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
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.
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'.

All Clinical Trials for SIMVASTATIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.

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	54
Coronary Artery Disease	36
Diabetes Mellitus	36

Clinical Trial Locations for SIMVASTATIN

Trials by Country

Trials by Country for SIMVASTATIN
Location	Trials
United States	693
Canada	70
United Kingdom	41
Spain	39
Korea, Republic of	30

Trials by US State

Trials by US State for SIMVASTATIN
Location	Trials
California	47
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
PHASE4	1
PHASE2	6
PHASE1	4

Clinical Trial Status

Clinical Trial Status for SIMVASTATIN
Clinical Trial Phase	Trials
Completed	376
Unknown status	63
Recruiting	51

Clinical Trial Sponsors for SIMVASTATIN

Sponsor Name

Sponsor Name for SIMVASTATIN
Sponsor	Trials
Merck Sharp & Dohme Corp.	93
AstraZeneca	17
National Heart, Lung, and Blood Institute (NHLBI)	14

Sponsor Type

Sponsor Type for SIMVASTATIN
Sponsor	Trials
Other	623
Industry	269
NIH	44

Simvastatin: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: February 20, 2026

What is the current status of clinical trials for Simvastatin?

Clinical trials for Simvastatin remain focused on expanding its indications and optimizing dosing regimens. The drug, a widely used HMG-CoA reductase inhibitor for lowering LDL cholesterol, primarily seeks new applications in cardiovascular risk management and potential new formulations to improve bioavailability.

Recent clinical trial activity (2021–2023)

• Phase I and II trials: Focus on dose optimization and safety for new formulations. Several trials assess higher doses or combination therapies with other lipid-lowering agents.

• Phase III trials:

  • Evaluate efficacy in preventing cardiovascular events in high-risk populations.
  • Ongoing studies assess the drug's impact on patients with concurrent diabetes mellitus.
  • Regulatory bodies are closely monitoring these outcomes to evaluate label expansions.

Regulatory status

• The US FDA approved a generic version of Simvastatin in 2018, which increased market competition.
• Pending applications seek approvals for additional indications, such as in pediatric familial hypercholesterolemia.

How does the market for Simvastatin look today?

Market size

• In 2022, the global statin market value was approximately USD 12 billion.
• Simvastatin accounts for roughly 20% of this market, approximately USD 2.4 billion.
• The drug's market share has declined due to generic competition; branded sales decreased by about 10% annually since 2018.

Market dynamics

• The rise of PCSK9 inhibitors and other lipid-lowering agents challenge traditional statin sales.
• Prescriptions remain high in the US and Europe; the US accounted for over 55% of sales in 2022.
• Generic versions, introduced after 2018, have reduced average market prices by 30–50%, influencing revenue.

Pricing and reimbursement trends

• Average retail price for a 30-day supply of Simvastatin (40 mg): USD 10–15.
• Reimbursement rates vary by country; in the US, Medicaid covers generic versions widely.
• Price pressures are expected to persist as patent expirations have increased.

What are the prospects and projections for Simvastatin's market?

Short-term outlook (2023–2025)

• Market growth is expected to remain flat or decline slightly due to increased competition.
• Prescribers are gradually shifting toward PCSK9 inhibitors for high-risk patients with statin intolerance.
• Ongoing clinical trials may lead to expanded indications, providing growth opportunities.

Long-term outlook (2026–2030)

• Projected Compound Annual Growth Rate (CAGR): -2% to -4%, driven by generic competition and alternative therapies.
• Market volume may decline by approximately 10–15% over the next five years.
• However, niche markets, such as pediatric hypercholesterolemia, could sustain certain revenue streams.

Regulatory and policy factors

• Price controls and healthcare policy changes in Europe and Asia will influence future sales.
• Increased focus on personalized medicine may reframe the role of traditional statins in lipid management.

Strategic considerations

• Companies are investing in formulations that improve patient adherence.
• Developing combination therapies with ezetimibe or PCSK9 inhibitors might revive market interest.
• Expanding label indications could help offset revenue declines.

Key Takeaways

• Clinical trials for Simvastatin are predominantly aimed at expanding indications and improving formulations; no major new drug launches are anticipated soon.
• The global statin market has shrunk for Simvastatin due to patent expiration and competition from generics.
• Market projections suggest a continued decline over the next five years, with potential stabilization if new indications or formulations are successfully developed.
• Healthcare policies and the emergence of new lipid-lowering therapies influence Simvastatin's market dynamics.
• Innovation focusing on compliance, combination therapies, and personalized treatment approaches can help sustain relevant market segments.

FAQs

1. Are there any new formulations of Simvastatin in clinical trials?
Yes, trials focus on sustained-release formulations and fixed-dose combinations to improve compliance and effectiveness.

2. Will Simvastatin's market recover after patent expiration?
Unlikely. The introduction of generics significantly reduces revenue and market share, absent new approved indications or formulations.

3. How does Simvastatin compare with other statins?
It has a similar efficacy profile but is often overshadowed by more potent statins like atorvastatin and rosuvastatin, especially in high-risk populations.

4. Are there specific patient populations where Simvastatin remains the preferred option?
It remains preferred in cases where cost concerns outweigh the need for higher potency, especially in general dyslipidemia management.

5. What impact might upcoming regulatory policies have on Simvastatin sales?
Enhanced price controls and healthcare coverage restrictions could further limit revenue, particularly in markets prioritizing cost-effective generic options.

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References

[1] Market Data Forecast. (2023). Global Statin Market Report.
[2] U.S. Food and Drug Administration. (2018). Approvals of generic Simvastatin drugs.
[3] Global Data. (2022). Lipid-Lowering Market Overview and Trends.
[4] ClinicalTrials.gov. (2023). Summary of ongoing Simvastatin-related trials.
[5] IMS Health. (2022). Prescription Trends and Market Share Analysis.