Tracleer (bosentan; Johnson & Johnson) was the first oral therapy to be developed specifically for the treatment of PH. Tracleer is a competitive endothelin receptor type A and B antagonist, with overexpression of endothelin in PH being associated with excessive vasoconstriction, pulmonary vasculature remodeling, and thrombosis formation.
Once the market leader and the first-to-market drug for pulmonary hypertension (PH), Tracleer (bosentan; Johnson & Johnson), will now be succeeded by Johnson & Johnson’s next-generation endothelin receptor antagonist (ERA) Opsumit (macitentan; Johnson & Johnson/Nippon Shinyaku). Opsumit has demonstrated morbidity evidence that Tracleer lacks, and further possesses an improved hepatotoxicity profile. A combination of generic erosion and patients switching to Opsumit will set Tracleer’s sales into decline over the forecast period. Nevertheless, Tracleer will continue to benefit from prescribing trends increasingly integrating ERAs into combination regimens, which may help to offset losses.
LIST OF FIGURES
9 Figure 1: Tracleer for pulmonary hypertension – SWOT analysis
10 Figure 2: Datamonitor Healthcare’s drug assessment summary of Tracleer for pulmonary hypertension
11 Figure 3: Datamonitor Healthcare’s drug assessment summary of Tracleer for pulmonary hypertension
13 Figure 4: Tracleer sales for pulmonary hypertension across the US, Japan, and five major EU markets, by country, 2016–25
LIST OF TABLES
5 Table 1: Tracleer drug profile
7 Table 2: Tracleer pivotal trial data in pulmonary hypertension
14 Table 3: Tracleer sales for pulmonary hypertension across the US, Japan, and five major EU markets, by country ($m), 2016–25
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