Abstract
NexoBridⓇ is a topical formulation for eschar removal, a botanical biological drug product that consists of a concentrate of proteolytic enzymes enriched in bromelain sourced from the botanical raw material（BRM）, stems of Ananas comosus（L.） Merr（pineapple plant）, as the active pharmaceutical ingredient（API）. It is applied by mixing a lyophilized product containing the API with hydrating vehicle gel before use. Since the proteolytic action of the active ingredient can selectively degrade and remove thermally injured burn eschar, it is expected to contribute to medical care as an alternative to the conventional excisional, surgical debridement. MediWound, an Israeli pharmaceutical company, conducted clinical studies of NexoBrid abroad, and NexoBrid has been approved in more than 40 countries, including Europe and the United States. In Japan, the efficacy and safety of NexoBrid was confirmed in a phase III study in adults and children with burns, and the drug was approved in December 2022. This article presents the history of development, characteristics, and the results of clinical studies of NexoBrid.
