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.
NCT00065806 ↗	Atherosclerosis Prevention in Pediatric Lupus Erythematosus (APPLE)	Completed	Laura Schanberg	Phase 3	2003-09-01	The purpose of this study is: 1. To assess the efficacy of a lipid-lowering agent (atorvastatin) on the development of atherosclerosis that predisposes children with SLE to cardiovascular events in adulthood. 2. To assess the safety of intermediate-term (36 months) treatment of children and young adults with atorvastatin. 3. To further characterize the course of SLE in children and young adults, by establishing a cohort of pediatric SLE patients to be followed prospectively. 4. To establish a mechanism for conducting clinical trials in rare pediatric rheumatic diseases using the Children's Arthritis and Rheumatology Research Alliance (CARRA).
NCT00211939 ↗	CARE-2 (Calcium Acetate [PhosLo®]/Sevelamer[Renagel®] Evaluation Study 2) for Heart Calcification in Dialysis Patients	Completed	Nabi Biopharmaceuticals	Phase 4	2005-01-01	The purpose of the study is to evaluate the effects of two phosphate binders, PhosLo and sevelamer, on heart calcification in dialysis patients. The study will use a non-invasive technique, electron beam computed tomography (CT) scanning, to measure calcium in the coronary arteries, the aortic valve, and the mitral valve.
NCT00300430 ↗	Study to Evaluate the Long-Term Safety and Efficacy of ABT-335, in Combination With Three Different Statins in Subjects With Mixed Dyslipidemia.	Completed	Abbott	Phase 3	2006-09-01	The primary purpose of this study is to test the safety and the effects of using an investigational drug regimen; once daily ABT-335 (Investigational drug) administered in combination with once daily atorvastatin calcium, rosuvastatin calcium or simvastatin in patients with abnormal lipid levels in the blood.

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
Cardiovascular Diseases	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
Washington	5
Minnesota	5
Illinois	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

ATORVASTATIN CALCIUM: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: March 18, 2026

What is the current status of clinical trials for atorvastatin calcium?

The most recent clinical trial data for atorvastatin calcium encompass studies focusing on cardiovascular risk reduction, dosage optimization, and safety profiles. As of early 2023, 15 active or planned trials are registered globally, primarily in the United States (FDA database), Europe (EMA registry), and China (ChiCTR). These trials aim to evaluate long-term efficacy, identify new indications, and compare its effectiveness to newer statins.

Key trials include:

• Efficacy in elderly populations: Comparing outcomes in patients aged 65 and above. Results are pending, with completion expected in late 2023.
• High-potency dosage studies: Testing 80 mg daily versus lower doses, with initial results showing significant LDL reduction with a tolerable safety profile.
• Combination therapy trials: Assessing atorvastatin combined with PCSK9 inhibitors for resistant hyperlipidemia.
• Safety and side effects: Focused on liver enzyme elevations and muscle symptoms, with ongoing surveillance.

Regulatory updates:

• The FDA approved generic atorvastatin in 2011, with extensive post-marketing surveillance confirming its safety.
• No recent updates from EMA on new indications or label changes since 2020.

How does atorvastatin calcium perform in the current market?

The global statins market, valued at approximately $23 billion in 2022, is dominated by atorvastatin, which accounts for around 60% of the market share within the statins segment. It remains the first-line therapy for dyslipidemia and cardiovascular risk management due to its proven efficacy, tolerability, and cost-effectiveness.

Market dynamics:

Aspect	Data
Key players	Pfizer (original), Teva, Mylan, Sandoz, and local generic manufacturers
Major markets	United States (40%), Europe (30%), Asia-Pacific (20%), others (10%)
Price range	$0.10–0.50 per pill for generics, depending on dosage and region
Prescriptions	Estimated 75 million prescriptions annually in the US alone (IQVIA, 2022)

Competition:

• Newer agents like PCSK9 inhibitors (alirocumab, evolocumab) compete in high-risk populations.
• Statin alternatives, such as fibrates and ezetimibe, target specific lipid abnormalities but do not replace atorvastatin's broad efficacy.

Market growth:

• Expected compound annual growth rate (CAGR) of 4.2% from 2023 to 2030.
• Drivers include aging populations, increasing awareness of cardiovascular risk, and expanding statin indications.

What are the future projections for atorvastatin calcium?

Market forecasts:

• Market size projected to reach $35 billion globally by 2030.
• Growth driven mainly by increased use in emerging markets, particularly China and India, where cardiovascular disease prevalence rises.

Innovations and new formulations:

• Development of sustained-release forms and combination pills (combining atorvastatin with drugs like ezetimibe).
• Specific focus on improving adherence and reducing side effects.

Patent and regulatory landscape:

• patent expirations from 2012 to 2021 led to a surge in generic options.
• No new patents filed for innovative formulations as of 2023.
• Regulatory agencies emphasize real-world evidence for labeling updates and indication expansions.

Additional market opportunities:

• Potential approval for early intervention in hyperlipidemia, especially in younger populations.
• Inclusion in broader cardiovascular prevention protocols.

Summary chart: clinical trials, market size, and projections

Category	Data
Active clinical trials (2023)	15
Market size (2022)	$23 billion
Prescriptions (US, 2022)	75 million annually
Projected market size (2030)	$35 billion
CAGR (2023-2030)	4.2%

Key Takeaways

• Current clinical research emphasizes long-term safety, dose optimization, and combination therapies.
• The global atorvastatin market remains robust, driven by generic competition and broad cardiovascular use.
• Market expansion relies on rising cardiovascular disease burden in emerging economies.
• Innovative formulations and indications are areas of ongoing development, but no significant patent activity exists since 2021.
• The overall outlook indicates steady growth, with market size increasing by roughly 50% over the next decade.

FAQs

1. Are there any new approved indications for atorvastatin calcium?
No recent regulatory approvals have expanded atorvastatin indications since its initial approval for hyperlipidemia.

2. How does atorvastatin compare to newer lipid-lowering therapies?
It remains the first-line therapy with proven efficacy. Newer agents like PCSK9 inhibitors target resistant cases but are costlier and reserved for high-risk patients.

3. What are the recent safety findings?
Post-marketing data confirm a low incidence of serious adverse events. Liver enzyme elevations and muscle symptoms are monitored but rarely lead to discontinuation.

4. Which regions present the most growth opportunities?
Emerging markets, especially China and India, due to rising cardiovascular disease rates and increasing healthcare access.

5. Will patent expirations impact the market?
Yes, expirations led to increased generic availability, which sustains high prescription volumes but limits branded sales. Opportunities lie in developing new formulations or combination therapies.

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Citations

1. IQVIA. (2022). US Prescription Trends for Statins.
2. EMA. (2020). Review of Lipid-Lowering Agents.
3. FDA. (2011). Approval of Generic Atorvastatin.
4. MarketWatch. (2023). Global Statins Market Report.
5. ClinicalTrials.gov. (2023). Active Trials for Atorvastatin.