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).

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

Rivaroxaban Clinical Trials Update, Market Analysis, and Projection

Last updated: April 28, 2026

What is rivaroxaban’s current clinical and regulatory positioning?

Rivaroxaban is marketed as an oral, direct Factor Xa inhibitor for multiple indications across cardiovascular, thromboembolic, and vascular-bleeding risk settings. It has broad label coverage in key geographies (EU and US), with ongoing post-marketing surveillance and incremental clinical development tied to dosing strategies, combination regimens, and special populations.

Key late-stage and platform-like trial themes include:

• Switching or reducing intensity of antithrombotic therapy after an index event (often against established comparators like warfarin/VKA or other antithrombotics).
• Expansion in disease subsets (renal impairment bands, body-weight extremes, older age).
• Peri-procedural strategies and bleeding-risk minimization protocols.
• Head-to-head competitive positioning versus other DOACs and anticoagulation regimens.

Practical implication for market projection: rivaroxaban’s trial pipeline in recent years has not changed the basic drug identity (oral Xa inhibition) but has supported label durability across multiple cardiology and vascular care pathways and helped retain share against delayed-onset entrants via expanded use cases and optimized dosing.

Which trials are driving the most relevant pipeline outcomes?

Publicly visible development for rivaroxaban over the last decade is dominated by:

• New indication confirmations and label extensions in AF, VTE treatment/prevention, and CAD/PAD populations.
• Rivaroxaban regimen optimization for specific subgroups and special clinical scenarios.
• Continued comparative effectiveness in real-world and pragmatic settings.

For investment-grade interpretation, the most material drivers are not early-phase pharmacology studies. They are: 1) label expansions (or strengthened label language tied to higher-value patient segments), 2) bleeding-risk differentiation, and 3) reductions in discontinuation and treatment switching in routine care.

Impact on near- to mid-term revenue: the clinical narrative is steady-state rather than breakthrough. The revenue model is therefore anchored to (i) persistence of guideline-supported use, (ii) ongoing guideline incorporation, and (iii) continued payer reimbursement.

How large is the rivaroxaban market today?

Rivaroxaban belongs to the “top-of-class” DOAC group. The market is measured in prescriptions and total anticoagulant spend across atrial fibrillation (AF), VTE (DVT/PE), and coronary or peripheral artery disease (CAD/PAD) settings.

Market sizing approach used here (high signal, low ambiguity)

• Unit economics: revenue tied to marketed dose utilization and persistence.
• Penetration: share of oral anticoagulant starts in eligible populations.
• Competitive substitution: DOAC and warfarin dynamics, plus local formulary policies.

The most defensible market view for rivaroxaban across investors is that it remains a leading DOAC globally, with growth depending on:

• AF and VTE epidemiology (and screening),
• guideline adoption,
• payer tightening and step edits,
• and conversion away from VKAs where DOACs stay cost-effective.

What do market drivers imply for 2025–2032 growth?

Market growth for rivaroxaban is constrained by category maturity (DOAC penetration is already high in many developed markets), but it is supported by three tailwinds and one headwind.

Tailwinds

• AF and VTE incidence growth: aging and diagnosis rates lift addressable patient pool.
• Clinical inertia in established regimens: once a patient is stabilized on a DOAC, switching rates are often lower than initiation rates.
• Guideline durability: major cardiology guidance continues to support DOACs for stroke prevention in AF and for VTE prophylaxis/treatment.

Headwind

• Competitive DOAC price compression: the DOAC class has pricing and reimbursement pressure, especially where generics or lower-cost entrants gain formulary position.

Net effect on growth profile

• Near term: modest growth led by continued penetration in under-served segments and incremental expansion in use cases.
• Mid term: flattish to low-single-digit percentage growth risk rises as generics and price competition intensify.
• Upside case: if a dosing or regimen optimization trial leads to guideline language changes or reduces discontinuation for bleeding, it can protect utilization against switch behavior.

How does clinical differentiation translate into payer behavior and share retention?

For DOACs, the economic battleground is usually:

• dosing schedule (adherence),
• bleeding event management costs,
• persistence and discontinuation due to adverse events,
• and formulary placement.

Rivaroxaban’s clinical profile supports continued payer coverage because:

• it is widely integrated into treatment pathways for AF and VTE,
• it has extensive comparative evidence across DOACs and VKAs, and
• it has established physician familiarity that reduces switching.

What is the forecast for rivaroxaban’s market trajectory?

A clean numeric forecast requires a single-source baseline (e.g., category size and rivaroxaban share). This prompt provides none of those quantifiable inputs. Under the constraints, a complete and accurate revenue forecast cannot be produced without introducing unsupported numbers.

Therefore, the projection here is expressed as a directional forecast with the bounded ranges implied by category maturity and pricing pressure:

• 2025–2027: low growth, with revenue resilience from persistence and protocol standardization.
• 2028–2032: growth slows toward inflation plus population growth, with margin pressure from competitive pricing and formulary tiering.

Where are the highest probability business risks?

1) Generic and lower-cost DOAC displacement in high-volume markets that run aggressive pharmacy benefit management and tiering. 2) Bleeding safety perceptions if real-world signals shift relative to class averages, impacting switching decisions. 3) Guideline shifts that re-rank DOAC preference by subgroup (renal function, age, weight, or interaction profiles). 4) Price negotiations for large public payers and large PBMs.

What are the highest probability business opportunities?

1) New or strengthened label language around peri-procedural management and short-term prophylaxis strategies that reduce clinician uncertainty. 2) Further subgroup optimization that reduces bleeding and improves adherence, improving persistence economics. 3) Combination strategies in CAD/PAD pathways that increase average treated population per eligible patient segment. 4) Real-world evidence programs that support payer value cases, especially around bleeding event reductions and lower hospitalization costs.

How should investors interpret the clinical update cadence?

The practical interpretation of rivaroxaban’s development pattern is:

• Most value is in regimen refinement and label durability rather than “reinvention.”
• Competitive advantage is more about persistence, formulary positioning, and guideline embedding than about a new mechanism or radical efficacy step-change.

For portfolio construction, that translates into:

• a lower volatility growth profile than late-stage pipeline biotechs,
• but higher sensitivity to pricing and reimbursement than innovation-heavy anticoagulants.

What to watch over the next 24 months

• Any payer category reshuffling that changes tier placement or prior authorization requirements for DOACs.
• Subgroup data that modifies how clinicians choose DOACs in borderline renal function or high-bleeding-risk populations.
• Real-world discontinuation and bleeding event patterns versus class competitors.

Key Takeaways

• Rivaroxaban remains a top-tier DOAC with broad indication coverage, and recent development emphasis stays on label durability, regimen optimization, and subgroup refinement.
• The market growth outlook is bounded by category maturity, with performance driven more by persistence, payer policy, and price compression than by transformative clinical events.
• The main upside is utilization protection through regimen guidance and subgroup optimization that improves adherence and reduces discontinuation; the main downside is generics and lower-cost DOAC displacement across formularies.
• Investment monitoring should prioritize reimbursement mechanics, formulary tiering, and real-world safety and persistence trends over early-phase novelty.

FAQs

1. Is rivaroxaban still relevant in atrial fibrillation treatment guidelines?
   Yes. DOACs including rivaroxaban remain standard options for stroke prevention in AF in guideline-based practice, with selection influenced by renal function, bleeding risk, and drug interaction profiles.

2. What is the main commercial threat to rivaroxaban?
   DOAC price compression from competition and formulary tiering moves, particularly where lower-cost alternatives gain access.

3. What clinical trial outcomes most affect rivaroxaban’s market trajectory?
   Label expansions that increase addressable patient segments and data that reduces bleeding or improves persistence enough to change routine prescribing behavior.

4. How do real-world trends matter for rivaroxaban’s revenue?
   Switching, discontinuation, and hospitalization rates linked to bleeding or adherence directly affect net prescription volume and payer outcomes.

5. Does rivaroxaban’s mechanism reduce pipeline risk?
   It reduces scientific risk because the mechanism is established and guidelines already incorporate DOAC therapy, but commercial risk remains tied to reimbursement and competitive pricing.

References

[1] European Medicines Agency. Xarelto (rivaroxaban) EPAR and product information.
[2] U.S. Food and Drug Administration. Xarelto (rivaroxaban) prescribing information.
[3] Eikelboom JW, Connolly SJ, Bosch J, et al. Rivaroxaban with or without aspirin in stable cardiovascular disease. New England Journal of Medicine.
[4] Patel MR, Mahaffey KW, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. New England Journal of Medicine.
[5] Bauersachs R, Berkowitz SD, Brighton TA, et al. Oral rivaroxaban for symptomatic venous thromboembolism. The New England Journal of Medicine.