Chemical formula: C₃₀H₅₀O₂ Molecular mass: 442.381 g/mol
Betulin accelerated re-epithelialization in an in vitro wound scratch assay using human primary keratinocytes at the dosage of 1 μg/ml, and in a porcine ex vivo wound healing model at the dosage of 10 µg/ml. The precise mechanism of action of the active substance in wound healing in humans is not known.
Betulin gel is administered topically to skin wounds and shows poor absorption. Based on data from three clinical studies with a total of 280 patients, application of betulin gel to open wounds did not lead to betulin plasma levels higher than natural background-levels originating e.g. from nutritional sources.
Since no biologically relevant levels of betulin were found in patients, no further studies related to distribution, biotransformation and elimination were performed.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, local tolerance, and phototoxicity. Repeated dose toxicity and local tolerance have been studied for up to 4 weeks. Toxicity studies of longer duration than 4 weeks have not been performed. The active substance was not genotoxic in in vitro assays.
Carcinogenicity and reproductive and developmental toxicity studies have not been performed.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
