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Last Updated: April 3, 2025

CLINICAL TRIALS PROFILE FOR CRESTOR


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505(b)(2) Clinical Trials for CRESTOR

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial TypeTrial IDTitleStatusSponsorPhaseStart DateSummary
OTC NCT04846231 ↗ Supplements, Placebo, or Rosuvastatin Study Recruiting AstraZeneca Phase 2 2021-04-23 A research study that is evaluating a low dose of an FDA approved statin medication in comparison to several commercially available over the counter dietary supplements which are marketed for cholesterol health. The study is comparing their effect on LDL cholesterol. LDL-cholesterol is low-density cholesterol and is sometimes referred to as "bad" cholesterol. Participants must live in Ohio and have a documented elevated LDL cholesterol level between 70-189mg/dL, must not currently be taking a statin or one of the dietary supplements included in the trial. Participants willing to discontinue a prohibited supplement for 4 weeks prior to enrollment will be allowed to participate. Trial participation is 4 weeks. Study medication will be provided at no charge. There will be 2 visits which include a lab draw at any Cleveland Clinic laboratory. Participants will be randomized (like a coin flip) to be in one of 8 possible groups: Rosuvastatin, Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice, or placebo. The study will enroll 200 participants.
OTC NCT04846231 ↗ Supplements, Placebo, or Rosuvastatin Study Recruiting The Cleveland Clinic Phase 2 2021-04-23 A research study that is evaluating a low dose of an FDA approved statin medication in comparison to several commercially available over the counter dietary supplements which are marketed for cholesterol health. The study is comparing their effect on LDL cholesterol. LDL-cholesterol is low-density cholesterol and is sometimes referred to as "bad" cholesterol. Participants must live in Ohio and have a documented elevated LDL cholesterol level between 70-189mg/dL, must not currently be taking a statin or one of the dietary supplements included in the trial. Participants willing to discontinue a prohibited supplement for 4 weeks prior to enrollment will be allowed to participate. Trial participation is 4 weeks. Study medication will be provided at no charge. There will be 2 visits which include a lab draw at any Cleveland Clinic laboratory. Participants will be randomized (like a coin flip) to be in one of 8 possible groups: Rosuvastatin, Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice, or placebo. The study will enroll 200 participants.
>Trial Type>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 2 of 2 entries

All Clinical Trials for CRESTOR

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00115830 ↗ Rho Kinase in Patients With Atherosclerosis Completed Brigham and Women's Hospital Phase 3 2004-12-01 The purpose of the study is to investigate the effects of atorvastatin (Lipitor) and rosuvastatin (Crestor), United States Food and Drug Administration (FDA) approved drugs commonly prescribed by doctors to lower cholesterol, on certain functions of platelets (cells that cause blood clots), white blood cells (cells that are responsible for inflammation), and blood flow regulation by arteries. This is important because we are looking at ways to more effectively prevent atherosclerosis (plaque buildup in blood vessels) and heart disease. Many studies have demonstrated that these drugs are effective at reducing inflammation and stabilizing plaques. We are interested in better understanding the effects of these medicines on inflammation (pain and swelling) and the mechanism by which they act. Hypothesis: Atorvastatin (40mg) will reduce inflammatory markers and activity more than Rosuvastatin (10mg) in spite of equal LDL-C reduction.
NCT00079638 ↗ Comparative Efficacy Evaluation of Lipids When Treated With Niaspan & Statin or Other Lipid-Modifying Therapies-COMPELL Completed Kos Pharmaceuticals Phase 4 2004-04-01 The purpose of this study is to evaluate the effectiveness of first-line treatment using Niaspan (an extended release version of niacin) and statins versus other drugs that lower lipid levels, in subjects with elevated fat levels in their blood (dyslipidemia). Statins are a class of medication that is often prescribed to patients who need to lower their cholesterol levels.
NCT00184951 ↗ Pharmacokinetic Study of Rosuvastatin and Lopinavir/Ritonavir in HIV Patients Completed Abbott Phase 2 2004-04-01 open-label, multiple dose, single-group, 12 week trial in HIV-infected patients with hyperlipidemia while using lopinavir/ritonavir; both male or female subjects.
NCT00184951 ↗ Pharmacokinetic Study of Rosuvastatin and Lopinavir/Ritonavir in HIV Patients Completed AstraZeneca Phase 2 2004-04-01 open-label, multiple dose, single-group, 12 week trial in HIV-infected patients with hyperlipidemia while using lopinavir/ritonavir; both male or female subjects.
NCT00184951 ↗ Pharmacokinetic Study of Rosuvastatin and Lopinavir/Ritonavir in HIV Patients Completed Radboud University Phase 2 2004-04-01 open-label, multiple dose, single-group, 12 week trial in HIV-infected patients with hyperlipidemia while using lopinavir/ritonavir; both male or female subjects.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 5 of 5 entries

Clinical Trial Conditions for CRESTOR

Condition Name

291814100051015202530HypercholesterolemiaAtherosclerosisHealthyHyperlipidemia[disabled in preview]
Condition Name for CRESTOR
Intervention Trials
Hypercholesterolemia 29
Atherosclerosis 18
Healthy 14
Hyperlipidemia 10
[disabled in preview] 0
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Condition MeSH

3722202000510152025303540HypercholesterolemiaAtherosclerosisMyocardial IschemiaCoronary Artery Disease[disabled in preview]
Condition MeSH for CRESTOR
Intervention Trials
Hypercholesterolemia 37
Atherosclerosis 22
Myocardial Ischemia 20
Coronary Artery Disease 20
[disabled in preview] 0
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Clinical Trial Locations for CRESTOR

Trials by Country

+
Trials by Country for CRESTOR
Location Trials
United States 393
Canada 76
Italy 36
Japan 35
Mexico 34
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Trials by US State

+
Trials by US State for CRESTOR
Location Trials
California 18
Texas 17
Ohio 17
Florida 13
North Carolina 13
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Clinical Trial Progress for CRESTOR

Clinical Trial Phase

39.0%35.6%23.7%005101520253035404550Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for CRESTOR
Clinical Trial Phase Trials
Phase 4 46
Phase 3 42
Phase 2/Phase 3 2
[disabled in preview] 28
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Clinical Trial Status

72.4%10.3%8.6%8.6%0102030405060708090100110120130CompletedUnknown statusTerminated[disabled in preview]
Clinical Trial Status for CRESTOR
Clinical Trial Phase Trials
Completed 126
Unknown status 18
Terminated 15
[disabled in preview] 15
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Clinical Trial Sponsors for CRESTOR

Sponsor Name

trials05101520253035404550AstraZenecaOdense University HospitalMerck Sharp & Dohme Corp.[disabled in preview]
Sponsor Name for CRESTOR
Sponsor Trials
AstraZeneca 48
Odense University Hospital 4
Merck Sharp & Dohme Corp. 4
[disabled in preview] 6
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Sponsor Type

51.6%44.8%0020406080100120140OtherIndustryNIH[disabled in preview]
Sponsor Type for CRESTOR
Sponsor Trials
Other 130
Industry 113
NIH 7
[disabled in preview] 2
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Clinical Trials, Market Analysis, and Projections for Crestor (Rosuvastatin)

Introduction to Crestor (Rosuvastatin)

Crestor, also known by its generic name rosuvastatin, is a statin medication used to lower cholesterol and prevent cardiovascular disease. It is one of the most widely prescribed statins globally.

Current Clinical Trials and Pipeline

While Crestor itself is not in the active clinical trial phase as it is already an approved medication, several studies continue to evaluate its efficacy and safety in various contexts.

  • Comparative Studies: Trials like the SPORT (Supplements, Placebo, or Rosuvastatin Study) compare the efficacy of low-dose rosuvastatin with placebo and common supplements in impacting lipid and inflammatory biomarkers. This study, supported by AstraZeneca, aims to provide insights into the optimal use of statins in managing lipid profiles[4].

Market Analysis

The market for rosuvastatin, including Crestor, is significant and continues to evolve due to several factors.

Global Market Size

The global rosuvastatin calcium market size was estimated to be USD 600.64 million in 2024 and is projected to reach USD 631.33 million in 2025. By 2033, the market is expected to expand to USD 940.6 million, growing at a Compound Annual Growth Rate (CAGR) of 5.11% during the forecast period[5].

Regional Market Trends

  • United States: The U.S. market for rosuvastatin is expected to witness steady growth driven by increasing healthcare expenditure, rising prevalence of cardiovascular diseases, and a growing demand for cost-effective cholesterol-lowering drugs[5].
  • Global: The increasing global prevalence of dyslipidemia, due to factors such as obesity, sedentary lifestyles, and unhealthy dietary habits, is expected to drive the demand for statins like rosuvastatin. However, generic erosion of branded statins, including Crestor, will impact sales in some regions[3].

Competitive Landscape

The statin market, including rosuvastatin, faces competition from other cholesterol-lowering therapies.

  • Generic Erosion: The sales of branded statins like Crestor are expected to decline due to generic erosion. For example, Pfizer’s Lipitor and AstraZeneca’s Crestor have seen significant generic competition, which affects their market share[3].
  • New Therapies: The launch of new therapies, such as PCSK9 inhibitors (e.g., Merck’s MK-0616) and CETP inhibitors (e.g., NewAmsterdam Pharma’s obicetrapib), will also impact the market dynamics for traditional statins like rosuvastatin[3].

Projections and Future Outlook

Sales Projections

Despite the challenges from generic competition and new therapies, rosuvastatin is expected to maintain a significant market presence.

  • Market Share: While the market share of branded statins may decline, rosuvastatin will continue to be a major player in the cholesterol-lowering drug market due to its established efficacy and safety profile[5].

Growth Drivers

  • Increasing Prevalence of Dyslipidemia: The growing global prevalence of dyslipidemia due to lifestyle factors and an aging population will continue to drive the demand for cholesterol-lowering medications like rosuvastatin[3].
  • Cost-Effectiveness: Rosuvastatin, especially in its generic form, is expected to remain a cost-effective option for managing cholesterol levels, which will be a key factor in its continued use[5].

Key Takeaways

  • Market Size: The global rosuvastatin calcium market is projected to grow to USD 940.6 million by 2033.
  • Competitive Landscape: The market faces competition from generics and new therapies like PCSK9 inhibitors.
  • Growth Drivers: Increasing prevalence of dyslipidemia and the cost-effectiveness of rosuvastatin will drive its continued use.
  • Clinical Trials: Ongoing studies continue to evaluate the efficacy and safety of rosuvastatin in various contexts.

FAQs

What is the current market size of rosuvastatin calcium?

The global rosuvastatin calcium market size was estimated to be USD 600.64 million in 2024 and is projected to reach USD 631.33 million in 2025[5].

How is the market for rosuvastatin expected to grow?

The market is expected to grow at a CAGR of 5.11% from 2025 to 2033, reaching USD 940.6 million by 2033[5].

What are the main drivers of growth for the rosuvastatin market?

The main drivers include the increasing global prevalence of dyslipidemia, cost-effectiveness of rosuvastatin, and ongoing healthcare expenditure[3][5].

How does generic competition affect the sales of Crestor?

Generic competition significantly impacts the sales of branded statins like Crestor, leading to a decline in market share and sales[3].

Are there any new therapies that could impact the market for rosuvastatin?

Yes, new therapies such as PCSK9 inhibitors and CETP inhibitors are expected to enter the market and impact the dynamics for traditional statins like rosuvastatin[3].

Sources

  1. AstraZeneca - Clinical Trials Appendix - H1 2024 Results Update.
  2. GlobalData - NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025.
  3. GlobalData - Dyslipidemia market expected to reach $15.53bn across 7MM by 2032.
  4. Journal of the American College of Cardiology - Comparative Effects of Low-Dose Rosuvastatin, Placebo, and 6 Common Supplements.
  5. Global Growth Insights - Rosuvastatin Calcium Market Size | Forecast 2025 To 2033.

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