NDAORALTABLET, FOR SUSPENSION
Approved
Sep 2017
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
12
Data completeness
6/8 — Strong
TRACLEER (bosentan) by Johnson & Johnson is . Approved for pulmonary arterial hypertension. First approved in 2017.
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TRACLEER (bosentan) is an oral endothelin receptor antagonist approved for pulmonary arterial hypertension (PAH) in adults to improve exercise ability and decrease clinical worsening. The drug works by blocking both ETA and ETB receptors on vascular endothelium and smooth muscle, reducing the pathogenic effects of elevated endothelin-1 (ET-1) that characterizes PAH. It is available as a tablet for suspension formulation and represents a foundational therapy in the PAH treatment landscape alongside prostanoid and phosphodiesterase inhibitor classes.
$0.0BPart D
1.6 years to LOEMechanism of Action
. Bosentan has a slightly higher affinity for ET A receptors than for ET B receptors. The clinical impact of dual endothelin blockage is unknown. Endothelin-1 (ET-1) is a neurohormone, the effects of which are mediated by binding to ET A and ET B receptors in the endothelium and vascular smooth…
Indications (1)
Clinical Trials (12)
A Study in Healthy Men to Test How Bosentan Influences the Amount of Nerandomilast in the Blood
Started Aug 2025
16 enrolled
Healthy
A Study in Healthy Men to Test Whether Bosentan Influences the Amount of BI 425809 in the Blood
Started Mar 2023
14 enrolled
Healthy
Study to Evaluate the Effect of Bosentan on the Pharmacokinetics of Lurbinectedin in Patients With Advanced Solid Tumors
Started Jan 2021
11 enrolled
Advanced Solid Tumor
Bioequivalence Study of Bosentan 125 mg Tablets Immediate Release (IR) Versus Tracleer® 125 mg Tablets IR In Healthy Subjects
Started May 2018
64 enrolled
Bioequivalence
Effect of BIA 5-1058 400 mg on the Steady State Pharmacokinetics of Bosentan
Started Feb 2018
44 enrolled
Pulmonary Arterial Hypertension
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.