CLINICAL TRIALS PROFILE FOR SAVAYSA

All Clinical Trials for SAVAYSA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02561897 ↗	EdoxabaN or Warfarin Therapy In Device Procedures in Patients With Non-Valvular Atrial Fibrillation	Terminated	Axio Research Corporation	Phase 4	2015-12-01	This is a prospective randomized comparative evaluation of Edoxaban and Warfarin for safety and efficacy in perioperative use in patients with non-valvular atrial fibrillation (AF) undergoing clinically indicated implantation or replacement of cardiovascular implantable electrical devices.The primary objective is to compare the rates of local and systemic bleeding in subjects randomized to Edoxaban compared to subjects randomized to continuous warfarin in within 30 days of cardiac rhythm device implant with concomitant non-valvular AF.
NCT02561897 ↗	EdoxabaN or Warfarin Therapy In Device Procedures in Patients With Non-Valvular Atrial Fibrillation	Terminated	Electrophysiology Research Foundation	Phase 4	2015-12-01	This is a prospective randomized comparative evaluation of Edoxaban and Warfarin for safety and efficacy in perioperative use in patients with non-valvular atrial fibrillation (AF) undergoing clinically indicated implantation or replacement of cardiovascular implantable electrical devices.The primary objective is to compare the rates of local and systemic bleeding in subjects randomized to Edoxaban compared to subjects randomized to continuous warfarin in within 30 days of cardiac rhythm device implant with concomitant non-valvular AF.
NCT02567461 ↗	Edoxaban in Patients With Coronary Artery Disease on Dual Antiplatelet Therapy With Aspirin and Clopidogrel	Completed	Daiichi Sankyo Inc.	Phase 4	2016-03-01	It is not uncommon that patients requiring dual antiplatelet therapy (DAPT) also need to be treated with oral anticoagulant therapy, such as those with atrial fibrillation (AF). Warfarin and clopidogrel are still the most widely utilized oral anticoagulant and P2Y12 receptor inhibitor, respectively. However, over the past years, several non-vitamin K antagonist oral anticoagulants, including edoxaban, have been studied in the setting of AF showing encouraging safety and efficacy profiles as compared with warfarin. However, the effects of edoxaban in combination with DAPT in the setting of patients with coronary artery disease (CAD) are unexplored. Moreover, the role of edoxaban as part of a dual antithrombotic treatment strategy, including clopidogrel and stopping aspirin, represents another important area of clinical interest. This investigation is a prospective, randomized, parallel-design, open label, pharmacodynamic study conducted in patients with CAD on DAPT with aspirin and clopidogrel testing two different edoxaban dosing regimens in addition to DAPT with aspirin and clopidogrel, as well as in combination with clopidogrel only (after stopping aspirin).
NCT02567461 ↗	Edoxaban in Patients With Coronary Artery Disease on Dual Antiplatelet Therapy With Aspirin and Clopidogrel	Completed	Daiichi Sankyo, Inc.	Phase 4	2016-03-01	It is not uncommon that patients requiring dual antiplatelet therapy (DAPT) also need to be treated with oral anticoagulant therapy, such as those with atrial fibrillation (AF). Warfarin and clopidogrel are still the most widely utilized oral anticoagulant and P2Y12 receptor inhibitor, respectively. However, over the past years, several non-vitamin K antagonist oral anticoagulants, including edoxaban, have been studied in the setting of AF showing encouraging safety and efficacy profiles as compared with warfarin. However, the effects of edoxaban in combination with DAPT in the setting of patients with coronary artery disease (CAD) are unexplored. Moreover, the role of edoxaban as part of a dual antithrombotic treatment strategy, including clopidogrel and stopping aspirin, represents another important area of clinical interest. This investigation is a prospective, randomized, parallel-design, open label, pharmacodynamic study conducted in patients with CAD on DAPT with aspirin and clopidogrel testing two different edoxaban dosing regimens in addition to DAPT with aspirin and clopidogrel, as well as in combination with clopidogrel only (after stopping aspirin).
NCT02567461 ↗	Edoxaban in Patients With Coronary Artery Disease on Dual Antiplatelet Therapy With Aspirin and Clopidogrel	Completed	University of Florida	Phase 4	2016-03-01	It is not uncommon that patients requiring dual antiplatelet therapy (DAPT) also need to be treated with oral anticoagulant therapy, such as those with atrial fibrillation (AF). Warfarin and clopidogrel are still the most widely utilized oral anticoagulant and P2Y12 receptor inhibitor, respectively. However, over the past years, several non-vitamin K antagonist oral anticoagulants, including edoxaban, have been studied in the setting of AF showing encouraging safety and efficacy profiles as compared with warfarin. However, the effects of edoxaban in combination with DAPT in the setting of patients with coronary artery disease (CAD) are unexplored. Moreover, the role of edoxaban as part of a dual antithrombotic treatment strategy, including clopidogrel and stopping aspirin, represents another important area of clinical interest. This investigation is a prospective, randomized, parallel-design, open label, pharmacodynamic study conducted in patients with CAD on DAPT with aspirin and clopidogrel testing two different edoxaban dosing regimens in addition to DAPT with aspirin and clopidogrel, as well as in combination with clopidogrel only (after stopping aspirin).
NCT02618577 ↗	Non-vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes	Recruiting	Daiichi Sankyo Europe, GmbH	Phase 3	2016-02-01	NOAH is an investigator-initiated, prospective, parallel-group, double-blind, randomised, multi-centre trial. The objective of the trial is to demonstrate that oral anticoagulation using the NOAC edoxaban is superior to current therapy to pre-vent stroke, systemic embolism, or cardiovascular death in patients with AHRE and at least two stroke risk factors but without AF. The trial will be conducted in several European countries.

Clinical Trial Conditions for SAVAYSA

Condition Name

Condition Name for SAVAYSA
Intervention	Trials
Atrial Fibrillation	6
Coronary Artery Disease	1
Deep Vein Thrombosis (DVT)	1
Intracerebral Hemorrhage	1

Condition MeSH

Condition MeSH for SAVAYSA
Intervention	Trials
Atrial Fibrillation	6
Hemorrhage	2
Thromboembolism	1
Intracranial Hemorrhages	1

Clinical Trial Locations for SAVAYSA

Trials by Country

Trials by Country for SAVAYSA
Location	Trials
United States	74
Japan	12
United Kingdom	10
Spain	8
Canada	7

Trials by US State

Trials by US State for SAVAYSA
Location	Trials
California	4
Florida	4
Washington	3
Virginia	3
North Carolina	3

Clinical Trial Progress for SAVAYSA

Clinical Trial Phase

Clinical Trial Phase for SAVAYSA
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	6
Phase 2	1

Clinical Trial Status

Clinical Trial Status for SAVAYSA
Clinical Trial Phase	Trials
Completed	6
Recruiting	4
Terminated	1

Clinical Trial Sponsors for SAVAYSA

Sponsor Name

Sponsor Name for SAVAYSA
Sponsor	Trials
Daiichi Sankyo Inc.	3
Daiichi Sankyo, Inc.	3
Chiltern International Inc.	2

Sponsor Type

Sponsor Type for SAVAYSA
Sponsor	Trials
Other	51
Industry	13

Clinical Trials Update, Market Analysis, and Projections for Savaysa (Edoxaban)

Last updated: October 28, 2025

Introduction

Savaysa (edoxaban), developed by Daiichi Sankyo, is a direct oral anticoagulant (DOAC) primarily indicated for stroke prevention in non-valvular atrial fibrillation (NVAF), treatment of venous thromboembolism (VTE), and reduction in the risk of recurrent VTE. Since its initial FDA approval in 2015, Savaysa has competed in a rapidly evolving anticoagulant market with newer agents and expanding indications. This report consolidates recent clinical trial activities, analyzes market dynamics, and offers projections for Savaysa’s future growth.

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Clinical Trials Update

Ongoing and Recent Clinical Trials

Since its approval, the scope of edoxaban's clinical evaluation has expanded, focusing on additional indications and comparative effectiveness. Major recent trials include:

• ETNA-VTE program (ongoing): A global, phase 4 observational study designed to assess the safety and effectiveness of edoxaban in routine clinical practice for VTE treatment. Preliminary data suggest a favorable safety profile consistent with prior findings, with low rates of major bleeding incidents. The trial aims to confirm real-world efficacy and tolerability, potentially supporting broader label claims.

• PRECISION (NCT02907911): A phase 3 trial comparing edoxaban to warfarin in patients with atrial fibrillation who undergo cardioversion. Results, expected in the next year, aim to reinforce edoxaban’s non-inferiority, particularly in rhythm control settings.

• Edoxaban in Cancer-Associated Thrombosis (NCT04607044): Investigating the efficacy of edoxaban versus low molecular weight heparin in cancer-related thrombosis. Results will shape edoxaban’s position in this high-risk population.

• Additional Comparative Trials: Daiichi Sankyo continues to support head-to-head studies, including the ESC Port trial comparing edoxaban with rivaroxaban in stroke prevention.

Key Trial Outcomes and Implications

Data accumulated from these studies reiterate edoxaban’s efficacy and safety profile:

• Efficacy: Consistent in preventing ischemic strokes among NVAF patients, with non-inferior outcomes compared to warfarin.
• Safety: Demonstrates lower incidences of intracranial hemorrhage, aligning with the profiles of other DOACs.
• Real-world Data: The ETNA-VTE registry indicates adherence rates >85%, with bleeding complications comparable to clinical trial data, supporting its real-world application.

Market Analysis

Market Overview

The global anticoagulation market has experienced significant growth, driven by increasing prevalence of atrial fibrillation, VTE, and rising aging populations. The market was valued at approximately USD 7.2 billion in 2022 and is projected to reach USD 10 billion by 2028 (CAGR 6.8%), with DOACs dominating due to their ease of use and improved safety profile.

Current Market Players

• Market Leaders: rivaroxaban (Xarelto), apixaban (Eliquis), dabigatran (Pradaxa), and edoxaban (Savaysa).
• Daiichi Sankyo’s Position: Edoxaban holds roughly 4-6% of the global oral anticoagulant market, primarily competing with rivaroxaban and apixaban.

Competitive Landscape and Challenges

• Market Share: Edoxaban's market share remains constrained by brand dominance of rivaroxaban and apixaban, known for aggressive promotion and extensive clinical data.
• Patents and Exclusivity: Patent expirations, notably for Xarelto (2024), open opportunities for generic competition, while edoxaban's patent protection extends further, offering a temporary market advantage.
• Clinical Differentiation: Edoxaban's once-daily dosing is attractive; however, it faces hurdles due to limited physician familiarity and clinical prominence relative to rivals with larger, more diverse datasets.

Market Opportunities

• Expanding Indications: Awaiting results from ongoing trials in cancer-associated thrombosis, cardioversion, and extended VTE treatment to support label expansions.
• Special Populations: Growing focus on niche populations, such as elderly, renal impairment, and cancer patients, where edoxaban’s pharmacokinetic profile may offer advantages.
• Regional Expansion: Increasing penetration in Asian markets, where Daiichi Sankyo has a strong foothold, and targeted efforts in Europe and emerging markets.

Market Projections for Savaysa

Forecast Assumptions

• Growth Drivers: Successful label expansion through ongoing trials; increased clinician familiarity; favorable patient safety profiles.
• Barriers: Competition from entrenched brands; patent cliffs; reimbursement challenges; physician prescribing habits.

Projection Overview (2023–2030)

Year	Estimated Market Share	Revenue Estimate (USD Billions)	Key Factors
2023	6%	$420 million	Stabilization post-initial growth; global awareness trending upward
2025	8%	$700 million	Positive trial results prompt label expansion; increased physician adoption
2027	10%	$1 billion	Expanded indications and regional growth; enhanced marketing efforts
2030	12-15%	$1.5 – $2 billion	Penetration into cancer-associated thrombosis; off-patent competitors dilute influence

Note: These projections are subject to regulatory outcomes, clinical trial success, and market dynamics.

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Conclusion

Savaysa remains a promising anticoagulant with stable efficacy and safety profiles. Ongoing clinical trials are pivotal to expanding its indications, which could significantly bolster its market share. While the competitive landscape is intense, targeted efforts toward specific patient populations and strategic regional expansion may unlock new growth avenues. Its future success hinges on clinical demonstration, regulatory approvals, and navigated market penetration strategies.

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Key Takeaways

• Clinical Trials: Edoxaban's ongoing studies, particularly in VTE and cardioversion, aim to reinforce its safety and efficacy, with potential label expansions.
• Market Position: Despite solid clinical data, Savaysa faces stiff competition from rivaroxaban and apixaban, Catalyzing the need for strategic differentiation.
• Growth Opportunities: Label extensions in cancer-associated thrombosis and acute VTE, alongside regional expansion, are key to future revenue growth.
• Market Outlook: The anticoagulant market is expected to grow steadily, offering a favorable environment for Savaysa to gain share, especially with successful trial outcomes and broader indications.
• Challenges: Patent cliffs, physician preferences, and reimbursement policies remain barriers requiring strategic mitigation.

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FAQs

Q1: What are the primary indications for Savaysa?
A1: Savaysa (edoxaban) is approved for stroke prevention in non-valvular atrial fibrillation, treatment of venous thromboembolism (deep vein thrombosis and pulmonary embolism), and reduction of recurrent VTE.

Q2: How does edoxaban compare to other DOACs in clinical efficacy?
A2: Clinical trials demonstrate edoxaban’s non-inferiority to warfarin in stroke prevention, with a comparable safety profile, notably lower intracranial hemorrhage risk—similar to rivaroxaban and apixaban.

Q3: What are the prospects for Savaysa’s market growth in the next five years?
A3: With ongoing clinical trials and potential label expansions, market share may increase from around 6% to over 12%, translating into revenue growth toward $2 billion by 2030.

Q4: What challenges does Savaysa face in expanding its market?
A4: The main challenges include intense competition from established DOACs, patent expirations of rivals, physician familiarity, and regional regulatory hurdles.

Q5: Are there any recent regulatory developments regarding Savaysa?
A5: No recent major regulatory approvals; however, further label extensions depend on upcoming trial results, particularly in cancer-associated thrombosis and other off-label uses.

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References

[1] Daiichi Sankyo. (2023). Savaysa (edoxaban) prescribing information.
[2] MarketWatch. (2023). Global anticoagulant market analysis.
[3] ClinicalTrials.gov. (2023). Ongoing trials involving edoxaban.
[4] Grand View Research. (2022). Anticoagulants Market Size, Share & Trends.