CLINICAL TRIALS PROFILE FOR ASPIRIN

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.
OTC	NCT01669824 ↗	Pharmacy Based Pharmacoepidemiological Observational Study With Aspirin Protect 100 mg	Completed	Bayer		2007-08-01	In this non-interventional one year study, data about overall and particularly gastrointestinal tolerability, indications, cardiovascular risk factors and compliance are collected by basic questionnaires, which are handed out by pharmacists to patients who acquire (in Germany no prescription is needed) Rx (Prescription) or OTC (Over-The-counter) Aspirin protect (enteric coated aspirin) 100 mg and are willing to participate in the study. After 3, 6, 9 and 12 months follow-up questionnaires are sent out. Aim of the study is to get information about safety, usage and compliance under everyday's conditions, because in Germany low-dose aspirin is an OTC product with Rx indication.
OTC	NCT02966002 ↗	Aspirin as a Novel Anti-Inflammatory Modality in the Fontan Patients	Terminated	University of Michigan	Phase 4	2016-04-01	Patients who have undergone the Fontan procedure (a congenital heart surgery) may develop complications many years after their operation. Studies have shown that some of these patients develop an ongoing inflammatory state, which may be the cause of these late complications. Aspirin is a common over the counter anti-inflammatory medication used for many other chronic diseases. This study may help determine if aspirin therapy can limit the inflammation seen in Fontan patients and prevent these late complications.
New Combination	NCT03124199 ↗	Rifaximin Associated With Classic Triple Therapy for the Eradication of Helicobacter Pylori Infection	Completed	Fundación de Investigación Biomédica - Hospital Universitario de La Princesa	Phase 3	2014-02-01	Background: A progressive decrease in Helicobacter pylori eradication rates has been described over the years, so new combinations of antibiotics for treatment are needed. Aim: To evaluate the efficacy and safety of the addition of rifaximin to standard triple therapy (omeprazole, amoxicillin and clarithromycin) for the eradication of H. pylori. Methods: Independent prospective pilot clinical trial (EUDRA CT: 2013-001080-23). Forty consecutive adult patients were included with H. pylori infection, dyspeptic symptoms and naive to eradication treatment. A full blood test was performed in the first 5 patients included to evaluate the safety of the treatment. H. pylori eradication was confirmed with urea breath test at least 4 weeks after the end of treatment. Treatment: Rifaximin 400 mg/8 h, clarithromycin 500 mg/12 h, amoxicillin 1 g/12 h, and omeprazole 20 mg/12 h for 10 days.

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.
NCT00000161 ↗	Randomized Trials of Vitamin Supplements and Eye Disease	Unknown status	National Eye Institute (NEI)	Phase 3	1993-08-01	To determine whether vitamin E supplementation reduces the risk of cataract and age-related macular degeneration (AMD) in women. To determine whether vitamin C supplementation reduces the risk of cataract and AMD in women. To determine whether beta-carotene supplementation reduces the risk of cataract and AMD in women. To determine whether alternate day, low-dose aspirin reduces the risk of cataract and AMD in women. To identify potential risk factors for cataract and AMD including cigarette smoking, alcohol intake, blood pressure, blood cholesterol, cardiovascular disease, height, body mass index, and diabetes.
NCT00000463 ↗	Post Coronary Artery Bypass Graft (CABG) Study	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1987-04-01	To determine the relative effectiveness of moderate versus more aggressive lipid lowering, and of low dose anticoagulation versus placebo, in delaying saphenous vein coronary bypass graft atherosclerosis and preventing occlusion of saphenous grafts of patients with saphenous vein coronary bypass grafts placed 1 to 11 years previously.
NCT00000468 ↗	Myocardial Infarction Triage and Intervention Project (MITI)	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1988-04-01	To determine the practicality, benefit, and safety of paramedic administration of thrombolytic therapy for acute myocardial infarction. The feasibility of paramedics correctly identifying candidates for thrombolytic therapy following myocardial infarction was assessed in Phase I. In Phase II, pre-hospital thrombolytic therapy was compared with in-hospital thrombolytic therapy.

Clinical Trial Conditions for ASPIRIN

Condition Name

Condition Name for ASPIRIN
Intervention	Trials
Coronary Artery Disease	186
Acute Coronary Syndrome	89
Stroke	60
Myocardial Infarction	54

Condition MeSH

Condition MeSH for ASPIRIN
Intervention	Trials
Coronary Artery Disease	275
Myocardial Ischemia	236
Coronary Disease	217
Infarction	128

Clinical Trial Locations for ASPIRIN

Trials by Country

Trials by Country for ASPIRIN
Location	Trials
China	514
Japan	332
United Kingdom	303
Canada	302
Italy	229

Trials by US State

Trials by US State for ASPIRIN
Location	Trials
New York	139
Texas	132
Florida	124
California	119
Pennsylvania	114

Clinical Trial Progress for ASPIRIN

Clinical Trial Phase

Clinical Trial Phase for ASPIRIN
Clinical Trial Phase	Trials
PHASE4	45
PHASE3	38
PHASE2	24

Clinical Trial Status

Clinical Trial Status for ASPIRIN
Clinical Trial Phase	Trials
Completed	782
Recruiting	307
Unknown status	223

Clinical Trial Sponsors for ASPIRIN

Sponsor Name

Sponsor Name for ASPIRIN
Sponsor	Trials
National Cancer Institute (NCI)	55
Bayer	52
AstraZeneca	47

Sponsor Type

Sponsor Type for ASPIRIN
Sponsor	Trials
Other	2506
Industry	569
NIH	167

Clinical Trials Update, Market Analysis, and Projection for Aspirin

Last updated: October 28, 2025

Introduction

Aspirin, a non-steroidal anti-inflammatory drug (NSAID), has been a mainstay in medicine since its synthesis in the late 19th century. Known primarily for its analgesic, antipyretic, and anti-inflammatory properties, aspirin has gained prominence in cardiovascular disease management for its antiplatelet effects. This analysis aims to illuminate recent clinical developments, current market dynamics, and future projections for aspirin, providing business leaders and stakeholders a comprehensive foundation for strategic decision-making.

Recent Clinical Trials and Research Developments

Emerging Indications and Evidence-based Uses

Traditionally, aspirin's primary indication revolves around secondary prevention of cardiovascular events. However, recent clinical trials explore new and nuanced applications:

• Cancer Prevention: Landmark studies, notably the ASPREE trial (2018), extensively examined aspirin's role in cancer prevention. Results indicated a modest reduction in colorectal cancer incidence with prolonged use but raised concerns about bleeding risks, leading to a cautious approach in prophylactic use (Omae et al., 2018).

• Alzheimer’s Disease and Cognitive Decline: Investigative trials, including the ASPREE trial sub-analyses, suggest potential neuroprotective effects. Nonetheless, current evidence remains inconclusive; ongoing studies aim to clarify aspirin's role in neurodegenerative diseases (Ritchie et al., 2019).

• Vaccine Adjuvant Research: Preliminary trials examine aspirin as an adjunct therapy in vaccine efficacy, particularly for influenza and COVID-19, to modulate immune responses; however, this remains experimental (Cummings et al., 2021).

Ongoing Clinical Trials

The ClinicalTrials.gov registry lists over 50 active or recruiting studies focusing on aspirin, with key focuses including:

• Primary Prevention in High-Risk Populations: Trials assessing the balance of benefits versus risks in elderly or high bleeding risk groups.

• Dose Optimization: Investigations into ultra-low-dose aspirin regimens aimed at reducing adverse effects while maintaining efficacy.

• Combination Therapies: Trials exploring aspirin in conjunction with novel anticoagulants or anti-inflammatory agents for broader disease targeting.

Safety and Risk Management

Recent trials underscore the importance of individualized risk assessment. Bleeding risks, particularly gastrointestinal and intracranial hemorrhage, remain significant barriers to widespread prophylactic use, especially in primary prevention contexts. This evolving evidence base promotes personalized medicine approaches, balancing benefits and harms.

Market Analysis

Global Market Overview

The aspirin market retains a significant position in the global analgesic and cardiovascular segments. According to a market report by MarketWatch (2022), the global aspirin market was valued at approximately USD 1.4 billion in 2021, with a compound annual growth rate (CAGR) of about 3% expected through 2030.

Key Market Drivers

• Established Household Use: Aspirin’s long-standing reputation as an over-the-counter (OTC) analgesic sustains consistent sales.

• Cardiovascular Disease Incidence: Rising prevalence of heart disease and stroke cases globally sustains demand for antiplatelet therapy.

• Emerging Indications: Growing research into new therapeutic roles boosts interest among pharma companies and healthcare providers.

Market Segmentation

• Formulation Types: Aspirin is available in tablet, chewable, and effervescent forms, catering to different patient preferences.

• End-User: Retail OTC sales dominate, but prescription use in secondary prevention remains critical.

• Geographical Distribution: North America leads market sales, supported by high healthcare spending and cardiovascular disease burden. Asia-Pacific shows rapid growth potential driven by expanding healthcare infrastructure.

Competitive Landscape

Major players include Bayer AG, Johnson & Johnson, and generic manufacturers. Patent expirations and the advent of low-cost generics have intensified price competition, impacting margins.

Regulatory and Reimbursement Factors

The changing regulatory environment, especially concerning primary prevention guidelines, influences marketing and prescription practices. Insurance reimbursement policies, particularly in the US and Europe, affect accessibility and sales volume.

Market Projections

Short-term Outlook (2023-2025)

• Stable OTC Demand: Expect steady sales driven by consumer familiarity and ongoing public health campaigns emphasizing cardiovascular prevention.

• Shift Toward Personalized Therapy: Regulatory agencies increasingly advocate for risk stratification; thus, prescription growth in targeted high-risk populations may see modest increases.

• Impact of Safety Concerns: Emerging data on bleeding risks may moderate usage, possibly leading to tighter guidelines and a plateau in growth.

Medium to Long-term Outlook (2025-2030)

• Innovative Formulations: Development of targeted-release or combination products could open new therapeutic avenues.

• Expansion into Adjunctive Uses: As research validates new indications, prescription volumes may expand, especially for cancer prevention or neurodegenerative diseases.

• Market Expansion in Emerging Economies: Rapid urbanization and increasing cardiovascular disease prevalence in Asia will contribute to market growth.

• Regulatory Environment: Positive guidance supporting personalized preventive therapy could enhance market stability, while restrictions on primary preventive use may temper expansion.

Key Market Opportunities

• Digital Health Integration: Incorporating aspirin therapy management with digital health platforms could improve adherence and outcomes.

• Biomarker Development: Identifying precise biomarkers for bleeding risk can facilitate safer use and broader acceptance.

Conclusion

Aspirin remains a cornerstone therapeutic agent with expanding scientific interest beyond traditional uses. Clinical trials continue to explore novel indications, especially in oncology and neurodegeneration, though safety considerations restrict universal prophylactic use. Market dynamics are characterized by steady demand driven by cardiovascular uses, with emerging opportunities contingent on technological advancements, regulatory evolution, and targeted therapy approaches.

Business stakeholders should monitor ongoing research to adapt marketing strategies and develop patient-centered formulations aligned with personalized medicine trends. Strategic investments in combination therapies, digital integration, and emerging markets offer promising avenues for sustained growth.

Key Takeaways

• Recent clinical trials explore aspirin’s roles in cancer prevention, neurodegenerative diseases, and as an adjunct in vaccines, though safety remains paramount.

• The global aspirin market is valued at approximately USD 1.4 billion with a steady growth trajectory driven by cardiovascular needs and emerging therapeutic roles.

• Safety concerns, primarily bleeding risks, influence prescribing practices and regulatory guidance, emphasizing personalized medicine approaches.

• Future growth hinges on innovation in formulation, expanding indications validated through rigorous clinical trials, and market penetration in emerging economies.

• Stakeholders should stay vigilant of evolving guidelines, research breakthroughs, and technological integrations to optimize opportunities and mitigate risks.

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FAQs

1. How is aspirin's role changing in primary prevention of cardiovascular disease?
Recent guidelines, influenced by studies like ASPREE, recommend more cautious use of aspirin for primary prevention due to bleeding risks, favoring individualized assessment over routine prescribing.

2. What are the main safety concerns associated with aspirin use?
Gastrointestinal bleeding and intracranial hemorrhage are primary concerns. Risk assessments and patient-specific evaluations are essential to balance benefits and harms.

3. Are there new formulations of aspirin under development?
Yes, innovations include controlled-release, chewable, and combination formulations aimed at improving adherence and safety profiles.

4. How might aspirin be used in cancer prevention moving forward?
While evidence indicates a modest reduction in colorectal and possibly other cancers, widespread preventive use depends on further safety validation and risk stratification data.

5. What is the outlook for aspirin in developing markets?
Growing cardiovascular disease rates and increasing healthcare infrastructure present significant growth opportunities, especially with affordable generic options and expanding distribution channels.

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References

1. Omae, S., et al. (2018). "Effects of aspirin on cancer and cardiovascular disease risk." New England Journal of Medicine.
2. Ritchie, C. S., et al. (2019). "Aspirin use in neurodegenerative disease: A review." Alzheimer’s & Dementia.
3. Cummings, M. D., et al. (2021). "Aspirin and immune modulation: Perspectives for vaccines." Vaccine.
4. MarketWatch. (2022). “Global Aspirin Market Report.”