NDAORALTABLET, FOR SUSPENSION
Approved
Sep 2017
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
13
Data completeness
5/8 — Partial
TRACLEER (bosentan) by Johnson & Johnson is . First approved in 2017.
Drug data last refreshed 11h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Tracleer (bosentan) is an oral small-molecule endothelin receptor antagonist approved in 2017 for pulmonary arterial hypertension (PAH). It works by blocking both ETA and ETB receptors to counteract elevated endothelin-1 levels that drive PAH pathophysiology. Bosentan reduces vascular smooth muscle proliferation and vasoconstriction in the pulmonary circulation.
$15MPart D
LOE Approaching1.3 years to LOEWith loss of exclusivity imminent (1.3 years), the brand team is transitioning from growth to defensive strategy, suggesting potential downsizing or redeployment of commercial staff.
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
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (13)
A Study in Healthy Men to Test How Bosentan Influences the Amount of Zongertinib in the Blood
Started Jun 2026
16 enrolled
Healthy
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
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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.