Table 6. Authorized barrier therapies—CE mark & FDA 510k license.
| Organ | Clinical syndrome | Trade name | US FDA registration | CE mark | Composition |
|---|---|---|---|---|---|
| Labia | Aphthous ulcer | Orafate® | US FDA 510k Class II | Pending Class II | Polymerized sucralfate gel |
| Gingiva | Gingivitis; periodontitis; implant mucositis | Orafate® | US FDA 510k Class II | Pending Class II | Polymerized sucralfate gel |
| Oral palate | Lichen planus | Orafate® | US FDA 510k Class II | Pending Class II | Polymerized sucralfate gel |
| Oropharynx | Pharyngitis | ViruProtect® | None | CE mark Class II | Glycerin trypsin |
| Oropharynx | Ulcerative mucositis | ProThelial® | US FDA 510k Class II | Pending Class II | Polymerized sucralfate paste |
| Oropharynx | Oral mucositis pain | Episil® | US FDA 510k Class I | CE mark Class I | Glycerol dioleate, soy phosphatidyl choline, propylene glycol, polysorbate 80, ethanol |
| Oropharynx | Oral mucositis pain | Caphosol® | US FDA 510k Class I | CE mark Class I | Disodium & monosodium phosphate, calcium and sodium chloride |
| Oropharynx | Oral mucositis pain | Gelclair® | US FDA 510k Class I | CE mark Class I | Hyaluronate, polyvinylpyrrolidone, propylene glycol, PEG-40, hydroxyethylcellulose, hydrogenated castor oil |
| Oropharynx | Oral mucositis pain | MuGard® | US FDA 510k Class I | CE mark Class I | Carbomer, homopolymer a, polysorbate 60, phosphoric acid, benzyl alcohol, glycerin, citrate |
| Esophagus | GERD, NERD | Ziverel® | None | CE mark Class III | Hyaluronate/chondroitin sulfate, poloxamer 407 |
| Esophagus | GERD, NERD | Esoxx® | None | CE mark Class III | Hyaluronate/chondroitin sulfate, poloxamer 407 |
| Esophagus | Ulcerative mucositis | ProThelial® | US FDA 510k | Pending Class III | Polymerized sucralfate paste |
| Gastroesophageal | GERD | Gaviscon® | US FDA monograph | None | Alginate |
| Gastroesophageal | GERD, NERD | EsolgafateTM | None | Pending Class III | Polymerized sucralfate suspension |
| Small intestine | Chemo-mucositis | ProThelial® | None | Pending Class III | Polymerized sucralfate paste |
| Colon | Irritable bowel syndrome | Enterofate® | None | Pending Class III | Polymerized sucralfate capsule |
| Colon | Diarrhea | Gelenterum® | None | CE mark Class III | Gelatin tannic acid |
| Colon | Diarrhea | Tasectan® | None | CE mark Class III | Gelatin tannic acid |
| Colon | Radiation proctitis | ProctiGard® | US FDA 510k Class II | None | Carbomer, homopolymer a, polysorbate 60, phosphoric acid, benzyl alcohol, glycerin, citrate |
| Colon | Radiation proctitis | ColofateTM | None | Pending Class III | Polymerized sucralfate enema |
| Colon | Ulcerative colitis | ColofateTM | None | Pending Class III | Polymerized sucralfate enema |
| Colon | Pouchitis | ColofateTM | None | Pending Class III | Polymerized sucralfate enema |
GERD, gastroesophageal reflux disease; NERD, non-erosive reflux disease.