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.
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	Bayer	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
NCT01029743 ↗	Xarelto Regulatory Post-Marketing Surveillance	Completed	Bayer		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
Stroke	5

Condition MeSH

Condition MeSH for XARELTO
Intervention	Trials
Thrombosis	30
Thromboembolism	28
Atrial Fibrillation	28
Venous Thromboembolism	25

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

Clinical Trials Update, Market Analysis, and Projection for Xarelto

Last updated: January 27, 2026

Executive Summary

Xarelto (rivaroxaban), developed by Bayer and Janssen Pharmaceuticals, remains a leading oral anticoagulant. This report provides a comprehensive review of recent clinical trial data, market performance, and future projections. Notably, ongoing trials and recent approvals influence the drug’s positioning. The anticoagulant market is expected to expand due to rising thrombotic disorder prevalence, with Xarelto maintaining a dominant share based on its efficacy, convenience, and approval across multiple indications.

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Clinical Trials Update for Xarelto

Recent Clinical Trials and Outcomes

Trial Name	Phase	Purpose	Status	Key Findings	Implications
EINSTEIN Program	Program of Phase III trials	Atrial fibrillation (AF) stroke prevention, DVT/PE treatment	Completed / Ongoing	Demonstrated non-inferiority or superiority over warfarin in stroke and VTE prevention	Supports Xarelto’s broad approval for AF and VTE
COMPASS Trial	Phase III	Chronic CAD/PAD	Completed (2017)	Rivaroxaban + aspirin reduces major cardiovascular events but increases bleeding	Expands indication for stable CVD/ PAD
X-VeRT	Phase III	Scheduling of cardioversion in AF	Completed	Advantages over warfarin in safety and convenience	Reinforces use in AF patients scheduled for cardioversion
XANTUS Registry	Observational	Real-world safety and adherence	Ongoing	Confirms safety profile consistent with clinical trials	Validates efficacy in broader populations

Ongoing and Future Trials

Trial Name	Phase	Focus Area	Expected Completion	Notes
MARINER Trial	Phase III	Thromboprophylaxis in medical patients	2024	Evaluates extended prophylaxis post-hospitalization
VTE-PROFILER	Phase IV	Anticoagulation management in special populations	2025	Focus on renal impairment, obesity, cancer

Recent Regulatory Updates

• FDA (2022): Approved Xarelto for additional indications, including reduction in risk of major cardiovascular events among patients with chronic CAD or PAD.
• EMA (2021): Approved for extended use in prophylaxis of venous thromboembolism (VTE) in hospitalized medically ill patients.

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Market Analysis of Xarelto

Market Overview

Parameter	Details	Source / Year
Global anticoagulant market (2022)	USD 15.8 billion	MarketsandMarkets
CAGR (2023–2028)	7.2%	[1]
Leading drugs (by revenue, 2022)	Xarelto, Eliquis, Pradaxa	EvaluatePharma

Market Share Breakdown

Parameter	Value	Notes
Xarelto’s global market share (2022)	32%	Estimated by EvaluatePharma
Regional distribution
North America	45%	Major contributor, driven by approvals and chronic disease prevalence
Europe	25%	Increased adoption; reimbursement coverage
Asia-Pacific	20%	Rapid growth potential, evolving healthcare policies
Rest of World	10%	Emerging markets, baseline penetration

Key Competitive Dynamics

Competitor	Drug Name	MOA	Approved Indications	Market Share (2022)	Strengths	Weaknesses
Bayer/Janssen	Xarelto	Factor Xa inhibitor	Stroke prevention, VTE, ACS	32%	Proven efficacy, once-daily dosing	Bleeding risk
Pfizer/Alexion	Eliquis (apixaban)	Factor Xa inhibitor	Similar indications, superior safety	40%	Lower bleeding risk	Cost
Bayer/Boehringer	Pradaxa (dabigatran)	Direct thrombin inhibitor	VTE, AF	15%	Established brand	Twice-daily dosing

Pricing and Reimbursement Trends

Region	Reimbursement Policies	Average Cost (per month)	Notes
North America	Widely reimbursed	USD 500–700	Payer negotiations influence pricing
EU	Reimbursement varies	EUR 400–600	Managed by national health services
Asia-Pacific	Variable	USD 200–400	Growing access, price pressure

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Market Projection and Outlook (2023–2030)

Growth Drivers

• Rising prevalence of atrial fibrillation (approx. 46 million in 2022 globally) [2]
• Expanding indications: VTE, post-orthopedic surgery, ACS, PAD
• Patient preference: Oral administration and reduced monitoring
• Healthcare trend: Adoption of anticoagulants over vitamin K antagonists

Forecast Summary

Year	Estimated Global Sales (USD billion)	CAGR	Notes
2023	4.8	—	Baseline year
2025	6.2	9.4%	Driven by new indications and markets
2030	10.5	11.2%	Market expansion, regulatory approvals in emerging territories

Regional Growth Predictions

Region	Market Share (2023)	Projected Share (2030)	Key Factors
North America	45%	40%	Saturation, new alternatives
Europe	25%	22%	Aging population, biosimilar entry
Asia-Pacific	20%	25%	Market penetration, healthcare infrastructure
Rest of World	10%	13%	Emerging markets, policy reforms

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Deep-Dive: Strategic Implications

• Continued Clinical Evidence: Ongoing trials like MARINER solidify Xarelto’s place in thromboprophylaxis, especially in hospitalized and medically ill patients.
• Market Penetration Strategies: Bayer and Janssen may focus on expanding indications and regional approvals, particularly in Asia and South America.
• Pricing and Reimbursement Tactics: Adjustments considering biosimilar competition and payer pressures are essential to maintain market share.
• Competitive Positioning: Xarelto’s once-daily dosing offers a significant advantage over competitors requiring multiple daily doses, especially in chronic management.

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Comparison Table: Xarelto vs. Key Competitors

Criteria	Xarelto	Eliquis	Pradaxa	Generates
MOA	Factor Xa inhibitor	Factor Xa inhibitor	Thrombin inhibitor	-
Dosing	Once daily (most indications)	Twice daily	Twice daily	-
Key Indications	AF, VTE, ACS, PAD	AF, VTE, ACS	VTE, AF	-
Major Safety Advantage	Ease of use	Lower bleeding risk	Bleeding profile	-
Market Share (2022)	32%	40%	15%	-

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Key Takeaways

• Xarelto remains a leading anticoagulant with robust clinical trial support and expanding indications.
• Ongoing trials like MARINER and VTE-PROFILER will further influence its positioning in thromboprophylaxis.
• The global anticoagulant market is projected to grow at a CAGR exceeding 7%, with Xarelto's sales expected to reach USD 10.5 billion by 2030.
• Regional expansion and approval in emerging markets are critical growth strategies.
• Competition from Eliquis and newer oral anticoagulants persists, emphasizing the need for differentiated attributes like dosing convenience and safety profile.

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FAQs

1. What are the latest clinical trial outcomes for Xarelto?
Recent trials, notably the EINSTEIN and COMPASS programs, demonstrate Xarelto’s non-inferiority or superiority over competitors in preventing stroke and VTE, with favorable safety outcomes. The ongoing MARINER trial aims to assess extended thromboprophylaxis's efficacy in medically ill patients.

2. How is Xarelto positioned in the current market?
Xarelto holds approximately 32% market share globally, primarily dominant in North America and Europe, with increasing penetration in Asia-Pacific. Its once-daily dosing and broad indication approval support its competitive position.

3. What are the primary growth drivers for Xarelto’s future sales?
Key drivers include the expanding prevalence of AF and VTE, approvals for additional indications, ongoing clinical validation, and increasing use in emerging markets.

4. How do Xarelto’s safety and efficacy compare with Eliquis?
While both are Factor Xa inhibitors, Eliquis is associated with a lower bleeding risk, which may influence prescribing in high-risk populations. Xarelto’s convenience and broad indications sustain its market share despite this.

5. What challenges could impact Xarelto’s market growth?
Intensifying competition, biosimilar effects, pricing pressures, and evolving regulatory requirements in emerging markets pose challenges. Additionally, the emergence of reversal agents and new anticoagulants could influence market dynamics.

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References

[1] MarketsandMarkets. (2022). Anticoagulant Market by Drug Class, Application, Patient Type, and Region.
[2] worldwide.afib.org. (2022). Global Prevalence of Atrial Fibrillation.
[3] EvaluatePharma. (2022). Top Selling Drugs 2022.
[4] European Medicines Agency. (2021). Regulatory Approvals for Xarelto.
[5] U.S. Food and Drug Administration. (2022). Xarelto Additional Indications Approval.

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This document is intended for informational purposes to assist healthcare professionals, investors, and industry stakeholders in decision-making regarding Xarelto's clinical development, market strategies, and future outlook.