMBL registry synonym — accepted as the source's own label CHEMBL1064 ↗
Known as Lacersa ChEMBL registry synonym — accepted as the source's own label CHEMBL1064 ↗
Known as MK-733 ChEMBL registry synonym — accepted as the source's own label CHEMBL1064 ↗
Known as MK0733 “MK0733, simvastatin / Duration of Treatment: 12 Weeks” NCT00398294 ↗
3

“MK0733, simvastatin / Duration of Treatment: 27 Weeks” NCT00551447 ↗

NCT00092157 ↗

NCT00397826 ↗

Known as NSC-758706 ChEMBL registry synonym — accepted as the source's own label CHEMBL1064 ↗
Known as Ranzolont ChEMBL registry synonym — accepted as the source's own label CHEMBL1064 ↗
Known as SIM “We recently showed capability of VPA/Simvastatin (SIM) combination to potentiate the antitumor activity of gemcitabine/nab-paclitaxel in vitro and in vivo PDAC preclinical models.” PMID 39300376 ↗ Sep 2024
2

“The investigators hypothesize that simvastatin (SIM) may improve the efficacy of first- line Nivolumab and Oxaliplatin-based chemotherapy” NCT07213557 ↗

“Simvastatin (SIM)” NCT01335997 ↗

Known as SIMVA “The purpose of this study was to examine the efficacy and safety of ezetimibe (EZE) coadministered with simvastatin (SIMVA) in a large cohort of African Americans with primary...” PMID 16749654 ↗ May 2006
Known as Simvador ChEMBL registry synonym — accepted as the source's own label CHEMBL1064 ↗
Known as simvastatin (Vytorin) “simvastatin (Vytorin)” NCT00127218 ↗
Known as Simvastatin (Zocor) “Simvastatin (Zocor)” NCT00817843 ↗
1

“Simvastatin (ZOCOR)” NCT01332617 ↗

Known as Simvastatin component of juvisync ChEMBL registry synonym — accepted as the source's own label CHEMBL1064 ↗
Known as Simvastatin component of polycap ChEMBL registry synonym — accepted as the source's own label CHEMBL1064 ↗
Known as Simvastatin component of simcor ChEMBL registry synonym — accepted as the source's own label CHEMBL1064 ↗
Known as Simvastatin component of vytorin ChEMBL registry synonym — accepted as the source's own label CHEMBL1064 ↗
Known as Simvastatina ChEMBL registry synonym — accepted as the source's own label CHEMBL1064 ↗
Known as Simvastatine ClinicalTrials.gov intervention name — accepted as the source's own label NCT00281476 ↗
1

NCT01382511 ↗

Known as SMV “Simvastatin (SMV) is one of the family members of statins, it has been showed in many previous studies that the simvastatin when dissolved with methylcellulose in situ gel with...” NCT04824898 ↗
2

“The purpose of the present study was to investigate the efficacy of autologous Platelet rich fibrin (PRF) or PRF and Simvastatin (SMV) with open flap debridement (OFD) in the...” NCT02120872 ↗

“Atorvastatin (ATV) and Simvastatin (SMV) are specific competitive inhibitors of 3-hydroxy-2-methyl-glutaryl coenzyme A reductase.” NCT02060032 ↗

Known as Synvinolin ChEMBL registry synonym — accepted as the source's own label CHEMBL1064 ↗
Known as Zocor “The purpose of this study is to determine the safety, tolerability and efficacy of a combination therapy interferon beta-1a(Avonex) plus simvastatin (Zocor) vs. interferon...” NCT00146068 ↗
13

“Both Niaspan (KOS Pharmaceuticals) and simvastatin (Zocor; Merck Pharmaceuticals) are commercially available drugs that are FDA approved for management of hyperlipidemia at the...” NCT00307307 ↗

“The purpose of this study is to see if a drug called simvastatin (brand name Zocor) beneficially affects the level of certain molecules (such as proteins) in the spinal fluid of people.” NCT01142336 ↗

“Name of Drugs: Niaspan (niacin extended-release tablets), Lipitor® (atorvastatin), Zocor® (simvastatin), Zetia™ (ezetimibe), and Crestor® (rosuvastatin)” NCT00079638 ↗

“Simvastatin is a cholesterol-lowering drug approved by the FDA in 1991 and is now commercially available as Zocor (Merck) or as a generic agent.” NCT02534376 ↗

“The second group, run at the same time will take Zocor(simvastatin) 40 mg per day with standard counseling” NCT00365742 ↗

“The drug for treatment of elevated cholesterol is simvastatin (Zocor).” NCT00316095 ↗

“The Rho protein can be inhibited with a drug, simvastatin (Zocor®).” NCT00255242 ↗

“standard-care lipid-lowering therapy: Zocor or Lipitor” NCT01567826 ↗

“simvastatin [Zocor] 20, 40, or 80 mg” PMID 20136164 ↗ 2010

“Simvastatin (Zocor)” NCT00208117 ↗

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Known as Zocor heart-pro ChEMBL registry synonym — accepted as the source's own label CHEMBL1064 ↗
Action Inhibit “simvastatin (a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor)” NCT00004266 ↗