NDAORALTABLET
Approved
Nov 2001
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
12
Data completeness
4/8 — Partial
TRACLEER (bosentan) by Johnson & Johnson is . Approved for pulmonary arterial hypertension. First approved in 2001.
Drug data last refreshed 18h ago
Mechanism 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
Worked on TRACLEER at Johnson & Johnson? Share your interview experience or compensation data (+7 days Pro)
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.