Tracleer
(Bosentan)ApprovedSmall molecule
Johnson & JohnsonBosentan is used to treat pulmonary arterial hypertension, a condition where blood pressure in the lungs becomes dangerously high, making it harder for the heart to pump blood through the lungs.[2] Tracleer is currently approved and in use across 43 indications[4].[1]
Tracleer is one of 765 small molecule programs targeting Single ventricle. It is currently in Approved.
43
Indications
88
Total Trials
5
Active Trials
764
Competitors
2
FDA Applications
NDA/BLA/ANDA regulatory filings
2
Patents
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 42 indications
Competition
Competitive Landscape
1063 competitors in Pancreatic Cancer
#DrugCompanyPhaseTrials
1Tracleer
Johnson & JohnsonApproved
Gemzar
GGynecologic Oncology Group
Preclinical
Medrol
PfizerPreclinical
Byetta
AstraZenecaPreclinical
Feraheme
AAzurity Pharmaceuticals
Preclinical
ABI-007
Bristol-Myers SquibbPreclinical
Active Comparator
ModernaPreclinical
Sulfonylureas
Eli LillyPreclinical
Thiazolidinediones
SanofiPreclinical
Alpha-Glucosidase Inhibitors
SanofiPreclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Pulmonary Arterial Hypertension16 trials
Show 13 more trials
Bosentan In Exercise Induced Pulmonary Arterial Hypertension in CongenitaL Heart diseasE
Unknown status·—·Phase 2·NCT01827059·12 enrolled
Pulmonary Hypertension6 trials
Show 3 more trials
Comparison of Efficacy Different Treatment Regimens in Pulmonary Hypertension Secondary to Lung Disease and or Hypoxia
Unknown status·—·Phase 4·NCT01449253·60 enrolled
Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Hypertension Patients
Unknown status·—·Phase 3·NCT01712997·90 enrolled
BOS6 trials
Systemic Sclerosis4 trials
36 more indications
Scleroderma3 trials
Tics3 trials
Interstitial Lung Disease3 trials
Hypertension3 trials
CLE3 trials
Asthma2 trials
Chronic Thromboembolic Pulmonary Hypertension2 trials
Function2 trials
Bosentan for Severe Mitral Valve Dysfunction
Unknown status·—·Phase 1/2·NCT01270750·10 enrolled
Endothelin Receptor Function and Acute Stress
Active, not recruiting·—·N/A·NCT02116335·320 enrolled
Idiopathic Pulmonary Fibrosis2 trials
Exercise2 trials
Diastolic Heart Failure1 trial
Safety and Efficacy of Bosentan in Patients With Diastolic Heart Failure and Secondary Pulmonary Hypertension
Completed·—·Phase 3·NCT00820352·20 enrolled
Patients With Advanced Solid Tumors1 trial
Pancreatic Cancer1 trial
Gemcitabine, Nab-Paclitaxel, and Bosentan for the Treatment of Unresectable Pancreatic Cancer
Recruiting·—·Phase 1·NCT04158635·21 enrolled
Peripheral Arterial Disease1 trial
Glaucoma1 trial
Chronic Obstructive Pulmonary Disease1 trial
Study of Bosentan in the Treatment of Stable Severe Chronic Obstructive Pulmonary Disease Patients
Unknown status·—·Phase 2·NCT02093195·40 enrolled
Pulmonary Fibrosis1 trial
Clinical Trial1 trial
Pilot Study1 trial
Treatment of Resistant Port-wine Stains With Bosentan and Pulsed Dye Laser: a Pilot Study
Completed·—·Phase 2·NCT02317679·4 enrolled
Metastatic Melanoma1 trial
Diabetic Nephropathy1 trial
Bosentan Use in Patients With Diabetic Nephropathy
Terminated·—·Phase 3·NCT00638131·1 enrolled
Prolonged1 trial
Hepatopulmonary Syndrome1 trial
Congenital Heart Disease1 trial
Thromboangiitis Obliterans1 trial
Sleep Apnea1 trial
Pulmonary Sarcoidosis1 trial
Vascular Dysfunction1 trial
Oral1 trial
Regulatory
FDA Approval Timeline[5]
Nov 20, 2001
TRACLEER
NDA NDA021290
Sep 5, 2017
TRACLEER
NDA NDA209279
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Tracleer drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Bosentan. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]
- [7]
Details
Drug Info
Quick Facts
- Mechanism of Action
- Endothelin Receptor, ET-A/ET-B Antagonist[3]
- Modality
- Small molecule[3]
- Highest Phase
- Approved[1]
- Company