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Last Updated: February 16, 2025

CLINICAL TRIALS PROFILE FOR ASPIRIN


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505(b)(2) Clinical Trials for Aspirin

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 NCT00011063 ↗ Effect of Ginkgo Biloba on Phenytoin Elimination Completed National Institutes of Health Clinical Center (CC) Phase 1 2001-02-01 This study will examine how the herbal remedy ginkgo biloba may affect the body's elimination of other medicines. Many people take ginkgo biloba to improve memory, mental alertness and overall feeling of well being. Since this product is considered a food supplement and not a drug, it is not subject to the rigorous pre-market testing required for prescription and over-the-counter (OTC) drugs. As a result, information has not been collected on possible interactions between ginkgo biloba and other medications. This study will look at how ginkgo biloba affects the elimination of phenytoin-a medication used to treat patients with seizures. Normal healthy volunteers 21 years of age or older may be eligible for this 40-day study. Candidates will provide a medical history and undergo a physical examination and routine blood tests. Women of childbearing age must use a reliable form of birth control other than oral contraceptives ("the pill"). For at least 2 weeks before the study and throughout its duration, study participants may not have any of the following: 1) medications that can affect platelet function (e.g., aspirin, Motrin, Advil, Nuprin, ibuprofen, etc.); 2) alcoholic beverages; 3) grapefruit and grapefruit juice; and 4) all medications except those given by study personnel. On day 1 of the study, subjects take one 500-mg dose of phenytoin at 8:00 A.M.. On an empty stomach. (Subjects fast the night before taking the phenytoin and are allowed to eat breakfast 2 hours after the dose). Blood samples are drawn just before dosing and again at 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 32, 48, 72 and 96 hours after the dose. Blood drawn on this first study day is collected through a catheter (small plastic tube) placed in a vein to avoid multiple needlesticks. After the 12-hour sample is collected, the subject goes home and then returns to the clinic for the remaining blood draws, which are taken by direct needlestick. When the blood sampling is completed, subjects begin ginkgo therapy. The NIH Clinical Center provides participants a supply of 60-mg capsules of ginkgo to take twice a day (at 8 A.M. and 8 P.M..) for 4 weeks. At the end of the 4 weeks, subjects are given a second dose of phenytoin as described above and repeat the blood sampling procedure. Subjects continue taking ginkgo during this second phenytoin study.
OTC NCT00267293 ↗ Ibuprofen Alone and in Combination With Acetaminophen for Treatment of Fever Completed Children Youth and Family Consortium Phase 4 2006-01-01 Currently, when a child has fever either ibuprofen (e.g. Motrin, Advil) or acetaminophen (e.g. Tylenol) is given. Both Ibuprofen and Acetaminophen are approved for over the counter use for treatment of fever by the Food and Drug Administration (FDA). This study hopes to determine whether giving both medications together is better than giving one medication alone for the treatment of fever.
OTC NCT00267293 ↗ Ibuprofen Alone and in Combination With Acetaminophen for Treatment of Fever Completed Penn State University Phase 4 2006-01-01 Currently, when a child has fever either ibuprofen (e.g. Motrin, Advil) or acetaminophen (e.g. Tylenol) is given. Both Ibuprofen and Acetaminophen are approved for over the counter use for treatment of fever by the Food and Drug Administration (FDA). This study hopes to determine whether giving both medications together is better than giving one medication alone for the treatment of fever.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Aspirin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000151 ↗ Early Treatment Diabetic Retinopathy Study (ETDRS) Completed National Eye Institute (NEI) Phase 3 1979-12-01 To evaluate the effectiveness of both argon laser photocoagulation and aspirin therapy in delaying or preventing progression of early diabetic retinopathy to more severe stages of visual loss and blindness. To help determine the best time to initiate photocoagulation treatment in diabetic retinopathy. To monitor closely the effects of diabetes mellitus and of photocoagulation on visual function. To produce natural history data that can be used to identify risk factors and test etiologic hypotheses in diabetic retinopathy.
NCT00000152 ↗ Randomized Trial of Beta-Carotene and Macular Degeneration Unknown status National Eye Institute (NEI) Phase 3 1982-04-01 To determine whether 50 mg of beta-carotene taken every other day reduces the risk of developing age-related macular degeneration (AMD) among male U.S. physicians who were aged 40 to 84 in 1982. To investigate the possible relationship of AMD with other antioxidants, including selenium and vitamins A, C, and E. To identify potential risk factors for development of AMD. Possible risk factors include height, systemic hypertension, cardiovascular disease, blood cholesterol, cigarette smoking, iris and skin color, sunlight exposure, body mass index, diabetes, and alcohol intake.
NCT00000157 ↗ Randomized Trial of Aspirin and Cataracts in U.S. Physicians Terminated National Eye Institute (NEI) Phase 3 1982-04-01 To determine whether 325 mg of aspirin taken on -alternate days reduces the risk of developing cataract among male U.S. physicians who were aged 40 to 84 in 1982. To identify potential risk factors for cataract development, such as age, blood pressure, blood cholesterol, height, diabetes, medication use, and history of previous eye trauma or surgery.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Aspirin

Condition Name

Condition Name for Aspirin
Intervention Trials
Coronary Artery Disease 179
Acute Coronary Syndrome 85
Stroke 53
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Condition MeSH

Condition MeSH for Aspirin
Intervention Trials
Coronary Artery Disease 266
Myocardial Ischemia 235
Coronary Disease 217
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Clinical Trial Locations for Aspirin

Trials by Country

Trials by Country for Aspirin
Location Trials
China 457
Japan 319
United Kingdom 300
Canada 295
Italy 226
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Trials by US State

Trials by US State for Aspirin
Location Trials
New York 135
Texas 129
Florida 121
California 115
Pennsylvania 109
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Clinical Trial Progress for Aspirin

Clinical Trial Phase

Clinical Trial Phase for Aspirin
Clinical Trial Phase Trials
Phase 4 525
Phase 3 339
Phase 2/Phase 3 73
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Clinical Trial Status

Clinical Trial Status for Aspirin
Clinical Trial Phase Trials
Completed 765
Recruiting 236
Unknown status 223
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Clinical Trial Sponsors for Aspirin

Sponsor Name

Sponsor Name for Aspirin
Sponsor Trials
National Cancer Institute (NCI) 54
Bayer 50
AstraZeneca 47
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Sponsor Type

Sponsor Type for Aspirin
Sponsor Trials
Other 2216
Industry 556
NIH 160
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The Aspirin Market: Clinical Trials, Market Analysis, and Projections

Introduction to Aspirin

Aspirin, a drug that has been in use for over 125 years, continues to be a cornerstone in the treatment and prevention of various medical conditions. From its traditional use in pain relief and anti-inflammatory treatments to its emerging roles in cancer prevention and cardiovascular health, aspirin remains a highly researched and widely used medication.

Current Market Analysis

Global Market Size and Growth

The global aspirin market has shown significant growth in recent years. As of 2023, the market size was valued at USD 2.49 billion, increasing to USD 2.58 billion in 2024. It is projected to grow at a Compound Annual Growth Rate (CAGR) of 4.62%, reaching USD 3.42 billion by 2030[1][5].

Regional Market Share

The market is segmented geographically, with North America holding a major share of over 40% of the global revenue, valued at USD 1005.8 million in 2024. Europe follows closely, with a market share of more than 30%, valued at USD 754.35 million in 2024. The Asia-Pacific region is expected to dominate the market growth due to low costs and increased government support, with a CAGR of 5.2% from 2024 to 2031[2].

Distribution Channels and End Users

The aspirin market is distributed through various channels, including hospital pharmacies, online pharmacies, and retail pharmacies. The end users include hospitals, clinics, and other healthcare facilities. The market is also segmented by product type, with oral administration being the dominant route due to the rising prevalence of cardiac disorders[3].

Clinical Trials and Emerging Uses

Ongoing Research and Clinical Trials

Despite being 125 years old, aspirin remains a subject of intense clinical research. Over 170 clinical trials are currently listed on the ClinicalTrials.gov platform, a number significantly higher than many other commonly used medications[4].

Cardiovascular Health

  • Trials such as the "Aspirin to Target Arterial Events in Chronic Kidney Disease (ATTACK)" and "ASPIrin in Reducing Events in Dialysis (ASPIRED)" are investigating the role of aspirin in reducing cardiovascular events in patients with chronic kidney disease and those on dialysis[4].

Cancer Prevention

  • Research is ongoing to explore aspirin's potential in preventing cancer, particularly colorectal cancer. These studies could open new market niches for aspirin if the findings are positive[3].

Respiratory Health

  • A trial at Johns Hopkins University is examining the effective dose of aspirin in patients with Chronic Obstructive Pulmonary Disease (COPD) to improve respiratory symptoms and reduce mortality[4].

Mental Health

  • The "Salicylic Augmentation in Depression (SAD)" study is investigating whether aspirin can reduce symptoms of depression when used in conjunction with antidepressant medication[4].

Technological Advancements in Drug Delivery

Technological advancements in drug delivery systems have led to the development of aspirin formulations with variable release times. These formulations enable controlled aspirin release, allowing for once-daily dosing and potentially minimizing gastrointestinal adverse effects. This improves patient adherence and supports the expansion of the aspirin market[3].

Market Drivers

Increasing Prevalence of Cardiovascular Diseases

The rising prevalence of cardiovascular diseases such as heart attacks and strokes is a significant driver for the aspirin market. Aspirin is widely used to treat and prevent these conditions, making it a crucial therapeutic option as these disorders become more common globally[3].

Technological Advancements

Advancements in drug delivery systems, such as controlled-release formulations, are enhancing patient compliance and reducing side effects, thereby driving market growth[3].

Rising Geriatric Population

The global aging population is leading to an increase in age-related illnesses, including cardiovascular disease and arthritis. Aspirin's role in treating these conditions positions it for continued market growth[3].

Market Opportunities

Increasing R&D Activities

Ongoing research and clinical trials are exploring aspirin's potential beyond its traditional uses. Emerging applications in cancer prevention, dementia, and other diseases could create new market opportunities if validated[1][3].

Strategic Collaborations and Partnerships

Partnerships between pharmaceutical companies, academic institutions, and healthcare organizations are accelerating innovation, research, and market penetration. These collaborations can lead to the development of novel formulations, combination products, and expanded geographic reach[3].

Market Challenges

Availability of Alternative Therapies

The presence of alternative therapies and medications poses a challenge to the aspirin market. However, aspirin's broad range of applications and its cost-effectiveness continue to make it a preferred option for many conditions[3].

Regional Insights

North America

  • North America holds a significant market share, driven by the high prevalence of cardiovascular diseases and the extensive use of aspirin in preventive care. The United States is the largest market within this region, with a market size of USD 793.58 million in 2024[2].

Europe

  • Europe is expected to grow due to an increased number of cases of migraine and other cardiovascular conditions. The region's market size was valued at USD 754.35 million in 2024[2].

Asia-Pacific

  • The Asia-Pacific region is anticipated to dominate the market growth due to low costs and increased government support. This region is expected to grow at a CAGR of 5.2% from 2024 to 2031[2].

Key Takeaways

  • The global aspirin market is projected to grow significantly, reaching USD 3.42 billion by 2030.
  • Ongoing clinical trials are exploring new uses for aspirin, including cancer prevention and mental health.
  • Technological advancements in drug delivery systems are improving patient compliance and reducing side effects.
  • The rising prevalence of cardiovascular diseases and the aging population are key drivers for the market.
  • Strategic collaborations and partnerships are crucial for market expansion and innovation.

FAQs

What is the current global market size of the aspirin market?

The global aspirin market size was valued at USD 2.49 billion in 2023 and is expected to reach USD 2.58 billion in 2024[1][5].

What is the projected CAGR for the aspirin market from 2024 to 2030?

The aspirin market is projected to grow at a CAGR of 4.62% from 2024 to 2030[1][5].

Which region dominates the aspirin market?

North America holds the largest market share, with over 40% of the global revenue, followed by Europe and the Asia-Pacific region[2].

What are some of the emerging uses of aspirin being researched in clinical trials?

Emerging uses include cancer prevention, particularly colorectal cancer, and potential benefits in chronic kidney disease, COPD, and mental health conditions like depression[4].

How do technological advancements impact the aspirin market?

Technological advancements in drug delivery systems, such as controlled-release formulations, improve patient compliance and reduce side effects, supporting market growth[3].

Sources

  1. GlobeNewswire: "The $3.42 Billion Aspirin Industry 2025-2030 - Emerging Opportunities in Aspirin's Anticancer and Dementia Research Drive Potential for R&D and Strategic Partnerships"[1].
  2. Cognitive Market Research: "Global Aspirin Market Report 2024"[2].
  3. Data Bridge Market Research: "Global Aspirin Market – Industry Trends and Forecast to 2030"[3].
  4. Aspirin Foundation: "Aspirin Summaries : 125 Years of aspirin (Issue 4) : The future for aspirin"[4].
  5. GII Research: "Aspirin Market by Product, Packaging, Dosage Form ... - GII Research"[5].

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