SIMVASTATIN
Simvastatin is an HMG-CoA reductase inhibitor indicated to reduce the risk of total mortality by reducing coronary heart disease death, non-fatal myocardial infarction, stroke, and the need for coronary and non-coronary revascularization procedures. It is used in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, or diabetes who are at high risk of coronary events. Additionally, it is indicated as an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia, hypertriglyceridemia, or primary dysbetalipoproteinemia, and in patients (adults and children aged 10 and older) with heterozygous familial hypercholesterolemia. It is also used as an adjunct to other therapies for homozygous familial hypercholesterolemia.
How SIMVASTATIN Works
Simvastatin is a prodrug that is hydrolyzed after administration to its active $\beta$-hydroxyacid form, simvastatin acid. This metabolite inhibits HMG-CoA reductase, the rate-limiting enzyme that catalyzes the conversion of HMG-CoA to mevalonate, a necessary precursor in the endogenous biosynthesis of cholesterol.
Details
- Status
- Prescription
- First Approved
- 2006-06-23
- Routes
- ORAL
- Dosage Forms
- TABLET, TABLET, ORALLY DISINTEGRATING
SIMVASTATIN Approval History
What SIMVASTATIN Treats
9 indicationsSIMVASTATIN is approved for 9 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Coronary Heart Disease
- Cerebrovascular Disease
- Peripheral Vascular Disease
- Diabetes
- Primary Hyperlipidemia
- Heterozygous Familial Hypercholesterolemia
- Homozygous Familial Hypercholesterolemia
- Primary Dysbetalipoproteinemia
SIMVASTATIN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in SIMVASTATIN's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications SIMVASTATIN treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to SIMVASTATIN
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
140 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02968810 results posted | NCI-2016-01719 NCI-2016-01719, N01-CN-2012-00035 | Ph 2 | active not recruiting | Simvastatin in Preventing Liver Cancer in Patients With Liver Cirrhosis |
| NCT00858637 results posted | MCI-196-E11 | Ph 3 | completed | Efficacy and Safety Study of MCI-196 Versus Simvastatin for Dyslipidaemia in Chronic Kidney Disease (CKD) Subjects on Dialysis |
| NCT02675309 | MT-8554-E05 | Ph 1 | completed | A Study to Investigate the Effect of MT-8554 on the Pharmacokinetics of Simvastatin and Rosuvastatin in Healthy Subjects |
| NCT02197234 results posted | D5160C00014 2014-002070-36 | Ph 1 | completed | Study to Assess the Effect of AZD9291 on the Blood Levels of Simvastatin in Patients With EGFRm+ NSCLC |
| NCT03889795 | C3 | Ph 1 | active not recruiting | Phase IB Metformin, Digoxin, Simvastatin in Solid Tumors |
| NCT06948747 | D7260C00017 | Ph 1 | completed | A Study to Investigate the Effect of AZD5004 on Rosuvastatin, Atorvastatin, Simvastatin, Repaglinide and the Effect of Erythromycin on AZD5004 in Healthy Participants |
| NCT03896217 MS-OPT results posted | 16/0730 & 2017-003008-30 | Ph 2 | completed | Simvastatin in Secondary Progressive Multiple Sclerosis |
| NCT01602029 ROSES | roses_pill | Ph 2 | completed | Randomized Double Blind Placebo Control Study in Patients with Schizophrenia |
| NCT03387670 MS-STAT2 | 17/0158 2017-003328-56 | Ph 3 | completed | Multiple Sclerosis-Simvastatin Trial 2 |
| NCT06186622 | 18631 J2A-MC-GZPG | Ph 1 | completed | A Drug-Drug Interaction Study of Orforglipron (LY3502970) in Healthy Overweight and Obese Participants |
| NCT02735707 REMAP-CAP | U1111-1189-1653 2015-002340-14, 602525 | Ph 3 | recruiting | Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia |
| NCT02096588 results posted | J13160 J13160, NA_00091900 | Ph 2 | terminated | Detection and Prevention of Anthracycline-Related Cardiac Toxicity With Concurrent Simvastatin |
| NCT06399783 | Sim vs Cs | Ph 4 | not yet recruiting | Topical Simvastatin Versus Topical Steroid in Treatment of Alopecia Areata |
| NCT06207682 | CL020_168 | Ph 1 | completed | Effect of Repeated Oral Doses of Avacopan on the Pharmacokinetics (PK) of a Single Dose of Simvastatin |
| NCT06016218 | 260981 | Ph 1, Ph 2 | completed | Effect of Local Application of Simvastatin Versus Bone Powder on Implant Bone Changes |
| NCT03454529 results posted | 2017-073 NCI-2018-00044, 2017-073 | Ph 2 | completed | The Effect of Simvastatin on Breast Cancer Cell Growth in Women With Stage I-II Breast Cancer |
| NCT05542095 SimCA | SimCA Trial | Ph 1 | withdrawn | Simvastatin Nasal Rinses for the Treatment of COVID-19 Mediated Dysomsia |
| NCT03780673 2018-001698-25 | LIVERHOPE_EFFICACY | Ph 2, Ph 3 | completed | Efficacy of the Combination of Simvastatin Plus Rifaximin in Patients With Decompensated Cirrhosis to Prevent ACLF Development |
| NCT02713945 RASTAT | RC31/15/7826 | Ph 3 | completed | Treatment With HMG-COA Reductase Inhibitor of Growth and Bone Abnormalities in Children With Noonan Syndrome |
| NCT03510884 results posted | EFC14643 2017-001903-60, U1111-1193-0721 | Ph 3 | completed | An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia |
| NCT00655993 | 00746 | Ph 1 | completed | Effect of Statin Therapy on C-reactive Protein Levels in Patients With Chronic Obstructive Lung Disease (COPD) |
| NCT02188121 FITNESS results posted | 2014P001599 | Ph 4 | completed | Fixed Dose Intervention Trial of New England Enhancing Survival in SMI Patients |
| NCT05580250 | 18353 J2D-JE-CVAD | Ph 1 | withdrawn | A Study of LY3526318 in Healthy Male Japanese Participants |
| NCT05657015 | Local drug delivery | Ph 4 | completed | Lepidium Sativum Extract Versus Simvastatin as an Adjunctive Local Delivery Agents to Non-Surgical Periodontal Therapy |
| NCT02743364 results posted | NCI-2016-00437 NCI-2016-00437, N01-CN-2012-00035 | Ph 2 | completed | Simvastatin in Reducing Pancreatitis in Patients With Recurrent, Acute or Chronic Pancreatitis |
| NCT01763866 LAPLACE-2 results posted | 20110115 2012-001363-70 | Ph 3 | completed | LDL-C Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy-2 |
| NCT02871687 | 2016P000094 | Ph 1 | completed | Effect of Statin Use on Aldosterone Secretion |
| NCT02542969 | MGL-3196-03 | Ph 1 | completed | Drug Interaction Study of MGL-3196 With Rosuvastatin and Simvastatin |
| NCT03775070 SavDCM | 201806014MINB | Ph 2 | completed | Simvastatin Therapy in Patients With Dilated Cardiomyopathy. |
| NCT05306379 Statin-DDI | AUR-VCS-2021-02 | Ph 1 | completed | Drug-Drug Interaction Study to Investigate Effects of Voclosporin on Pharmacokinetics of Simvastatin |
| NCT01156545 | NCCCTS-10-489 BIBW 2992 1200.113 | Ph 2 | completed | BIBW 2992 Plus Simvastatin vs. BIBW 2992 in Previously Treated Patients With Advanced Non-adenocarcinomatous NSCLC |
| NCT02476006 results posted | LPS14245 2015-000620-28, U1111-1163-0984 | Ph 3 | completed | Safety, Tolerability, and Effect of Alirocumab in High Cardiovascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies (ODYSSEY APPRISE) |
| NCT05230472 | EMASU M D 219 /2020 | Ph 4 | completed | Effect of Statin Therapy on Mortality in Patients With Ventilator Associated Pneumonia |
| NCT01952288 results posted | B1195-I | Ph 4 | completed | Simvastatin for mTBI |
| NCT02787590 PD STAT | PDSTAT2015 2015-000148-40, 16108482 | Ph 2 | completed | Simvastatin as a Neuroprotective Treatment for Moderate Parkinson's Disease |
| NCT05008068 | 0012490 | Ph 1 | completed | Effect of Local Application of Platelet-rich Fibrin Scaffold Loaded With Simvastatin on Peri-implant Bone Changes |
| NCT01979185 results posted | SPD602-114 | Ph 1 | completed | Effect of SSP-004184 (SPD602) on the Pharmacokinetics of Simvastatin in Healthy Adult Subjects |
| NCT01953835 | 117171 | Ph 1 | completed | A Two-part Study to Investigate the Interaction and Pharmacokinetics of GSK2586184 |
| NCT02714569 results posted | 16417 I8Q-MC-GSEA | Ph 1 | completed | A Study to Evaluate LY3202328 in Overweight Healthy Participants and Dyslipidemia |
| NCT04803500 | PER 15-1M | Ph 2 | completed | Simvastatin Around Immediate Implant |
| NCT03510715 results posted | EFC14660 2017-002297-39, U1111-1200-2046 | Ph 3 | completed | An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Homozygous Familial Hypercholesterolemia |
| NCT04343001 CRASH-19 | 2020-KEP-420 | Ph 3 | withdrawn | Coronavirus Response - Active Support for Hospitalised Covid-19 Patients |
| NCT03929744 | 17416 J2A-MC-GZGA | Ph 1 | completed | A Study of LY3502970 in Healthy Participants |
| NCT01382472 MICROS | MICROS | Ph 4 | completed | Microcirculation In Acute Coronary Syndromes |
| NCT01999309 | 43806 | Ph 3 | completed | Simvastatin Addition for Patients With Recent-onset Schizophrenia |
| NCT02061397 SOS results posted | The SOS Trial | Ph 1, Ph 2 | completed | Safety of Simvastatin in LAM and TSC |
| NCT02300259 results posted | 15523 I7T-MC-RMAG | Ph 1 | completed | A Study of LY2623091 in Healthy Participants |
| NCT02399709 ADDICSTATINE | ADDICSTATINE | Ph 2 | completed | Trial to Evaluate the Efficacy of Simvastatin for Smoking Cessation |
| NCT02390843 AflacST1402 | IRB00078790 | Ph 1 | completed | Simvastatin With Topotecan and Cyclophosphamide in Relapsed and/or Refractory Pediatric Solid and CNS Tumors |
| NCT02533141 | OPHT-240215 | Ph 4 | withdrawn | Effect of Simvastatin Withdrawal on Ocular Endothelial Function |
Showing 50 of 140 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SIMVASTATIN FDA Label Details
Indications & Usage
FDA Label (PDF)SIMVASTATIN is indicated for the treatment of Coronary Heart Disease; Cerebrovascular Disease; Peripheral Vascular Disease; Diabetes; Primary Hyperlipidemia; Heterozygous Familial Hypercholesterolemia; Homozygous Familial Hypercholesterolemia; Primary Dysbetalipoproteinemia; Hypertriglyceridemia.
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Full clinical data, patents, trials, and competitive landscape for simvastatin.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.