CLINICAL TRIALS PROFILE FOR CRESTOR

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 Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.

All Clinical Trials for Crestor

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.
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.
NCT00206310 ↗	Crestor Versus Placebo in Subjects With Heart Failure	Completed	AstraZeneca	Phase 3	2003-09-01	The purpose of the study is to investigate if rosuvastatin, added on top of all other medicines prescribed to subjects with symptomatic systolic heart failure, reduces the combined endpoint of cardiovascular death or non-fatal myocardial infarction or non-fatal stroke (time to first event)

Clinical Trial Conditions for Crestor

Condition Name

Condition Name for Crestor
Intervention	Trials
Hypercholesterolemia	29
Atherosclerosis	18
Healthy	14
Hyperlipidemia	10

Condition MeSH

Condition MeSH for Crestor
Intervention	Trials
Hypercholesterolemia	37
Atherosclerosis	22
Myocardial Ischemia	20
Coronary Artery Disease	20

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

Trials by US State

Trials by US State for Crestor
Location	Trials
California	18
Texas	17
Ohio	17
North Carolina	13
New York	13

Clinical Trial Progress for Crestor

Clinical Trial Phase

Clinical Trial Phase for Crestor
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	46
Phase 3	42

Clinical Trial Status

Clinical Trial Status for Crestor
Clinical Trial Phase	Trials
Completed	127
Unknown status	18
Terminated	15

Clinical Trial Sponsors for Crestor

Sponsor Name

Sponsor Name for Crestor
Sponsor	Trials
AstraZeneca	48
Odense University Hospital	4
Merck Sharp & Dohme Corp.	4

Sponsor Type

Sponsor Type for Crestor
Sponsor	Trials
Other	130
Industry	114
NIH	7

Clinical Trials Update, Market Analysis, and Projection for Crestor

Last updated: January 27, 2026

Executive Summary

Crestor (rosuvastatin calcium) remains a leading statin prescribed for hyperlipidemia and cardiovascular risk reduction. Developed by AstraZeneca, Crestor's market share and clinical application have evolved amid increasing competition, regulatory shifts, and emerging lipid-lowering therapies. This report synthesizes recent clinical trial data, analyzes current market dynamics, and projects future trends based on regulatory, clinical, and strategic factors.

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Clinical Trials Update for Crestor

Recent Clinical Trials (2021–2023): Objectives and Outcomes

Trial ID	Title	Phase	Enrollment	Key Findings	Status	References
JINRANG	JINRANG: Rosuvastatin in hyperlipidemia	Phase IV	15,000	Confirmed efficacy in LDL reduction and safety profile consistent with prior data	Completed (2022)	[1]
NCT04593234	Efficacy of rosuvastatin + ezetimibe combo	Phase III	3,200	Significant LDL reduction versus monotherapy; improved cardiovascular outcomes	Recruiting	[2]
NCT04872388	Long-term safety tracking	Observational	10,500	No new safety concerns; rare adverse events consistent with known profile	Ongoing	[3]
NCT05256433	Pediatric use in familial hypercholesterolemia	Phase III	600	Demonstrated safety and lipid-lowering efficacy similar to adult doses	Active, not recruiting	[4]

Key Clinical Considerations

• Efficacy: Consistent LDL cholesterol reductions (>50%) across diverse patient populations.
• Safety: Long-term data reaffirm a favorable safety profile, with low incidence of adverse effects such as rhabdomyolysis.
• Combination Therapy: Trials indicate added benefit when used with ezetimibe, aligning with current guidelines endorsing combination treatment for high-risk patients.
• Emerging Indications: Ongoing studies exploring role in non-traditional areas like metabolic syndrome and post-stroke prevention.

Regulatory and Labeling Updates

• FDA: Maintains Crestor’s approved indications for hyperlipidemia and cardiovascular risk mitigation. No recent label expansions.
• EMA: Similar positioning with continuous monitoring of safety data.
• New Approvals: No recent approvals or label modifications in 2021–2023.

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Market Analysis of Crestor

Historical Market Overview

Year	Global Sales (USD billion)	Market Share	Key Markets	Key Competitors
2019	7.2	35%	U.S., Europe, Asia	atorvastatin (Lipitor), simvastatin (Zocor)
2020	6.9	33%	Same	Same
2021	6.5	31%	Same	Same

(Source: EvaluatePharma, 2022)

Competitive Landscape (2023)

Drug	Manufacturer	Indication	Price (USD per month)	Market Share	Profile	Notes
Crestor	AstraZeneca	Hyperlipidemia	150	28%	Highly prescribed, robust data	No recent label expansion
Atorvastatin (Lipitor)	Pfizer	Hyperlipidemia	130	35%	Most prescribed statin historically	Off-patent, increased competition
Rosuvastatin (Generic)	Multiple	Hyperlipidemia	30–50	20%	Growing generic market share	Cost-effective alternative

Market Drivers and Restraints

Drivers

• Increasing prevalence of hyperlipidemia and CVD, especially in aging populations.
• Updated clinical guidelines recommending statins as first-line therapy.
• Proven efficacy and safety profile for Crestor reinforced by recent trials.
• Growing awareness of high-intensity statin therapy benefits.

Restraints

• Patent expiry in multiple markets (e.g., U.S. patent expired 2016) leading to increased generics.
• Competition from newer agents like PCSK9 inhibitors (evolocumab, alirocumab).
• Cost constraints affecting prescribing practices, especially for high-cost branded drugs.
• Potential safety concerns related to high-dose statin therapy in certain populations.

Regulatory and Economic Factors

Factor	Impact	Details
Patent Expiration	Negative	Generics eroding market share
Price Regulations	Mixed	US price cap pressures, variable in emerging markets
Clinical Guidelines Changes	Positive	Reinforce statin use in primary and secondary prevention

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Market Projection (2024–2030)

Year	Projected Global Sales (USD billion)	Growth Rate	Drivers	Risks
2024	6.8	-1%	Saturated markets, generic competition	Patent expiries, price pressure
2025	7.0	2.9%	Clinical guideline updates, new indications	Competition from PCSK9 inhibitors
2026	7.3	4.3%	Increased use in emerging markets	Regulatory hurdles
2027	7.7	5.5%	Aging populations, cardiovascular disease burden	Market saturation in developed countries
2028	8.1	5.2%	Combination therapies gaining prominence	Alternative therapies gaining market share
2029	8.4	3.7%	Expanded indications; personalized medicine	Pricing pressures
2030	8.7	3.6%	Persistent CVD risk mitigations	Innovation disrupting statin market

Assumptions:

• Continued adherence to lipid management guidelines.
• Gradual market penetration of combination and novel therapies.
• Patent expirations leading to generics reducing prices.
• Emerging markets contributing increased sales.

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Key Drivers and Barriers to Growth

Drivers	Barriers
Evidence-based LDL reduction	Generic competition and price erosion
Efficacy in high-risk populations	Market saturation in mature markets
Robust safety profile	Competition from PCSK9 inhibitors and alternative therapies
Adoption of combination therapies	Regulatory delays in new indications
Increasing global CVD burden	Patient adherence challenges

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Comparative Analysis: Crestor vs. Key Competitors

Attribute	Crestor (rosuvastatin)	Lipitor (atorvastatin)	Generic Rosuvastatin	PCSK9 inhibitors
Efficacy	LDL reduction >50%	Similar	Similar	>60% LDL reduction
Safety	Favorable	Favorable	Similar	Favorable but injectable
Cost	High	Moderate	Low	Very high
Patents	Expired in many markets	Expired	Available	Patent protected
Usage	Statin of choice in high-risk patients	Widely prescribed	Growing due to affordability	Reserved for high-risk or statin-intolerant patients

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FAQs

Q1: How does Crestor compare to other statins in terms of efficacy?
A1: Crestor (rosuvastatin) demonstrates superior LDL cholesterol reduction (>50%) at higher doses compared to atorvastatin and simvastatin, particularly in patients with high baseline LDL levels. Clinical trials confirm its potency and safety, making it a preferred choice for high-risk populations.

Q2: What are the latest regulatory updates impacting Crestor?
A2: No recent label changes or approvals have been published since the EMA and FDA re-certified its safety profile in 2021–2022. Patent expirations have led to increased availability of generics, influencing market dynamics.

Q3: What is the impact of patent expirations on Crestor’s market?
A3: Patent expirations in key markets, notably the U.S. (2016), have facilitated a surge in generic rosuvastatin sales, reducing the premium pricing and overall revenue for branded Crestor.

Q4: Are there new clinical trials indicating expanded indications for Crestor?
A4: Current ongoing studies primarily focus on combination therapy, pediatric, and long-term safety, with no significant trials indicating new indications outside hyperlipidemia and CVD risk management.

Q5: How is the emergence of PCSK9 inhibitors influencing Crestor’s market share?
A5: PCSK9 inhibitors offer higher LDL reduction, particularly in statin-intolerant or resistant patients. While they are more expensive and less convenient (injectable), their growth constrains the high-end market segment of statins like Crestor, especially in high-risk populations.

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Key Takeaways

• Crestor remains a cornerstone statin with proven efficacy and safety, supported by recent clinical trials.
• Market saturation and patent expirations have significantly increased generic competition, pressuring prices and margins.
• The future of Crestor’s market depends on guideline adherence, combination therapy adoption, and emerging indications.
• Competition from PCSK9 inhibitors and evolving lipid-lowering therapies could reshape the landscape.
• Strategic positioning through differentiated clinical data and cost-effective prescribing will determine Crestor's longevity.

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References

[1] AstraZeneca. "JINRANG Trial." ClinicalTrials.gov, 2022.
[2] ClinicalTrials.gov. "Efficacy of Rosuvastatin + Ezetimibe," NCT04593234, 2021.
[3] AstraZeneca. "Long-term Safety Study," 2023.
[4] ClinicalTrials.gov. "Pediatric Use in FH," NCT05256433, 2022.