Birch bark extract

Birch bark extract is rich in triterpenoids with beneficial biological and pharmacological activities. Some of the compounds identified in it include betulin, lupeol, betulinic acid, oleanolic acid, and erythrodiol.^A249945 Birch bark extract is obtained from the white part of the birch tree bark, and the main species of trees used for production are Betula pendula Roth (silver birch) and Betula pubescens Ehrh. (white birch), although hybrids of both species are used as well.^L42380 Two oleogel formulations of birch bark extract (Oleogel-S10, 10% of triterpene dry extract in sunflower oil) have been approved by the European Medicines Agency.L42365,L42370 Filsuvez, one of these two formulations, is approved for the treatment of partial thickness wounds in patients with epidermolysis bullosa (EB), a rare group of hereditary disorders of the skin, mucous membranes, and internal epithelial linings characterized by extreme skin fragility and blister development.^L42390 Filsuvez was subsequently approved for the same indication by the US FDA in December 2023.^L50031

The EMA marketing authorization for Episalvan^L42370 was withdrawn by the manufacturer in 2022.