MedPath

Birch bark extract

Generic Name
Birch bark extract
Brand Names
Filsuvez
Drug Type
Small Molecule
CAS Number
84012-15-7
Unique Ingredient Identifier
6NQM402G7Y
Background

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 The EMA marketing authorization for Episalvan was withdrawn by the manufacturer in 2022.

Indication

Filsuvez, a preparation of birch bark extract, is indicated for the treatment of partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in patients 6 months and older.

Associated Conditions
Partial Thickness Wounds

Long-term EASE Trial Shows Promise: Birch Triterpenes Demonstrates Sustained Wound Reduction in Epidermolysis Bullosa Patients

• Phase 3 EASE trial reveals birch triterpenes (Filsuvez) demonstrates sustained reduction in wound burden for epidermolysis bullosa patients over 24 months of treatment. • The topical therapy showed a favorable long-term safety profile, with most adverse events being mild-to-moderate in severity among 77.1% of participants. • Study investigator Dr. Anna Bruckner reports encouraging results for patients with dystrophic and junctional epidermolysis bullosa, with no increased risk of wound infections or squamous cell carcinoma.

Losartan Use Safely Eases RDEB Symptoms in Children, Trial Data Shows

A Phase 1/2 clinical trial has demonstrated that losartan, a blood pressure medication, safely reduces symptoms of recessive dystrophic epidermolysis bullosa (RDEB) in children, particularly benefiting those with severe disease. The treatment was well tolerated, showing no serious safety concerns, and sets the stage for further Phase 3 trials.
© Copyright 2025. All Rights Reserved by MedPath