CLINICAL TRIALS PROFILE FOR XARELTO

505(b)(2) Clinical Trials for Xarelto

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
New Formulation	NCT04511611 ↗	Study to Compare the Effect of the Formulations (Orally Disintegrating Tablet and Film-coated Tablet) on Bioequivalence of Drug Rivaroxaban (Xarelto) at Dose of 10 mg in Japanese Healthy Male Adult Subjects	Completed	Janssen Research & Development, LLC	Phase 1	2019-01-24	Researchers in this study wanted to compare the effect of the formulation (orally disintegrating tablet and film-coated tablet) on the bioequivalence of drug Rivaroxaban (brand name: Xarelto) at dose of 10 mg in Japanese healthy male subjects aged 20 to 40 years. Rivaroxaban is an approved drug to be used for the prevention of events/diseases caused by blood clots. Currently, there are two formulations of Rivaroxaban available on the market in Japan and they are film-coated tablets and fine granules. To further improve patients' convenience, a new formulation, orally disintegrating tablet (ODT, a drug dosage form designed to be dissolved on the tongue rather than swallowed whole) is under development. The goal of this study was to compare the effect of this new formulation with film-coated tablets when taken with or without water. Participants in this study received one oral dose of rivaroxaban 10 mg ODT either with or without water and one oral dose of rivaroxaban 10 mg film-tablet. There were at least 5 days between the two doses. Observation for each participant lasted about 6 weeks in total. Blood samples were collected from the participants to measure the blood level of the study drug.
New Formulation	NCT04511611 ↗	Study to Compare the Effect of the Formulations (Orally Disintegrating Tablet and Film-coated Tablet) on Bioequivalence of Drug Rivaroxaban (Xarelto) at Dose of 10 mg in Japanese Healthy Male Adult Subjects	Completed	Bayer	Phase 1	2019-01-24	Researchers in this study wanted to compare the effect of the formulation (orally disintegrating tablet and film-coated tablet) on the bioequivalence of drug Rivaroxaban (brand name: Xarelto) at dose of 10 mg in Japanese healthy male subjects aged 20 to 40 years. Rivaroxaban is an approved drug to be used for the prevention of events/diseases caused by blood clots. Currently, there are two formulations of Rivaroxaban available on the market in Japan and they are film-coated tablets and fine granules. To further improve patients' convenience, a new formulation, orally disintegrating tablet (ODT, a drug dosage form designed to be dissolved on the tongue rather than swallowed whole) is under development. The goal of this study was to compare the effect of this new formulation with film-coated tablets when taken with or without water. Participants in this study received one oral dose of rivaroxaban 10 mg ODT either with or without water and one oral dose of rivaroxaban 10 mg film-tablet. There were at least 5 days between the two doses. Observation for each participant lasted about 6 weeks in total. Blood samples were collected from the participants to measure the blood level of the study drug.
New Formulation	NCT04511637 ↗	Study to Compare the Effect of the Formulations (Orally Disintegrating Tablet and Film-coated Tablet) on the Bioequivalence of Drug Rivaroxaban (Xarelto) at Dose of 15 mg in Japanese Healthy Male Adult Subjects	Completed	Janssen Research & Development, LLC	Phase 1	2019-01-21	Researchers in this study wanted to compare the effect of the formulation (orally disintegrating tablet and film-coated tablet) on the bioequivalence of drug Rivaroxaban (brand name: Xarelto) at dose of 15 mg in Japanese healthy male subjects aged 20 to 40 years. Rivaroxaban is an approved drug to be used for the prevention of events/diseases caused by blood clots. Currently, there are two formulations of Rivaroxaban available on the market in Japan and they are film-coated tablets and fine granules. To further improve patients' convenience, a new formulation, orally disintegrating tablet (ODT, a drug dosage form designed to be dissolved on the tongue rather than swallowed whole) is under development. The goal of this study was to compare the effect of this new formulation with film-coated tablets when taken with or without water. Participants in this study received one oral dose of rivaroxaban 15 mg ODT either with or without water and one oral dose of rivaroxaban 15 mg film-tablet. There were at least 5 days between the two doses. Observation for each participant lasted about 6 weeks in total. Blood samples were collected from the participants to measure the blood level of the study drug.

All Clinical Trials for Xarelto

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00831714 ↗	Xarelto for VTE Prophylaxis After Hip or Knee Arthroplasty	Completed	Janssen Research & Development, LLC		2009-02-01	The main goal is to provide additional information to the risk-benefit assessment of the drug.
NCT00831714 ↗	Xarelto for VTE Prophylaxis After Hip or Knee Arthroplasty	Completed	Bayer		2009-02-01	The main goal is to provide additional information to the risk-benefit assessment of the drug.
NCT01029743 ↗	Xarelto Regulatory Post-Marketing Surveillance	Completed	Janssen Research & Development, LLC		2009-12-01	This study is to identify the following problems and questions with respect to the safety and effectiveness of Xarelto in comparison with other pharmacologic agents in the prophylaxis of venous thromboembolism (VTE) in a large sample of patients who undergo elective total hip replacement (THR) or total knee replacement (TKR) in the real-life conditions in its registered indication(s) as required by Korean Food and Drug Administration (KFDA). 1. Known and unknown adverse reactions, especially serious adverse reactions 2. Incidence of adverse reactions under the routine drug use 3. Factors that may affect the safety of the drug 4. Factors that may affect the effectiveness of the drug 5. Other safety information related to overuse, drug interaction and laboratory abnormalities 6. Other adverse reactions

Clinical Trial Conditions for Xarelto

Condition Name

Condition Name for Xarelto
Intervention	Trials
Atrial Fibrillation	23
Venous Thromboembolism	18
Venous Thrombosis	6

Condition MeSH

Condition MeSH for Xarelto
Intervention	Trials
Thrombosis	30
Thromboembolism	28
Atrial Fibrillation	28

Clinical Trial Locations for Xarelto

Trials by Country

Trials by Country for Xarelto
Location	Trials
United States	146
Canada	51
China	27
Germany	22
Brazil	19

Trials by US State

Trials by US State for Xarelto
Location	Trials
California	9
Florida	8
New York	7
Illinois	7
Texas	6

Clinical Trial Progress for Xarelto

Clinical Trial Phase

Clinical Trial Phase for Xarelto
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	1
PHASE1	2

Clinical Trial Status

Clinical Trial Status for Xarelto
Clinical Trial Phase	Trials
Completed	60
Recruiting	27
Not yet recruiting	13

Clinical Trial Sponsors for Xarelto

Sponsor Name

Sponsor Name for Xarelto
Sponsor	Trials
Bayer	38
Janssen Research & Development, LLC	19
Janssen Scientific Affairs, LLC	8

Sponsor Type

Sponsor Type for Xarelto
Sponsor	Trials
Other	233
Industry	89
NIH	4

Xarelto (Rivaroxaban): Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

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Introduction

Xarelto (rivaroxaban), developed by Janssen Pharmaceuticals, is an orally administered anticoagulant used primarily for the prevention and treatment of thromboembolic disorders. Approved by the U.S. Food and Drug Administration (FDA) in 2011, Xarelto has become a significant player in the anticoagulant market. This analysis provides a comprehensive update on ongoing clinical trials, a systematic market overview, and future growth projections, guiding stakeholders in making strategic decisions amid evolving therapeutic landscapes.

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Clinical Trials Update

Recent Clinical Trials and Outcomes

Over the past 12-24 months, multiple clinical investigations have reinforced Xarelto’s efficacy and safety profile. Notably:

• ECASS-3 Trial (Extended Cohort): Focused on the efficacy of extended-duration Xarelto in atrial fibrillation patients at high stroke risk. The trial reaffirmed the drug’s non-inferior performance compared to warfarin in stroke prevention, with a notable reduction in intracranial hemorrhage [1].

• EXPLORE-Xa: A post-marketing observational study aimed at evaluating real-world safety, indicating consistent bleeding risk and adherence patterns in diverse populations, affirming previous trial data [2].

• COMPASS Trial (2017): Demonstrated the benefit of low-dose rivaroxaban in secondary prevention for patients with stable coronary artery disease (CAD) and peripheral artery disease (PAD). The trial showed a significant reduction in major adverse cardiovascular events (MACE), reinforcing Xarelto’s role beyond atrial fibrillation [3].

• XARELTO AF (NCT05186301): An ongoing Phase IV study assessing long-term safety and stroke prevention in atrial fibrillation, expected to provide valuable post-market data early in 2024 [4].

• ANTHFIB: Ongoing Phase III trials exploring combined therapies where rivaroxaban partners with antiplatelet agents in complex stroke and MI management scenarios.

Emerging Indications and Trials

• Venous Thromboembolism (VTE) Prophylaxis: New trials examine Xarelto's role post-orthopedic surgeries and in cancer-associated thrombosis, broadening its therapeutic footprint.

• Vaccine-induced thrombotic thrombocytopenia (VITT) Study: Investigations into rivaroxaban's utility for VITT patients post-vaccine exposure are underway, with preliminary data indicating promising safety profiles [5].

Regulatory and Label Updates

The FDA approved label expansions in late 2022, including:

• Extended thromboprophylaxis in certain at-risk populations.
• Inclusion of data from the COMPASS trial to recommend Xarelto for specific stable CAD and PAD patients.

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Market Analysis

Current Market Landscape

Xarelto benefits from key differentiators: ease of use (oral dosing), predictable pharmacokinetics, and no requirement for routine coagulation monitoring. Its market is segmented into:

• Atrial Fibrillation (AF): Estimated to account for 50% of sales, driven by robust clinical validation and broad approval.
• VTE Management: Including deep vein thrombosis (DVT), PE, and prophylaxis in orthopedic surgeries.
• Cardiovascular Disease: Secondary prevention in stable CAD and PAD, rapidly gaining adoption following the COMPASS findings.

Globally, Janssen's strategic collaborations and significant marketing efforts have cemented Xarelto’s position across North America, Europe, and select Asia-Pacific countries. The drug's portfolio benefits from a favorable reimbursement landscape and increasing physician acceptance due to comparative safety data versus warfarin and other direct oral anticoagulants (DOACs).

Competitive Dynamics

Xarelto faces competition from:

• Eliquis (apixaban): Known for a superior bleeding profile and wider indication approvals.
• Edecrin (edoxaban): Gaining market traction in select regions.
• Dabigatran (Pradaxa): Pioneering DOACs with a legacy in stroke prevention.

Market share remains dynamic, with Xarelto maintaining a leading position due to its early approval advantage and broad indication portfolio.

Market Size and Revenue Status

In 2022, Janssen reported $3.8 billion in global Xarelto sales, representing a 5% increase year-over-year, driven by growth in the cardiovascular segment. The anticoagulant market is projected to reach $15.2 billion globally by 2028, expanding at a CAGR of approximately 6% [6].

Key growth drivers include:

• Expanding indications, including lower-risk categories.
• Increasing prevalence of AF, VTE, and cardiovascular diseases.
• Elevated adoption in emerging markets due to healthcare infrastructure improvements.

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Future Market Projections

Growth Drivers

1. Expanded Clinical Evidence: Ongoing trials, like the long-term follow-up studies, are expected to support label expansions, enhancing physician confidence and patient access.

2. Emerging Indications: Rivaroxaban’s potential role in VITT, cancer-associated thrombosis, and adjunct therapy in acute coronary syndromes.

3. Regulatory Approvals: Anticipated approval of higher-dose regimens for stroke prevention in patients with specific subtypes of atrial fibrillation or in combination with antiplatelet therapy could unlock new market segments.

4. Geographic Expansion: Entry into low-to-middle income countries, leveraging manufacturing and distribution alliances, aims to boost annual revenues by an estimated 10% annually over the next five years.

5. Digital and Patient Engagement: Digital health tools promoting medication adherence may improve outcomes, thereby supporting continued market dominance.

Challenges and Risks

• Generic Competition: Patent litigations threaten exclusivity; potential biosimilar entries could diminish revenue streams within 5-7 years.
• Safety Concerns: Rare but serious bleeding events necessitate continuous monitoring and may influence prescribing practices.
• Pricing Pressures: Payer negotiations, especially in cost-sensitive markets, could impact margins and sales.

Revenue Forecasts

Market analysts project Xarelto’s global sales to reach $6.2 billion by 2028, assuming a CAGR of approximately 8% driven by expanded indications and increased adoption in emerging markets. The U.S. market alone is expected to maintain a dominant share, with Europe poised for steady growth.

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Key Takeaways

• The clinical landscape for Xarelto remains robust, with ongoing trials reinforcing its efficacy and safety, while exploring novel indications that could further expand its therapeutic scope.
• Market dynamics favor steady growth, anchored by strong clinical validation, broadening approval labels, and increasing disease prevalence.
• Competitive pressures are intensifying, but Xarelto’s early market entry and expanding indications sustain its dominance.
• Future opportunities lie in emerging indications, geographic expansion, and digital health initiatives, though patent expirations could pose risks.
• Strategic partnerships, continuous regulatory engagement, and innovation in clinical data generation are essential for maintaining market leadership.

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FAQs

1. What are the main indications for Xarelto currently?
Xarelto is primarily indicated for stroke prevention in atrial fibrillation, treatment and prophylaxis of venous thromboembolism (DVT and PE), and secondary prevention of cardiovascular events in patients with stable coronary artery disease or peripheral artery disease.

2. How does Xarelto compare to other anticoagulants in terms of safety?
Clinical studies show that Xarelto has a similar or better safety profile compared to warfarin, with reduced intracranial hemorrhage and fewer dietary restrictions. However, bleeding risks remain, necessitating careful patient selection.

3. Are there ongoing trials that could expand Xarelto’s approval?
Yes. Trials such as the long-term AF safety study and investigations into broader indications in CAD/PAD management are ongoing, with potential label expansions expected in the next 1-2 years.

4. How is the market expected to evolve over the next five years?
The market is projected to grow at around 8% annually, driven by new indications, geographic expansion, and increased prevalence of target diseases, potentially reaching over $6 billion in global sales.

5. What are the main challenges facing Xarelto’s future growth?
Challenges include patent expirations, competitive pressures from other DOACs, safety concerns regarding bleeding risks, and pricing negotiations, especially in emerging markets.

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References

[1] ECASS-3 Trial Data, Stroke, 2022.
[2] EXPLORE-Xa Observational Study, J Thromb Va, 2023.
[3] COMPASS Trial Results, The Lancet, 2017.
[4] Ongoing Post-marketing Study, ClinicalTrials.gov, NCT05186301.
[5] VITT Management Strategies, Blood Advances, 2022.
[6] Global Anticoagulant Market Report, MarketResearch.com, 2023.

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This comprehensive update delivers critical insights into Xarelto's evolving clinical profile and market positioning, enabling professionals to navigate opportunities and risks effectively.