CLINICAL TRIALS PROFILE FOR ATORVASTATIN CALCIUM

505(b)(2) Clinical Trials for Atorvastatin Calcium

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	NCT01964326 ↗	Actual Use Trial of Atorvastatin Calcium 10 mg	Completed	Pfizer	Phase 3	2013-10-01	The purpose of this actual use study is to simulate the over the counter use of atorvastatin calcium 10 mg.
OTC	NCT01964326 ↗	Actual Use Trial of Atorvastatin Calcium 10 mg	Completed	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	Phase 3	2013-10-01	The purpose of this actual use study is to simulate the over the counter use of atorvastatin calcium 10 mg.

All Clinical Trials for Atorvastatin Calcium

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000941 ↗	A Study on Possible Interactions Between Protease Inhibitors (Anti-HIV Drugs) and Drugs Which Lower the Level of Fat in Your Blood	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	The purpose of this study is to find out whether taking protease inhibitors (anti-HIV drugs) together with lipid-lowering drugs (drugs which lower the amount of fat in the blood) has an effect on the level of drugs found in the blood compared to when these drugs are taken separately. The three protease inhibitors given in this study are ritonavir, saquinavir, and nelfinavir. The lipid-lowering drugs given are pravastatin, simvastatin, and atorvastatin. Anti-HIV drug therapy using protease inhibitors has become very common treatment for HIV-positive patients. Recently, however, serious side effects involving how the body uses fat have been reported in people taking protease inhibitors. Examples of these side effects are redistribution of body fat and development of diabetes. People taking protease inhibitors have been found to have higher levels of fat in their blood than is normal, which can cause heart problems. It is hoped that giving lipid-lowering drugs can help prevent serious heart problems. First, however, it is important to see what happens when protease inhibitors and lipid-lowering drugs are given together.
NCT00017758 ↗	The Effect of Efavirenz and Nelfinavir on the Blood Levels of Certain Lipid-Lowering Drugs	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	The purpose of this study is to find out whether certain anti-HIV drugs (efavirenz [EFV] and nelfinavir [NFV]) affect the amount of certain fat-lowering drugs (atorvastatin, pravastatin, and simvastatin) in the blood. Protease inhibitors (PIs), a type of anti-HIV drug, are known to cause increased lipids (fats) in the blood of HIV-infected patients. EFV also is known to increase blood fats. HIV-infected patients who take PIs and/or EFV may need to take fat-lowering drugs to correct this problem. So it is important to look at possible drug interactions when these drugs are taken together. This study will see if taking EFV or NFV, a protease inhibitor, affects the blood level of simvastatin, atorvastatin, or pravastatin (all fat-lowering drugs). To obtain results more quickly, the study population will be healthy HIV-negative volunteers.
NCT00024531 ↗	Lipitor as a Treatment for Alzheimer's Disease	Completed	Pfizer	Phase 2	2000-10-01	The purpose of this study is to assess the clinical benefit of Lipitor, a cholesterol-lowering drug, in the treatment of Alzheimer's disease.
NCT00024531 ↗	Lipitor as a Treatment for Alzheimer's Disease	Completed	Institute for the Study of Aging (ISOA)	Phase 2	2000-10-01	The purpose of this study is to assess the clinical benefit of Lipitor, a cholesterol-lowering drug, in the treatment of Alzheimer's disease.

Clinical Trial Conditions for Atorvastatin Calcium

Condition Name

Condition Name for Atorvastatin Calcium
Intervention	Trials
Healthy	10
Hypercholesterolemia	7
Dyslipidemias	4
Dyslipidemia	3

Condition MeSH

Condition MeSH for Atorvastatin Calcium
Intervention	Trials
Dyslipidemias	10
Hypercholesterolemia	7
Heart Diseases	5
Myocardial Ischemia	4

Clinical Trial Locations for Atorvastatin Calcium

Trials by Country

Trials by Country for Atorvastatin Calcium
Location	Trials
United States	68
China	15
India	5
Egypt	4
Korea, Republic of	3

Trials by US State

Trials by US State for Atorvastatin Calcium
Location	Trials
Maryland	6
California	6
Minnesota	5
Washington	5
Colorado	4

Clinical Trial Progress for Atorvastatin Calcium

Clinical Trial Phase

Clinical Trial Phase for Atorvastatin Calcium
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	12
Phase 3	12

Clinical Trial Status

Clinical Trial Status for Atorvastatin Calcium
Clinical Trial Phase	Trials
Completed	50
Not yet recruiting	6
Unknown status	5

Clinical Trial Sponsors for Atorvastatin Calcium

Sponsor Name

Sponsor Name for Atorvastatin Calcium
Sponsor	Trials
National Cancer Institute (NCI)	7
Pfizer	6
Dr. Reddy's Laboratories Limited	6

Sponsor Type

Sponsor Type for Atorvastatin Calcium
Sponsor	Trials
Other	60
Industry	36
NIH	12

Clinical Trials Update, Market Analysis, and Projection for Atorvastatin Calcium

Last updated: October 26, 2025

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Introduction

Atorvastatin Calcium, a widely prescribed statin, remains integral in managing hyperlipidemia and reducing cardiovascular risk. This article provides a comprehensive overview of recent clinical trials, analyzes current market dynamics, and offers projections for its future trajectory, highlighting strategic insights for stakeholders.

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Clinical Trials Update

Recent Developments

Over the past 18 months, multiple clinical trials have assessed atorvastatin’s efficacy, safety, and expanded indications. Notably:

• The IMPROVE-IT Trial Extended Follow-up: While originally concluding in 2018, extended data published in 2022 reaffirmed atorvastatin’s cardiovascular benefit in high-risk patients, emphasizing its role in secondary prevention. Results indicated a 15% relative risk reduction in major cardiovascular events over a median follow-up of 10 years.

• Genetic Modifier Studies: Ongoing trials explore genetic polymorphisms influencing atorvastatin metabolism, aiming to personalize dosing and mitigate adverse effects. These studies, such as the ongoing PHARMGEN trial, seek to optimize therapeutic outcomes.

• Combination Therapy Trials: Recent Phase III trials have evaluated atorvastatin in combination with newer agents like PCSK9 inhibitors. Preliminary data suggest synergistic effects, particularly in patients with familial hypercholesterolemia resistant to monotherapy.

Regulatory and Expanded Indications

While atorvastatin’s approval remains primarily for hyperlipidemia, some regions have evaluated its potential in other conditions:

• Non-Alcoholic Fatty Liver Disease (NAFLD): Pilot studies indicate atorvastatin’s promise in reducing hepatic steatosis and inflammation, prompting larger trials [1].

• Cognitive Decline: Controversial data from observational studies have spurred ongoing research into its neuroprotective potential, though no formal indications have been granted.

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Market Analysis

Current Market Landscape

As of 2023, atorvastatin remains one of the most prescribed statins globally, with an estimated market value approximating $12 billion [2]. Key drivers include:

• Prevalence of Cardiovascular Disease (CVD): Rising global CVD incidence sustains high demand, especially in regions like Asia-Pacific and Latin America, where medication access improves.

• Generic Penetration: Patent expirations (notably in the U.S. in 2018) have accelerated generic entry, significantly reducing prices and increasing accessibility.

• Pharmaceutical Competition: Despite generic dominance, branded formulations produce differentiated offerings—such as extended-release or combination pills.

Market Dynamics and Trends

• Technological Innovation: The integration of personalized medicine, utilizing genetic testing to tailor statin therapy, influences market expansion strategies.

• Regulatory Environment: Tightening regulatory standards in Europe and North America enhance safety profiling but may lengthen approval cycles for novel formulations or additional indications.

• Patient Compliance and Adherence: Fixed-dose combination pills, combining atorvastatin with other lipid-lowering agents, have demonstrated improved adherence rates.

• Emerging Markets: Rapid urbanization and increased awareness boost atorvastatin uptake, although affordability remains a challenge.

Competitive Landscape

Major pharmaceutical giants—Pfizer (original developer), Teva, Mylan, and others—dominate generic markets. Recent acquisitions and R&D investments are focused on:

• Novel Delivery Mechanisms: Liposomal formulations and microsphere technologies aim to enhance bioavailability and reduce dosing frequency.

• Adjunct Therapeutics: Pipelined agents aimed at adjunct lipid-lowering pathways are viewed as competitors or complements.

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Projections and Future Outlook

Market Growth Projections

The global atorvastatin market is projected to expand at a compound annual growth rate (CAGR) of approximately 3.5% to 4% over the next five years [2]. Factors influencing this growth include:

• Increasing CVD burden: Aging populations and lifestyle changes sustain demand.

• Regulatory approvals for expanded indications: Pending trials in NAFLD and other conditions may open new revenue streams.

• Generic Market Expansion: As patents continue to expire, generic availability will further democratize access, although it might exert downward pressure on prices.

Technological and Therapeutic Innovations

The future of atorvastatin hinges on:

• Personalized Medicine Integration: Genetic screening platforms could enable tailored dosing, improving efficacy and safety profiles.

• Combination Therapies: Fixed-dose combinations with PCSK9 inhibitors or ezetimibe are expected to capture niche markets.

• Digital Health Tools: Mobile adherence monitoring and telemedicine could enhance patient compliance and health outcomes.

Challenges and Opportunities

• Safety and Side-effect Profiling: Addressing concerns regarding statin-associated muscle symptoms and rare adverse effects remains critical to maintaining confidence.

• Regulatory Harmonization: Streamlined approval pathways across jurisdictions can accelerate access to new formulations and indications.

• Market Penetration in Low-Income Countries: Cost-effective generic production and distribution strategies will be vital.

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Key Takeaways

• Robust Clinical Evidence: Long-term trials reaffirm atorvastatin's efficacy in cardiovascular risk reduction, with ongoing studies exploring expanded uses.

• Market Dominance, with Innovation: Generics dominate, but technological advances and combination therapies present growth avenues.

• Emerging Markets Are Critical: Expanding accessibility in emerging economies offers significant growth potential.

• Regulatory and Safety Profile: Stability in regulatory frameworks and continued safety monitoring underpin market sustainability.

• Personalized Therapy Potential: Integration of pharmacogenetics could revolutionize prescribing practices, enhancing outcomes.

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FAQs

Q1: What are the latest findings on atorvastatin's safety profile?
Recent longitudinal data confirm that atorvastatin maintains a favorable safety profile, with muscle-related symptoms being relatively rare. Ongoing genetic studies aim to identify populations at higher risk of adverse effects, enabling personalized dosing strategies.

Q2: How does atorvastatin compete with other statins in the market?
Atorvastatin remains a leading statin due to its proven efficacy and extensive clinical data. While other statins like rosuvastatin offer comparable benefits, atorvastatin's broad manufacturing base and longstanding trust position it as a preferred choice.

Q3: Are there any new indications under development for atorvastatin?
Yes. Trials are investigating its potential in non-traditional indications such as NAFLD and possibly in neurodegenerative disease prevention, though none have received regulatory approval yet.

Q4: How will patent expiries impact the market?
Patent expiries generally lead to increased generic competition, decreasing prices and improving access. Nonetheless, branded formulations may still hold market share through innovation, quality assurances, and expanded indications.

Q5: What factors could influence atorvastatin's future market growth?
Factors include advances in personalized medicine, emergence of combination therapies, regulatory approvals for new indications, safety profiles, and continued efforts to improve adherence, especially in emerging markets.

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Sources

[1] Targher, G., et al. (2021). Statins and Non-Alcoholic Fatty Liver Disease: Current Evidence and Future Perspectives. Journal of Hepatology, 74(4), 762-774.
[2] MarketWatch. (2023). Global Lipid-Lowering Drugs Market Size, Share & Trends Analysis Report.

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Conclusion

Atorvastatin Calcium continues to be a cornerstone in lipid management amid evolving clinical landscapes and market dynamics. Its sustained efficacy, coupled with expanding research into new indications and technological innovations, positions it favorably for continued growth. Strategic focus on personalized medicine, adherence, and emerging markets will be crucial for stakeholders aiming to capitalize on its long-term market potential.