Ralinepag (Arena Pharmaceuticals/Everest Medicines) is a selective prostaglandin I2 receptor agonist. PGI2 agonists are potent vasodilators and platelet aggregation inhibitors, which also help relax smooth muscle cells by counteracting the effect of vasoconstrictive mediators.
Ralinepag (Arena Pharmaceuticals/Everest Medicines) lags behind in its development compared to other oral prostacyclins. The availability of Orenitram (treprostinil; United Therapeutics) and Uptravi (selexipag; Johnson & Johnson/Nippon Shinyaku), with larger evidence bases and established patient shares, will likely pose tough competition for ralinepag when it reaches the market. Additionally, ralinepag may suffer from its lack of novelty. Thus far, it is undifferentiated from competitors considering its narrow targeted patient population of pulmonary arterial hypertension (PAH) patients and its “me-too” status. Moreover, ralinepag’s weak efficacy demonstrated in its Phase II trial is uncompetitive. Datamonitor Healthcare awaits the announcement of a Phase III trial, as preparations are under way. Meanwhile, Arena Pharmaceuticals would do well to find a large strategic partner to maximize ralinepag’s chances of success.
LIST OF FIGURES
10 Figure 1: INOpulse for pulmonary hypertension – SWOT analysis
11 Figure 2: Datamonitor Healthcare’s drug assessment summary of INOpulse for pulmonary hypertension
12 Figure 3: Datamonitor Healthcare’s drug assessment summary of INOpulse for pulmonary hypertension
14 Figure 4: INOpulse sales for pulmonary hypertension in the US, 2016–25
LIST OF TABLES
6 Table 1: INOpulse drug profile
7 Table 2: INOpulse Phase III trials in pulmonary arterial hypertension
9 Table 3: INOpulse Phase II data in pulmonary arterial hypertension
10 Table 4: INOpulse Phase II trials in PH-IPF
15 Table 5: INOpulse sales for pulmonary hypertension in the US ($m), 2016–25
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