Drug intelligence / Profile preview

birch triterpenes

Development stage
Approved
Lead developer
Chiesi
Modality
Small Molecules
Administration
Topical
01

Overview

Birch triterpenes is a botanical drug product consisting of a dry extract from the outer bark of *Betula pendula* Roth and *Betula pubescens* Ehrh. (birch bark). Formulated as a topical gel under the brand name Filsuvez, it is approved for the treatment of partial-thickness wounds associated with junctional and dystrophic epidermolysis bullosa (EB) in patients 6 months of age and older. The therapeutic effect is attributed to its ability to modulate the inflammatory response and stimulate the migration and differentiation of keratinocytes, primarily through the activation of the Nrf2 (Nuclear factor erythroid 2-related factor 2) pathway. The drug was originally developed by Birken AG, then acquired by Amryt Pharma, which was subsequently acquired by Chiesi. It has received approval in both the European Union and the United States.

Brand names
Filsuvez
Other names
birch bark extractBetulae cortex extractum siccumBetula pendula bark extractBetula pubescens bark extract
02

Targets

NFE2L2 (Nuclear factor (erythroid-derived 2)-like 2)

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