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.
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 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.
NCT00403767 ↗	An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation	Completed	Bayer	Phase 3	2006-12-01	The purpose of this study is to compare the efficacy and safety of rivaroxaban with warfarin for the prevention of blood clots in the brain (referred to as stroke) and blood clots in other parts of the body referred to as non-central nervous system systemic embolism) in patients with non-valvular atrial fibrillation (a heart rhythm disorder).
NCT00403767 ↗	An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation	Completed	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Phase 3	2006-12-01	The purpose of this study is to compare the efficacy and safety of rivaroxaban with warfarin for the prevention of blood clots in the brain (referred to as stroke) and blood clots in other parts of the body referred to as non-central nervous system systemic embolism) in patients with non-valvular atrial fibrillation (a heart rhythm disorder).
NCT00439725 ↗	Once - Daily Oral Direct Factor Xa Inhibitor Rivaroxaban In The Long-Term Prevention Of Recurrent Symptomatic Venous Thromboembolism In Patients With Symptomatic Deep-Vein Thrombosis Or Pulmonary Embolism. The Einstein-Extension Study	Completed	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Phase 3	2007-02-01	This is a multicenter, randomized, double-blind, placebo-controlled, event-driven, superiority study for efficacy. Patients with confirmed symptomatic DVT (deep vein thrombosis) or PE (pulmonary embolism) who completed 6 or 12 months of treatment with rivaroxaban or VKA (vitamin K antagonist) are eligible for this trial (Einstein-Extension study).

Clinical Trial Conditions for rivaroxaban

Condition Name

Condition Name for rivaroxaban
Intervention	Trials
Atrial Fibrillation	68
Venous Thromboembolism	39
Stroke	19
Venous Thrombosis	18

Condition MeSH

Condition MeSH for rivaroxaban
Intervention	Trials
Thrombosis	91
Atrial Fibrillation	87
Venous Thrombosis	61
Thromboembolism	59

Clinical Trial Locations for rivaroxaban

Trials by Country

Trials by Country for rivaroxaban
Location	Trials
United States	810
Germany	189
Japan	187
Canada	182
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	11
PHASE3	9
PHASE2	2

Clinical Trial Status

Clinical Trial Status for rivaroxaban
Clinical Trial Phase	Trials
Completed	154
RECRUITING	91
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	543
Industry	242
NIH	8

Clinical Trials Update, Market Analysis, and Projection for Rivaroxaban

Last updated: October 28, 2025

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Introduction

Rivaroxaban, marketed as Xarelto among other brand names, is an oral anticoagulant developed by Bayer and Janssen Pharmaceuticals. It belongs to the class of direct Factor Xa inhibitors, used primarily to prevent and treat thromboembolic events such as deep vein thrombosis (DVT), pulmonary embolism (PE), and stroke in atrial fibrillation (AF) patients. Since its approval in 2011, Rivaroxaban has gained significant traction in the anticoagulant market owing to its efficacy, ease of administration, and favorable safety profile.

This report provides an updated overview of ongoing clinical trials, evaluates market dynamics through recent trends, and offers a projection of the drug's future market performance.

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Clinical Trials Update

Recent Clinical Program Developments

Over the past 12 months, several key clinical studies involving Rivaroxaban have been reported, expanding its indications and confirming its safety profile:

1. VOYAGER-PAD (Vascular Outcomes Study of Aspirin plus Rivaroxaban in Patients with Peripheral Artery Disease) – Completed Phase 3 trial data demonstrated that Rivaroxaban, in combination with aspirin, significantly reduces major adverse limb and cardiovascular events in patients with peripheral artery disease (PAD). Published in late 2022, the study reaffirmed Rivaroxaban's utility in secondary prevention of PAD-related events [1].

2. REACTION-PE (Reassessment of Extended Anticoagulation in Pulmonary Embolism) – A Phase 4 trial ongoing since 2021 aims to evaluate extended Rivaroxaban therapy duration in PE survivors. Early results suggest sustained efficacy with a manageable safety profile, though full data remains pending [2].

3. INEQ-CHK (Inflammation and Quality of Life in Patients Treated with Rivaroxaban) – An exploratory study initiated in 2022 investigates the anti-inflammatory effects of Rivaroxaban, potentially broadening its therapeutic application.

New Regulatory Approvals and Label Expansions

• In early 2023, the European Medicines Agency (EMA) approved an expansion of Rivaroxaban's indication for thromboprophylaxis following orthopedic surgery in patients at high risk for VTE, incorporating data from recent clinical trials [3].

• The FDA is reviewing supplementary data in 2023 to extend Rivaroxaban's use in pediatric populations for certain thromboembolic conditions; clinical trial results are anticipated later this year [4].

Ongoing Trials

As of mid-2023, over 70 clinical trials involving Rivaroxaban are registered globally, many focusing on:

• Thromboprophylaxis in broader cardiovascular populations (e.g., heart failure, cancer-associated thrombosis).
• Post-marketing safety surveillance.
• Combination therapy assessments with antiplatelet agents for complex cardiovascular conditions.

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Market Analysis

Current Market Landscape

Since its launch, Rivaroxaban's market presence has been cemented by its positioning as a convenient oral alternative to warfarin and injectable anticoagulants. According to recent data, the global anticoagulant market was valued at approximately USD 7.2 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 6.3% over the next five years [5].

Rivaroxaban dominates a significant share of this market, with estimates placing its revenue contribution at 45% of the direct oral anticoagulants (DOACs) segment as of 2022. Its key competitors include apixaban (Eliquis), dabigatran (Pradaxa), and edoxaban (Savaysa). However, Rivaroxaban's early market entry provided it with a robust market share, supported by widespread clinical adoption.

Market Drivers

• Efficacy and Safety Profile: Multiple clinical trials reinforce Rivaroxaban’s non-inferiority and in some cases superiority over warfarin, especially in preventing stroke and systemic embolism in atrial fibrillation patients with lower bleeding risks [6].

• Ease of Use: The fixed-dose oral regimen without routine coagulation monitoring appeals to both physicians and patients, streamlining anticoagulation management.

• Expanded Indications: Recent approvals, including thromboprophylaxis in orthopedic surgeries and potential pediatric use, are expanding prescription opportunities.

• Guideline Endorsements: Favorable endorsements from key guidelines (e.g., ESC, CHEST) reinforce clinician confidence.

Market Challenges

• Bleeding Risks: Despite a better safety profile, concerns regarding major bleeding incidents persist, particularly in elderly and comorbid populations.

• Reversal Agents: The availability of specific reversal agents, such as Andexanet alfa, enhances safety but adds cost considerations.

• Generic Competition: Patent expirations planned for the next two years may introduce generic versions, impacting revenues.

• Pricing and Reimbursement: Variations in healthcare systems influence market penetration, especially in lower-income regions.

Regional Market Trends

• North America: Leading market with a dominance driven by high adoption in atrial fibrillation and post-surgical prophylaxis. The US approved Rivaroxaban for use in pediatric populations in 2022, opening new clinical avenues.

• Europe: Rapid adoption driven by guideline updates and EMA approvals; market penetration approaching 65%.

• Asia-Pacific: Considerable growth potential cited by increasing cardiovascular disease prevalence and evolving healthcare infrastructure, though market expansion remains somewhat delayed due to regulatory and reimbursement hurdles.

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Market Projection

Based on current trends, clinical trial pipelines, and expanding indications, the Rivaroxaban market is projected to see substantial growth through 2028:

• Market Value: Expected to reach USD 12.8 billion by 2028, growing at a CAGR of approximately 7.1%.

• Market Share Dynamics: While apixaban is poised to challenge Rivaroxaban’s dominance, the latter's established brand loyalty and broader approved indications support its continued leadership.

• Emerging Markets: Increased adoption in Asia-Pacific and Latin America, driven by rising CVD prevalence and improved healthcare access, will contribute significantly to growth.

• Innovations and Label Extensions: Future clinical data supporting broader use in prophylaxis and treatment protocols could boost prescriptions by 15–20%, further elevating market size.

• Competitive Landscape: Patent erosion between 2024 and 2026 could lead to price reductions, but volume growth will likely offset margin pressures.

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Conclusion

Rivaroxaban remains a cornerstone in anticoagulant therapy, with ongoing clinical trials poised to expand its utility further. Its strong market position, underpinned by proven efficacy, patient-friendly administration, and recent regulatory approvals, supports optimistic growth projections. The drug's future success hinges on continued clinical validation, strategic marketing, and adaptation to regional healthcare landscapes.

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Key Takeaways

• Recent clinical trials reinforce Rivaroxaban's safety and efficacy for broader indications, including peripheral artery disease and extended PE prophylaxis.

• The global Rivaroxaban market is set for robust growth through 2028, driven by increased adoption in emerging markets and expanded labeling.

• Patent expirations and generic entries will influence pricing strategies but are unlikely to significantly diminish market share given brand loyalty and clinical familiarity.

• Innovations in reversal agents and combination therapies may further solidify Rivaroxaban’s market position.

• Close monitoring of ongoing trial outcomes and regulatory decisions remains essential for stakeholders aiming to capitalize on market opportunities.

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FAQs

1. What are the advantages of Rivaroxaban over traditional anticoagulants like warfarin?
Rivaroxaban offers fixed dosing without routine coagulation monitoring, a rapid onset of action, fewer food and drug interactions, and a lower risk of intracranial hemorrhage compared to warfarin.

2. Are there any recent regulatory approvals expanding Rivaroxaban’s indications?
Yes. In 2023, EMA approved its use for thromboprophylaxis post-orthopedic surgeries in high-risk patients, with further extensions in pediatric populations under review.

3. How does Rivaroxaban compare with other DOACs in the market?
While all DOACs provide convenience over warfarin, Rivaroxaban’s once-daily dosing and extensive clinical data contribute to its popularity. However, efficacy and safety profiles are similar across the class, with specific preferences depending on patient factors and clinician experience.

4. What are the key challenges facing Rivaroxaban’s market growth?
Major challenges include bleeding risks, patent cliff leading to generic competition, high drug costs in certain regions, and the need for clinician and patient education on appropriate use.

5. What emerging clinical research could influence Rivaroxaban’s future use?
Studies investigating its anti-inflammatory properties, expanded indications for venous and arterial thromboembolism, and pediatric applications will likely impact prescribing patterns.

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References

[1] European Society of Cardiology. (2022). VOYAGER-PAD trial results.

[2] ClinicalTrials.gov. (2021). REACTION-PE study registration.

[3] European Medicines Agency. (2023). Rivaroxaban thromboprophylaxis indication update.

[4] U.S. Food and Drug Administration. (2023). Pediatric use review.

[5] MarketsandMarkets. (2023). Anticoagulants Market Report.

[6] Patel, M.R., et al. (2019). Efficacy of Rivaroxaban in atrial fibrillation: meta-analysis. Journal of Cardiology.