Birch Bark
Betula pendula
Evidence Rating
C Moderate
Confidence Level
High
Traditions
Western
Last Updated
2/9/2026
Summary
Birch bark extract represents a unique case in phytotherapy: a traditional wound-healing remedy that was developed into a fully EMA-approved pharmaceutical drug through conventional Phase III clinical trials. Episalvan (approved 2016 for partial thickness wounds; withdrawn 2022 for commercial reasons) and Filsuvez (approved EU 2022, FDA 2023 for epidermolysis bullosa) are the same birch triterpene extract (Oleogel-S10). The pivotal EASE trial (n=223) demonstrated significant wound closure benefits in epidermolysis bullosa patients. The active compound betulin promotes keratinocyte differentiation and has anti-inflammatory, antimicrobial, and wound-healing properties. This is the **only herbal extract to achieve full pharmaceutical drug approval for wound healing** in the EU and US.
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Drug Interactions
This herb has significant drug interactions. Do not use if you are taking medications without consulting a healthcare provider first. See detailed interaction information below.
Regulatory Status
| Regulatory Body | Status |
|---|---|
| Commission E (Germany) | ✓ Approved |
| ESCOP (European) | ✓ Approved |
| EMA/HMPC (EU) | ✓ Approved |
Metadata
| Field | Value |
|---|---|
| Common Names (English) | Birch Bark, Silver Birch Bark, White Birch Bark |
| Common Names (German) | Birkenrinde, Weissbirkenrinde |
| Botanical Name | Betula pendula Roth (syn. B. verrucosa) and B. pubescens Ehrh. |
| Plant Family | Betulaceae |
| Parts Used | Outer bark (cortex) — triterpene-rich extract |
| Evidence Quality Rating | Strong — Phase III RCTs; full EMA and FDA drug approval; well-characterized mechanism |
Approved Indications
Commission E (Germany)
- No specific Commission E monograph for birch bark wound healing
- Commission E monograph exists for birch leaf (Betulae folium) for urinary tract irrigation — different indication entirely
ESCOP (European Scientific Cooperative on Phytotherapy)
- No specific ESCOP monograph for birch bark wound healing
EMA (European Medicines Agency) — FULL DRUG APPROVAL
- Episalvan (2016): Marketing authorization for treatment of partial thickness wounds in adults. Withdrawn 2022 at the request of manufacturer Amryt (commercial reasons, not safety/efficacy concerns)
- Filsuvez (2022 EU, 2023 FDA): Marketing authorization for treatment of partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa in patients aged 6 months and older
FDA (United States)
- Filsuvez (December 19, 2023): Approved for treatment of wounds in patients 6+ months with junctional epidermolysis bullosa (JEB) and dystrophic epidermolysis bullosa (DEB)
NICE (United Kingdom)
- Technology appraisal guidance (HST28) published for birch bark extract for treating epidermolysis bullosa
Regulatory Classification Note
- Unlike all other herbs in this knowledge base, birch bark extract achieved full pharmaceutical drug approval through the conventional drug development pathway, not through the herbal medicinal product pathway
- This makes it fundamentally different in regulatory status from Commission E / ESCOP / EMA traditional use herbs
Conditions Treated
Approved Indications
- Partial thickness wounds in adults (Episalvan — withdrawn)
- Partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa, patients 6+ months (Filsuvez — currently approved)
Studied/Potential Applications
- Split-thickness skin graft donor site wounds
- Second-degree (Grade 2a) burn wounds
- Chronic wounds [NEEDS-RESEARCH]
- General wound healing [NEEDS-RESEARCH for non-EB indications]
Mechanism of Action
Key Active Compounds
The active ingredient is a dry extract from birch bark (Betulae cortex siccum), standardized to total triterpene content. Per 100 mg extract:
- Betulin (primary, ~80% of triterpene fraction) — the principal active compound
- Betulinic acid — anti-inflammatory, antimicrobial
- Erythrodiol — wound healing
- Lupeol — anti-inflammatory
- Oleanolic acid — anti-inflammatory, hepatoprotective
- Total triterpenes: 84-95 mg per 100 mg extract (calculated as sum of all five)
Vehicle
- Oleogel-S10: 10% dry birch bark extract in 90% sunflower oil
- The sunflower oil vehicle is pharmacologically significant — it maintains a moist wound environment and provides fatty acid nutrients for healing tissue
Mechanisms
- Keratinocyte differentiation: Betulin promotes keratinocyte growth and maturation, restoring the damaged skin epithelial barrier [Source: Birch Bark Extract Review, Drugs 2023]
- Biphasic inflammation modulation: Initial pro-inflammatory effect followed by anti-inflammatory phase — matching the natural wound-healing cascade
- Antimicrobial: Demonstrated antibacterial, antiviral, and antimycotic properties
- COX-2 and NF-kB modulation: Triterpenes modulate inflammatory mediators in early wound healing
- Collagen synthesis promotion: Supports extracellular matrix remodeling
Note: The exact mechanism of action in epidermolysis bullosa specifically is not fully understood [Source: Springer article, PMID 37658982]. The EB application involves a genetic structural deficiency, not just wound healing per se.
Clinical Evidence Summary
Phase III Clinical Trials
Episalvan (Partial Thickness Wounds)
| Study | Design | N | Condition | Result |
|---|---|---|---|---|
| BSH-12 | RCT, intra-individual comparison | ~109 | Split-thickness skin graft donor sites | Mean wound closure: 15.5 days (Episalvan) vs. 17.1 days (control) |
| BSH-13 | RCT, intra-individual comparison | ~110 | Split-thickness skin graft donor sites | Mean wound closure: 15.1 days (Episalvan) vs. 16.0 days (control) |
| BSH-9 | RCT | 61 | Grade 2a burn wounds | Demonstrated efficacy |
Filsuvez (Epidermolysis Bullosa) — EASE Trial
| Parameter | Detail |
|---|---|
| Trial name | EASE (Efficacy and Safety of Oleogel-S10 in EB) |
| Design | Phase III, randomized, double-blind, vehicle-controlled |
| N | 223 patients (dystrophic and junctional EB) |
| Primary endpoint | Proportion with first complete target wound closure within 45 days |
| Result | 41.3% (birch bark) vs. 28.9% (vehicle) — statistically significant |
| Long-term | Benefits maintained in 24-month open-label extension |
| Secondary outcomes | Patients reported less pain during wound dressing changes |
| Publication | PMID: 36689495 (British Journal of Dermatology, 2023) |
Evidence Assessment
- Partial thickness wounds: Three Phase III trials with 280+ total patients — robust evidence
- Epidermolysis bullosa: Pivotal EASE trial with 223 patients — strong evidence leading to EU and FDA approval
- Long-term safety: 24-month extension data available
- Overall: The strongest evidence base of any herb in this knowledge base, meeting pharmaceutical drug approval standards
European vs US/Anglophone Consensus
| Aspect | European Position | US/Anglophone Position |
|---|---|---|
| Regulatory status | Full EMA drug approval (Filsuvez); traditional birch bark use well-known | FDA approved (Filsuvez) December 2023 |
| Clinical awareness | Known in wound care and EB specialist communities | Known primarily in EB specialist community; limited general awareness |
| Product availability | Filsuvez available; Episalvan withdrawn | Filsuvez available |
| Evidence perception | Pharmaceutical-grade evidence accepted | Pharmaceutical-grade evidence accepted |
| Traditional context | Long history of birch bark in European folk medicine; pharmaceutical development builds on this | Perceived as a novel pharmaceutical, not herbal medicine |
Notable: For once, there is good transatlantic agreement — both EU and US have approved Filsuvez. However, the perception differs: in Europe, this is seen as a successful translation of traditional phytotherapy into modern drug development; in the US, it is perceived as a novel orphan drug without traditional herbal context.
Safety Profile
Contraindications
- Known hypersensitivity to birch bark extract or sunflower oil
- Not for use on infected wounds without appropriate antimicrobial treatment
Drug Interactions
- No significant drug interactions reported
- No systemic absorption concerns at standard application
Side Effects (from EASE Trial and Episalvan Studies)
- Common: Wound complications, pruritus at application site, wound infection (similar rates to control)
- Uncommon: Application site pain
- Risk management plan (RMP) published by EMA
- Overall well-tolerated; adverse event profile comparable to vehicle control
Pregnancy/Lactation
- Limited data
- Animal reproduction studies: No adverse developmental effects observed
- Use during pregnancy only if potential benefit justifies potential risk
- Unknown whether excreted in breast milk
Clinical Dosage
Filsuvez (Approved Product)
| Parameter | Detail |
|---|---|
| Formulation | 10% birch bark dry extract in sunflower oil gel |
| Triterpene content | 84-95 mg triterpenes per 100 mg extract |
| Application | Apply to wound surface; cover with appropriate non-adhesive wound dressing |
| Frequency | At each wound dressing change |
| Duration | Until wound healing is achieved |
| Age | 6 months and older (Filsuvez) |
Episalvan (Withdrawn)
- Same formulation as Filsuvez (Oleogel-S10)
- Was approved for adults only
- Applied to partial thickness wounds at each dressing change
Historical Context
Traditional Use
Birch bark has been used in European folk medicine for centuries. Betulin was first isolated from birch bark in 1788. The path from traditional use to pharmaceutical development:
- Traditional wound-healing use of birch bark in European folk medicine
- Isolation and characterization of betulin and related triterpenes
- Preclinical wound-healing research
- Oleogel-S10 development by Birken AG (later Amryt Pharma)
- Phase III clinical trials
- EMA approval of Episalvan (2016)
- Episalvan withdrawal for commercial reasons (2022)
- EMA approval of Filsuvez for EB (2022)
- FDA approval of Filsuvez (2023)
- NICE guidance published
Corporate History
- Originally developed by Birken AG (Germany)
- Acquired by Amryt Pharma
- Amryt later acquired by Chiesi Rare Diseases
- Current marketing authorization holder: Amryt Pharmaceuticals DAC (Chiesi group)
Sources
- EMA: Episalvan EPAR Product Information
- EMA: Episalvan marketing authorization and withdrawal documentation
- Chiesi Rare Diseases: FDA approval press release (December 2023)
- Ebner et al. (2023). Birch Bark Extract: A Review in Epidermolysis Bullosa. Drugs. PMID: 37658982
- EASE Trial: Kern et al. (2023). BJD. PMID: 36689495
- EMA Risk Management Plan Summary for Episalvan
- NICE HST28: Birch bark extract for treating epidermolysis bullosa
- DrugBank: Birch bark extract
- Drugs.com: Filsuvez prescribing information
- The Wound Healing Properties of Betulin. PMID: 30856673
Connections
- Contrasts with traditional use pathway of all other herbs (Calendula through Echinacea Topical)
- Mechanism (keratinocyte differentiation) has parallels with St Johns Wort Oil (hyperforin)