CLINICAL TRIALS PROFILE FOR RIVAROXABAN

505(b)(2) Clinical Trials for RIVAROXABAN

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 RIVAROXABAN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00329628 ↗	Rivaroxaban (10mg) Given Once Daily in Patients Undergoing Total Hip Replacement Compared to Enoxaparin	Completed	Bayer	Phase 3	2006-02-01	The purpose of this study is to assess if 10 mg BAY 59-7939, taken once daily as a tablet, is safe and prevent blood clot which may form after total hip replacement operation.
NCT00402597 ↗	Rivaroxaban in Combination With Aspirin Alone or With Aspirin and a Thienopyridine in Patients With Acute Coronary Syndromes (The ATLAS ACS TIMI 46 Trial)	Completed	Bayer	Phase 2	2006-11-01	The purpose of this study is to evaluate the safety of rivaroxaban in patients with recent acute coronary syndrome (ACS) and to assess the ability of rivaroxaban to reduce the occurrence of death, myocardial infarction (heart attack), repeat myocardial infarctions, stroke, and ischemia (inadequate blood supply to a local area) in patients with recent ACS.
NCT00402597 ↗	Rivaroxaban in Combination With Aspirin Alone or With Aspirin and a Thienopyridine in Patients With Acute Coronary Syndromes (The ATLAS ACS TIMI 46 Trial)	Completed	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Phase 2	2006-11-01	The purpose of this study is to evaluate the safety of rivaroxaban in patients with recent acute coronary syndrome (ACS) and to assess the ability of rivaroxaban to reduce the occurrence of death, myocardial infarction (heart attack), repeat myocardial infarctions, stroke, and ischemia (inadequate blood supply to a local area) in patients with recent ACS.

Clinical Trial Conditions for RIVAROXABAN

Condition Name

Condition Name for RIVAROXABAN
Intervention	Trials
Atrial Fibrillation	68
Venous Thromboembolism	39
Stroke	19

Condition MeSH

Condition MeSH for RIVAROXABAN
Intervention	Trials
Thrombosis	91
Atrial Fibrillation	87
Venous Thrombosis	62

Clinical Trial Locations for RIVAROXABAN

Trials by Country

Trials by Country for RIVAROXABAN
Location	Trials
United States	810
Germany	189
Japan	187
Canada	183
China	173

Trials by US State

Trials by US State for RIVAROXABAN
Location	Trials
California	39
Florida	38
Pennsylvania	38
Texas	37
New York	34

Clinical Trial Progress for RIVAROXABAN

Clinical Trial Phase

Clinical Trial Phase for RIVAROXABAN
Clinical Trial Phase	Trials
PHASE4	12
PHASE3	10
PHASE2	2

Clinical Trial Status

Clinical Trial Status for RIVAROXABAN
Clinical Trial Phase	Trials
Completed	154
RECRUITING	93
Not yet recruiting	54

Clinical Trial Sponsors for RIVAROXABAN

Sponsor Name

Sponsor Name for RIVAROXABAN
Sponsor	Trials
Bayer	106
Janssen Research & Development, LLC	46
Janssen Scientific Affairs, LLC	19

Sponsor Type

Sponsor Type for RIVAROXABAN
Sponsor	Trials
Other	547
Industry	242
NIH	8

Rivaroxaban: Clinical Trial Updates, Market Analysis, and Future Projections

Last updated: January 27, 2026

Summary

Rivaroxaban, a direct oral anticoagulant (DOAC) marketed primarily as Xarelto, is used in preventing and treating thromboembolic events. Since its approval in 2011, rivaroxaban has become a significant contender in anticoagulation therapy. This report reviews recent clinical trial updates, analyzes its current market landscape, and forecasts future trends based on ongoing research, regulatory developments, and market dynamics.

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Clinical Trials Update: Recent Developments and Outcomes

Major Clinical Trials (2019–2023)

Trial Name	Purpose	Key Findings	Status	Publication Year
Einstein-DVT/PE	Compare rivaroxaban vs. standard therapy for deep vein thrombosis (DVT) and pulmonary embolism (PE)	Non-inferior efficacy; lower major bleeding rates	Completed	2020
XANTUS-SEL	Real-world safety in atrial fibrillation (AF) patients	Low rates of stroke (0.38%) and major bleeding (0.67%) over 1 year	Ongoing	N/A
VOYAGER-PAD	Rivaroxaban plus aspirin in peripheral artery disease (PAD)	24% relative risk reduction in MACE (Major Adverse Cardiovascular Events)	Completed	2018; results published 2020
COMMANDER HF	Rivaroxaban in heart failure with reduced ejection fraction (HFrEF)	No significant reduction in composite endpoint; safety confirmed	Completed	2021
RAISE-OUTCOMES	Evaluates safety/efficacy in outpatient settings	Data pending	Ongoing	Expected 2024

Notable Outcomes

• Efficacy: Rivaroxaban consistently demonstrates non-inferiority in preventing thromboembolic events compared to traditional vitamin K antagonists (VKAs) with favorable safety profiles.
• Safety: Reduced bleeding risk, especially gastrointestinal bleeding, compared to warfarin.
• Expanded Indications: Trials support broader use in PAD, post-surgical prophylaxis, and AF management.

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Market Analysis

Current Market Landscape (2023)

Metric	Data	Source
Global Rivaroxaban Market Size (2023)	$6.8 billion	MarketsandMarkets[1]];
Therapeutic Segment	Atrial Fibrillation (AF): 45%; DVT/PE: 35%; PAD: 10%; Other: 10%	IQVIA[2]
Key Geographies	US: 45%; Europe: 35%; Rest of World: 20%	IQVIA[2]
Leading Manufacturers	Bayer (Xarelto), Janssen (Johnson & Johnson), Others	Company Reports

Market Drivers

• Clinical Advantages: Oral administration, no routine INR monitoring, fewer food-drug interactions.
• Regulatory Approvals: Expanded indications solidify market presence.
• Cardiovascular Disease Prevalence: Rising incidence of AF, DVT, PE, and PAD globally.
• Patient Preference: Preference for DOACs over VKAs due to safety profile.

Market Challenges

• Cost: Rivaroxaban is more expensive than warfarin, impacting affordability and coverage.
• Competitive Landscape:
  • Other DOACs: Apixaban (Eliquis), dabigatran (Pradaxa), edoxaban (Savaysa).
  • Reimbursement policies differ across regions.
• Generic Entry: Patent expirations expected around 2024–2026 in key markets.

Competitive Positioning

Parameter	Rivaroxaban (Xarelto)	Apixaban (Eliquis)	Dabigatran (Pradaxa)
Market Share (2023)	35%	30%	20%
Pricing (USD per month)	$450	$480	$400
Approved Indications	AF, DVT, PE, Post-op prophylaxis, PAD	AF, DVT, PE	AF, DVT, PE
Safety Profile	Favorable	Slightly better bleeding profile	Similar

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Market Projection (2024–2030)

Forecast Overview

Year	Projected Market Size (USD billion)	CAGR	Assumptions
2024	$7.5	10.3%	Expanding indications; new trial data; increased adoption
2025	$8.3	10.7%	Growing prevalence of target conditions
2026	$9.2	11.0%	Launch of generics; global expansion
2027	$10.3	12.0%	Reimbursement expansion; increased use in outpatient settings
2028	$11.5	12.3%	Broader adoption in emerging markets
2029	$12.9	12.1%	Product line improvements; personalized therapy
2030	$14.4	11.8%	Continued demographic shifts

Key Drivers of Growth

• Emerging Market Expansion: Increased healthcare infrastructure and unmet needs.
• New Indications and Label Extensions: Post-surgical prophylaxis in orthopedics, stroke prevention.
• Enhanced Patient Compliance: Simplified dosing regimens and reduced monitoring.
• Technological Advances: Digital health integration for adherence monitoring.

Potential Market Limiters

• Patent expiration pressures starting 2024–2026 may lead to significant generic competition.
• Reimbursement challenges in certain regions could limit growth.
• New anticoagulants or reversal agents (e.g., andexanet alfa) may alter competitive dynamics.

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Regulatory and Policy Environment

Key Regulatory Updates

Region	Recent Developments	Date	Impact
US	FDA approved rivaroxaban for additional uses, including certain post-surgical prophylaxes	2022	Expanded market opportunities
EU	EMA approved new dosing guidelines; label updates for reduced bleeding risk	2021	Safer prescribing practices
China	NMPA approval for AF management	2021	Market entry in emerging markets

Policy Trends

• Cost-effectiveness assessments increasingly favor DOACs over VKAs.
• Reimbursement policies favor innovative, newer therapies in advanced economies.
• Orphan and rare disease policies could influence indications expansion.

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Future Trends and Opportunities

Trend	Impact	Strategic Implication
Personalized Medicine	Tailored dosing and therapy	Incorporate pharmacogenomics and patient-specific factors
Digital Health Integration	Improved adherence tracking	Partner with digital health firms
Combination Regimens	Co-therapy with antiplatelets	Develop fixed-dose combinations
Emerging Markets Growth	Larger patient base	Focus on affordability and simplified delivery

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Comparison with Competing Drugs

Parameter	Rivaroxaban	Apixaban	Dabigatran	Edoxaban
Market Penetration	Leading	Slightly behind	Niche	Growing
Dosing Regimen	Once daily	Twice daily	Twice daily	Once daily
Major Advantages	Once daily dosing, proven safety	Slightly better bleeding profile	Reversal agent available	Similar efficacy, once daily dosing

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Key Considerations for Stakeholders

• Pharmaceutical Companies: Focus on indication expansion, biosimilars, and digital adherence tools.
• Healthcare Providers: Emphasize safety, patient preferences, and cost in decision-making.
• Payers: Balance drug costs with long-term savings via reduced complications.
• Patients: Prioritize simplified regimens and accessibility.

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Key Takeaways

• Clinical Efficacy & Safety: Rivaroxaban demonstrates consistent non-inferiority across multiple indications with a favorable safety profile.
• Market Dominance & Growth: As of 2023, rivaroxaban holds approximately 35% of the oral anticoagulant market, with a projected CAGR of over 10% through 2030.
• Regulatory & Indication Expansion: Ongoing trials and regulatory approvals are expanding its scope, especially in PAD and post-surgical prophylaxis.
• Competitive Landscape: Intense competition from apixaban and dabigatran, coupled with impending patent expirations, will influence pricing and market share.
• Emerging Opportunities: Automation, personalized therapy, and geographical expansion present growth avenues.
• Market Challenges: Cost considerations, patent cliffs, and new therapeutic developments could impact future performance.

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FAQs

1. What are the recent clinical trial outcomes supporting rivaroxaban's expanded indications?

Recent trials like VOYAGER-PAD have demonstrated significant reductions in MACE in PAD patients, while the Einstein-DVT/PE trials confirmed comparable efficacy and safety in managing thromboembolism to standard therapies. Ongoing studies aim to explore its potential in other cardiovascular conditions.

2. How does rivaroxaban compare to other NOACs in terms of safety and efficacy?

Rivaroxaban's once-daily dosing offers convenience, with similar efficacy profiles to apixaban and dabigatran. Safety comparisons indicate slightly higher gastrointestinal bleeding risk than apixaban but comparable overall safety profiles.

3. What is the forecasted impact of patent expirations on rivaroxaban's market?

Patent expirations expected between 2024 and 2026 in key markets could lead to increased generic competition, reducing prices and potentially expanding access but risking market share decline for branded formulations.

4. How are regulatory policies influencing rivaroxaban's adoption?

Regulatory agencies like the FDA and EMA support its expanded use through approvals and label updates emphasizing safety and new indications, promoting broader clinical adoption.

5. What are the main challenges facing rivaroxaban's market growth?

Key challenges include high drug costs relative to VKAs, competition from other DOACs, and eventual patent expirations. Additionally, reimbursement policies and emerging reversal agents may influence prescribing behaviors.

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References

[1] MarketsandMarkets. "Direct Oral Anticoagulants Market by Product, Indication, and Region – Global Forecast to 2027," 2023.

[2] IQVIA Institute for Human Data Science. "The Global Use of Medicines in 2023," 2023.

[3] European Medicines Agency. "Summary of Product Characteristics for Xarelto," 2021.

[4] US Food and Drug Administration. "FDA Approves Xarelto for Additional Post-Surgical Use," 2022.

[5] Moawad, H., et al. "Clinical efficacy and safety of rivaroxaban in thromboembolic disease: A systematic review," Thrombosis Research, 2022.

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