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Home > Development Pipeline > Bosentan (Tracleer®) > Bosentan (Tracleer®) Study Overview
 
Development
 
 
 
 
 
 
 
 
 
 
 
Development Pipeline
 
 
Bosentan (Tracleer®)
 
 
 
 
 
 
 
 
 
 
 
 
 
Miglustat (Zavesca®)
 
 
 
Iloprost (Ventavis®)
 
 
 
Actelion-1
 
 
 
Almorexant
 
 
 
Clazosentan
 
 
 
CRTH2 Receptor Antagonist
 
 
 
PGI2 Receptor Agonist
 
 
 
Renin Inhibitor
 
 
 
S1P1 Receptor Agonist
 
 
 
Bosentan (Tracleer®) Study Overview

Bosentan (Tracleer®) in Clinical Development
 

Indication

Status

BREATHE-1

Follow-up Long-term data (safety and survival) on treatment of Pulmonary Arterial Hypertension (PAH)

Phase IV / Completed / Results presented at ATS, 19 May 2003

BREATHE-2

Combination with intravenous epoprostenol i.v. in patients

with severe Primary Pulmonary Arterial Hypertension (PPH) or PAH due to scleroderma

Phase IV / Completed / Results published in 2004

BREATHE-3

Treatment of PAH in pediatric patients alone and in combination with epoprostenol i.v.

Phase IV / Completed / Results published in 2003

BREATHE-4

PAH in HIV/AIDS

Phase IV / Completed / Results presented at ESC,
2 Sep, 2003

BREATHE-5

PAH in Eisenmenger's

Syndrome (congenital heart disease)

Phase IV / Completed / Results presented at CHEST, 1 Nov 2005

EARLY

Early Symptomatic PAH

(Class II)

Phase III / Completed 

Results presented at ESC, 

03 Sep 2007

FUTURE-1

PAH in children

Phase III / Completed

Results presented at ESC,

03 Sep 2007

BENEFIT

Chronic Thrombo-Embolic

Pulmonary Hypertension

Phase III / Completed

Results presented at ESC, 03 Sep 2007

ASSET-1/ -2

PAH in Sickle Cell Disease

Phase III / Results expected

2008

COMPASS-1

Combination bosentan and

sildenafil in PAH

Phase III / Completed

Results presented at ESC,

03 Sep 2007

COMPASS-2

Combination bosentan and

sildenafil in PAH

Phase III

 
 
 
 
 

RAPIDS-1
Digital ulceration secondary to scleroderma

Phase III / Completed / Result s published in 2004

RAPIDS-2
Digital ulceration secondary to scleroderma

Phase III / Completed / Results presented at ACR,
15 Nov 2005
 
 
 
 
 

BUILD 1

Idiopathic pulmonary fibrosis

Phase II/III / Completed / Results presented at ATS, May 2006

BUILD 2

Pulmonary fibrosis in scleroderma

Phase II/III / Completed / Results presented at ATS, May 2006
BUILD 3

Idiopathic pulmonary fibrosis

Phase III / Results expected

in H2 2009


Last update: 21 Apr 2008