rebamipide + benzydamine hydrochloride (Cairo University)

Rebamipide + benzydamine hydrochloride refers to the comparative evaluation of two distinct small-molecule agents used topically for the management of oral mucositis. Rebamipide is a mucosal cytoprotective agent that stimulates the synthesis of endogenous prostaglandins (particularly PGE2) and acts as a scavenger for reactive oxygen species, thereby protecting the oral mucosa from damage. Benzydamine hydrochloride is a non-steroidal anti-inflammatory drug (NSAID) that exhibits local anesthetic and analgesic properties by inhibiting pro-inflammatory cytokines such as TNF-alpha and blocking voltage-gated sodium channels. In a Phase III clinical trial (NCT04685395) sponsored by Cairo University, these two agents were studied as head-to-head comparator gargle formulations for the prevention and management of chemo- and radiotherapy-induced oral mucositis in head and neck cancer patients. The trial demonstrated that rebamipide was non-inferior to benzydamine in preventing severe mucositis and superior in reducing the overall severity of radiation-induced oral mucositis. Currently, no fixed-dose combination product containing both ingredients is marketed.

Other names

rebamipide + benzydamine HClrebamipide and benzydamine HCl