CLINICAL TRIALS PROFILE FOR ELIQUIS

All Clinical Trials for Eliquis

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01675076 ↗	Strategy of Continued Versus Interrupted Novel Oral Anti-coagulant at Time of Device Surgery in Patients With Moderate to High Risk of Arterial Thromboembolic Events	Completed	Bayer	Phase 3	2013-01-01	The purpose of this study is to determine the best strategy to manage novel oral anti-coagulants (NOACs) at the time of pacemaker or defibrillator surgery. The Investigators hypothesize that performing device surgery without interruption of the novel oral anti-coagulant will result in a reduced rate of clinically significant hematoma.
NCT01675076 ↗	Strategy of Continued Versus Interrupted Novel Oral Anti-coagulant at Time of Device Surgery in Patients With Moderate to High Risk of Arterial Thromboembolic Events	Completed	Boehringer Ingelheim	Phase 3	2013-01-01	The purpose of this study is to determine the best strategy to manage novel oral anti-coagulants (NOACs) at the time of pacemaker or defibrillator surgery. The Investigators hypothesize that performing device surgery without interruption of the novel oral anti-coagulant will result in a reduced rate of clinically significant hematoma.
NCT01675076 ↗	Strategy of Continued Versus Interrupted Novel Oral Anti-coagulant at Time of Device Surgery in Patients With Moderate to High Risk of Arterial Thromboembolic Events	Completed	Bristol-Myers Squibb	Phase 3	2013-01-01	The purpose of this study is to determine the best strategy to manage novel oral anti-coagulants (NOACs) at the time of pacemaker or defibrillator surgery. The Investigators hypothesize that performing device surgery without interruption of the novel oral anti-coagulant will result in a reduced rate of clinically significant hematoma.
NCT01675076 ↗	Strategy of Continued Versus Interrupted Novel Oral Anti-coagulant at Time of Device Surgery in Patients With Moderate to High Risk of Arterial Thromboembolic Events	Completed	Heart and Stroke Foundation of Canada	Phase 3	2013-01-01	The purpose of this study is to determine the best strategy to manage novel oral anti-coagulants (NOACs) at the time of pacemaker or defibrillator surgery. The Investigators hypothesize that performing device surgery without interruption of the novel oral anti-coagulant will result in a reduced rate of clinically significant hematoma.
NCT01675076 ↗	Strategy of Continued Versus Interrupted Novel Oral Anti-coagulant at Time of Device Surgery in Patients With Moderate to High Risk of Arterial Thromboembolic Events	Completed	Ottawa Heart Institute Research Corporation	Phase 3	2013-01-01	The purpose of this study is to determine the best strategy to manage novel oral anti-coagulants (NOACs) at the time of pacemaker or defibrillator surgery. The Investigators hypothesize that performing device surgery without interruption of the novel oral anti-coagulant will result in a reduced rate of clinically significant hematoma.

Clinical Trial Conditions for Eliquis

Condition Name

Condition Name for Eliquis
Intervention	Trials
Venous Thromboembolism	16
Atrial Fibrillation	14
Pulmonary Embolism	6
Deep Vein Thrombosis	5

Condition MeSH

Condition MeSH for Eliquis
Intervention	Trials
Thromboembolism	20
Atrial Fibrillation	20
Thrombosis	18
Venous Thromboembolism	17

Clinical Trial Locations for Eliquis

Trials by Country

Trials by Country for Eliquis
Location	Trials
United States	262
Canada	35
United Kingdom	24
Germany	14
Switzerland	10

Trials by US State

Trials by US State for Eliquis
Location	Trials
California	11
Minnesota	11
Pennsylvania	10
North Carolina	10
Texas	9

Clinical Trial Progress for Eliquis

Clinical Trial Phase

Clinical Trial Phase for Eliquis
Clinical Trial Phase	Trials
Phase 4	19
Phase 3	16
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for Eliquis
Clinical Trial Phase	Trials
Completed	29
Recruiting	20
Unknown status	6

Clinical Trial Sponsors for Eliquis

Sponsor Name

Sponsor Name for Eliquis
Sponsor	Trials
Bristol-Myers Squibb	29
Pfizer	9
Canadian Institutes of Health Research (CIHR)	6

Sponsor Type

Sponsor Type for Eliquis
Sponsor	Trials
Other	149
Industry	47
NIH	5

Eliquis (Apixaban): Clinical Trials, Market Analysis, and Projections

Introduction to Eliquis

Eliquis, or apixaban, is an oral selective Factor Xa inhibitor used to prevent and treat various thromboembolic conditions, including atrial fibrillation, deep vein thrombosis (DVT), and pulmonary embolism (PE). Here, we will delve into the latest updates from clinical trials, market analysis, and projections for this widely used anticoagulant.

Clinical Trials and Real-World Data

Phase 3 Trials and Real-World Evidence

Eliquis has been extensively studied in several Phase 3 clinical trials, including the ARISTOTLE and AVERROES studies for stroke risk reduction in non-valvular atrial fibrillation (NVAF) patients, and the AMPLIFY and AMPLIFY-EXT studies for the treatment of DVT and PE[4].

Real-world data analyses, such as those from the ACROPOLIS™ program, have provided additional insights into the safety and effectiveness of Eliquis. These studies have shown that Eliquis is associated with lower rates of recurrent venous thromboembolism (VTE) and similar rates of major bleeding compared to warfarin and low molecular weight heparin (LMWH)[1].

Recent Observational Studies

A recent retrospective observational study, the ATHENS study, assessed the clinical impact of switching between Eliquis and rivaroxaban in NVAF patients. The study found that switching between these direct oral anticoagulants (DOACs) did not significantly alter the risk of stroke/systemic embolism or major bleeding, although it highlighted the importance of careful patient management during transitions[4].

EXPANSE Clinical Trials Program

The EXPANSE Clinical Trials Program, which includes nearly 60,000 patients worldwide, continues to evaluate Eliquis across multiple indications and patient populations. This program includes several ongoing and completed Phase 3 trials, such as the ADOPT trial, which investigated the prevention of VTE in patients with acute medical illness[3].

Market Analysis

Market Size and Growth

The Eliquis market was valued at USD 31.04 billion in 2023 and is projected to reach USD 75.53 billion by 2031, growing at a compound annual growth rate (CAGR) of 9.3% from 2024 to 2031. This growth is driven by increasing awareness of atrial fibrillation and other thromboembolic conditions, rising healthcare expenditures, and the expanding availability of medications in various markets[2].

Key Market Drivers

• Growing Awareness and Diagnoses: Increased awareness and diagnoses of conditions such as atrial fibrillation are expanding the patient population that may be prescribed Eliquis.
• Healthcare Expenditure and Access: Rising healthcare expenditures and improved access to medications are facilitating greater use of Eliquis.
• Market Exclusivity and Patent Protection: The patent protection of Eliquis limits generic competition, allowing for sustained revenue generation.
• Effective Marketing Strategies: Partnerships and marketing strategies between pharmaceutical companies and healthcare providers enhance the visibility and market penetration of Eliquis.
• Expansion to New Markets: Introduction of Eliquis in emerging markets with growing healthcare infrastructure is driving market growth[2].

Market Challenges

• Generic Competition: The eventual expiration of patent protection for Eliquis may lead to the availability of generic alternatives, impacting market share and pricing.
• Regulatory Challenges: Rigorous regulatory scrutiny can delay or hinder the approval of new formulations or indications.
• Adverse Effects and Safety Concerns: The risk of bleeding complications may lead to patient reluctance and affect adoption among healthcare providers.
• High Cost: The relatively high cost of Eliquis may limit its accessibility, particularly in regions with less healthcare funding or among uninsured patients.
• Market Saturation: The increasing number of competing anticoagulants can dilute Eliquis’s market share and lead to price competition[2].

Geographic Market Segmentation

The Eliquis market is segmented geographically, reflecting diverse healthcare landscapes and regulatory environments.

• North America: Driven by high healthcare expenditure, advanced healthcare infrastructure, and a growing aging population, North America is a significant market for Eliquis.
• Europe: Market dynamics in Europe are influenced by varying healthcare policies and the presence of alternative anticoagulants. Countries like Germany, France, and the UK exhibit robust adoption rates.
• Asia-Pacific: This region presents a rapidly growing opportunity due to an increasing burden of lifestyle-related diseases and rising healthcare spending.
• Middle East and Africa: Despite challenges such as limited healthcare resources and lower awareness levels, there is considerable potential for growth as healthcare investments rise[2].

End-User Segmentation

The Eliquis market is primarily categorized by its end-users, including:

• Hospitals: Significant end-users, administering Eliquis for managing acute care conditions such as atrial fibrillation, DVT, and PE.
• Outpatient Clinics: Providing a continuum of care for patients transitioning from hospital stays or managing chronic conditions.
• Pharmacies: Playing a crucial role in the distribution and utilization dynamics of Eliquis[2].

Financial Performance and Projections

Bristol Myers Squibb reported strong sales for Eliquis, with $3 billion in sales for the third quarter of 2024, an 11% increase from the previous year. This performance contributed to the company's decision to raise its full-year revenue and adjusted earnings guidance. The company expects sales to increase by around 5% and has adjusted its earnings guidance to 75 cents to 95 cents per share[5].

Key Takeaways

• Clinical Trials: Eliquis has demonstrated efficacy and safety in various Phase 3 trials and real-world data analyses.
• Market Growth: The Eliquis market is projected to grow significantly, driven by increasing awareness, healthcare expenditures, and market exclusivity.
• Geographic Segmentation: The market is diverse across regions, with North America, Europe, and the Asia-Pacific region being key markets.
• End-User Segmentation: Hospitals, outpatient clinics, and pharmacies are crucial end-users.
• Financial Performance: Strong sales and revenue growth are expected to continue, driven by the drug's performance and the company's strategic initiatives.

FAQs

What are the primary indications for Eliquis?

Eliquis is approved for multiple indications, including stroke risk reduction in patients with non-valvular atrial fibrillation, treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and reduction in the risk of recurrent DVT and PE following initial therapy[4].

What are the key drivers of the Eliquis market?

Key drivers include growing awareness and diagnoses of thromboembolic conditions, rising healthcare expenditures, market exclusivity due to patent protection, effective marketing strategies, and expansion into new markets[2].

What are the potential challenges facing the Eliquis market?

Challenges include generic competition upon patent expiration, regulatory challenges, adverse effects and safety concerns, high cost limiting accessibility, and market saturation due to competing anticoagulants[2].

How is the Eliquis market segmented geographically?

The market is segmented into North America, Europe, Asia-Pacific, and the Middle East and Africa, each with unique healthcare landscapes and regulatory environments[2].

What is the financial outlook for Eliquis?

Eliquis has shown strong sales growth, contributing to Bristol Myers Squibb's increased revenue and adjusted earnings guidance. The market is projected to continue growing, reaching USD 75.53 billion by 2031[2][5].

Sources

1. Bristol-Myers Squibb-Pfizer Alliance. "Findings Released from Real-World Data Analysis of Eliquis (apixaban) for the Treatment of Venous Thromboembolism in Patients with Active Cancer." News Release, 2019.
2. Verified Market Research. "Eliquis Market Size, Share, Scope, Trends, Growth & Forecast." Verified Market Research, 2023.
3. Pfizer. "New Data Presented On Phase 3 Trial Of ELIQUIS (apixaban) In The Prevention Of Venous Thromboembolism In Patients With Acute Medical Illness." Press Release, 2011.
4. Bristol-Myers Squibb. "Retrospective Observational Study Assessing Real-World Clinical Impact of Switching or Continuing Eliquis or Rivaroxaban Presented at the European Society of Cardiology (ESC) Congress 2023." News Release, 2023.
5. NBC DFW. "Bristol Myers Squibb Tops Earnings Estimates and Hikes Outlook Helped by Eliquis and New Drugs." NBC DFW, 2024.