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).

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	92
Atrial Fibrillation	87
Venous Thrombosis	62
Venous Thromboembolism	60

Clinical Trial Locations for rivaroxaban

Trials by Country

Trials by Country for rivaroxaban
Location	Trials
United States	810
Germany	190
Japan	187
Canada	183
China	174

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	13
PHASE3	11
PHASE2	2

Clinical Trial Status

Clinical Trial Status for rivaroxaban
Clinical Trial Phase	Trials
Completed	154
RECRUITING	94
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	548
Industry	245
NIH	8

Last updated: July 27, 2026

Rivaroxaban clinical trials update, market analysis, and market projection (2026–2036)

Rivaroxaban is a marketed factor Xa inhibitor with mature global commercialization and an expanding late-stage pipeline in cardiometabolic, vascular, and oncology-adjacent indications. Market growth from 2026 forward depends on (1) continued uptake in high-volume anticoagulation settings (atrial fibrillation and VTE treatment/prevention), (2) penetration of newer regimen niches (lower-dose and protocolized use), and (3) the pace of penetration in additional indication expansions where phase 3 outcomes can add incremental TAM. The near-to-mid term pipeline is also shaped by payer constraints, generic and biosimilar competitive dynamics for competing anticoagulants, and ongoing head-to-head and combination-study evidence that can shift guideline positioning.

What this update covers

• Clinical trials: late-stage and post-approval studies across AF, VTE, CAD/PAD, oncology/thrombosis, and special populations.
• Market: current competitive positioning, adoption drivers, and pricing/payer constraints.
• Projections: global and major-region growth framework using indication-level demand and competitive risk.

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What is the latest clinical trials status for rivaroxaban (phase 3 and key phase 4 updates)?

Featured-snippet answer: Rivaroxaban’s most commercially material clinical evidence remains anchored in atrial fibrillation (stroke prevention), VTE treatment and prevention, and CAD/PAD use. Late-stage updates tend to focus on incremental subpopulations (elderly, renal impairment cohorts, post-revascularization protocols), regimen optimization, and safety-efficacy evidence to support label refinements and guideline incorporation. Post-marketing studies continue to expand real-world evidence on bleeding risk management and adherence patterns.

Atrial fibrillation (AF): what new evidence is most likely to move the needle?

AF remains the largest volume indication class globally for oral anticoagulants. Trial updates for rivaroxaban in AF typically target:

• Risk-stratified bleeding reduction strategies (dose adherence, lab monitoring avoidance tradeoffs, and co-medication patterns).
• Real-world outcomes in older and higher comorbidity populations.
• Protocolized switching and interruption strategies around procedures.

Commercial linkage

• Any phase 3 or robust phase 4 data that reduces major bleeding rates or improves persistence usually has immediate market impact because AF patients are high lifetime users.

VTE treatment and prevention: what is the current late-stage focus?

For VTE, trials typically examine:

• Duration of therapy optimization (extended vs fixed-duration strategies).
• High-risk recurrence and recurrence biomarker subgroups.
• Protocols around thrombectomy and post-acute management.

Commercial linkage

• Small percentage improvements in persistence and recurrence reduction can translate into large absolute patient-month gains in a high-base population.

CAD/PAD and peripheral vascular disease: where can rivaroxaban expand?

Rivaroxaban’s vascular franchise has commercial leverage in CAD/PAD populations where trials seek:

• Post-revascularization and post-acute stabilization evidence.
• Combination strategies with antiplatelet therapy in carefully defined bleeding-risk windows.
• Longer-term outcomes beyond early follow-up.

Commercial linkage

• Vascular indications often have adoption bottlenecks caused by bleeding risk and clinician comfort with regimen selection. Trial data that tightens risk stratification can accelerate penetration.

Cancer-associated thrombosis and oncology adjacency: does rivaroxaban have growth runway?

Oncology-associated thrombosis is a competitive area where guideline adoption can swing by trial endpoints (recurrent VTE, major bleeding, clinically relevant non-major bleeding). Recent trial updates in this space generally aim at:

• Bleeding risk management by cancer type and gastrointestinal or genitourinary involvement.
• Practical regimen integration in oncology workflows.

Commercial linkage

• If rivaroxaban demonstrates consistent net benefit in real-world or meta-analytic outcomes, it can lift share in a growing TAM.

Manufacturing and safety studies (phase 4): what to watch

For rivaroxaban, post-marketing studies typically track:

• Intracranial bleeding and major bleeding definitions across coding variability.
• Persistence and discontinuation drivers.
• Adherence after dose interruptions and bridging.

Commercial linkage

• Real-world persistence often determines whether guideline recommendations convert into durable revenue.

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How big is the rivaroxaban market, and what are the main revenue drivers by indication?

Featured-snippet answer: Rivaroxaban’s revenue base is dominated by anticoagulation demand for atrial fibrillation and VTE. CAD/PAD contributes additional share, with further upside tied to label refinements and guideline uptake in vascular prevention and high-risk subgroups. Growth is constrained by payer controls, competitive oral anticoagulants, and broader generic penetration patterns across the class.

Indication-level demand drivers

1. AF stroke prevention
   • High prevalence and chronic treatment duration.
   • Sensitivity to bleeding risk and clinician trust in dosing protocols.
2. VTE treatment
   • Larger patient turnover with shorter course lengths, but high incidence-driven demand.
3. VTE prevention
   • Extended prophylaxis and secondary prevention add cumulative exposure.
4. CAD/PAD
   • Growth depends on adoption in high-bleeding-risk patients and the ability to manage antiplatelet combinations.

Pricing and payer dynamics

Key market constraints include:

• Contracting with managed care and hospital formularies.
• Pharmacy benefit restrictions and step therapy among oral anticoagulants.
• Competition among factor Xa inhibitors and direct thrombin inhibitors with similar clinical messaging.

Competitive landscape affecting rivaroxaban share

• Other oral anticoagulants compete for AF and VTE, with differentiators usually centered on bleeding profiles, dosing simplicity, reversal strategies, and guideline endorsements.
• Clinician switching is influenced by formulary placement and net clinical benefit in specific subgroups.

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What market projection for rivaroxaban is most defensible from 2026 to 2036?

Featured-snippet answer: A defensible projection framework treats rivaroxaban revenue growth as a combination of (1) baseline patient growth in AF and VTE, (2) share retention or incremental share gains driven by clinical evidence, and (3) pricing erosion offset by volume. In a mature class with payer pressure, growth typically depends more on volume durability and label/geography penetration than on net price increases.

Projection model structure (practical framework)

Use a three-bucket approach:

Bucket A: Base demand (AF + VTE)

• Growth proportional to incidence/prevalence and persistence.
• Persistence linked to real-world adherence and bleeding management confidence.

Bucket B: Expansion demand (CAD/PAD vascular prevention, oncology-associated thrombosis niches)

• Controlled by trial outcomes that improve net benefit.
• Sensitive to label changes and guideline inclusion timing.

Bucket C: Competitive and pricing offset

• Net price erosion from contracting dynamics.
• Share pressure from competing oral anticoagulants and switching behavior.

What can move the projection up or down

Upside drivers

• Positive late-stage or high-quality phase 4 evidence in high-volume cohorts that reduces major bleeding.
• Label expansion or protocol guidance that enables broader use.
• Improved persistence through reduced discontinuations.

Downside drivers

• Payer restriction tightening after formulary reviews.
• Safety signals in special populations leading to reduced adoption.
• Competitive switching due to superior coverage or better outcomes in head-to-head evidence.

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How do clinical trial outcomes influence rivaroxaban uptake and guideline adoption?

Featured-snippet answer: Uptake depends on whether trial endpoints translate into clinician confidence in net clinical benefit for real-world patients. For rivaroxaban, the biggest commercial link is to major bleeding reduction and the ability to maintain anticoagulation adherence without increases in clinically significant bleeding.

Endpoint types that matter commercially

• Major bleeding (including intracranial hemorrhage).
• Clinically relevant non-major bleeding.
• Net clinical benefit and composite outcomes that include efficacy and safety.
• Subgroup consistency (elderly, renal impairment, concomitant antiplatelet therapy, oncology histology risks).

Time lag: trial results to revenue impact

• Labeling and guideline inclusion typically lag trial readouts by planning cycles.
• Real-world conversion depends on formulary update cycles and clinician education.

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What patents protect rivaroxaban and how does that affect generic entry risk?

Featured-snippet answer: Rivaroxaban’s commercial future is shaped less by imminent primary compound patent cliffs for the molecule and more by jurisdiction-specific formulation/process and method-of-use estates plus regulatory and litigation history. Generic competition risk is primarily about whether downstream patents still block specific dosage forms, strengths, or manufacturing approaches in key markets.

Where patent coverage typically matters

• Formulation patents (drug product and dissolution profiles).
• Manufacturing/process patents.
• Method-of-use (indication- or regimen-specific) patents.

Business impact

• If downstream patents are narrow or already expired, generic entry accelerates.
• If strong formulation or process patents remain in force in specific jurisdictions, market access can stay staggered and pricing pressure slower.

(High-accuracy patent mapping requires jurisdictional Orange Book and litigation docket review, which is not included in this input set.)

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What is the Orange Book status of rivaroxaban, and where are the likely launch windows for generics?

Featured-snippet answer: Orange Book status affects FDA approval timing and launch sequencing for ANDA filers, but the real commercial launch windows for rivaroxaban depend on which patents are listed for each listed drug/strength and whether Paragraph IV certifications triggered litigation. Without the specific Orange Book patent listing set for each strength and jurisdictional exclusivity status, launch window estimation cannot be stated precisely.

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How does rivaroxaban compare with apixaban and other DOACs on clinical differentiation?

Featured-snippet answer: The class competes on net clinical benefit and bleeding patterns in AF and VTE. Clinicians pick among DOACs based on subgroup evidence, patient characteristics (age, renal function, GI bleeding risk), and payer coverage. Market share is sensitive to guideline preference in major patient segments and to how each agent’s safety profile performs in real-world adherence.

Competitive differentiation that impacts market share

• Bleeding profile in high-risk subsets.
• Dosing convenience and clinician workflows.
• Reversal strategy access and hospital protocols.
• Payer formularies and dispensing channel incentives.

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Key Takeaways

• Rivaroxaban’s growth outlook is driven by continued demand in AF and VTE, plus incremental vascular and oncology-associated thrombosis adoption where evidence supports net clinical benefit.
• Clinical trial updates matter most if they improve major bleeding outcomes and reduce discontinuations in real-world-like populations.
• Market projections from 2026–2036 should be built on indication-level demand and persistence, with pricing and share erosion from competition offsetting some volume gains.
• Patent and Orange Book status determine launch timing for specific strengths and dosage forms, but precise windowing requires strength-by-strength listed patent sets and associated certifications.

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FAQs

1. Which rivaroxaban indications are most likely to expand after phase 3 results?
2. How do real-world adherence and bleeding management drive rivaroxaban persistence in atrial fibrillation?
3. What trial endpoints have historically correlated with guideline uptake for oral anticoagulants like rivaroxaban?
4. How do payer formulary changes typically affect rivaroxaban revenue within a year of guideline updates?
5. Which patient subgroups (renal impairment, elderly, oncology GI risk) most influence rivaroxaban net clinical benefit perception?

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References

No sources were provided in the prompt, and none are cited in this response.