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Last Updated: May 20, 2025

CLINICAL TRIALS PROFILE FOR TRACLEER


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All Clinical Trials for Tracleer

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00071461 ↗ Efficacy and Safety of Oral Bosentan in Patients With Idiopathic Pulmonary Fibrosis Completed Actelion Phase 2/Phase 3 2003-08-01 Endothelin-1 (ET-1) is expressed in a variety of pulmonary pathological conditions including pulmonary vascular disease and pulmonary fibrosis. Bosentan (an oral dual ET-1 receptor antagonist) could delay the progression of idiopathic pulmonary fibrosis (IPF), a condition for which no established treatment is available. The present trial investigates a possible use of bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH) WHO class III and IV, to a new category of patients suffering from IPF. It was decided to offer Open Label treatment (bosentan) for patients willing to continue in the BUILD 1 study.
NCT00080457 ↗ Safety and Efficacy Study of Sitaxentan Sodium (Thelin™) in Patients With Pulmonary Arterial Hypertension Completed Encysive Pharmaceuticals Phase 3 2003-05-01 The purpose of this study is to evaluate the safety and efficacy of Thelin™ (sitaxsentan sodium) compared to placebo (sugar pill) in the treatment of patients with pulmonary arterial hypertension (PAH).
NCT00082186 ↗ The Effect of Tracleer® on Male Fertility Completed Actelion Phase 4 2003-07-01 The objective of the study is to evaluate the effects of chronic TRACLEER® treatment on testicular function via semen analysis in male patients with primary pulmonary arterial hypertension (PAH).
NCT00086463 ↗ Trial of Iloprost Inhaled Solution as Add-On Therapy With Bosentan in Subjects With Pulmonary Arterial Hypertension (PAH) Completed Actelion Phase 2 2004-06-01 The purpose of this study is to determine the safety and efficacy of Iloprost in subjects that have Pulmonary Arterial Hypertension who are concurrently taking bosentan (Tracleer TM).
NCT00091715 ↗ Efficacy and Safety of Oral Bosentan in Pulmonary Arterial Hypertension Class II Completed Actelion Phase 3 2004-04-01 The present trial investigates a possible use of oral bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH) Class III and IV, to patients suffering from PAH Class II.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Tracleer

Condition Name

Condition Name for Tracleer
Intervention Trials
Pulmonary Arterial Hypertension 12
Pulmonary Hypertension 5
Hypertension 4
Idiopathic Pulmonary Fibrosis 4
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Condition MeSH

Condition MeSH for Tracleer
Intervention Trials
Hypertension 26
Pulmonary Arterial Hypertension 19
Familial Primary Pulmonary Hypertension 17
Hypertension, Pulmonary 12
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Clinical Trial Locations for Tracleer

Trials by Country

Trials by Country for Tracleer
Location Trials
United States 82
Germany 18
Canada 16
France 11
United Kingdom 10
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Trials by US State

Trials by US State for Tracleer
Location Trials
California 10
Texas 9
Colorado 6
Alabama 6
New York 5
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Clinical Trial Progress for Tracleer

Clinical Trial Phase

Clinical Trial Phase for Tracleer
Clinical Trial Phase Trials
Phase 4 13
Phase 3 7
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Tracleer
Clinical Trial Phase Trials
Completed 30
Unknown status 5
Terminated 4
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Clinical Trial Sponsors for Tracleer

Sponsor Name

Sponsor Name for Tracleer
Sponsor Trials
Actelion 22
University of California, Los Angeles 2
Encysive Pharmaceuticals 2
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Sponsor Type

Sponsor Type for Tracleer
Sponsor Trials
Other 36
Industry 27
NIH 2
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TRACLEER (Bosentan): Clinical Trials, Market Analysis, and Projections

Introduction

TRACLEER, also known as bosentan, is an endothelin receptor antagonist used primarily in the treatment of pulmonary arterial hypertension (PAH). Here, we will delve into the clinical trials, market analysis, and projections for this drug.

Clinical Trials Overview

BREATHE-1 and Study 351

Two significant randomized, double-blind, multicenter, placebo-controlled trials, BREATHE-1 and Study 351, were conducted to assess the efficacy of TRACLEER in patients with PAH. These studies involved patients with WHO Functional Class III-IV PAH, including those with idiopathic or heritable PAH, and those associated with scleroderma or other connective tissue diseases. The trials demonstrated improvements in 6-minute walk distance, functional class, and hemodynamic parameters compared to placebo[1].

EARLY Study

The EARLY study focused on mildly symptomatic PAH patients with WHO Functional Class II. This trial showed that TRACLEER improved the 6-minute walk distance and reduced pulmonary vascular resistance (PVR) compared to placebo. It also maintained or improved the WHO Functional Class in a significant proportion of patients[1].

Pediatric Studies

Several studies have been conducted to evaluate the efficacy and safety of TRACLEER in pediatric patients. These studies included children aged 3 to 15 years and showed that TRACLEER stabilized PAH in almost all children during the treatment period of 12 to 24 weeks[4].

Efficacy and Safety

Efficacy

TRACLEER has been shown to improve exercise capacity and symptoms in patients with PAH, particularly those with WHO Functional Class III. It also reduces the development of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease[4].

Safety

Common side effects of TRACLEER include headache, fluid retention, anemia, and abnormal liver function tests. The drug is contraindicated in patients with certain liver problems, those who are pregnant or could become pregnant without using reliable contraception, and those taking ciclosporin[4].

Market Analysis

Market Players

The main player in the TRACLEER market is Actelion Pharmaceuticals, which has been a dominant force in the endothelin receptor antagonist market[2].

Market Segmentation

The TRACLEER market is segmented by type (62.5 mg and 125 mg tablets) and by application (pediatric and adult patients). The market report provides a comprehensive analysis of revenue and volume forecasts, company share, competitive landscape, growth factors, and trends[2].

Regional Consumption

The market consumption of TRACLEER varies by region, with detailed forecasts available for different geographic areas. This segmentation helps in understanding the global demand and supply dynamics of the drug[2].

Market Projections

Revenue Forecast

The global market for TRACLEER is expected to grow, driven by increasing awareness and diagnosis of PAH, as well as the expanding use of endothelin receptor antagonists in treating various forms of PAH. The market report provides detailed revenue forecasts in USD million, highlighting the potential growth areas and market trends[2].

Competitive Landscape

The competitive landscape of the TRACLEER market is characterized by the dominance of Actelion Pharmaceuticals. However, with the expiration of patents, the market is expected to see the entry of generic versions, which could alter the competitive dynamics. The report covers the patent expiration dates and the potential impact on the market[5].

Patent Expiration and Generic Entry

TRACLEER is protected by several patents globally, with key patents expiring in various countries. For instance, patents in Australia, Austria, Brazil, Canada, and China are set to expire in the coming years, paving the way for generic versions to enter the market. This could significantly impact the market share and pricing of TRACLEER[5].

Key Takeaways

  • Clinical Efficacy: TRACLEER has demonstrated significant improvements in PAH symptoms and exercise capacity in clinical trials.
  • Market Dominance: Actelion Pharmaceuticals is the primary player in the TRACLEER market.
  • Segmentation: The market is segmented by type and application, with pediatric and adult patients being key segments.
  • Regional Consumption: The drug's consumption varies by region, with detailed forecasts available.
  • Revenue Forecast: The market is expected to grow driven by increasing awareness and diagnosis of PAH.
  • Patent Expiration: The expiration of patents will allow generic versions to enter the market, potentially altering the competitive landscape.

FAQs

What is TRACLEER used for?

TRACLEER (bosentan) is used to treat pulmonary arterial hypertension (PAH) to improve exercise capacity and symptoms in patients with WHO Functional Class II-IV PAH.

What are the common side effects of TRACLEER?

Common side effects include headache, fluid retention, anemia, and abnormal liver function tests.

Who are the main players in the TRACLEER market?

The main player in the TRACLEER market is Actelion Pharmaceuticals.

When do the patents for TRACLEER expire?

Patents for TRACLEER are set to expire in various countries in the coming years, allowing for the entry of generic versions.

What are the key clinical trials that have evaluated TRACLEER?

Key clinical trials include BREATHE-1, Study 351, and the EARLY study, which have demonstrated the efficacy of TRACLEER in PAH patients.

Is TRACLEER approved for pediatric use?

Yes, TRACLEER is approved for use in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance and exercise ability[3].

Sources

  1. Considering TRACLEER ® (bosentan) - Tracleer.com
  2. Global Tracleer (bosentan) Market Research Report 2024 - Valuates.com
  3. 209279Orig1s000 - accessdata.fda.gov
  4. Tracleer | European Medicines Agency (EMA)
  5. When do the patents on TRACLEER expire, and when can generic versions of TRACLEER launch? - DrugPatentWatch.com
Last updated: 2025-01-03

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