CLINICAL TRIALS PROFILE FOR BOSENTAN

All Clinical Trials for BOSENTAN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00077584 ↗	Efficacy and Safety of Oral Bosentan on Healing/Prevention of Digital (Finger) Ulcers in Patients With Scleroderma	Completed	Actelion	Phase 3	2003-10-01	In an earlier clinical trial, RAPIDS-1, conducted in scleroderma patients with or without digital ulcers at baseline, bosentan significantly reduced the number of new digital ulcers versus placebo. The purpose of the present trial (RAPIDS-2) is to evaluate the prevention and healing effects of bosentan versus placebo on digital ulcers over a 24-week treatment period.
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.
NCT00070590 ↗	Efficacy and Safety of Oral Bosentan in Pulmonary Fibrosis Associated With Scleroderma	Completed	Actelion	Phase 2/Phase 3	2003-07-01	Clinical and experimental studies suggest that bosentan could delay the progression of interstitial lung disease (ILD) associated with systemic sclerosis (SSc), a condition for which no established efficacious treatment is available. The present trial investigates a possible use of oral 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 ILD associated with SSc.
NCT00023296 ↗	Nitric Oxide and Transfusion Therapy for Sickle Cell Patients With Pulmonary Hypertension	Completed	Mallinckrodt	Phase 1	2001-07-27	This study will test whether inhaling nitric oxide (NO) gas mixed with room air can improve pulmonary hypertension (high blood pressure in the lungs) in patients with sickle cell anemia. Patients with sickle cell disease 18 years of age or older may be eligible to participate in one or more parts of this three-stage study, as follows: Stage 1 Patients undergo the following tests to determine the cause of their pulmonary hypertension: blood tests; echocardiogram (heart ultrasound); asthma test; oxygen breathing study with measurement of arterial blood oxygen levels; chest X-ray; lung scans; MRI of the heart; 6-minute walk test; night-time oxygen measurement while sleeping; and exercise studies. Stage 2 Patients have a detailed MRI evaluation of the heart and are admitted to the NIH Clinical Center intensive care unit (ICU) for the following test: A plastic tube is placed in a vein in the patient's arm and another tube is placed in a deeper neck or leg vein. A third tube is inserted through the vein into the heart and the lung artery to measure blood pressures in the heart and lungs directly. Following baseline measurements, three medications (inhaled oxygen, infused prostaglandin, and inhaled NO) are delivered for 2 hours each, separated by a 30-minute washout period. A small blood sample is drawn during the NO administration. Patients who cannot be treated with nitric oxide or for whom the treatment does not work may receive monthly exchange transfusions for 3 months. For this procedure, 3 to 5 five units of the patient's blood is removed and replaced with 3 to 5 units that do not have sickle hemoglobin. Some patients who do not respond to NO or exchange transfusions may receive an alternative therapy, such as oxygen, prostacyclin, L-arginine, bosentan or sidenafil. Stage 3 Patients remain in the ICU with catheters in place for another 24 hours. During this time they breathe NO. Lung pressures are measured every 4 hours and blood is drawn every 8 hours. They then stay in the hospital 1 more day for observation. Patients then breathe nitric oxide continuously for 2 months using a tank of gas that delivers the NO through tubes placed in the nose. They may do this at home on an outpatient basis or may remain in the hospital for the 2 months. Patients have an echocardiogram and blood tests every week and do a 6-minute walk test every 2 weeks....
NCT00023296 ↗	Nitric Oxide and Transfusion Therapy for Sickle Cell Patients With Pulmonary Hypertension	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 1	2001-07-27	This study will test whether inhaling nitric oxide (NO) gas mixed with room air can improve pulmonary hypertension (high blood pressure in the lungs) in patients with sickle cell anemia. Patients with sickle cell disease 18 years of age or older may be eligible to participate in one or more parts of this three-stage study, as follows: Stage 1 Patients undergo the following tests to determine the cause of their pulmonary hypertension: blood tests; echocardiogram (heart ultrasound); asthma test; oxygen breathing study with measurement of arterial blood oxygen levels; chest X-ray; lung scans; MRI of the heart; 6-minute walk test; night-time oxygen measurement while sleeping; and exercise studies. Stage 2 Patients have a detailed MRI evaluation of the heart and are admitted to the NIH Clinical Center intensive care unit (ICU) for the following test: A plastic tube is placed in a vein in the patient's arm and another tube is placed in a deeper neck or leg vein. A third tube is inserted through the vein into the heart and the lung artery to measure blood pressures in the heart and lungs directly. Following baseline measurements, three medications (inhaled oxygen, infused prostaglandin, and inhaled NO) are delivered for 2 hours each, separated by a 30-minute washout period. A small blood sample is drawn during the NO administration. Patients who cannot be treated with nitric oxide or for whom the treatment does not work may receive monthly exchange transfusions for 3 months. For this procedure, 3 to 5 five units of the patient's blood is removed and replaced with 3 to 5 units that do not have sickle hemoglobin. Some patients who do not respond to NO or exchange transfusions may receive an alternative therapy, such as oxygen, prostacyclin, L-arginine, bosentan or sidenafil. Stage 3 Patients remain in the ICU with catheters in place for another 24 hours. During this time they breathe NO. Lung pressures are measured every 4 hours and blood is drawn every 8 hours. They then stay in the hospital 1 more day for observation. Patients then breathe nitric oxide continuously for 2 months using a tank of gas that delivers the NO through tubes placed in the nose. They may do this at home on an outpatient basis or may remain in the hospital for the 2 months. Patients have an echocardiogram and blood tests every week and do a 6-minute walk test every 2 weeks....

Clinical Trial Conditions for BOSENTAN

Condition Name

Condition Name for BOSENTAN
Intervention	Trials
Pulmonary Arterial Hypertension	29
Pulmonary Hypertension	24
Hypertension, Pulmonary	8
Systemic Sclerosis	7

Condition MeSH

Condition MeSH for BOSENTAN
Intervention	Trials
Hypertension	69
Pulmonary Arterial Hypertension	46
Familial Primary Pulmonary Hypertension	43
Hypertension, Pulmonary	40

Clinical Trial Locations for BOSENTAN

Trials by Country

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Trials by Country for BOSENTAN
Location	Trials
United States	399
Germany	40
Canada	36
France	31
Australia	28

Trials by US State

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Trials by US State for BOSENTAN
Location	Trials
California	32
Texas	26
New York	23
Pennsylvania	21
Colorado	21

Clinical Trial Progress for BOSENTAN

Clinical Trial Phase

Clinical Trial Phase for BOSENTAN
Clinical Trial Phase	Trials
Phase 4	24
Phase 3	35
Phase 2/Phase 3	5

Clinical Trial Status

Clinical Trial Status for BOSENTAN
Clinical Trial Phase	Trials
Completed	76
Terminated	21
Unknown status	17

Clinical Trial Sponsors for BOSENTAN

Sponsor Name

Sponsor Name for BOSENTAN
Sponsor	Trials
Actelion	50
University of California, Los Angeles	5
National Heart, Lung, and Blood Institute (NHLBI)	4

Sponsor Type

Sponsor Type for BOSENTAN
Sponsor	Trials
Other	150
Industry	81
NIH	7

Clinical Trials, Market Analysis, and Projections for Bosentan

Introduction

Bosentan, a dual endothelin receptor antagonist, is a crucial medication in the treatment of pulmonary arterial hypertension (PAH). This article will delve into recent clinical trials, market analysis, and future projections for bosentan, providing a comprehensive overview of its efficacy, safety, market dynamics, and growth prospects.

Clinical Trials: Efficacy and Safety

COMPASS-2 Trial

One of the significant clinical trials involving bosentan is the COMPASS-2 trial. This study evaluated the effect of adding bosentan to stable sildenafil therapy in patients with symptomatic PAH. The trial was designed as a prospective, international, randomized, double-blind, placebo-controlled, event-driven study. The primary endpoint was the time to the first confirmed morbidity/mortality event.

• The results showed that adding bosentan to sildenafil was not superior to sildenafil monotherapy in delaying the time to the first morbidity/mortality event. However, there was a significant improvement in the 6-minute walk distance (6MWD) at 16 weeks, with a mean between-treatment difference of +21.8 meters[1].

Combination Therapy with Iloprost

Another study investigated the addition of inhaled iloprost to bosentan in patients with idiopathic PAH. This multicenter, open, randomized, controlled trial was terminated early due to a futility analysis predicting failure to meet the predetermined sample size.

• The trial failed to show a positive effect of adding inhaled iloprost to bosentan, with no significant difference in the primary endpoint of 6MWD or secondary endpoints such as functional class, peak oxygen uptake, and time to clinical worsening[4].

Bosentan’s Impact on 6MWD and PVR

Clinical pharmacology reviews have highlighted that bosentan significantly affects both 6MWD and pulmonary vascular resistance (PVR). In adult patients, bosentan treatment resulted in a mean increase in 6MWD of +33 meters and a mean decrease in PVR of -249 dyne*sec/cm^5. Approximately 49% of bosentan’s treatment effect on 6MWD can be explained by its effect on PVR[3].

Market Analysis

Global Market Size and Growth

The global bosentan market is experiencing significant growth. As of 2023, the market size was substantial, and it is projected to grow at a notable compound annual growth rate (CAGR) from 2024 to 2031.

• The Type I segment of the bosentan market accounted for a noticeable share in 2023 and is expected to experience significant growth in the near future. Similarly, the Application 1 segment is projected to expand at a significant CAGR throughout the forecast period[2].

Market Dynamics

The bosentan market is influenced by various factors, including raw material availability, regulatory changes, economic conditions, and environmental and safety regulations. Companies such as BOC Sciences and Toronto Research Chemicals are focusing on strategy building and expanding their product portfolios to strengthen their positions in the global market.

• Regional analysis indicates that bosentan market production and consumption vary significantly across different regions due to factors like raw material availability and regulatory environments. The report provides detailed insights into key industry segments and their global, regional, and country-level insights[2].

Competitive Landscape

The bosentan market is competitive, with several key players. These companies are investing in research and development to enhance their product offerings and expand their market share.

• The competitive landscape includes detailed analyses of market trends, drivers, opportunities, restraints, and technological roadmaps. This information is crucial for new entrants as well as existing companies operating in the bosentan market[2].

Market Projections

Forecast Period

The forecast period for the bosentan market spans from 2025 to 2031. During this time, the market is expected to grow significantly driven by increasing demand for PAH treatments and advancements in healthcare infrastructure.

• The report provides a detailed forecast, including market size, revenue/volume share, and CAGR. It also includes segment analysis, regional analysis, and country-specific data, which are essential for understanding future market opportunities[2].

Technological Roadmap

The technological roadmap for the bosentan market involves continuous innovation and improvement in manufacturing processes. This includes the development of new formulations and delivery systems to enhance patient compliance and treatment efficacy.

• The report highlights the importance of environmental and safety regulations in shaping the chemical industry, including the production of bosentan. Companies are expected to invest in sustainable practices and adhere to stringent regulatory standards[2].

Key Takeaways

• Clinical Efficacy: Bosentan has shown mixed results in clinical trials. While it improves 6MWD and reduces PVR, combination therapies have not always been superior to monotherapy.
• Market Growth: The global bosentan market is projected to grow significantly from 2025 to 2031, driven by increasing demand and technological advancements.
• Market Dynamics: The market is influenced by various factors including raw material availability, regulatory changes, and economic conditions.
• Competitive Landscape: The market is competitive with key players focusing on strategy building and product portfolio expansion.

FAQs

What is the primary use of bosentan in clinical practice?

Bosentan is primarily used in the treatment of pulmonary arterial hypertension (PAH) to improve exercise capacity and slow disease progression.

What were the findings of the COMPASS-2 trial?

The COMPASS-2 trial found that adding bosentan to stable sildenafil therapy did not delay the time to the first morbidity/mortality event but improved the 6-minute walk distance at 16 weeks.

How does bosentan affect pulmonary vascular resistance (PVR)?

Bosentan significantly decreases PVR, with approximately 49% of its treatment effect on 6MWD explained by its effect on PVR.

What is the projected growth rate of the global bosentan market?

The global bosentan market is expected to grow at a significant compound annual growth rate (CAGR) from 2024 to 2031, driven by increasing demand and technological advancements.

Which companies are key players in the bosentan market?

Key players include BOC Sciences and Toronto Research Chemicals, among others, which are focusing on strategy building and expanding their product portfolios.

Sources

1. European Respiratory Journal: "Bosentan added to sildenafil therapy in patients with pulmonary arterial hypertension: the COMPASS-2 randomised, double-blind, placebo-controlled, non-inferiority trial."
2. Cognitive Market Research: "Bosentan Market Report 2024 (Global Edition)"
3. FDA: "Clinical Pharmacology Efficacy Review NDA0209279 Tracleer (bosentan) dispersible tablets"
4. European Respiratory Journal: "Combining inhaled iloprost with bosentan in patients with idiopathic pulmonary arterial hypertension"