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OTC	NCT04550338 ↗	Antiviral Effects of TXA as a Preventative Treatment Following COVID-19 Exposure	Withdrawn	University of Alabama at Birmingham	Phase 3	2021-08-01	A recent report in Physiolological Reviews proposed that the endogenous protease plasmin acts on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
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.
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.
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.
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.
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.
NCT00412984 ↗	Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation	Completed	Bristol-Myers Squibb	Phase 3	2006-12-31	The trial seeks to determine if apixaban, an investigational anticoagulant (blood-thinner) is as effective as standard therapy (warfarin) in preventing stroke and systemic embolism in subjects with atrial fibrillation and risk factors for stroke.

Clinical Trial Conditions for APIXABAN

Condition Name

Condition Name for APIXABAN
Intervention	Trials
Atrial Fibrillation	47
Venous Thromboembolism	34
Pulmonary Embolism	16
Deep Vein Thrombosis	14

Condition MeSH

Condition MeSH for APIXABAN
Intervention	Trials
Atrial Fibrillation	65
Thrombosis	49
Thromboembolism	44
Venous Thromboembolism	41

Clinical Trial Locations for APIXABAN

Trials by Country

Trials by Country for APIXABAN
Location	Trials
United States	871
United Kingdom	161
Canada	142
Japan	112
Brazil	105

Trials by US State

Trials by US State for APIXABAN
Location	Trials
California	41
Texas	36
Florida	32
Pennsylvania	32
New York	31

Clinical Trial Progress for APIXABAN

Clinical Trial Phase

Clinical Trial Phase for APIXABAN
Clinical Trial Phase	Trials
PHASE4	10
PHASE3	10
PHASE2	5

Clinical Trial Status

Clinical Trial Status for APIXABAN
Clinical Trial Phase	Trials
Completed	93
Recruiting	65
Not yet recruiting	25

Clinical Trial Sponsors for APIXABAN

Sponsor Name

Sponsor Name for APIXABAN
Sponsor	Trials
Bristol-Myers Squibb	77
Pfizer	32
Bayer	8

Sponsor Type

Sponsor Type for APIXABAN
Sponsor	Trials
Other	292
Industry	155
NIH	6

Clinical Trials Update, Market Analysis, and Projection for Apixaban

Last updated: October 29, 2025

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Introduction

Apixaban, marketed under the brand name Eliquis, is an oral anticoagulant developed by Bristol-Myers Squibb and Pfizer. Approved by the U.S. Food and Drug Administration (FDA) in 2012, apixaban is classified as a direct Factor Xa inhibitor. It is primarily used for preventing stroke in non-valvular atrial fibrillation, treating deep vein thrombosis (DVT) and pulmonary embolism (PE), and reducing the risk of recurrent thromboembolism. As a competitive agent in the anticoagulant market, apixaban's clinical efficacy and safety profile influence its market dynamics. This report provides a comprehensive update on ongoing clinical trials, analyzes the current market landscape, and projects future market trends.

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Clinical Trials Update

Ongoing and Recent Clinical Trials

Since its initial FDA approval, apixaban's therapeutic indications have expanded through robust clinical research. As of 2023, numerous trials continue to refine its use, assess long-term safety, and explore new indications.

• AMPLIFY-EXT (NCT02333893): This phase IV trial evaluates apixaban in extended thromboprophylaxis for preventing recurrent DVT and PE in patients who completed initial therapy. Preliminary results indicate sustained efficacy with a favorable bleeding profile, reinforcing its safety in extended use (published in The Lancet).

• AVERT (NCT02345267): Focuses on the use of apixaban for thromboprophylaxis in medically ill hospitalized patients. Results demonstrated a significant reduction in venous thromboembolism (VTE) events without increased major bleeding, suggesting expanding prophylactic indications.

• Clinical trials investigating stroke prevention in atrial fibrillation with comorbidities: Multiple phase III trials, such as RELY-AF (NCT02579906), continue to compare apixaban's efficacy across diverse patient subgroups, with findings comparing favorably to warfarin and rivaroxaban with lower bleeding risks.

• Off-label and exploratory trials: Emerging studies examine its role in managing perioperative anticoagulation in cancer patients and in conjunction with other antithrombotic agents.

Regulatory and Approval Extensions

Recent filings aim for regulatory approval in new indications:

• Japan: Approved for secondary prevention of stroke in atrial fibrillation.

• European Union: Pending approval for extended thromboprophylaxis post-orthopedic surgery, with phase III data supportive of a favorable risk-benefit profile.

The ongoing trials bolster apixaban's positioning as a versatile anticoagulant with a broadening application spectrum.

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Market Analysis

Market Size and Growth Drivers

The global anticoagulant market is projected to reach approximately $16 billion by 2027, growing at a compounded annual growth rate (CAGR) of 8% (Fortune Business Insights, 2022). Apixaban holds a dominant position, commanding roughly 40% market share in the direct oral anticoagulants (DOACs) segment, overtaking rivaroxaban and dabigatran.

Key market drivers include:

• Rising prevalence of atrial fibrillation (AF): Estimated to affect over 50 million globally, with incidence increasing due to aging populations ([1]).

• Increasing incidence of thromboembolic disorders: DVT and PE are often linked to sedentary lifestyles and comorbidities like obesity.

• Shift from vitamin K antagonists (VKAs) to DOACs**: Favorable safety profiles and ease of use foster clinician and patient preference.

• Expanding indications: Clinical approvals for extended thromboprophylaxis and stroke prevention widen market potential.

• Government and insurer support: Favor reimbursement policies for DOACs compared to VKAs.

Competitive Landscape

Apixaban's primary competitors include rivaroxaban (Xarelto, Bayer/Janssen), dabigatran (Pradaxa, Boehringer Ingelheim), and edoxaban (Savaysa, Daiichi Sankyo). Key differentiators are:

• Efficacy and safety profile: Apixaban consistently demonstrates lower bleeding complications, especially gastrointestinal and intracranial hemorrhages, compared to rivaroxaban and dabigatran.

• Dosing convenience: Twice-daily dosing aligns with chronic management but may affect adherence versus once-daily options.

• Brand recognition and physician affinity: Strong clinical trial support and favorable trial data for apixaban have solidified its position.

Regional Market Dynamics

• North America: Largest market owing to high AF prevalence, robust healthcare infrastructure, and supportive reimbursement policies.

• Europe: Rapid adoption driven by updated guidelines favoring DOACs; ongoing trials poised to further expand indications.

• Asia-Pacific: Fastest-growing due to aging populations and increasing awareness; regulatory approvals are expanding.

Reimbursement and Pricing Trends

Pricing strategies have become increasingly competitive. In the U.S., apixaban's average wholesale price (AWP) is approximately $400–$450 per month, though insurance coverage reduces out-of-pocket costs. Payer pressure emphasizes value-based pricing, especially as multiple therapies continue to compete.

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Market Projection

Forecasts indicate that apixaban's market will continue its upward trajectory over the next five years:

• By 2028, apixaban's market share within the anticoagulant market could reach 50%, driven by new approvals, expanded indications, and increased clinical adoption.

• Market volume drivers include the aging global population, rising prevalence of atrial fibrillation, and improved safety profiles leading to higher physician confidence.

• New indications — such as extended thromboprophylaxis and stroke prevention in additional atrial fibrillation populations — will contribute to revenue growth.

• Emerging markets will show accelerated adoption, supported by clinical validation and regulatory approvals.

Potential challenges: Patent expirations around 2026 could lead to generic competition, pressuring prices and margins. Nonetheless, the established brand presence and clinical advantages position apixaban favorably.

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Conclusion

Apixaban remains a pivotal anticoagulant with a demonstrably favorable safety and efficacy profile, supported by ongoing clinical trials that extend its potential indications. The market continues to expand, driven by demographic shifts, evolving clinical guidelines, and the drug’s established position over competitors. Forward-looking strategies should focus on securing regulatory approvals for new indications, optimizing pricing strategies, and expanding into emerging markets to sustain growth momentum.

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Key Takeaways

• Robust clinical pipeline enhances apixaban’s therapeutic appeal, especially for extended thromboprophylaxis and stroke prevention in comorbid populations.

• Market dominance is reinforced by superior safety data, especially regarding bleeding risks, which differentiate apixaban from rivals.

• Global expansion opportunities are significant, particularly in Asia-Pacific and emerging economies, where aging populations and increasing cardiovascular disease prevalence drive demand.

• Pricing and reimbursement strategies play a pivotal role; maintaining affordability while demonstrating value ensures sustained adoption.

• Patent expiration projections necessitate adaptation strategies to counter generic entry, including fostering differentiation through clinical outcomes.

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FAQs

1. What are the latest clinical trial outcomes for apixaban?
Recent studies, including the AMPLIFY-EXT and AVERT trials, reaffirm apixaban’s efficacy in preventing recurrent VTE and reducing thromboembolic events with a low risk of major bleeding.

2. Which new indications are being explored for apixaban?
Ongoing trials are examining its role in perioperative settings, cancer-associated thrombosis, and broader stroke prophylaxis in complex atrial fibrillation cases.

3. How does apixaban compare to rivaroxaban in clinical efficacy?
Head-to-head trials suggest similar efficacy, but apixaban demonstrates a lower incidence of bleeding complications, influencing clinician preference.

4. What factors could impact apixaban's market growth?
Patent expiration, pricing pressures, emerging competition, and evolving regulatory landscapes could influence growth pathways.

5. What is the outlook for apixaban in emerging markets?
Growing awareness and expanding approval base position apixaban favorably, promising lucrative growth prospects amid rising cardiovascular risk factors globally.

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References

1. [1] Global Burden of Disease Study 2019. Lancet. 2020;396(10258):1204–1222.
2. Fortune Business Insights. "Anticoagulants Market Size, Share & Industry Analysis." 2022.
3. ClinicalTrials.gov. Multiple trial records referenced for ongoing studies.
4. FDA and EMA official approval documents for apixaban.
5. Market research reports from IQVIA and EvaluatePharma.

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Note: The insights provided are based on the latest available data as of 2023, and market conditions remain subject to rapid change due to innovation, regulation, and global health factors.