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Epinastine hydrochloride (SKE-18) is a second-generation antihistamine and mast cell stabilizer that functions as a highly selective antagonist of the histamine H1 receptor. While epinastine is already approved and marketed in Japan by Sato Pharmaceutical in oral (Alesion tablets) and ophthalmic (Alesion ophthalmic solution) formulations for allergic conditions, SKE-18 represents a novel topical ointment formulation. Sato Pharmaceutical is currently developing this ointment in Phase 2 clinical trials specifically for the treatment of pruritus (itching) associated with inflammatory skin disorders such as eczema, dermatitis, and prurigo. The topical application is designed to provide localized relief from itching by inhibiting histamine-mediated inflammatory responses in the skin while minimizing the systemic exposure and side effects typically associated with oral antihistamines.
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