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
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).
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	Bayer	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).
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).
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.
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.

Clinical Trial Conditions for RIVAROXABAN

Condition Name

Condition Name for RIVAROXABAN
Intervention	Trials
Atrial Fibrillation	65
Venous Thromboembolism	38
Stroke	18
Venous Thrombosis	18

Condition MeSH

Condition MeSH for RIVAROXABAN
Intervention	Trials
Thrombosis	89
Atrial Fibrillation	84
Thromboembolism	58
Venous Thrombosis	56

Clinical Trial Locations for RIVAROXABAN

Trials by Country

+

−

Trials by Country for RIVAROXABAN
Location	Trials
United States	807
Japan	187
Germany	184
Canada	180
China	168

Trials by US State

+

−

Trials by US State for RIVAROXABAN
Location	Trials
California	39
Florida	38
Texas	37
Pennsylvania	37
New York	33

Clinical Trial Progress for RIVAROXABAN

Clinical Trial Phase

Clinical Trial Phase for RIVAROXABAN
Clinical Trial Phase	Trials
Phase 4	86
Phase 3	96
Phase 2/Phase 3	17

Clinical Trial Status

Clinical Trial Status for RIVAROXABAN
Clinical Trial Phase	Trials
Completed	147
Recruiting	77
Not yet recruiting	54

Clinical Trial Sponsors for RIVAROXABAN

Sponsor Name

Sponsor Name for RIVAROXABAN
Sponsor	Trials
Bayer	105
Janssen Research & Development, LLC	46
Janssen Scientific Affairs, LLC	19

Sponsor Type

Sponsor Type for RIVAROXABAN
Sponsor	Trials
Other	506
Industry	233
NIH	7

Rivaroxaban: Clinical Trials, Market Analysis, and Projections

Introduction to Rivaroxaban

Rivaroxaban, marketed under the brand name Xarelto, is an oral anticoagulant and a factor Xa inhibitor. It is widely used for the prevention and treatment of venous thromboembolism (VTE), stroke in patients with atrial fibrillation, and other thrombotic conditions. Here, we will delve into recent clinical trials, market analysis, and future projections for rivaroxaban.

Recent Clinical Trials

PREVENT-HD Trial

The PREVENT-HD trial was a randomized controlled trial designed to assess the efficacy and safety of rivaroxaban in nonhospitalized patients with symptomatic COVID-19 who were at risk for thrombosis. The trial, conducted between August 2020 and April 2022, involved 1284 patients who were randomly assigned to receive either 10 mg of oral rivaroxaban or a placebo daily for 35 days. The primary efficacy outcome was the time to the first occurrence of a composite of symptomatic venous thromboembolism, myocardial infarction, ischemic stroke, acute limb ischemia, non-central nervous system systemic arterial embolism, hospitalization, or death through day 35.

The results showed that the primary efficacy outcome occurred in 22 of 641 patients in the rivaroxaban group and 19 of 643 patients in the placebo group, with no significant difference between the two groups (hazard ratio, 1.16 [95% CI, 0.63–2.15]; P=0.63)[1].

PIONEER AF-PCI Trial

The PIONEER AF-PCI trial was an international, multi-center, randomized, open-label clinical trial that evaluated the safety of rivaroxaban compared to warfarin in patients with nonvalvular atrial fibrillation who had undergone percutaneous coronary intervention (PCI) with stent placement. The trial demonstrated that rivaroxaban was associated with a reduced risk of clinically significant bleeding and net adverse clinical events (NACE) compared to warfarin[4].

Market Analysis

Current Market Size and Growth

The global rivaroxaban market has been experiencing significant growth. As of 2024, the market size was valued at approximately USD 8,706.3 million and is projected to reach USD 13,970 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 8.2% during the forecast period[2].

Another report indicates that the rivaroxaban market was valued at USD 14.89 million in 2022 and is expected to reach USD 25.59 million by 2030, growing at a CAGR of 7.0% during the forecast period of 2023-2030[3].

Market Drivers

Several factors are driving the growth of the rivaroxaban market:

• High Prevalence of Thromboembolic Disorders: The increasing incidence of deep vein thrombosis, pulmonary embolism, and other thrombotic conditions is a significant driver. This is further exacerbated by a rapidly aging population, increased obesity, and diabetes rates, and a higher number of surgical interventions[5].
• Advantages Over Traditional Anticoagulants: Rivaroxaban offers several advantages over traditional anticoagulants like warfarin, including a predictable pharmacokinetic profile, no need for routine monitoring, lower risk of drug interactions, and ease of oral administration[3].
• Expanding Geriatric Population: The growing geriatric population, which is more prone to thromboembolic disorders, is another key driver[5].

Market Restraints

Despite the growth, there are several restraints to the market:

• High Cost of Drugs: The high cost of rivaroxaban and its potential side effects, such as muscle pain, headache, dizziness, and others, are significant restraints[3].
• Side Effects: The drug's side effects can deter some patients and healthcare providers from using it.

Competitive Landscape

The rivaroxaban market is dominated by key players such as Bayer AG, Janssen Pharmaceuticals Inc., Dr. Reddy's Laboratories Ltd., Taj Pharmaceuticals Limited, and Anant Pharmaceuticals Pvt. Ltd. These companies are continuously involved in research and development to expand the drug's indications and improve its market position[5].

Market Projections

Forecasted Market Size

By 2030, the rivaroxaban market is expected to reach USD 13,970 million, growing at a CAGR of 8.2% from 2024 to 2030. Another projection suggests the market will reach USD 25.59 million by 2030, growing at a CAGR of 7.0% from 2023 to 2030[2][3].

Emerging Markets

Emerging markets present a significant opportunity for rivaroxaban manufacturers. The rising prevalence of thromboembolic disorders in these regions, coupled with improving healthcare infrastructure and increasing awareness and diagnosis rates, creates a favorable environment for market expansion[3].

Research and Development

Continued R&D efforts are expected to expand the market potential of rivaroxaban. Research into new indications, such as treating additional cardiovascular conditions or exploring combination therapies, could lead to expanded treatment options and increased market penetration[3].

Key Takeaways

• Clinical Trials: Recent trials like PREVENT-HD and PIONEER AF-PCI have provided valuable insights into the efficacy and safety of rivaroxaban in various patient populations.
• Market Growth: The rivaroxaban market is projected to grow significantly, driven by the high prevalence of thromboembolic disorders, advantages over traditional anticoagulants, and an expanding geriatric population.
• Market Size: The market is expected to reach USD 13,970 million by 2030, with a CAGR of 8.2% from 2024 to 2030.
• Emerging Markets: Expanding into emerging markets and ongoing R&D efforts will provide significant opportunities for market growth.

FAQs

What is the current market size of rivaroxaban and its projected growth?

The current market size of rivaroxaban was valued at approximately USD 8,706.3 million in 2024 and is projected to reach USD 13,970 million by 2030, growing at a CAGR of 8.2% during the forecast period[2].

What are the main drivers of the rivaroxaban market?

The main drivers include the high prevalence of thromboembolic disorders, advantages over traditional anticoagulants, and an expanding geriatric population[5].

What are the restraints to the rivaroxaban market?

The restraints include the high cost of the drug and its potential side effects[3].

Which companies are the key players in the rivaroxaban market?

Key players include Bayer AG, Janssen Pharmaceuticals Inc., Dr. Reddy's Laboratories Ltd., Taj Pharmaceuticals Limited, and Anant Pharmaceuticals Pvt. Ltd.[5].

What are the emerging opportunities for the rivaroxaban market?

Emerging markets and ongoing R&D efforts to explore new indications and combination therapies present significant opportunities for market growth[3].

Sources

1. Rivaroxaban for Prevention of Thrombotic Events, Hospitalization ... - Circulation, 2023
2. Global Rivaroxaban Market Insights, Forecast to 2030 - Valuates Reports
3. Global Rivaroxaban Market – Industry Trends and Forecast to 2030 - Data Bridge Market Research
4. Findings Presented at ACC.24 Showed XARELTO® (rivaroxaban) ... - Janssen
5. Rivaroxaban Market Size, Share, Growth, Forecast, [2024-2034] - Prophecy Market Insights