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 The EMA marketing authorization for Episalvan was withdrawn by the manufacturer in 2022.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

Clinical Trials

A Study to Learn About the Safety and Efficacy of the Drug Oleogel-S10 in Japanese Patients With Epidermolysis Bullosa

Phase 3

Not yet recruiting

Conditions: Epidermolysis Bullosa
Junctional Epidermolysis Bullosa
Epidermolysis Bullosa, Dystrophic
Epidermolysis Bullosa, Junctional
Skin Abnormalities
Congenital Abnormalities
Connective Tissue Disease
Collagen Diseases
Skin Diseases
Genetic Diseases, Inborn

Interventions: Drug: Oleogel-S10

First Posted Date: 2025-04-08

Last Posted Date: 2025-04-08

Lead Sponsor: Chiesi Farmaceutici S.p.A.

Target Recruit Count: 6

Registration Number: NCT06917690

Locations: 🇯🇵
Kurume University Hospital, Fukuoka, Japan
🇯🇵
Niigata University Medical and Dental Hospital, Niigata, Japan
🇯🇵
Hokkaido University Hospital, Sapporo-shi, Japan

A Study to Assess the Incidence of Skin Cancers in Patients With Epidermolysis Bullosa Receiving Filsuvez

Recruiting

Conditions: Epidermolysis Bullosa, Dystrophic
Epidermolysis Bullosa, Junctional

Interventions: Drug: Filsuvez

First Posted Date: 2024-05-21

Last Posted Date: 2025-03-17

Lead Sponsor: Amryt Pharma

Target Recruit Count: 580

Registration Number: NCT06423573

Locations: 🇫🇷
CHU de Toulouse, Hôpital Larrey, Toulouse, France

A Study of Oleogel-S10 Gel for the Treatment of Radiation Dermatitis in People With Breast Cancer

Phase 2

Completed

Conditions: Breast Cancer Stage
Breast Cancer Stage I
Breast Cancer
Breast Cancer Stage II
Breast Cancer Stage III
Breast Cancer Stage IV

Interventions: Drug: Triamcinolone Acetonide
Drug: Oleogel-S10

First Posted Date: 2022-01-13

Last Posted Date: 2024-08-28

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 18

Registration Number: NCT05190770

Locations: 🇺🇸
Memorial Sloan Kettering at Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Monmouth (All protocol activities), Middletown, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Westchester (All Protocol Activities), Harrison, New York, United States

and more 1 locations

Phase III Efficacy and Safety Study of Oleogel-S10 in Epidermolysis Bullosa

Phase 3

Completed

Conditions: Epidermolysis Bullosa

Interventions: Drug: Oleogel-S10
Drug: Control gel

First Posted Date: 2017-03-03

Last Posted Date: 2023-07-20

Lead Sponsor: Amryt Research Limited

Target Recruit Count: 223

Registration Number: NCT03068780

Locations: 🇸🇬
Kandang Kerbau (KK) Women's and Children's Hospital, Singapore, Singapore
🇺🇸
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
🇺🇸
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States

and more 48 locations

Oleogel-S10 Versus Standard of Care in Healing of Grade 2a Burn Wounds

Phase 3

Completed

Conditions: Burns

Interventions: Drug: Oleogel-S10 ointment
Device: Octenilin® wound gel

First Posted Date: 2012-08-06

Last Posted Date: 2015-09-28

Lead Sponsor: Birken AG

Target Recruit Count: 61

Registration Number: NCT01657292

Locations: 🇩🇪
Universitätsklinikum Schleswig-Holstein, Lübeck, Germany
🇩🇪
Unfallkrankenhaus Berlin, Berlin, Germany
🇬🇧
Broomfield Hospital, Chelmsford, United Kingdom

and more 6 locations

Oleogel-S10 in Wound Healing of Inherited Epidermolysis Bullosa (BEB-10)

Phase 2

Completed

Conditions: Inherited Epidermolysis Bullosa

Interventions: Drug: Oleogel-S10
Device: Mepilex® soft silicone faced polyurethane foam dressing

First Posted Date: 2011-02-11

Last Posted Date: 2018-01-23

Lead Sponsor: Birken AG

Target Recruit Count: 10

Registration Number: NCT01294241

Locations: 🇩🇪
EB Center at the Department of Dermatology, University Medical Center, Freiburg, Germany

Trial to Compare Intra-individually the Efficacy and Tolerance of Oleogel-S10 Versus Moist Wound Healing Dressing Alone in Accelerating the Epithelialization of Split Thickness Skin Graft Donor Sites

Phase 2

Completed

Conditions: Accelerating the Epithelialization of Split Thickness Skin Graft

Interventions: Procedure: Moist wound healing dressings alone (Mepilex) on the other half of the skin graft donor site
Drug: Oleogel-S10

First Posted Date: 2011-02-11

Last Posted Date: 2015-04-03

Lead Sponsor: Birken AG

Target Recruit Count: 24

Registration Number: NCT01294254

Locations: 🇩🇪
Universitäts-Hautklinik Freiburg, Freiburg, Germany
🇩🇪
Universitätsklinikum der Ernst-Moritz-Arndt-Universität Greifswald, Greifswald, Germany

The Efficacy and Tolerability of Oleogel-S-10 in Patients With Actinic Keratoses

Phase 2

Completed

Conditions: Actinic Keratoses

Interventions: Drug: Oleogel-S10 100 mg/g
Drug: Placebo (petroleum jelly)

First Posted Date: 2008-11-06

Last Posted Date: 2015-09-14

Lead Sponsor: Birken AG

Target Recruit Count: 165

Registration Number: NCT00786994

Locations: 🇬🇷
University Dermatology Hospital, Heraklion, Greece
🇬🇷
National University, "Andreas Syggros" Skin & Venereal Diseases Hospital, Athens, Greece
🇩🇪
Charité University Hospital, Berlin, Germany

and more 1 locations

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