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.

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
Ohio	17
Texas	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

Last updated: April 27, 2026

CRESTOR (rosuvastatin) Clinical Trials Update, Market Analysis, and Projection

What is CRESTOR and what is its current clinical-trials footprint?

CRESTOR is the brand name for rosuvastatin, an HMG-CoA reductase inhibitor used for dyslipidemia and cardiovascular risk reduction. Clinical development for CRESTOR as a standalone product is not currently driven by new “first-in-class” trials; instead, the late-stage and ongoing clinical record centers on new label expansions, population subgroups, dosing strategies, and comparative regimens that use rosuvastatin as the active.

Because rosuvastatin is off-patent in many geographies, the most decision-relevant “clinical trials update” for CRESTOR today is about ongoing evidence generation that supports guideline alignment and payer coverage, not about new, novel CRESTOR-specific molecular IP.

Key ongoing evidence streams that routinely involve rosuvastatin (including CRESTOR)

• Secondary prevention intensification: high- versus moderate-intensity strategies in established atherosclerotic cardiovascular disease populations.
• Statin combination and add-on context: trials where rosuvastatin is the backbone with adjunct therapies (e.g., ezetimibe, PCSK9 inhibitors) to quantify incremental lipid lowering and event risk.
• Safety and tolerability in real-world-risk cohorts: renal impairment, older adults, and muscle-symptom history.
• Adherence and persistence interventions: pragmatic studies that affect outcomes and formulary management.

Net clinical implication for market projections

• Ongoing trials and evidence reviews generally support rosuvastatin use as a core, guideline-concordant statin backbone, which sustains formulary placement and patient access.
• The market effect comes from coverage strength rather than from new efficacy breakthroughs tied to CRESTOR’s brand IP.

Note: The specific CRESTOR-branded trial entries and completion status vary by registry and query scope. If you need a registry-by-registry list of each trial (NCT/clinicaltrials.gov, EudraCT, ISRCTN) with status and endpoints, a complete extraction is required.

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How large is the CRESTOR opportunity and what drives demand?

CRESTOR competes in the global statin market, where demand is driven by:

• Guideline adherence to LDL-C lowering targets in primary and secondary prevention.
• Intensity selection: rosuvastatin is widely used for high-intensity regimens.
• Generic penetration: rosuvastatin generics constrain brand premium, so brand economics depend on contracting, rebates, and channel mix.
• Therapeutic persistence: statins have well-established discontinuation dynamics; pharmacy benefit design and step edits influence persistence.

Demand drivers by segment

• Primary prevention: growth tied to expanded eligibility models and absolute risk stratification.
• Secondary prevention: steadier volume due to chronic therapy and event recurrence risk.
• High-risk subgroups: patients with diabetes, chronic kidney disease, and established ASCVD tend to favor robust LDL-C lowering where rosuvastatin is a common choice.

Competitive context

• Within-class: atorvastatin and simvastatin compete on potency, tolerability, and dosing convenience.
• Cross-class: ezetimibe and PCSK9 inhibitors capture patients not at goal on statins, shifting rosuvastatin demand from “last-mile” to “backbone” use.

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What does the market structure imply for CRESTOR brand sales?

Brand sales for rosuvastatin in mature markets usually track:

1. Underlying statin total market growth (which is modest).
2. Share stability (rosuvastatin holds share due to potency and guideline role).
3. Brand discounting and contracting (brand premium compresses as generics gain pharmacy share).
4. Formulary tiering (preferred placement can sustain brand despite generic availability).

Business reality

• CRESTOR brand value is primarily a function of payer rebates and channel strategy, not a function of unique clinical differentiation at this stage.

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What is the forward projection for CRESTOR through the next 5 years?

A defensible projection requires separating:

• Total rosuvastatin (brand + generic) volume growth from
• Brand share and net price (driven by contracting and generic penetration pace).

Projection logic (directional)

• Underlying rosuvastatin use: stable to slight growth, supported by guideline-driven intensity and persistence.
• Brand CRESTOR: likely flat to declining in mature markets as generic share remains dominant; growth in emerging markets depends on pricing, reimbursement, and brand positioning.

Projection ranges (directional, scenario-based)

• Mature markets: brand net sales typically drift down as generic competition persists.
• Emerging markets: brand may hold better economics longer, but growth is often slower than total drug inflation due to generic entry timing.

For a precise numeric projection (CAGR by geography and brand net sales), a validated dataset is required. Without that dataset, any specific figures would be non-actionable for investment or R&D planning.

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What regulatory and guideline forces will matter most for CRESTOR?

CRESTOR’s commercial trajectory is pulled by:

• ACC/AHA and ESC dyslipidemia guidance (statin intensity recommendations and LDL-C targets).
• NICE and payer HTA logic in countries where cost-effectiveness governs access.
• Safety monitoring policy: renal impairment dosing guidance and statin-associated muscle symptom management.

Practical policy translation

• The more payers interpret rosuvastatin as cost-effective for reaching LDL-C targets, the more stable volumes remain.
• Step therapy for non-statin add-ons often increases reliance on statins as the first-line backbone, which supports rosuvastatin durability.

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How do clinical-trial trends affect competitive positioning versus non-statin therapies?

As therapies beyond statins mature, rosuvastatin’s role shifts toward:

• Maximizing statin-tolerability and LDL-C lowering to reduce “add-on” intensity.
• Supporting combination regimens to achieve targets while managing tolerability.

Key market consequence

• Even when PCSK9 inhibitors and other agents grow, rosuvastatin volume often persists because:
  • combination regimens are standard in guideline care pathways,
  • statins reduce baseline risk and help lower absolute incremental need.

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Key Takeaways

• CRESTOR is a mature, guideline-centered product class where the clinical “update” today is evidence-based support for LDL-C lowering strategies, not new brand-defining molecular trials.
• Market demand remains driven by preventive cardiology intensity, persistence, and payer contracting rather than by new clinical efficacy discontinuities.
• Brand economics are constrained by generic penetration; the most actionable lever is maintaining preferred positioning through rebates and formulary management.
• Forward-looking performance likely shows stable underlying rosuvastatin use with brand net sales pressure in mature markets, and comparatively better brand retention where generic entry is slower.

FAQs

1) Why does CRESTOR still matter commercially if rosuvastatin is generic in many markets?
Because guidelines keep statins as the backbone of LDL-C lowering, and brand value can persist via contracting, rebates, and preferred formulary placement even after generic entry.

2) What clinical endpoints most influence rosuvastatin adoption today?
LDL-C reduction to guideline targets, tolerability in higher-risk cohorts (renal impairment, older adults, prior intolerance), and real-world adherence/persistence that affects long-term outcomes.

3) How do non-statin therapies change rosuvastatin demand?
They usually convert rosuvastatin from “goal sole therapy” to “backbone therapy” in combination pathways, sustaining statin usage while expanding total lipid-lowering intensity.

4) What is the biggest threat to CRESTOR brand sales?
Faster generic share gains and formulary tier reclassification that compress net price and reduce prescription share.

5) What is the biggest upside for CRESTOR over the next five years?
Maintaining preferred formulary status and rebates in high-volume payer channels, and slower generic substitution in geographies where brand positioning remains strong.

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References

[1] National Library of Medicine. ClinicalTrials.gov. (Accessed 2026-04-28). https://clinicaltrials.gov/
[2] American College of Cardiology/American Heart Association. Guideline documents for cholesterol management and ASCVD risk reduction. (Accessed 2026-04-28). https://www.acc.org/
[3] European Society of Cardiology (ESC). Dyslipidaemia guidelines and related position statements. (Accessed 2026-04-28). https://www.escardio.org/