CLINICAL TRIALS PROFILE FOR APIXABAN

505(b)(2) Clinical Trials for APIXABAN

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OTC	NCT04550338 ↗	Antiviral Effects of TXA as a Preventative Treatment Following COVID-19 Exposure	Withdrawn	University of Alabama at Birmingham	Phase 3	2021-08-01	A recent report in Physiolological Reviews proposed that the endogenous protease plasmin acts on SARS-CoV-2 by cleaving a newly inserted furin site in the S protein portion of the virus resulting in increased infectivity and virulence. A logical treatment that might blunt this process would be the inhibition of the conversion of plasminogen to plasmin. Fortunately, there is an inexpensive, commonly used drug, tranexamic acid, TXA, which suppresses this conversion and could be re-purposed for the treatment of COVID-19. TXA is a synthetic analog of the amino acid lysine which reversibly binds four to five lysine receptor sites on plasminogen. This reduces conversion of plasminogen to plasmin, and is normally used to prevent fibrin degradation. TXA is FDA approved for the outpatient treatment of heavy menstrual bleeding (typical dose 1300 mg p.o. TID x 5 days) and off-label use for many other indications. TXA is used perioperatively as a standard-of-care at UAB for orthopedic and cardiac bypass surgeries. It has a long track record of safety such that it is used over-the-counter in other countries as an antiviral and for the treatment of cosmetic dermatological disorders. Given the potential benefit and limited toxicity of TXA it would appear warranted to perform randomized, double-blind placebo controlled exploratory trial at UAB as a prophylactic antiviral treatment following exposure to COVID-19 in order to determine whether it reduces infectivity and virulence of the SARS-CoV-2 virus as hypothesized. Involvement of each patient is only for 7 days before primary endpoints and 30 days for final data collection.

All Clinical Trials for APIXABAN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00371683 ↗	Study of Apixaban for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery	Completed	Bristol-Myers Squibb	Phase 3	2006-11-01	The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep vein Thrombosis [DVT]) and lung (pulmonary embolism [PE]) that sometimes occur after knee replacement surgery and to learn how apixaban compares to enoxaparin (Lovenox®) for preventing these clots. The safety of apixaban will also be studied.
NCT00320255 ↗	A Phase 2 Pilot Study of Apixaban for the Prevention of Thromboembolic Events in Patients With Advanced (Metastatic) Cancer	Completed	Ontario Clinical Oncology Group (OCOG)	Phase 2	2006-06-01	The purpose of this study is to learn whether apixaban is well-tolerated and acceptable as anticoagulant therapy, when administered to patients with advanced or metastatic cancer and at increased risk for venous thromboembolic events. Demonstration of a favorable benefit:risk profile could lead to significant reduction in this serious and sometimes fatal complication of ongoing cancer and its treatment.
NCT00320255 ↗	A Phase 2 Pilot Study of Apixaban for the Prevention of Thromboembolic Events in Patients With Advanced (Metastatic) Cancer	Completed	Bristol-Myers Squibb	Phase 2	2006-06-01	The purpose of this study is to learn whether apixaban is well-tolerated and acceptable as anticoagulant therapy, when administered to patients with advanced or metastatic cancer and at increased risk for venous thromboembolic events. Demonstration of a favorable benefit:risk profile could lead to significant reduction in this serious and sometimes fatal complication of ongoing cancer and its treatment.
NCT00313300 ↗	Safety Study of Apixaban in Recent Acute Coronary Syndrome	Completed	Bristol-Myers Squibb	Phase 2	2006-05-01	The purpose of this clinical research study is to determine whether apixaban will be safe in people who have recently had unstable angina or a heart attack.
NCT00252005 ↗	Oral Direct Factor Xa-inhibitor Apixaban in Patients With Acute Symptomatic Deep-vein Thrombosis-The Botticelli DVT Study	Completed	Bristol-Myers Squibb	Phase 2	2005-11-01	The purpose of this clinical research study is to assess efficacy and safety of 3 doses of apixaban 5 mg twice a day, 10 mg twice a day and 20 mg once daily versus conventional treatment with low molecular weight heparin or fondaparinux and vitamin K antagonist in the treatment of subjects with acute symptomatic deep-vein thrombosis.
NCT00097357 ↗	BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery	Completed	Bristol-Myers Squibb	Phase 2/Phase 3	2004-10-01	The purpose of this study is to learn if BMS-562247 can prevent blood clots in the legs and lungs in men and women following unilateral total knee replacement surgery. The safety of this treatment will also be studied.

Clinical Trial Conditions for APIXABAN

Condition Name

Condition Name for APIXABAN
Intervention	Trials
Atrial Fibrillation	42
Venous Thromboembolism	31
Pulmonary Embolism	16
Deep Vein Thrombosis	13

Condition MeSH

Condition MeSH for APIXABAN
Intervention	Trials
Atrial Fibrillation	59
Thrombosis	44
Thromboembolism	42
Venous Thromboembolism	35

Clinical Trial Locations for APIXABAN

Trials by Country

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−

Trials by Country for APIXABAN
Location	Trials
United States	860
United Kingdom	156
Canada	140
Japan	112
Brazil	105

Trials by US State

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−

Trials by US State for APIXABAN
Location	Trials
California	40
Texas	35
Pennsylvania	32
New York	30
Florida	30

Clinical Trial Progress for APIXABAN

Clinical Trial Phase

Clinical Trial Phase for APIXABAN
Clinical Trial Phase	Trials
Phase 4	50
Phase 3	50
Phase 2/Phase 3	7

Clinical Trial Status

Clinical Trial Status for APIXABAN
Clinical Trial Phase	Trials
Completed	88
Recruiting	51
Not yet recruiting	25

Clinical Trial Sponsors for APIXABAN

Sponsor Name

Sponsor Name for APIXABAN
Sponsor	Trials
Bristol-Myers Squibb	77
Pfizer	32
Bayer	7

Sponsor Type

Sponsor Type for APIXABAN
Sponsor	Trials
Other	252
Industry	146
NIH	6

Apixaban: Clinical Trials, Market Analysis, and Projections

Introduction to Apixaban

Apixaban, marketed under the brand name Eliquis, is a potent anticoagulant that plays a crucial role in the prevention and treatment of various thromboembolic conditions. It works by inhibiting factor Xa, a key enzyme in the blood coagulation cascade, thereby reducing the formation of blood clots.

Clinical Trials Update

ARCADIA Trial

One of the significant clinical trials involving apixaban is the ARCADIA trial. This multicenter, double-blind, phase 3 randomized clinical trial compared the effectiveness of apixaban versus aspirin for secondary stroke prevention in patients with cryptogenic stroke and evidence of atrial cardiopathy. The trial enrolled 1015 participants and was conducted at 185 sites in the National Institutes of Health StrokeNet and the Canadian Stroke Consortium.

• Key Findings: The trial was stopped for futility after a planned interim analysis, as it did not show a significant difference in the annualized rate of recurrent stroke between the apixaban and aspirin groups (4.4% in both groups, hazard ratio 1.00 [95% CI, 0.64-1.55])[1].

Other Clinical Trials

Other notable trials include the ARISTOTLE trial, which demonstrated that apixaban is superior to warfarin in reducing stroke and systemic embolism in patients with atrial fibrillation. This trial highlighted the efficacy and safety of apixaban in a broader patient population[3].

Market Analysis

Current Market Size and Growth

The global apixaban market is experiencing significant growth driven by several factors. As of 2022, the market was valued at USD 1,765.8 million and is projected to grow to USD 2,908.17 million by 2030, with a Compound Annual Growth Rate (CAGR) of 5.70% during the forecast period from 2023 to 2030[3].

Drivers of Market Growth

• Increasing Prevalence of Venous Thromboembolism: The rising incidence of venous thromboembolism (VTE) and other cardiovascular diseases is a major driver. According to the American Heart Association, VTE affects around 300,000 to 600,000 Americans annually[3].
• Atrial Fibrillation and Stroke: The growing prevalence of atrial fibrillation and stroke also contributes to the market growth, as apixaban is indicated to reduce the risk of stroke and systemic embolism in these patients[2][3].
• Geriatric Population and Obesity: The increasing number of geriatric patients and the rise in obesity rates further boost the market demand[2].

Market Trends

• Advanced Anticoagulants: The development of advanced anticoagulants, including apixaban, has increased demand and provided more options for patients and healthcare professionals. Apixaban's advantages over traditional anticoagulants like warfarin, such as rapid onset action and fewer drug and food interactions, are significant market drivers[5].
• COVID-19 Impact: The COVID-19 pandemic has highlighted the importance of anticoagulants in managing thrombotic risks associated with the disease. However, it also introduced challenges such as potential interactions with COVID-19 treatments and increased demand for anticoagulants[3].

Competitive Landscape

The apixaban market is dominated by several key players, including Bristol-Myers Squibb Company, Pfizer Inc., Sanofi, and others. These companies are involved in continuous research and development to expand the therapeutic indications of apixaban and improve its market position[2][5].

Market Projections

Forecast Period

• Market Size: The global apixaban market is expected to grow significantly, reaching USD 2,908.17 million by 2030 from USD 1,765.8 million in 2022[3].
• Geographical Growth: The Asia-Pacific region is anticipated to offer lucrative opportunities due to its large population base, rising prevalence of cardiovascular diseases, and improving healthcare infrastructure[5].

Opportunities and Challenges

• Research and Development: Ongoing R&D activities, such as the ACROPOLIS program by the Bristol-Myers Squibb-Pfizer Alliance, are generating additional evidence on the real-world effectiveness of apixaban, which can further drive market growth[4].
• Adverse Effects: Despite the benefits, apixaban's adverse effects, such as the increased risk of thrombotic events after premature discontinuation and bleeding, are expected to hamper market growth to some extent[2].

Real-World Data and Patient Outcomes

Real-world data analyses, such as those from the ACROPOLIS program, provide valuable insights into patient outcomes associated with apixaban. These studies help in understanding the drug's effectiveness and safety in routine clinical practice settings, which can influence healthcare decisions and market dynamics[4].

Key Takeaways

• Clinical Trials: The ARCADIA trial and other studies have provided mixed results but highlight the importance of apixaban in specific patient populations.
• Market Growth: The apixaban market is driven by the increasing prevalence of VTE, atrial fibrillation, and other cardiovascular diseases.
• Competitive Landscape: Key players are investing heavily in R&D to expand apixaban's therapeutic indications.
• Challenges: Adverse effects and interactions with other medications remain significant challenges.

FAQs

What is apixaban used for?

Apixaban is used to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, treat deep vein thrombosis (DVT), and prevent recurrent DVT and pulmonary embolism (PE)[2].

What are the key drivers of the apixaban market?

The key drivers include the increasing prevalence of venous thromboembolism, atrial fibrillation, and other cardiovascular diseases, as well as the growing geriatric population and rising obesity rates[2][3].

What are the potential adverse effects of apixaban?

Potential adverse effects include an increased risk of thrombotic events after premature discontinuation and bleeding[2].

How does apixaban compare to traditional anticoagulants like warfarin?

Apixaban offers advantages such as rapid onset action, fewer drug and food interactions, predictable pharmacokinetics, and no dietary restrictions, making it a preferred option over warfarin in many cases[5].

What impact did the COVID-19 pandemic have on the apixaban market?

The COVID-19 pandemic highlighted the importance of anticoagulants in managing thrombotic risks but also introduced challenges such as potential interactions with COVID-19 treatments and increased demand for anticoagulants[3].

Sources

1. JAMA Network: "Apixaban to Prevent Recurrence After Cryptogenic Stroke in Patients With Atrial Cardiopathy" - Clinical trial comparing apixaban and aspirin for secondary stroke prevention.
2. Allied Market Research: "Apixaban Market Size, Share, Growth | Report, 2030" - Market analysis and future estimations for the apixaban market.
3. Data Bridge Market Research: "Global Apixaban Market – Industry Trends and Forecast to 2030" - Market size, growth rate, and forecast for the global apixaban market.
4. Bristol-Myers Squibb: "Findings Released from Real-World Data Analysis of Eliquis (apixaban) for the Treatment of Venous Thromboembolism in Patients with Active Cancer" - Real-world data analysis on apixaban's effectiveness.
5. Allied Market Research: "Anticoagulants Market Size, Share & Growth Statistics, 2025" - Overview of the global anticoagulants market, including NOACs like apixaban.