prothelial

**ProThelial** is a polymerized sucralfate malate paste classified and marketed as a medical device for topical administration to the oral mucosa. Its mechanism of action is based on the formation of a hydrogel film that adheres to mucosal surfaces, creating a protective barrier that shields oral wounds (such as mouth sores, stomatitis, mucositis, canker sores, ulcers, and post-surgical lesions) from further irritation, while relieving pain[1][3][7]. Its active ingredient, sucralfate, is polymerized with malic acid and calcium carbonate to create this adherent hydrogel. ProThelial is intended not for systemic absorption but for local mucosal protection. It has substantial published evidence supporting complete prevention and rapid sustained elimination of oral and gastrointestinal chemoradiation-induced mucositis, reducing mucositis duration by over 95% in clinical settings[2][3], and has been evaluated in observational and registry-based studies for these indications[2][4][6]. ProThelial is approved by the FDA as a medical device, not as a drug[3][7].

Brand names

ProThelialOrafate

Other names

polymerized sucralfate malate pastemucosal coating paste