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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	22
Venous Thromboembolism	18
Venous Thrombosis	6
Stroke	5

Condition MeSH

Condition MeSH for XARELTO
Intervention	Trials
Thrombosis	30
Thromboembolism	28
Atrial Fibrillation	27
Venous Thromboembolism	25

Clinical Trial Locations for XARELTO

Trials by Country

Trials by Country for XARELTO
Location	Trials
United States	145
Canada	51
China	27
Brazil	19
Germany	17

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
Phase 4	32
Phase 3	31
Phase 2/Phase 3	5

Clinical Trial Status

Clinical Trial Status for XARELTO
Clinical Trial Phase	Trials
Completed	58
Recruiting	26
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	232
Industry	86
NIH	4

XARELTO Market Analysis and Financial Projection

Xarelto: Clinical Trials, Market Analysis, and Projections

Introduction to Xarelto

Xarelto, marketed by Janssen Pharmaceuticals, is a widely used oral anticoagulant that belongs to the class of factor Xa inhibitors. It is formulated as film-coated tablets, tablets, granules/powder for suspension, and suspension for oral administration. The drug is known for its role in reducing the risk of major thrombotic vascular events and is used globally, including in the US, UK, Australia, Germany, and Japan[2].

Mechanism of Action

Xarelto works by inhibiting factor Xa, an enzyme crucial in the production of thrombin, which is central to the blood clotting process. By blocking factor Xa, the drug reduces the levels of thrombin, thereby decreasing the risk of blood clots forming in veins and arteries[2].

Clinical Trials Update

Ongoing and Planned Trials

Xarelto is currently involved in several clinical trials, particularly focusing on its efficacy in various conditions.

• Peripheral Artery Disease (PAD): Xarelto is being studied for its role in reducing the risk of major thrombotic vascular events in adult patients with PAD. This includes its indication for both coronary artery disease (CAD) and PAD post-lower extremity revascularization (LER)[3].
• Other Conditions: Trials are also ongoing to evaluate Xarelto's effectiveness in other settings, such as those conducted by the Ottawa Hospital Research Institute, Canadian Institutes of Health Research (CIHR), and the Kidney Cancer Research Network of Canada, which are in Phase 2/Phase 3 stages[1].

Market Impact of Emerging Therapies

As Xarelto faces the impending loss of patent protection, new therapies are being developed to compete with it. For example, Bristol Myers Squibb and Johnson & Johnson are conducting large-scale trials for milvexian, a Factor XIa inhibitor, which aims to offer better safety profiles compared to existing anticoagulants like Xarelto and Eliquis. These new drugs are expected to impact the market dynamics significantly[4].

Market Analysis

Current Market Performance

Xarelto has been a high-performing drug in the anticoagulant market. In 2021, its annual sales were $6.3 billion, with peak sales reaching $7.2 billion in 2020. The drug's global sales stood at $2.365 billion in 2023, with a historical growth rate (CAGR) of 0.28% between 2020 and 2023[1][2].

Market Projections

Despite its strong current performance, Xarelto's market is expected to decline due to several factors:

• Generic Entry: The earliest date for generic entry is projected to be February 28, 2025, which could significantly impact Xarelto's market share and revenue[1].
• Emerging Therapies: The introduction of new anticoagulants like milvexian and asundexian is expected to compete with Xarelto, potentially reducing its market share[4].

However, Xarelto is expected to maintain a significant presence in the market, especially in the treatment of PAD and other cardiovascular conditions. The market size and insights into Xarelto's clinical developments and regulatory milestones are projected to support its continued relevance up to 2032[3].

Regional Market Analysis

Xarelto's market performance varies across different regions. In the United States, it is one of the top-selling oral anticoagulants, along with Eliquis and Pradaxa. The US anticoagulants market analysis shows that Xarelto has a substantial market share, although this is expected to change with the introduction of generics and new therapies[5].

Market Dynamics and Emerging Therapies

Growth Drivers

The anticoagulant market, including Xarelto, is driven by several factors:

• Growth in Geriatric Population: An increasing elderly population is more prone to cardiovascular diseases, driving the demand for anticoagulants[5].
• Rising Global Healthcare Expenditure: Increased healthcare spending globally supports the growth of the anticoagulant market[5].
• Increasing Diabetic Population: Diabetes is a risk factor for cardiovascular diseases, contributing to the demand for anticoagulants[5].

Challenges and Opportunities

• Bleeding Risks: Xarelto faces a boxed warning for potential bleeding risks from the FDA, which can impact its prescription rates[3].
• Competition from New Therapies: The emergence of new anticoagulants with potentially better safety profiles poses a significant challenge to Xarelto's market dominance[4].

Forward-Looking Insights and Sales Forecasts

Sales Projections

Despite the anticipated decline due to generic entry and competition from new therapies, Xarelto is expected to maintain a significant market presence. Sales projections indicate that Xarelto will continue to be a major player in the anticoagulant market, especially in the treatment of PAD and other cardiovascular conditions up to 2032[3].

Strategic Positioning

The report on Xarelto's market size and insights provides a thorough analysis of its clinical developments, regulatory milestones, and expected performance. This helps stakeholders understand the evolving landscape of PAD treatments and the strategic positioning of Xarelto within it[3].

Key Takeaways

• Clinical Trials: Xarelto is involved in ongoing trials for PAD and other conditions, with a focus on its efficacy and safety.
• Market Performance: Xarelto has strong current sales but is expected to decline with generic entry and competition from new therapies.
• Market Projections: Despite challenges, Xarelto is projected to remain a significant player in the anticoagulant market up to 2032.
• Emerging Therapies: New anticoagulants like milvexian and asundexian are being developed to compete with Xarelto.
• Market Dynamics: The anticoagulant market is driven by factors such as the growth in the geriatric population and rising global healthcare expenditure.

FAQs

What is the mechanism of action of Xarelto?

Xarelto works by inhibiting factor Xa, an enzyme involved in the production of thrombin, thereby reducing the risk of blood clots forming in veins and arteries[2].

When is the earliest date for generic entry of Xarelto?

The earliest date for generic entry of Xarelto is projected to be February 28, 2025, subject to changes due to patent challenges or generic licensing[1].

What are the emerging therapies competing with Xarelto?

Emerging therapies include milvexian and asundexian, which are Factor XIa inhibitors designed to offer better safety profiles compared to existing anticoagulants like Xarelto and Eliquis[4].

What are the key growth drivers for the anticoagulant market?

Key growth drivers include the growth in the geriatric population, rising global healthcare expenditure, increasing diabetic population, and escalating number of cancer patients and cardiovascular disease cases[5].

How is Xarelto positioned in the market for Peripheral Artery Disease (PAD)?

Xarelto is the sole therapy indicated for both coronary artery disease (CAD) and PAD post-lower extremity revascularization (LER), making it a significant player in the PAD treatment market[3].

Sources

1. Drug Patent Watch: XARELTO Drug Patent Profile.
2. GlobalData: The Global Drug sales of Xarelto (2020 - 2026, USD Millions).
3. Business Wire: Market Expansion for XARELTO in Peripheral Artery Disease Treatment through 2032.
4. BioPharma Dive: Bristol Myers, J&J plan tests of new blood thinner.
5. Business Wire: Global Anticoagulants Market (2021 to 2025) - Size & Forecast with Impact Analysis of COVID-19.