CLINICAL TRIALS PROFILE FOR PRADAXA

All Clinical Trials for Pradaxa

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01153698 ↗	Pradaxa (Dabigatran Etexilate) VTE Prevention After Elective Total Hip or Knee Replacement Surgery	Terminated	Boehringer Ingelheim		2010-08-01	an open, prospective, observational study to collect data on safety (major bleeding events) and efficacy (symptomatic venous thromboembolism(VTE)) of a switch from Enoxaparin to dabigatran etexilate in patients with total knee replacement (TKR) and total hip replacement (THR)
NCT01184989 ↗	Treatment of Patients Undergoing Primary Unilateral Elective Total Knee or Hip Replacement With Dabigatran Etexilate	Completed	Boehringer Ingelheim	Phase 4	2010-08-01	To supplement the current evidence of the effect of Pradaxa® (dabigatran etexilate) on coagulation parameters, including a calibrated thrombin time test, in patients with moderate renal impairment undergoing elective total hip- or knee-replacement surgery, this PK/PD study will be conducted.
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.
NCT01241539 ↗	Pharmacokinetics of Dabigatran Etexilate (Pradaxa®) During Haemodialysis	Completed	Boehringer Ingelheim	Phase 1	2010-11-01	The current study will allow the assessment of pharmacokinetics, pharmacodynamics, elimination rate and clearance of dabigatran etexilate during and following haemodialysis in ESRD patients.
NCT01339819 ↗	Impact of Dabigatran and Phenprocoumon on ADP Induced Platelet Aggregation in Patients With Atrial Fibrillation	Completed	Deutsches Herzzentrum Muenchen	Phase 4	2011-04-01	The aim of this study is to evaluate whether Dabigatran itself reduces ADP induced platelet aggregation measured by MEA as compared to Phenprocoumon after a two-week treatment with either agent.
NCT01352702 ↗	Impact of Dabigatran and Phenprocoumon on Clopidogrel Mediated ADP Induced Platelet Aggregation in Patients With Atrial Fibrillation	Terminated	Deutsches Herzzentrum Muenchen	Phase 4	2011-05-01	The aim of this study is to evaluate whether dabigatran reduces clopidogrel mediated ADP induced platelet aggregation measured by MEA as compared to phenprocoumon after a two-week treatment with either agent.

Clinical Trial Conditions for Pradaxa

Condition Name

Condition Name for Pradaxa
Intervention	Trials
Atrial Fibrillation	26
Venous Thromboembolism	5
Healthy	4
Pulmonary Embolism	3

Condition MeSH

Condition MeSH for Pradaxa
Intervention	Trials
Atrial Fibrillation	27
Thromboembolism	7
Venous Thromboembolism	6
Thrombosis	6

Clinical Trial Locations for Pradaxa

Trials by Country

Trials by Country for Pradaxa
Location	Trials
United States	100
Canada	23
Germany	12
United Kingdom	6
Korea, Republic of	5

Trials by US State

Trials by US State for Pradaxa
Location	Trials
Florida	6
Texas	6
Pennsylvania	4
North Carolina	4
New York	4

Clinical Trial Progress for Pradaxa

Clinical Trial Phase

Clinical Trial Phase for Pradaxa
Clinical Trial Phase	Trials
Phase 4	23
Phase 3	7
Phase 2	2

Clinical Trial Status

Clinical Trial Status for Pradaxa
Clinical Trial Phase	Trials
Completed	28
Recruiting	9
Unknown status	7

Clinical Trial Sponsors for Pradaxa

Sponsor Name

Sponsor Name for Pradaxa
Sponsor	Trials
Boehringer Ingelheim	20
The University of Hong Kong	2
Deutsches Herzzentrum Muenchen	2

Sponsor Type

Sponsor Type for Pradaxa
Sponsor	Trials
Other	113
Industry	29
NIH	2

Pradaxa (Dabigatran Etexilate): Clinical Trials, Market Analysis, and Projections

Introduction

Pradaxa, or dabigatran etexilate, is a novel reversible oral direct thrombin inhibitor that has revolutionized the treatment of venous thromboembolic events (VTE) and the prevention of stroke in patients with non-valvular atrial fibrillation. Here, we will delve into the latest clinical trials, market analysis, and projections for this significant anticoagulant.

Clinical Trials and Indications

Pediatric Use

Recently, the FDA approved Pradaxa Oral Pellets for pediatric patients aged 3 months to less than 12 years for the treatment of VTE and to reduce the risk of recurrence of VTE. This approval includes specific requirements for postmarketing studies to monitor safety and efficacy, including the assessment of bleeding events, post-thrombotic syndrome (PTS), and lack of efficacy[1].

Postmarketing Commitments

The FDA has mandated several postmarketing commitments, including the development of a desiccant container to mitigate the risk of patients confusing the drug packet with the desiccant. Additionally, the FDA requires periodic safety reports and detailed analyses of adverse events, such as bleeding and PTS, in the post-market safety database[1].

Comparative Studies

A significant FDA study involving over 134,000 Medicare patients found that Pradaxa was associated with a lower risk of clot-related strokes, bleeding in the brain, and death compared to warfarin. However, it also highlighted an increased risk of major gastrointestinal bleeding with Pradaxa use[3].

Market Analysis

Global Anticoagulation Market

The global anticoagulation market, which includes Pradaxa, was valued at USD 25.66 billion in 2024 and is projected to reach USD 53.48 billion by 2033, growing at a CAGR of 8.50% during the forecast period (2025-2033)[5].

Anticoagulant Reversal Drugs Market

The anticoagulant reversal drugs market, which is closely related to Pradaxa due to the availability of reversal agents like Praxbind (idarucizumab), is expected to reach USD 2.78 billion by 2030, expanding at a CAGR of 12.3% from 2025 to 2030. This growth is driven by the increasing number of bleeding disorders and the introduction of new drugs[2].

Market Projections

Growth Drivers

The market for Pradaxa and related anticoagulants is expected to grow due to several factors:

• Increasing Prevalence of Cardiovascular Diseases: The rising number of patients with conditions such as atrial fibrillation and VTE is driving the demand for effective anticoagulants.
• Advancements in Drug Technology: The introduction of new anticoagulants and reversal agents enhances treatment options and confidence in anticoagulant therapies.
• Expanding Indications: The recent approval for pediatric use and ongoing clinical trials are expected to expand the patient base for Pradaxa[1][2].

Regional Outlook

The anticoagulation market is segmented geographically, with North America currently being the largest market. However, Europe is expected to be the fastest-growing region due to increasing healthcare expenditures and a growing elderly population[5].

Competitive Landscape

The market for anticoagulants is competitive, with key players including Boehringer Ingelheim Pharmaceuticals, Pfizer Inc, AstraZeneca, and others. The expiration of patents for Pradaxa in 2025 and 2027 is expected to introduce generic competition, which could impact market dynamics[2][4].

Patent Expirations and Generic Competition

Three active patents covering Pradaxa are set to expire in 2025 and 2027, which will open the market to generic versions of dabigatran etexilate. This could lead to increased competition and potentially lower prices, affecting the market share of the branded version[4].

Key Takeaways

• Expanded Indications: Pradaxa has been approved for pediatric use, expanding its market potential.
• Postmarketing Studies: Ongoing studies are crucial for monitoring safety and efficacy in various patient populations.
• Market Growth: The anticoagulation market is projected to grow significantly, driven by increasing prevalence of cardiovascular diseases and advancements in drug technology.
• Competitive Landscape: The market is competitive, with key players and the impending introduction of generic versions.
• Regional Growth: North America is the largest market, but Europe is expected to be the fastest-growing region.

FAQs

What are the recent clinical trial updates for Pradaxa?

Pradaxa has been approved for use in pediatric patients aged 3 months to less than 12 years for the treatment and prevention of recurrence of VTE. Postmarketing studies are ongoing to monitor safety and efficacy.

How does Pradaxa compare to warfarin in terms of safety and efficacy?

Pradaxa is associated with a lower risk of clot-related strokes, bleeding in the brain, and death compared to warfarin but has a higher risk of major gastrointestinal bleeding.

What is the projected market size for the anticoagulation market by 2033?

The global anticoagulation market is projected to reach USD 53.48 billion by 2033, growing at a CAGR of 8.50% from 2025 to 2033.

Which regions are expected to drive the growth of the anticoagulation market?

North America is currently the largest market, but Europe is expected to be the fastest-growing region due to increasing healthcare expenditures and a growing elderly population.

When do the patents for Pradaxa expire?

The patents for Pradaxa are set to expire in 2025 and 2027, which will introduce generic competition to the market.

Sources

1. FDA Approval Letter for Pradaxa Oral Pellets: U.S. Food and Drug Administration, June 21, 2021.
2. Global Anticoagulant Reversal Drugs Market Report: Grand View Research, Inc.
3. FDA Drug Safety Communication on Pradaxa: U.S. Food and Drug Administration, May 13, 2014.
4. Generic Drug Opportunity Assessment - Dabigatran (Pradaxa): Research and Markets.
5. Anticoagulation Market Size and Forecast: Straits Research.