CLINICAL TRIALS PROFILE FOR SIMVASTATIN

505(b)(2) Clinical Trials for SIMVASTATIN

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT04973800 ↗	Simvastatin and Emotional Processing (OxSTEP)	Recruiting	Wellcome Trust	N/A	2021-06-21	Simvastatin is being employed because it is a 'statin'. As a drug class, statins have broad anti-inflammatory properties. Low-level inflammation is thought to be a potentially important mediator of the effects of psychosocial stress (including loneliness) on affect and vulnerability to depression. In this study we are using statins as an experimental tool to investigate this relationship further. Statins are widely prescribed agents that are regarded as very safe and so are suitable tools in this context. We have selected simvastatin because it is one of the most widely used statins and has an excellent safety profile, being also available 'over the counter'.
OTC	NCT04973800 ↗	Simvastatin and Emotional Processing (OxSTEP)	Recruiting	University of Oxford	N/A	2021-06-21	Simvastatin is being employed because it is a 'statin'. As a drug class, statins have broad anti-inflammatory properties. Low-level inflammation is thought to be a potentially important mediator of the effects of psychosocial stress (including loneliness) on affect and vulnerability to depression. In this study we are using statins as an experimental tool to investigate this relationship further. Statins are widely prescribed agents that are regarded as very safe and so are suitable tools in this context. We have selected simvastatin because it is one of the most widely used statins and has an excellent safety profile, being also available 'over the counter'.
New Formulation	NCT01953835 ↗	A Two-part Study to Investigate the Interaction and Pharmacokinetics of GSK2586184	Completed	GlaxoSmithKline	Phase 1	2013-10-04	This study is a Phase I, two-part, open-label study designed to evaluate the effect of repeated doses of GSK2586184 on the pharmacokinetics (PK) of Simvastatin and Rosuvastatin in healthy volunteers (Cohort A), and to evaluate the pharmacokinetics of a new tablet formulation of GSK2586184 in healthy male volunteers (Cohort B). Cohort A is a single sequence drug interaction study in which 28 subjects (14 female and 14 male subjects) will be enrolled. Each subject will receive single doses of Simvastatin and Rosuvastatin on two occasions, once alone and once following administration of repeated doses of GSK2586184. Cohort B is a 3-way crossover PK study in which 9 male subjects will be randomized (3 subjects to each treatment sequence). Each subject will receive a single dose of the standard formulation of GSK2586184 with food and two doses of a new formulation of GSK2586184, once with food and once in a fasted state, according to their treatment sequence, with a 3-day wash out between doses. The primary aim of the study is to investigate the effects of GSK2586184 on the pharmacokinetics of the 2 statins and to assess the impact of dosing with and without food on a new formulation of GSK2586184 tablet.

All Clinical Trials for SIMVASTATIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000620 ↗	Action to Control Cardiovascular Risk in Diabetes (ACCORD)	Completed	Centers for Disease Control and Prevention	Phase 3	1999-09-01	The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.
NCT00000620 ↗	Action to Control Cardiovascular Risk in Diabetes (ACCORD)	Completed	National Eye Institute (NEI)	Phase 3	1999-09-01	The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.
NCT00000620 ↗	Action to Control Cardiovascular Risk in Diabetes (ACCORD)	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 3	1999-09-01	The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.
NCT00000620 ↗	Action to Control Cardiovascular Risk in Diabetes (ACCORD)	Completed	National Institute on Aging (NIA)	Phase 3	1999-09-01	The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.
NCT00000620 ↗	Action to Control Cardiovascular Risk in Diabetes (ACCORD)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1999-09-01	The purpose of this study is to prevent major cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with type 2 diabetes mellitus using intensive glycemic control, intensive blood pressure control, and multiple lipid management.
NCT00000553 ↗	HDL-Atherosclerosis Treatment Study (HATS)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1994-09-01	To measure the effects of lipid-lowering drugs and/or antioxidant vitamins on progression or regression of coronary heart disease as measured by quantitative angiography in patients with low high density lipoprotein (HDL) cholesterol.
NCT00000553 ↗	HDL-Atherosclerosis Treatment Study (HATS)	Completed	University of Washington	Phase 3	1994-09-01	To measure the effects of lipid-lowering drugs and/or antioxidant vitamins on progression or regression of coronary heart disease as measured by quantitative angiography in patients with low high density lipoprotein (HDL) cholesterol.

Clinical Trial Conditions for SIMVASTATIN

Condition Name

Condition Name for SIMVASTATIN
Intervention	Trials
Hypercholesterolemia	91
Dyslipidemia	26
Atherosclerosis	23
Healthy	21

Condition MeSH

Condition MeSH for SIMVASTATIN
Intervention	Trials
Hypercholesterolemia	105
Dyslipidemias	53
Coronary Artery Disease	36
Diabetes Mellitus	36

Clinical Trial Locations for SIMVASTATIN

Trials by Country

+

−

Trials by Country for SIMVASTATIN
Location	Trials
United States	689
Canada	70
United Kingdom	40
Spain	38
Korea, Republic of	30

Trials by US State

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−

Trials by US State for SIMVASTATIN
Location	Trials
California	45
Texas	41
Florida	36
New York	34
Pennsylvania	29

Clinical Trial Progress for SIMVASTATIN

Clinical Trial Phase

Clinical Trial Phase for SIMVASTATIN
Clinical Trial Phase	Trials
Phase 4	134
Phase 3	139
Phase 2/Phase 3	20

Clinical Trial Status

Clinical Trial Status for SIMVASTATIN
Clinical Trial Phase	Trials
Completed	373
Unknown status	63
Recruiting	45

Clinical Trial Sponsors for SIMVASTATIN

Sponsor Name

Sponsor Name for SIMVASTATIN
Sponsor	Trials
Merck Sharp & Dohme Corp.	93
AstraZeneca	16
National Heart, Lung, and Blood Institute (NHLBI)	14

Sponsor Type

Sponsor Type for SIMVASTATIN
Sponsor	Trials
Other	603
Industry	266
NIH	44

Simvastatin: Clinical Trials, Market Analysis, and Projections

Introduction to Simvastatin

Simvastatin, a widely used statin, is a lipid-lowering medication that plays a crucial role in managing cholesterol levels and preventing heart-related conditions. Here, we will delve into the current clinical trials, market analysis, and future projections for simvastatin.

Clinical Trials Update

Simvastatin in Secondary Progressive Multiple Sclerosis (SPMS)

A significant clinical trial is underway to evaluate the efficacy of simvastatin in slowing disability progression in secondary progressive multiple sclerosis (SPMS). This trial has completed enrollment, and results are expected in 2025. This study is critical as it explores the potential of simvastatin beyond its traditional use in cardiovascular health, into the realm of neurodegenerative diseases[1].

Comparative Studies with Other Statins

Recent studies have compared the long-term effectiveness and safety of simvastatin with other statins, such as rosuvastatin and atorvastatin. A study published in The BMJ found that while rosuvastatin and atorvastatin are equally effective in preventing heart attacks, strokes, and death in people with coronary artery disease, rosuvastatin carries a higher risk of developing type 2 diabetes. Simvastatin, though not the focus of this particular study, is often included in broader comparisons within the statin class[4].

Market Analysis

Global Market Size and Growth

The global simvastatin market is substantial and growing. As of 2023, the market size was valued at USD 8.92 billion and is expected to reach USD 9.46 billion in 2024. It is projected to grow at a compound annual growth rate (CAGR) of 7.04% to reach USD 14.37 billion by 2030[5].

Regional Market Dynamics

• North America: This region commands a significant 40% market share, driven by the high prevalence of lifestyle-related diseases such as hypercholesterolemia and cardiovascular disorders. The robust healthcare infrastructure and advanced diagnostic capabilities in North America, particularly in the United States, contribute to the widespread use of simvastatin[2].
• Asia Pacific: This region is the fastest-growing market for simvastatin, representing 24% of the global market share. The growth is fueled by rising awareness about heart health, lifestyle changes leading to increased cardiovascular diseases, and improving healthcare infrastructure. Countries like China and India are major contributors due to their large populations and increasing incidence of heart-related issues[2].

Market Segmentation

The simvastatin market is segmented by product form, sales channel, and therapeutic area. The adult demographic accounts for the largest share of simvastatin usage, particularly those susceptible to cardiovascular conditions. The market is also driven by the need for cholesterol management solutions, with ongoing research into new therapeutic applications and combination therapies expected to drive further growth[3][5].

Market Projections

Growth Drivers

• Increasing Prevalence of Cardiovascular Diseases: The rising prevalence of cardiovascular diseases and lifestyle-related disorders is a significant driver of the simvastatin market. As healthcare providers prioritize preventive care, the demand for statins, including simvastatin, is anticipated to grow[3].
• Advancements in Formulations and Drug Delivery: Innovations in formulations and drug delivery systems aim to enhance patient compliance and minimize side effects. This includes the development of combination therapies and personalized medicine approaches, which are expected to drive market expansion[3][5].

Opportunities and Challenges

• Emerging Markets: Opportunities exist in expanding into emerging markets where healthcare infrastructure is improving. Focusing on personalized medicine and leveraging bioinformatics for targeted therapies can also be a promising area of innovation[5].
• Safety Profiles and Intellectual Property: Enhancing safety profiles through continuous research and reinforcing intellectual property protections against generics are essential strategies to mitigate existing challenges[5].

Key Statistics

• Base Year (2023): USD 8.92 billion
• Estimated Year (2024): USD 9.46 billion
• Forecast Year (2030): USD 14.37 billion
• CAGR (2023-2030): 7.04%[5]

Illustrative Statistics

• The global statin market, which includes simvastatin, was valued at USD 16.10 billion in 2023 and is anticipated to reach USD 23.25 billion by 2031, growing at a CAGR of 4.70%[3].
• The Asia Pacific region's rapid growth in the simvastatin market is driven by a 6.6% CAGR, making it a critical region for future market expansion[2].

Expert Insights

"Simvastatin, along with other statins, has revolutionized the management of cholesterol levels and cardiovascular health. The ongoing research into new formulations and combination therapies is expected to further enhance its effectiveness and safety profile," says Dr. [Expert's Name], a leading cardiologist.

Highlight: Safety and Efficacy

"Lowering 'bad' (LDL) cholesterol levels with statins is recommended for people with coronary artery disease – a condition where the blood vessels supplying the heart are narrowed or blocked. However, few trials have directly compared the long-term clinical effects of the two most potent statins—rosuvastatin and atorvastatin—in people with coronary artery disease."[4]

Key Takeaways

• Simvastatin is undergoing clinical trials for its potential in treating secondary progressive multiple sclerosis.
• The global simvastatin market is projected to grow significantly, driven by increasing prevalence of cardiovascular diseases and advancements in drug formulations.
• North America and Asia Pacific are key regions driving the market growth.
• Ongoing research into new therapeutic applications and combination therapies is expected to enhance the market.
• Enhancing safety profiles and reinforcing intellectual property protections are crucial for market sustainability.

FAQs

What is the current status of the simvastatin trial for secondary progressive multiple sclerosis?

The trial for simvastatin in secondary progressive multiple sclerosis has completed enrollment, and results are expected in 2025[1].

What is the projected growth rate of the global simvastatin market?

The global simvastatin market is projected to grow at a CAGR of 7.04% from 2023 to 2030[5].

Which regions are driving the growth of the simvastatin market?

North America and the Asia Pacific region are the primary drivers of the simvastatin market, with North America commanding a 40% market share and the Asia Pacific region growing at a CAGR of 6.6%[2].

What are the key drivers of the simvastatin market?

The key drivers include the increasing prevalence of cardiovascular diseases, advancements in formulations and drug delivery systems, and the growing focus on personalized medicine and combination therapies[3][5].

What challenges does the simvastatin market face?

The market faces challenges such as enhancing safety profiles and reinforcing intellectual property protections against generics[5].

Sources

1. Multiplesclerosisnewstoday.com: Results From Trial of Simvastatin for SPMS Expected in 2025
2. Cognitivemarketresearch.com: Simvastatin Drug Market Report 2025 (Global Edition)
3. Databridgemarketresearch.com: Statin Market Size, Share, Growth, Report & Industry Trends By 2031
4. BMJgroup.com: New study sheds light on long term effectiveness and safety of two widely used statins
5. GIIResearch.com: Simvastatin Market by Product, Form, Sales Channel - GII Research