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
NCT01210755 ↗	Study in Healthy Volunteers of the Reversion by Haemostatic Drugs of the Anticoagulant Effect of New Anti-thrombotics	Completed	University Hospital, Grenoble	Phase 4	2010-11-01	The purpose of this study is to evaluate whether the effect of the two new anticoagulants, Dabigatran and Rivaroxaban, can be reversed by non-specific and specific inhibitors. For Dabigatran the investigators will test the non-specific inhibitors: prothrombin complex concentrate (PCC), recombinant activated coagulation factor VII, and activated prothrombin-complex (FEIBA). For Rivaroxaban the investigators will test a specific Rivaroxaban decoy (FXa-GLAless). This will be done in a laboratory using blood plasma from healthy male volunteers.
NCT01344954 ↗	Single IV Administration of TB-402 for Prophylaxis of Venous Thromboembolic Events (VTE) After Total Hip Replacement Surgery	Completed	BioInvent International AB	Phase 2	2011-04-01	The purpose of this study is to evaluate the safety and efficacy of two doses of TB-402 administered as a single intravenous infusion for the prevention of VTE in subjects undergoing total hip replacement surgery.
NCT01344954 ↗	Single IV Administration of TB-402 for Prophylaxis of Venous Thromboembolic Events (VTE) After Total Hip Replacement Surgery	Completed	ThromboGenics	Phase 2	2011-04-01	The purpose of this study is to evaluate the safety and efficacy of two doses of TB-402 administered as a single intravenous infusion for the prevention of VTE in subjects undergoing total hip replacement surgery.

Clinical Trial Conditions for XARELTO

Condition Name

Condition Name for XARELTO
Intervention	Trials
Atrial Fibrillation	23
Venous Thromboembolism	18
Venous Thrombosis	6
Stroke	5

Condition MeSH

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

Clinical Trial Locations for XARELTO

Trials by Country

Trials by Country for XARELTO
Location	Trials
United States	146
Canada	51
China	27
Germany	22
Brazil	19

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
PHASE4	1
PHASE3	1
PHASE1	2

Clinical Trial Status

Clinical Trial Status for XARELTO
Clinical Trial Phase	Trials
Completed	60
Recruiting	27
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	233
Industry	89
NIH	4

XARELTO Market Analysis and Financial Projection

Last updated: April 27, 2026

Xarelto (rivaroxaban): Clinical Trials Update, Market Analysis and 2026-2030 Projection

What is Xarelto’s current clinical status across key development areas?

Xarelto is an established oral factor Xa inhibitor with ongoing trials that focus on (1) new patient populations, (2) new dosing strategies, and (3) comparative safety/efficacy endpoints against other anticoagulants. The product’s modern trial program is centered on label-expanding indications and refinement of antithrombotic regimens, including perioperative and combination-therapy contexts.

The latest high-level update is that Xarelto continues to be studied in phase 3 and phase 2 programs, with sponsor activity concentrated around:

• Venous thromboembolism (VTE) recurrence prevention
• Thrombosis prevention in atrial fibrillation (AF)
• Combination regimens with antiplatelet therapy in atherosclerotic disease settings
• Perioperative anticoagulation strategies and discontinuation/re-initiation pathways

Clinical development positioning (directionally)

• Trials continue to test either durational adjustments (shortened or extended treatment windows) or regimen adjustments (monotherapy versus combination therapy).
• Study designs typically target hard endpoints: stroke/systemic embolism, VTE recurrence, major bleeding, and clinically relevant non-major bleeding.

Which trials are most likely to move the label over the next cycle?

Across the anticoagulant class, the highest-probability label expansion lever is improving the benefit-risk profile in populations with competing ischemic and bleeding risks. In practice, that means phase 3 programs that:

• Stratify by baseline bleeding risk
• Use standardized bleeding definitions (commonly ISTH/ROCKET-style adjudication for comparators)
• Include subgroup analyses by renal function and age, given rivaroxaban exposure sensitivity

Actionable implication for R&D and investment

• If upcoming trials demonstrate lower major bleeding with non-inferior ischemic protection, payers and formularies respond faster than when endpoints are limited to surrogate efficacy.

(No further trial-by-trial dataset can be produced from the provided information.)

---

How large is Xarelto’s market today, and where does growth come from?

Xarelto’s global revenue base is driven by durable chronic-use indications (AF stroke prevention, VTE prophylaxis/therapy pathways, and secondary prevention contexts) and by steady uptake and switching within anticoagulant classes. The addressable market remains large because anticoagulation is chronic for many patients and because guideline adherence supports long-term use when benefits outweigh bleeding risk.

Market structure (key demand drivers)

• Chronic AF anticoagulation: long-duration treatment, high conversion to persistent therapy
• Post-acute VTE care: initial therapy plus extended secondary prevention
• Cardiovascular comorbidity overlap: combination and sequential therapy patterns influence net anticoagulant duration

Competitive landscape

• Primary competitive pressure comes from other DOACs (apixaban, dabigatran, edoxaban) and, in some markets, warfarin.
• Switching tends to be driven by local formulary positioning, payer rebates, and physician familiarity.
• Safety profile differences matter: major bleeding and GI bleeding rates affect payer uptake for senior and CKD populations.

---

What is the 2026-2030 revenue projection logic for Xarelto?

Projection for an established DOAC depends on three dominant forces:

1. Volume retention (new patients, persistence)
2. Net price (list price, discounts, rebates, regional tender dynamics)
3. Patent and generic erosion (if and when specific geographies encounter generic entry)

Without explicit patent expiry and generic launch timing by geography, a full numerical forecast cannot be stated without risking inaccuracy. A correct projection framework is still actionable:

Projection framework (what to model)

• Base-case trend: continued growth or modest decline driven by net price pressure versus new starts
• Scenario spread:
  • Bear case: accelerated net price erosion plus higher market share shift to apixaban (or other class competitors)
  • Bull case: stable formulary access plus improved adherence and guideline growth in AF/VTE cohorts
• Endpoint sensitivity: bleeding outcome guidance and real-world evidence can shift share faster than efficacy claims

---

Market outlook by segment (investor view)

1) AF anticoagulation

• Largest revenue gravity due to chronic use.
• Growth depends on detection rates and guideline adherence in aging populations.

2) VTE treatment and extended prevention

• More sensitive to regimen guidance and payer authorization rules.
• Sustained use hinges on lower bleeding and simplified transition protocols.

3) Atherosclerotic disease with combination therapy

• Competitive and policy-sensitive because regimen choice affects both anticoagulant and antiplatelet reimbursement.

---

Key Takeaways

• Xarelto’s ongoing clinical activity centers on label refinement: regimen and durational optimization in thrombotic and bleeding-risk populations.
• Revenue drivers remain chronic and high-persistence indications (especially AF), supported by VTE prevention pathways.
• A credible 2026 to 2030 projection must be built from volume retention, net price trajectory, and patent or generic entry timing by geography; without that timing, a numeric forecast cannot be stated accurately.

---

FAQs

1) Is Xarelto still under active clinical development?
Yes. The program remains focused on phase 2/3 studies targeting indication expansion and regimen optimization in thrombotic and bleeding-risk populations.

2) What endpoints determine whether trials can shift Xarelto’s label?
Stroke/systemic embolism, VTE recurrence, and major bleeding outcomes typically drive label-impact decisions.

3) Where does Xarelto face the most competitive pressure?
Within the DOAC class, especially in formularies that favor apixaban or where warfarin use remains entrenched.

4) What is the key commercial lever for 2026-2030 performance?
Net price and market-share retention, both of which are sensitive to payer contracting and any generic erosion.

5) Which patient groups influence growth the most?
Older AF and VTE cohorts where chronic anticoagulation demand is highest and where bleeding-risk management drives prescribing behavior.

---

References

[1] FDA. Xarelto (rivaroxaban) prescribing information. U.S. Food and Drug Administration.
[2] EMA. Xarelto (rivaroxaban) product information. European Medicines Agency.
[3] ClinicalTrials.gov. Xarelto (rivaroxaban) clinical trials database. National Library of Medicine.